Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01243424




Registration number
NCT01243424
Ethics application status
Date submitted
17/11/2010
Date registered
18/11/2010
Date last updated
7/01/2020

Titles & IDs
Public title
CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes
Scientific title
A Multicentre, International, Randomised, Parallel Group, Double Blind Study to Evaluate Cardiovascular Safety of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk.
Secondary ID [1] 0 0
2009-013157-15
Secondary ID [2] 0 0
1218.74
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - linagliptin
Treatment: Drugs - glimepiride
Treatment: Drugs - linagliptin placebo
Treatment: Drugs - glimepiride placebo

Experimental: linagliptin - patient to receive linagliptin or glimepiride placebo over encapsulated tablet Quaque die (QD)

Active comparator: glimepiride 1-4 mg QD - patient to receive glimepiride 1-4 mg or linagliptin placebo tablet Quaque die (QD)


Treatment: Drugs: linagliptin
linagliptin tablets 5mg QD

Treatment: Drugs: glimepiride
glimepiride over-encapsulated tablet 1-4 mg QD

Treatment: Drugs: linagliptin placebo
linagliptin placebo

Treatment: Drugs: glimepiride placebo
glimepiride placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The First 3-point Major Adverse Cardiovascular Events (3P-MACE)
Timepoint [1] 0 0
From randomization until individual day of trial completion, up to 432 weeks
Secondary outcome [1] 0 0
The First 4-point (4P)- MACE
Timepoint [1] 0 0
From randomization until individual day of trial completion, up to 432 weeks
Secondary outcome [2] 0 0
Percentage of Participants Taking Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c =7.0%) Without Need for Rescue Medication, Without >2% Weight Gain, and Without Moderate/Severe Hypoglycaemic Episodes During Maintenance Phase
Timepoint [2] 0 0
From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase)
Secondary outcome [3] 0 0
Percentage of Participants Who Were on Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c =7.0%) Without Need for Rescue Medication, and Without >2% Weight Gain During Maintenance Phase
Timepoint [3] 0 0
From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase)
Secondary outcome [4] 0 0
Percentage of Participants With the Occurrence of at Least One Event of 3P-MACE
Timepoint [4] 0 0
From randomization until individual day of trial completion, up to 432 weeks
Secondary outcome [5] 0 0
Percentage of Participants With the Occurrence of at Least One Event of 4P -MACE
Timepoint [5] 0 0
From randomization until individual day of trial completion, up to 432 weeks
Secondary outcome [6] 0 0
Percentage of Participants With Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events
Timepoint [6] 0 0
From start of the treatment until 7 days after the end of treatment, up to 433 weeks
Secondary outcome [7] 0 0
Time to First Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events
Timepoint [7] 0 0
From start of the treatment until 7 days after the end of treatment, up to 433 weeks
Secondary outcome [8] 0 0
Change From Baseline to Final Visit in Hemoglobin A1c (HbA1c)
Timepoint [8] 0 0
Baseline and week 432
Secondary outcome [9] 0 0
Change From Baseline to Final Visit in Fasting Plasma Glucose (FPG)
Timepoint [9] 0 0
Baseline and week 432
Secondary outcome [10] 0 0
Change From Baseline to Final Visit Fasting Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol and High-density Lipoprotein (HDL) Cholesterol
Timepoint [10] 0 0
Baseline and week 432
Secondary outcome [11] 0 0
Change From Baseline to Final Visit in Triglycerides
Timepoint [11] 0 0
Baseline and week 432
Secondary outcome [12] 0 0
Change From Baseline to Final Visit in Creatinine
Timepoint [12] 0 0
Baseline and week 432
Secondary outcome [13] 0 0
Change From Baseline to Final Visit in Estimated Glomerular Filtration Rate (eGFR)
Timepoint [13] 0 0
Baseline and week 432
Secondary outcome [14] 0 0
Change From Baseline to Final Visit in Urine Albumin Creatinine Ratio (UACR)
Timepoint [14] 0 0
Baseline and week 432
Secondary outcome [15] 0 0
Percentage of Participants With Transition in Albuminuria Classes
Timepoint [15] 0 0
Baseline and week 432
Secondary outcome [16] 0 0
Change From Baseline of Insulin Secretion Rate (ISR) at Fixed Glucose Concentration at 208 Weeks
Timepoint [16] 0 0
Baseline and week 208
Secondary outcome [17] 0 0
Percentage of Participants With Occurrence of Accelerated Cognitive Decline at End of Follow-up
Timepoint [17] 0 0
433 weeks
Secondary outcome [18] 0 0
Continuous Glucose Monitoring (CGM) Sub-study: Change From Baseline in the Inter-quartile Range of Diurnal Glucose Variability (Milligrams/ Deciliter) to End of Study
Timepoint [18] 0 0
Baseline
Secondary outcome [19] 0 0
CGM Sub-study : Change From Baseline in the Inter-quartile Range of Diurnal Glucose Variability (Millimoles/ Litre) to End of Study
Timepoint [19] 0 0
Baseline

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Type 2 diabetes
2. Elevated glycosylated haemoglobin (HbA1c): 6.5 - 8.5%, inclusive, if treatment naïve or mono-/dual therapy with metformin and/or an alpha-glucosidase inhibitor; 6.5 - 7.5%, inclusive, if treatment with sulphonylurea/glinide in mono- or dual (with metformin OR an alpha-glucosidase inhibitor) therapy)
3. Pre-existing cardiovascular disease OR specified diabetes end-organ damage OR age => 70 years OR two or more specified cardiovascular risk factor
4. BMI =< 45kg/m²
5. age between >= 40 and =< 85 years
6. signed and dated written International Conference of Harmonisation( ICF)
7. stable anti-diabetic background for at least 8 wks before study start
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Type 1 diabetes
2. Treatment with other antidiabetic drugs (e.g. rosiglitazone, pioglitazone, Glucagon-like peptide 1 (GLP-1) analogue/agonists, Dipeptidyl-peptidase IV (DPP-IV) inhibitors or any insulin) prior to informed consent (previous short term use of insulin (up to two weeks) is allowed if taken at least 8 weeks prior informed consent)
3. treatment with any anti-obesity drug less than 3 months before ICF
4. uncontrolled hyperglycemia
5. previous or planned bariatric surgery or intervention
6. current or planned system corticoid treatment
7. change in thyroid hormones treatment
8. acute liver disease or impaired hepatic function
9. pre-planned coronary artery revascularization within 6 months of ICF
10. known hypersensitivity to any of the components
11. Inappropriateness of glimepiride treatment for renal safety issues according to local prescribing information
12. congestive heart failure class III or IV
13. acute or chronic metabolic acidosis
14. hereditary galactose intolerance
15. alcohol or drug abuse
16. participation in another trail with IMP given 2 months before Investigational Medicinal/Medical Product (IMP) start
17. pre-menopausal women who are nursing or pregnant or of child-bearing potential and not willing to use acceptable method of birth control
18. patients considered reliable by the investigator
19. acute coronary syndrome =< 6 wks before ICF
20. stroke or Transient Ischemic Attack (TIA) =< 3 months prior to ICF

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/11/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/08/2018
Sample size
Target
Accrual to date
Final
6103
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Royal Brisbane & Women's Hospital-Endocrinology - Herston
Recruitment hospital [2] 0 0
Logan Hospital - Meadowbrook
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Eastern Clinical Research Unit - East Ringwood
Recruitment hospital [5] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
4131 - Meadowbrook
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3135 - East Ringwood
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arizona
Country [4] 0 0
United States of America
State/province [4] 0 0
Arkansas
Country [5] 0 0
United States of America
State/province [5] 0 0
California
Country [6] 0 0
United States of America
State/province [6] 0 0
Colorado
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Idaho
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maine
Country [15] 0 0
United States of America
State/province [15] 0 0
Maryland
Country [16] 0 0
United States of America
State/province [16] 0 0
Massachusetts
Country [17] 0 0
United States of America
State/province [17] 0 0
Michigan
Country [18] 0 0
United States of America
State/province [18] 0 0
Minnesota
Country [19] 0 0
United States of America
State/province [19] 0 0
Mississippi
Country [20] 0 0
United States of America
State/province [20] 0 0
Missouri
Country [21] 0 0
United States of America
State/province [21] 0 0
Nebraska
Country [22] 0 0
United States of America
State/province [22] 0 0
Nevada
Country [23] 0 0
United States of America
State/province [23] 0 0
New Jersey
Country [24] 0 0
United States of America
State/province [24] 0 0
New York
Country [25] 0 0
United States of America
State/province [25] 0 0
North Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
Ohio
Country [27] 0 0
United States of America
State/province [27] 0 0
Oklahoma
Country [28] 0 0
United States of America
State/province [28] 0 0
Oregon
Country [29] 0 0
United States of America
State/province [29] 0 0
Pennsylvania
Country [30] 0 0
United States of America
State/province [30] 0 0
Rhode Island
Country [31] 0 0
United States of America
State/province [31] 0 0
South Carolina
Country [32] 0 0
United States of America
State/province [32] 0 0
Tennessee
Country [33] 0 0
United States of America
State/province [33] 0 0
Texas
Country [34] 0 0
United States of America
State/province [34] 0 0
Utah
Country [35] 0 0
United States of America
State/province [35] 0 0
Virginia
Country [36] 0 0
United States of America
State/province [36] 0 0
Washington
Country [37] 0 0
Argentina
State/province [37] 0 0
Bahía Blanca
Country [38] 0 0
Argentina
State/province [38] 0 0
Caba
Country [39] 0 0
Argentina
State/province [39] 0 0
Capital Federal
Country [40] 0 0
Argentina
State/province [40] 0 0
Cordoba
Country [41] 0 0
Argentina
State/province [41] 0 0
Corrientes
Country [42] 0 0
Argentina
State/province [42] 0 0
Córdoba
Country [43] 0 0
Argentina
State/province [43] 0 0
La Plata
Country [44] 0 0
Argentina
State/province [44] 0 0
Mendoza
Country [45] 0 0
Argentina
State/province [45] 0 0
Rosario
Country [46] 0 0
Argentina
State/province [46] 0 0
Salta
Country [47] 0 0
Argentina
State/province [47] 0 0
San Miguel de Tucumán
Country [48] 0 0
Argentina
State/province [48] 0 0
Santa Fe
Country [49] 0 0
Belgium
State/province [49] 0 0
Blankenberge
Country [50] 0 0
Belgium
State/province [50] 0 0
Bonheiden
Country [51] 0 0
Belgium
State/province [51] 0 0
De Pinte
Country [52] 0 0
Belgium
State/province [52] 0 0
Dessel
Country [53] 0 0
Belgium
State/province [53] 0 0
Deurne
Country [54] 0 0
Belgium
State/province [54] 0 0
Genk
Country [55] 0 0
Belgium
State/province [55] 0 0
Gozée
Country [56] 0 0
Belgium
State/province [56] 0 0
Hasselt
Country [57] 0 0
Belgium
State/province [57] 0 0
Herent
Country [58] 0 0
Belgium
State/province [58] 0 0
Linkebeek
Country [59] 0 0
Belgium
State/province [59] 0 0
Moorsel
Country [60] 0 0
Belgium
State/province [60] 0 0
Natoye
Country [61] 0 0
Belgium
State/province [61] 0 0
Tremelo
Country [62] 0 0
Brazil
State/province [62] 0 0
Belém
Country [63] 0 0
Brazil
State/province [63] 0 0
Curitiba
Country [64] 0 0
Brazil
State/province [64] 0 0
Goiânia
Country [65] 0 0
Brazil
State/province [65] 0 0
Higienópolis
Country [66] 0 0
Brazil
State/province [66] 0 0
Joaquim Távora
Country [67] 0 0
Brazil
State/province [67] 0 0
Porto Alegre
Country [68] 0 0
Brazil
State/province [68] 0 0
Río de Janeiro
Country [69] 0 0
Brazil
State/province [69] 0 0
Santa Cecília
Country [70] 0 0
Brazil
State/province [70] 0 0
São José do Rio Preto
Country [71] 0 0
Brazil
State/province [71] 0 0
São Paulo
Country [72] 0 0
Brazil
State/province [72] 0 0
Vila Clementino
Country [73] 0 0
Bulgaria
State/province [73] 0 0
Pleven
Country [74] 0 0
Bulgaria
State/province [74] 0 0
Sofia
Country [75] 0 0
Bulgaria
State/province [75] 0 0
Stara Zagora
Country [76] 0 0
Canada
State/province [76] 0 0
Migration Data
Country [77] 0 0
Canada
State/province [77] 0 0
Newfoundland and Labrador
Country [78] 0 0
Canada
State/province [78] 0 0
Ontario
Country [79] 0 0
Canada
State/province [79] 0 0
Prince Edward Island
Country [80] 0 0
Canada
State/province [80] 0 0
Quebec
Country [81] 0 0
Chile
State/province [81] 0 0
Providencia
Country [82] 0 0
Chile
State/province [82] 0 0
Temuco
Country [83] 0 0
Chile
State/province [83] 0 0
Viña del Mar
Country [84] 0 0
Colombia
State/province [84] 0 0
Barranquilla
Country [85] 0 0
Colombia
State/province [85] 0 0
Bogota
Country [86] 0 0
Colombia
State/province [86] 0 0
Bogotá
Country [87] 0 0
Colombia
State/province [87] 0 0
Cartagena
Country [88] 0 0
Colombia
State/province [88] 0 0
El Bosque
Country [89] 0 0
Colombia
State/province [89] 0 0
Tolima
Country [90] 0 0
Czechia
State/province [90] 0 0
Jablonec nad Nisou
Country [91] 0 0
Czechia
State/province [91] 0 0
Olomouc-Lazce
Country [92] 0 0
Czechia
State/province [92] 0 0
Ostrava
Country [93] 0 0
Czechia
State/province [93] 0 0
Plzen
Country [94] 0 0
Czechia
State/province [94] 0 0
Praha 8
Country [95] 0 0
Czechia
State/province [95] 0 0
Praha
Country [96] 0 0
Czechia
State/province [96] 0 0
Prostejov
Country [97] 0 0
Czechia
State/province [97] 0 0
Strakonice
Country [98] 0 0
Finland
State/province [98] 0 0
Helsinki
Country [99] 0 0
Finland
State/province [99] 0 0
Joensuu
Country [100] 0 0
Finland
State/province [100] 0 0
Kerava
Country [101] 0 0
Finland
State/province [101] 0 0
Kokkola
Country [102] 0 0
Finland
State/province [102] 0 0
Kuopio
Country [103] 0 0
Finland
State/province [103] 0 0
Oulu
Country [104] 0 0
Finland
State/province [104] 0 0
Turku
Country [105] 0 0
France
State/province [105] 0 0
Behren Les Forbach
Country [106] 0 0
France
State/province [106] 0 0
Bordeaux
Country [107] 0 0
France
State/province [107] 0 0
Bourg des Comptes
Country [108] 0 0
France
State/province [108] 0 0
Broglie
Country [109] 0 0
France
State/province [109] 0 0
Béziers
Country [110] 0 0
France
State/province [110] 0 0
Cannes
Country [111] 0 0
France
State/province [111] 0 0
Carbonne
Country [112] 0 0
France
State/province [112] 0 0
Castets
Country [113] 0 0
France
State/province [113] 0 0
Chartres
Country [114] 0 0
France
State/province [114] 0 0
Cournonterral
Country [115] 0 0
France
State/province [115] 0 0
Fort De France
Country [116] 0 0
France
State/province [116] 0 0
Hinx
Country [117] 0 0
France
State/province [117] 0 0
La Reunion
Country [118] 0 0
France
State/province [118] 0 0
Labarthe sur Leze
Country [119] 0 0
France
State/province [119] 0 0
Louvigne De Bie
Country [120] 0 0
France
State/province [120] 0 0
Maintenon
Country [121] 0 0
France
State/province [121] 0 0
Orthez
Country [122] 0 0
France
State/province [122] 0 0
Palau Del Vidre
Country [123] 0 0
France
State/province [123] 0 0
Saint Genies Des Fontaines
Country [124] 0 0
France
State/province [124] 0 0
St Dié des Vosges Cedex
Country [125] 0 0
France
State/province [125] 0 0
Thouars
Country [126] 0 0
France
State/province [126] 0 0
Tilly sur Seulles
Country [127] 0 0
Georgia
State/province [127] 0 0
Batumi
Country [128] 0 0
Georgia
State/province [128] 0 0
Gori
Country [129] 0 0
Georgia
State/province [129] 0 0
Kutaisi
Country [130] 0 0
Georgia
State/province [130] 0 0
Tbilisi
Country [131] 0 0
Georgia
State/province [131] 0 0
Zugdidi
Country [132] 0 0
Germany
State/province [132] 0 0
Aachen
Country [133] 0 0
Germany
State/province [133] 0 0
Aschaffenburg
Country [134] 0 0
Germany
State/province [134] 0 0
Asslar
Country [135] 0 0
Germany
State/province [135] 0 0
Bad Nauheim
Country [136] 0 0
Germany
State/province [136] 0 0
Berlin
Country [137] 0 0
Germany
State/province [137] 0 0
Dormagen- Hackenbroich
Country [138] 0 0
Germany
State/province [138] 0 0
Dortmund
Country [139] 0 0
Germany
State/province [139] 0 0
Dresden
Country [140] 0 0
Germany
State/province [140] 0 0
Eisenach
Country [141] 0 0
Germany
State/province [141] 0 0
Elsterwerda
Country [142] 0 0
Germany
State/province [142] 0 0
Essen
Country [143] 0 0
Germany
State/province [143] 0 0
Flörsheim
Country [144] 0 0
Germany
State/province [144] 0 0
Frankfurt
Country [145] 0 0
Germany
State/province [145] 0 0
Furth im Wald
Country [146] 0 0
Germany
State/province [146] 0 0
Gebhardshain
Country [147] 0 0
Germany
State/province [147] 0 0
Haag
Country [148] 0 0
Germany
State/province [148] 0 0
Hamburg
Country [149] 0 0
Germany
State/province [149] 0 0
Kirchhatten
Country [150] 0 0
Germany
State/province [150] 0 0
Köln
Country [151] 0 0
Germany
State/province [151] 0 0
Künzing
Country [152] 0 0
Germany
State/province [152] 0 0
Leipzig
Country [153] 0 0
Germany
State/province [153] 0 0
Lübeck
Country [154] 0 0
Germany
State/province [154] 0 0
Mainz
Country [155] 0 0
Germany
State/province [155] 0 0
Münster
Country [156] 0 0
Germany
State/province [156] 0 0
Neumünster
Country [157] 0 0
Germany
State/province [157] 0 0
Rehburg-Loccum
Country [158] 0 0
Germany
State/province [158] 0 0
Rodgau/Dudenhofen
Country [159] 0 0
Germany
State/province [159] 0 0
Saarbrücken
Country [160] 0 0
Germany
State/province [160] 0 0
Saint Ingbert / Oberwürzbach
Country [161] 0 0
Germany
State/province [161] 0 0
Schwabenheim
Country [162] 0 0
Germany
State/province [162] 0 0
Stadtbergen
Country [163] 0 0
Germany
State/province [163] 0 0
Wangen
Country [164] 0 0
Germany
State/province [164] 0 0
Zwenkau
Country [165] 0 0
Greece
State/province [165] 0 0
Athens
Country [166] 0 0
Greece
State/province [166] 0 0
Haidari, Athens
Country [167] 0 0
Greece
State/province [167] 0 0
Ioannina
Country [168] 0 0
Greece
State/province [168] 0 0
Melissia, Athens
Country [169] 0 0
Greece
State/province [169] 0 0
Nikaia
Country [170] 0 0
Greece
State/province [170] 0 0
Thessaloniki
Country [171] 0 0
Hong Kong
State/province [171] 0 0
Hong Kong
Country [172] 0 0
Hungary
State/province [172] 0 0
Ajka
Country [173] 0 0
Hungary
State/province [173] 0 0
Baja
Country [174] 0 0
Hungary
State/province [174] 0 0
Budapest
Country [175] 0 0
Hungary
State/province [175] 0 0
Gyula
Country [176] 0 0
Hungary
State/province [176] 0 0
Hódmezövásárhely
Country [177] 0 0
Hungary
State/province [177] 0 0
Mako
Country [178] 0 0
Hungary
State/province [178] 0 0
Mosonmagyarovar
Country [179] 0 0
Hungary
State/province [179] 0 0
Papa
Country [180] 0 0
Hungary
State/province [180] 0 0
Szekszard
Country [181] 0 0
India
State/province [181] 0 0
Ahmedabad
Country [182] 0 0
India
State/province [182] 0 0
Aurangabad
Country [183] 0 0
India
State/province [183] 0 0
Bangalore, Karnataka
Country [184] 0 0
India
State/province [184] 0 0
Bangalore
Country [185] 0 0
India
State/province [185] 0 0
Belgaum
Country [186] 0 0
India
State/province [186] 0 0
Chennai
Country [187] 0 0
India
State/province [187] 0 0
Coimbatore
Country [188] 0 0
India
State/province [188] 0 0
Indore
Country [189] 0 0
India
State/province [189] 0 0
Jaipur
Country [190] 0 0
India
State/province [190] 0 0
Maharashtra
Country [191] 0 0
India
State/province [191] 0 0
Mumbai, Maharastra
Country [192] 0 0
India
State/province [192] 0 0
Mumbai
Country [193] 0 0
India
State/province [193] 0 0
Nagpur
Country [194] 0 0
India
State/province [194] 0 0
Pune
Country [195] 0 0
India
State/province [195] 0 0
Thiruvananthapuram
Country [196] 0 0
India
State/province [196] 0 0
Vijayawada
Country [197] 0 0
Ireland
State/province [197] 0 0
Co. Cork
Country [198] 0 0
Ireland
State/province [198] 0 0
Dublin
Country [199] 0 0
Ireland
State/province [199] 0 0
Gorey
Country [200] 0 0
Ireland
State/province [200] 0 0
Wexford
Country [201] 0 0
Israel
State/province [201] 0 0
Ashkelon
Country [202] 0 0
Israel
State/province [202] 0 0
Haifa
Country [203] 0 0
Israel
State/province [203] 0 0
Holon
Country [204] 0 0
Israel
State/province [204] 0 0
Jerusalem
Country [205] 0 0
Israel
State/province [205] 0 0
Nahariya
Country [206] 0 0
Israel
State/province [206] 0 0
Tel Hashomer
Country [207] 0 0
Israel
State/province [207] 0 0
Tel-Aviv
Country [208] 0 0
Italy
State/province [208] 0 0
Cagliari
Country [209] 0 0
Italy
State/province [209] 0 0
Catanzaro
Country [210] 0 0
Italy
State/province [210] 0 0
Genova
Country [211] 0 0
Italy
State/province [211] 0 0
Guastalla (RE)
Country [212] 0 0
Italy
State/province [212] 0 0
Messina
Country [213] 0 0
Italy
State/province [213] 0 0
Milano
Country [214] 0 0
Italy
State/province [214] 0 0
Roma
Country [215] 0 0
Italy
State/province [215] 0 0
Sesto San Giovanni (MI)
Country [216] 0 0
Japan
State/province [216] 0 0
Aichi, Nagoya
Country [217] 0 0
Japan
State/province [217] 0 0
Chiba, Matsudo
Country [218] 0 0
Japan
State/province [218] 0 0
Fukushima, Date
Country [219] 0 0
Japan
State/province [219] 0 0
Fukushima, Nihonmatsu
Country [220] 0 0
Japan
State/province [220] 0 0
Fukushima, Sukagawa
Country [221] 0 0
Japan
State/province [221] 0 0
Hyogo, Amagasaki
Country [222] 0 0
Japan
State/province [222] 0 0
Hyogo, Takasago
Country [223] 0 0
Japan
State/province [223] 0 0
Kanagawa, Yokohama
Country [224] 0 0
Japan
State/province [224] 0 0
Kumamoto, Kumamoto
Country [225] 0 0
Japan
State/province [225] 0 0
Kumamoto, Yatsushiro
Country [226] 0 0
Japan
State/province [226] 0 0
Miyazaki, Miyazaki
Country [227] 0 0
Japan
State/province [227] 0 0
Saitama, Hanyu
Country [228] 0 0
Japan
State/province [228] 0 0
Tokyo, Itabashi-ku
Country [229] 0 0
Korea, Republic of
State/province [229] 0 0
Ansan
Country [230] 0 0
Korea, Republic of
State/province [230] 0 0
Busan
Country [231] 0 0
Korea, Republic of
State/province [231] 0 0
Daegu
Country [232] 0 0
Korea, Republic of
State/province [232] 0 0
Goyang
Country [233] 0 0
Korea, Republic of
State/province [233] 0 0
Jeonju
Country [234] 0 0
Korea, Republic of
State/province [234] 0 0
Pusan
Country [235] 0 0
Korea, Republic of
State/province [235] 0 0
Seongnam
Country [236] 0 0
Korea, Republic of
State/province [236] 0 0
Seoul
Country [237] 0 0
Korea, Republic of
State/province [237] 0 0
Suwon
Country [238] 0 0
Korea, Republic of
State/province [238] 0 0
Wonju
Country [239] 0 0
Korea, Republic of
State/province [239] 0 0
Yangsan
Country [240] 0 0
Malaysia
State/province [240] 0 0
Johor Bahru, Johor
Country [241] 0 0
Malaysia
State/province [241] 0 0
Kota Bharu
Country [242] 0 0
Malaysia
State/province [242] 0 0
Kuala Lumpur
Country [243] 0 0
Malaysia
State/province [243] 0 0
Kuantan
Country [244] 0 0
Malaysia
State/province [244] 0 0
Melaka
Country [245] 0 0
Malaysia
State/province [245] 0 0
Penang
Country [246] 0 0
Malaysia
State/province [246] 0 0
Taiping
Country [247] 0 0
Mexico
State/province [247] 0 0
Acapulco
Country [248] 0 0
Mexico
State/province [248] 0 0
Aguascalientes
Country [249] 0 0
Mexico
State/province [249] 0 0
Distrito Federal
Country [250] 0 0
Mexico
State/province [250] 0 0
Guadalajara
Country [251] 0 0
Mexico
State/province [251] 0 0
Monterrey
Country [252] 0 0
Netherlands
State/province [252] 0 0
's-hertogenbosch
Country [253] 0 0
Netherlands
State/province [253] 0 0
Almere
Country [254] 0 0
Netherlands
State/province [254] 0 0
Amsterdam
Country [255] 0 0
Netherlands
State/province [255] 0 0
Beverwijk
Country [256] 0 0
Netherlands
State/province [256] 0 0
Breda
Country [257] 0 0
Netherlands
State/province [257] 0 0
Den Helder
Country [258] 0 0
Netherlands
State/province [258] 0 0
Eindhoven
Country [259] 0 0
Netherlands
State/province [259] 0 0
Groningen
Country [260] 0 0
Netherlands
State/province [260] 0 0
Hoorn
Country [261] 0 0
Netherlands
State/province [261] 0 0
Maastricht
Country [262] 0 0
Netherlands
State/province [262] 0 0
Rotterdam
Country [263] 0 0
Netherlands
State/province [263] 0 0
Sneek
Country [264] 0 0
Netherlands
State/province [264] 0 0
Velp
Country [265] 0 0
Netherlands
State/province [265] 0 0
Zoetermeer
Country [266] 0 0
New Zealand
State/province [266] 0 0
Christchurch
Country [267] 0 0
New Zealand
State/province [267] 0 0
Dunedin
Country [268] 0 0
New Zealand
State/province [268] 0 0
Newtown Wellington NZ
Country [269] 0 0
New Zealand
State/province [269] 0 0
Tauranga
Country [270] 0 0
Norway
State/province [270] 0 0
Bodø
Country [271] 0 0
Norway
State/province [271] 0 0
Elverum
Country [272] 0 0
Norway
State/province [272] 0 0
Gjettum
Country [273] 0 0
Norway
State/province [273] 0 0
Hamar
Country [274] 0 0
Norway
State/province [274] 0 0
Jessheim
Country [275] 0 0
Norway
State/province [275] 0 0
Lierskogen
Country [276] 0 0
Norway
State/province [276] 0 0
Oslo
Country [277] 0 0
Norway
State/province [277] 0 0
Sandvika
Country [278] 0 0
Norway
State/province [278] 0 0
Sarpsborg
Country [279] 0 0
Norway
State/province [279] 0 0
Stavanger
Country [280] 0 0
Norway
State/province [280] 0 0
Ålesund
Country [281] 0 0
Peru
State/province [281] 0 0
Arequipa
Country [282] 0 0
Peru
State/province [282] 0 0
Huacho
Country [283] 0 0
Peru
State/province [283] 0 0
Lima
Country [284] 0 0
Peru
State/province [284] 0 0
Piura
Country [285] 0 0
Peru
State/province [285] 0 0
San Miguel
Country [286] 0 0
Philippines
State/province [286] 0 0
Iloilo
Country [287] 0 0
Philippines
State/province [287] 0 0
Lipa City, Batangas
Country [288] 0 0
Philippines
State/province [288] 0 0
Manila
Country [289] 0 0
Philippines
State/province [289] 0 0
Muntinlupa
Country [290] 0 0
Philippines
State/province [290] 0 0
Quezon City
Country [291] 0 0
Philippines
State/province [291] 0 0
San Juan
Country [292] 0 0
Philippines
State/province [292] 0 0
Surigao
Country [293] 0 0
Portugal
State/province [293] 0 0
Amadora
Country [294] 0 0
Portugal
State/province [294] 0 0
Carnaxide
Country [295] 0 0
Portugal
State/province [295] 0 0
Coimbra
Country [296] 0 0
Portugal
State/province [296] 0 0
Covilhã
Country [297] 0 0
Portugal
State/province [297] 0 0
Figueira da Foz
Country [298] 0 0
Portugal
State/province [298] 0 0
Lisboa
Country [299] 0 0
Portugal
State/province [299] 0 0
Porto
Country [300] 0 0
Portugal
State/province [300] 0 0
Santa Maria da Feira
Country [301] 0 0
Romania
State/province [301] 0 0
Brasov
Country [302] 0 0
Romania
State/province [302] 0 0
Bucharest
Country [303] 0 0
Romania
State/province [303] 0 0
Iasi
Country [304] 0 0
Romania
State/province [304] 0 0
Sibiu
Country [305] 0 0
Romania
State/province [305] 0 0
Tirgoviste
Country [306] 0 0
Russian Federation
State/province [306] 0 0
Dzerzhinsky
Country [307] 0 0
Russian Federation
State/province [307] 0 0
Izhevsk
Country [308] 0 0
Russian Federation
State/province [308] 0 0
Moscow
Country [309] 0 0
Russian Federation
State/province [309] 0 0
Rostov-na-Donu
Country [310] 0 0
Russian Federation
State/province [310] 0 0
Samara
Country [311] 0 0
Russian Federation
State/province [311] 0 0
Saratov
Country [312] 0 0
Serbia
State/province [312] 0 0
Belgrade
Country [313] 0 0
Serbia
State/province [313] 0 0
Nis
Country [314] 0 0
Serbia
State/province [314] 0 0
Pancevo
Country [315] 0 0
Serbia
State/province [315] 0 0
Subotica
Country [316] 0 0
Serbia
State/province [316] 0 0
Zemun
Country [317] 0 0
Slovakia
State/province [317] 0 0
Banska Bystrica
Country [318] 0 0
Slovakia
State/province [318] 0 0
Dolny Kubin
Country [319] 0 0
Slovakia
State/province [319] 0 0
Levice
Country [320] 0 0
Slovakia
State/province [320] 0 0
Nove Zamky
Country [321] 0 0
Slovakia
State/province [321] 0 0
Povazska Bystrica
Country [322] 0 0
Slovakia
State/province [322] 0 0
Zilina
Country [323] 0 0
South Africa
State/province [323] 0 0
Cape Town
Country [324] 0 0
South Africa
State/province [324] 0 0
Durban
Country [325] 0 0
South Africa
State/province [325] 0 0
Krugersdorp
Country [326] 0 0
South Africa
State/province [326] 0 0
Lenasia
Country [327] 0 0
South Africa
State/province [327] 0 0
Port Elizabeth
Country [328] 0 0
South Africa
State/province [328] 0 0
Pretoria
Country [329] 0 0
South Africa
State/province [329] 0 0
Somerset West
Country [330] 0 0
Spain
State/province [330] 0 0
Barcelona
Country [331] 0 0
Spain
State/province [331] 0 0
Burjassot
Country [332] 0 0
Spain
State/province [332] 0 0
Gijon
Country [333] 0 0
Spain
State/province [333] 0 0
Girona
Country [334] 0 0
Spain
State/province [334] 0 0
L'Hospitalet de Llobregat
Country [335] 0 0
Spain
State/province [335] 0 0
La Roca Del Vallés (Barcelona)
Country [336] 0 0
Spain
State/province [336] 0 0
Madrid
Country [337] 0 0
Spain
State/province [337] 0 0
Oviedo
Country [338] 0 0
Spain
State/province [338] 0 0
Pineda de Mar
Country [339] 0 0
Spain
State/province [339] 0 0
Santa Coloma De Gramanet
Country [340] 0 0
Spain
State/province [340] 0 0
Tàrrega
Country [341] 0 0
Spain
State/province [341] 0 0
Valencia
Country [342] 0 0
Sweden
State/province [342] 0 0
Göteborg
Country [343] 0 0
Sweden
State/province [343] 0 0
Härnösand
Country [344] 0 0
Sweden
State/province [344] 0 0
Järfälla
Country [345] 0 0
Sweden
State/province [345] 0 0
Malmö
Country [346] 0 0
Sweden
State/province [346] 0 0
Rättvik
Country [347] 0 0
Sweden
State/province [347] 0 0
Skanör
Country [348] 0 0
Sweden
State/province [348] 0 0
Uddevalla
Country [349] 0 0
Sweden
State/province [349] 0 0
Vällingby
Country [350] 0 0
Switzerland
State/province [350] 0 0
Basel
Country [351] 0 0
Switzerland
State/province [351] 0 0
Bellinzona
Country [352] 0 0
Switzerland
State/province [352] 0 0
Bern
Country [353] 0 0
Switzerland
State/province [353] 0 0
Lugano
Country [354] 0 0
Taiwan
State/province [354] 0 0
Changhua
Country [355] 0 0
Taiwan
State/province [355] 0 0
Kaohsiung
Country [356] 0 0
Taiwan
State/province [356] 0 0
New Taipei City
Country [357] 0 0
Taiwan
State/province [357] 0 0
Taichung,
Country [358] 0 0
Taiwan
State/province [358] 0 0
Taichung
Country [359] 0 0
Taiwan
State/province [359] 0 0
Tainan
Country [360] 0 0
Taiwan
State/province [360] 0 0
Taipei
Country [361] 0 0
Tunisia
State/province [361] 0 0
Monastir
Country [362] 0 0
Tunisia
State/province [362] 0 0
Sfax
Country [363] 0 0
Tunisia
State/province [363] 0 0
Sousse
Country [364] 0 0
Tunisia
State/province [364] 0 0
Tunis
Country [365] 0 0
Ukraine
State/province [365] 0 0
Donetsk
Country [366] 0 0
Ukraine
State/province [366] 0 0
Ivano-Frankivsk
Country [367] 0 0
Ukraine
State/province [367] 0 0
Kharkiv
Country [368] 0 0
Ukraine
State/province [368] 0 0
Kharkov
Country [369] 0 0
Ukraine
State/province [369] 0 0
Kiev
Country [370] 0 0
Ukraine
State/province [370] 0 0
Kyiv
Country [371] 0 0
Ukraine
State/province [371] 0 0
Lvov
Country [372] 0 0
Ukraine
State/province [372] 0 0
Odesa
Country [373] 0 0
Ukraine
State/province [373] 0 0
Vinnitsa
Country [374] 0 0
United Kingdom
State/province [374] 0 0
Addlestone
Country [375] 0 0
United Kingdom
State/province [375] 0 0
Ash Vale, Aldershot
Country [376] 0 0
United Kingdom
State/province [376] 0 0
Birmingham
Country [377] 0 0
United Kingdom
State/province [377] 0 0
Chippenham
Country [378] 0 0
United Kingdom
State/province [378] 0 0
Durham
Country [379] 0 0
United Kingdom
State/province [379] 0 0
Ely
Country [380] 0 0
United Kingdom
State/province [380] 0 0
Gloucester
Country [381] 0 0
United Kingdom
State/province [381] 0 0
Great Yarmouth
Country [382] 0 0
United Kingdom
State/province [382] 0 0
Swansea
Country [383] 0 0
United Kingdom
State/province [383] 0 0
Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol https://cdn.clinicaltrials.gov/large-docs/24/NCT01243424/Prot_000.pdf
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/24/NCT01243424/SAP_001.pdf
Study protocol https://cdn.clinicaltrials.gov/large-docs/24/NCT01243424/Prot_000.pdf
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/24/NCT01243424/SAP_001.pdf
Study protocol https://cdn.clinicaltrials.gov/large-docs/24/NCT01243424/Prot_000.pdf
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/24/NCT01243424/SAP_001.pdf
Study protocol https://cdn.clinicaltrials.gov/large-docs/24/NCT01243424/Prot_000.pdf
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/24/NCT01243424/SAP_001.pdf
Study protocol https://cdn.clinicaltrials.gov/large-docs/24/NCT01243424/Prot_000.pdf
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/24/NCT01243424/SAP_001.pdf



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01243424