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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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) - The first occurrence of any of the following Clinical Event Committee (CEC) confirmed adjudicated components of the primary composite endpoint: CV death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), or nonfatal stroke is presented.
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 - The first key secondary endpoint was time to first occurrence of any of the following adjudicated components of the composite endpoint: CV death (including fatal stroke and fatal MI), non-fatal stroke, non-fatal MI (excluding silent MI), or hospitalisation for unstable angina pectoris.
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 - The second key secondary endpoint was a composite endpoint of treatment sustainability, defined as the percentage of patients 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 - The third key secondary endpoint was a composite endpoint of treatment sustainability, defined as percentage of patients 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 - Percentage of participants occurrence of at least one of the following adjudicated components of CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI) and non-fatal stroke is presented as secondary CV endpoint.
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 - Percentage of participants occurrence of at least one of the following adjudicated components of CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI), non-fatal stroke, and hospitalisation for unstable angina pectoris is presented as secondary CV endpoint.
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 - Percentage of participants with occurrence of any of the following components of the composite endpoint of all adjudication-confirmed events of:
CV death (including fatal stroke and fatal MI)
non-fatal MI
non-fatal stroke
hospitalisation for unstable angina pectoris
TIA
hospitalisation for heart failure
hospitalisation for coronary revascularisation procedures (CABG, PCI)
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 - Time to first occurrence of any of the following components of the composite endpoint of all adjudication-confirmed events of:
CV death (including fatal stroke and fatal MI)
non-fatal MI
non-fatal stroke
hospitalisation for unstable angina pectoris
Transient ischaemic attack (TIA)
hospitalisation for heart failure
hospitalisation for coronary revascularisation procedures (CABG, PCI)
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) - Change from baseline to final visit in HbA1c is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.
Timepoint [8] 0 0
Baseline and week 432
Secondary outcome [9] 0 0
Change From Baseline to Final Visit in Fasting Plasma Glucose (FPG) - Change from baseline to final visit in fasting plasma glucose (FPG) is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.
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 - Change from baseline to final visit in total cholesterol, low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.
Timepoint [10] 0 0
Baseline and week 432
Secondary outcome [11] 0 0
Change From Baseline to Final Visit in Triglycerides - Change from baseline to final visit in triglycerides is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.
Timepoint [11] 0 0
Baseline and week 432
Secondary outcome [12] 0 0
Change From Baseline to Final Visit in Creatinine - Change from baseline to final visit in creatinine is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.
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) - Change from baseline to final visit in eGFR is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.
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) - Change from baseline to final visit in UACR is presented as secondary diabetes-related endpoint. Least square mean is adjusted geometric mean (gMean) ratio. The Final Visit value referred to the last value obtained on-treatment.
Timepoint [14] 0 0
Baseline and week 432
Secondary outcome [15] 0 0
Percentage of Participants With Transition in Albuminuria Classes - Percentage of patients with transition in albuminuria classes is presented as secondary endpoint. Data for last value on treatment (LVOT) to baseline (base) is presented.
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 - The endpoint change from baseline of ISR at fixed glucose concentration at 208 weeks as derived from a 3-hour meal tolerance test is Beta-cell function sub-study endpoint.
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 - Occurrence of accelerated cognitive decline based on regression based index (RBI) score at end of follow-up (a dichotomous outcome measure; presence or absence of accelerated cognitive decline) is Cognition sub-study endpoint.
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 - Baseline data for the continuous glucose monitoring sub-study was collected and analyzed. However, the participant number was far less than original planned. The study was stopped early around week 64 (V9) due to recruitment issues and data were not pre-specified to be analyzed and reported at week 64 time point as target was with an estimated time point of 432 weeks for primary or secondary end points. Thus this endpoint was not analysed and only the baseline data collected were analysed and the results are reported in this CGM substudy endpoint.
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 - Baseline data for the continuous glucose monitoring sub-study was collected and analyzed. However, the participant number was far less than original planned. The study was stopped early around week 64 (V9) due to recruitment issues and data were not pre-specified to be analyzed and reported at week 64 time point as target was with an estimated time point of 432 weeks for primary or secondary end points. Thus this endpoint was not analysed and only the baseline data collected were analysed and the results are reported in this CGM substudy endpoint.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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United States of America
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Alabama
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Alaska
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Gori
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Berlin
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Chippenham
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Durham
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Ely
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United Kingdom
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Gloucester
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United Kingdom
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Great Yarmouth
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Swansea
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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
The aim of the study is to investigate the longterm impact on cardiovascular morbidity and
mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g., weight
and hypoglycaemia) of treatment with linagliptin in patients with type 2 diabetes at elevated
cardiovascular risk receiving usual care, and compare outcome against glimepiride.
Trial website
https://clinicaltrials.gov/show/NCT01243424
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

Summary results
Other publications