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/NCT01435616




Registration number
NCT01435616
Ethics application status
Date submitted
9/09/2011
Date registered
16/09/2011
Date last updated
13/04/2018

Titles & IDs
Public title
A Study in Patients With Type 2 Diabetes Mellitus
Scientific title
A Comparison of LY2605541 Versus Insulin Glargine as Basal Insulin Treatment in Combination With Oral Anti-Hyperglycemia Medications in Insulin-Naive Patients With Type 2 Diabetes Mellitus: A Double-Blind, Randomized Study
Secondary ID [1] 0 0
I2R-MC-BIAJ
Secondary ID [2] 0 0
12141
Universal Trial Number (UTN)
Trial acronym
IMAGINE 2
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
Experimental: LY2605541 - LY2605541 titrated based on blood glucose readings, administered subcutaneously (SC), once daily in combination with at least 2 pre-study oral antihyperglycemic medications (OAMs) prescribed by the personal physician, for 52 or 78 weeks

Active comparator: Glargine - Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to 52 Week Endpoint in Hemoglobin A1c (HbA1c)
Timepoint [1] 0 0
Baseline, 52 weeks
Secondary outcome [1] 0 0
Rate of Total and Nocturnal Hypoglycemia Events
Timepoint [1] 0 0
Baseline to 52 weeks
Secondary outcome [2] 0 0
Percentage of Participants With Hemoglobin A1c Equal or Less Than 6.5% and Less Than 7.0 %
Timepoint [2] 0 0
52 weeks
Secondary outcome [3] 0 0
Fasting Serum Glucose (By Laboratory Measurement)
Timepoint [3] 0 0
52 weeks
Secondary outcome [4] 0 0
Fasting Blood Glucose (By Participant Self-monitored Blood Glucose Readings)
Timepoint [4] 0 0
52 weeks
Secondary outcome [5] 0 0
6 Point Self-monitored Blood Glucose (SMBG)
Timepoint [5] 0 0
52 weeks
Secondary outcome [6] 0 0
Change From Baseline to 52 Weeks in Body Weight
Timepoint [6] 0 0
Baseline, 52 weeks
Secondary outcome [7] 0 0
Hemoglobin A1c
Timepoint [7] 0 0
52 weeks
Secondary outcome [8] 0 0
Insulin Dose Per Body Weight
Timepoint [8] 0 0
52 weeks
Secondary outcome [9] 0 0
Number of Insulin Dose Adjustments to Steady-State
Timepoint [9] 0 0
Baseline to 52 weeks
Secondary outcome [10] 0 0
European Quality of Life-5 Dimension (EQ-5D)
Timepoint [10] 0 0
52 weeks
Secondary outcome [11] 0 0
Insulin Treatment Satisfaction Questionnaire
Timepoint [11] 0 0
Up to 52 weeks
Secondary outcome [12] 0 0
Adult Low Blood Sugar Survey
Timepoint [12] 0 0
Up to 52 weeks
Secondary outcome [13] 0 0
Change From Baseline to 52 Weeks in Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), and High Density Lipoprotein Cholesterol (HDL-C)
Timepoint [13] 0 0
Baseline, 52 weeks
Secondary outcome [14] 0 0
Percentage of Participants With Equal or Above 2-, and 3-fold Upper Limits of Normal (ULN) for Total Bilirubin
Timepoint [14] 0 0
Up to 52 weeks
Secondary outcome [15] 0 0
Overall Treatment-Emergent Anti-LY2065541 Antibody Response (TEAR)
Timepoint [15] 0 0
Baseline to 78 weeks
Secondary outcome [16] 0 0
Intra-participant Variability of the Fasting Blood Glucose (FBG)
Timepoint [16] 0 0
52 weeks
Secondary outcome [17] 0 0
Percentage of Participants With Total and Nocturnal Hypoglycemic Events
Timepoint [17] 0 0
Baseline to 52 weeks
Secondary outcome [18] 0 0
Percentage of Participants With HbA1C Equal or Less Than 6.5% and Less Than 7.0 % and Without Nocturnal Hypoglycemia
Timepoint [18] 0 0
Up to 52 weeks
Secondary outcome [19] 0 0
Percentage of Participants With Equal or Above 2- and 3-fold ULN for Alanine Transaminase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) and Aspartate Transaminase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)
Timepoint [19] 0 0
Up to 52 weeks

Eligibility
Key inclusion criteria
* Have type 2 diabetes mellitus, not treated with insulin, for at least 1 year prior to the study
* Have been receiving at least 2 OAMs for at least 3 months before entering the study
* Have a hemoglobin A1c (HbA1c) value between 7.0% and 11.0%, inclusive, at screening
* Are capable of and willing to inject insulin with a vial and syringe and perform self blood glucose monitoring
* Women of childbearing potential only: are not breastfeeding, have a negative pregnancy test at the time of screening and randomization, intend to not become pregnant during the trial, have practiced a reliable method of birth control for at least 6 weeks prior to screening, and agree to use a reliable method of birth control during the study and until 2 weeks following the last dose of study drug
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks
* Use of rosiglitazone, pramlintide, or glucagon-like peptide 1 (GLP-1) receptor agonist (for example, exenatide, exenatide once weekly, or liraglutide) concurrently or within 3 months prior to screening
* Are currently taking, or have taken within the 3 months preceding screening, medications to promote weight loss
* Have had any episodes of severe hypoglycemia within 6 months prior to screening
* Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the 6 months prior to the study
* Have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association [NYHA] Cardiac Disease Classification)
* Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater or equal than 2 milligrams per deciliter (mg/dL)
* Have obvious clinical signs or symptoms of liver disease (excluding non- alcoholic fatty liver disease [NAFLD]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements at screening
* Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c
* Have active or untreated malignancy or have been in remission from clinically significant malignancy for less than 5 years
* Have fasting or non-fasting triglycerides greater than 400 mg/dL (greater than 4.5 millimoles per liter [mmol/L]) at screening
* Are using lipid-lowering medication at a dose that has not been stable for 90 days prior to screening
* Are using niacin preparations as a lipid lowering medication and bile acid sequestrants within 90 days prior to screening

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
1/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2014
Sample size
Target
Accrual to date
Final
1538
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Merewether
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Keswick
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Box Hill
Recruitment hospital [4] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Fremantle
Recruitment postcode(s) [1] 0 0
2291 - Merewether
Recruitment postcode(s) [2] 0 0
5035 - Keswick
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
6160 - Fremantle
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
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Hawaii
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maine
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Montana
Country [17] 0 0
United States of America
State/province [17] 0 0
New Hampshire
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oregon
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
South Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Tennessee
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Utah
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
Argentina
State/province [27] 0 0
Buenos Aires
Country [28] 0 0
Argentina
State/province [28] 0 0
Caba
Country [29] 0 0
Argentina
State/province [29] 0 0
Córdoba
Country [30] 0 0
Argentina
State/province [30] 0 0
Mar Del Plata
Country [31] 0 0
Brazil
State/province [31] 0 0
Marilia
Country [32] 0 0
Brazil
State/province [32] 0 0
Rio De Janeiro
Country [33] 0 0
Brazil
State/province [33] 0 0
Setor Oeste/Goiania
Country [34] 0 0
Brazil
State/province [34] 0 0
São Paulo
Country [35] 0 0
Canada
State/province [35] 0 0
Alberta
Country [36] 0 0
Canada
State/province [36] 0 0
British Columbia
Country [37] 0 0
Canada
State/province [37] 0 0
Manitoba
Country [38] 0 0
Canada
State/province [38] 0 0
Ontario
Country [39] 0 0
Canada
State/province [39] 0 0
Quebec
Country [40] 0 0
Finland
State/province [40] 0 0
Oulu
Country [41] 0 0
Finland
State/province [41] 0 0
Seinajoki
Country [42] 0 0
Germany
State/province [42] 0 0
Dippoldiswalde
Country [43] 0 0
Germany
State/province [43] 0 0
Dresden
Country [44] 0 0
Germany
State/province [44] 0 0
Friedrichsthal
Country [45] 0 0
Germany
State/province [45] 0 0
Furth Im Wald
Country [46] 0 0
Germany
State/province [46] 0 0
Goch
Country [47] 0 0
Germany
State/province [47] 0 0
Hamburg
Country [48] 0 0
Germany
State/province [48] 0 0
Ludwigshafen
Country [49] 0 0
Germany
State/province [49] 0 0
Münster
Country [50] 0 0
Germany
State/province [50] 0 0
Saarbrücken
Country [51] 0 0
Germany
State/province [51] 0 0
Schweinfurt
Country [52] 0 0
Germany
State/province [52] 0 0
Sulzbach
Country [53] 0 0
Greece
State/province [53] 0 0
Ampelokipoi
Country [54] 0 0
Greece
State/province [54] 0 0
Athens
Country [55] 0 0
Greece
State/province [55] 0 0
Thessaloniki
Country [56] 0 0
Hungary
State/province [56] 0 0
Budapest
Country [57] 0 0
Hungary
State/province [57] 0 0
Debrecen
Country [58] 0 0
Hungary
State/province [58] 0 0
Mako
Country [59] 0 0
Hungary
State/province [59] 0 0
Salgotarjan
Country [60] 0 0
Hungary
State/province [60] 0 0
Sopron
Country [61] 0 0
Israel
State/province [61] 0 0
Beer Sheva
Country [62] 0 0
Israel
State/province [62] 0 0
Haifa
Country [63] 0 0
Israel
State/province [63] 0 0
Raanana
Country [64] 0 0
Italy
State/province [64] 0 0
Carpi
Country [65] 0 0
Italy
State/province [65] 0 0
Castellanza
Country [66] 0 0
Italy
State/province [66] 0 0
Foggia
Country [67] 0 0
Italy
State/province [67] 0 0
Forli
Country [68] 0 0
Italy
State/province [68] 0 0
Rome
Country [69] 0 0
Italy
State/province [69] 0 0
Sesto San Giovanni
Country [70] 0 0
Lithuania
State/province [70] 0 0
Utena
Country [71] 0 0
Lithuania
State/province [71] 0 0
Vilnius
Country [72] 0 0
Mexico
State/province [72] 0 0
Coatzacoalcos
Country [73] 0 0
Mexico
State/province [73] 0 0
Mexico City
Country [74] 0 0
Mexico
State/province [74] 0 0
Monterrey
Country [75] 0 0
New Zealand
State/province [75] 0 0
Auckland
Country [76] 0 0
Poland
State/province [76] 0 0
Kamieniec Zabkowicki
Country [77] 0 0
Poland
State/province [77] 0 0
Katowice
Country [78] 0 0
Poland
State/province [78] 0 0
Krakow
Country [79] 0 0
Poland
State/province [79] 0 0
Lodz
Country [80] 0 0
Poland
State/province [80] 0 0
Ruda Slaska
Country [81] 0 0
Poland
State/province [81] 0 0
Szczecin
Country [82] 0 0
Poland
State/province [82] 0 0
Tychy
Country [83] 0 0
Poland
State/province [83] 0 0
Warsaw
Country [84] 0 0
Puerto Rico
State/province [84] 0 0
Hato Rey
Country [85] 0 0
Puerto Rico
State/province [85] 0 0
Manati
Country [86] 0 0
Puerto Rico
State/province [86] 0 0
San Juan
Country [87] 0 0
Romania
State/province [87] 0 0
Bucharest
Country [88] 0 0
Romania
State/province [88] 0 0
Cluj-Napoca
Country [89] 0 0
Romania
State/province [89] 0 0
Iasi
Country [90] 0 0
Romania
State/province [90] 0 0
Oradea
Country [91] 0 0
Romania
State/province [91] 0 0
Ploiesti
Country [92] 0 0
Romania
State/province [92] 0 0
Resita
Country [93] 0 0
Romania
State/province [93] 0 0
Targu-Mures
Country [94] 0 0
Russian Federation
State/province [94] 0 0
Cheboksary
Country [95] 0 0
Russian Federation
State/province [95] 0 0
Kazan
Country [96] 0 0
Russian Federation
State/province [96] 0 0
Kursk
Country [97] 0 0
Russian Federation
State/province [97] 0 0
Novosibirsk
Country [98] 0 0
Russian Federation
State/province [98] 0 0
Saint Petersburg
Country [99] 0 0
Slovakia
State/province [99] 0 0
Bratislava
Country [100] 0 0
Slovakia
State/province [100] 0 0
Sala
Country [101] 0 0
Slovakia
State/province [101] 0 0
Vranov Nad Toplou
Country [102] 0 0
South Africa
State/province [102] 0 0
Paarl
Country [103] 0 0
South Africa
State/province [103] 0 0
Parow
Country [104] 0 0
South Africa
State/province [104] 0 0
Somerset West
Country [105] 0 0
Spain
State/province [105] 0 0
Alicante
Country [106] 0 0
Spain
State/province [106] 0 0
Cordoba
Country [107] 0 0
Spain
State/province [107] 0 0
Pozuelo De Alarcon
Country [108] 0 0
Spain
State/province [108] 0 0
Requena
Country [109] 0 0
Spain
State/province [109] 0 0
Seville
Country [110] 0 0
Spain
State/province [110] 0 0
Toledo
Country [111] 0 0
Turkey
State/province [111] 0 0
Gaziantep
Country [112] 0 0
Turkey
State/province [112] 0 0
Hatay
Country [113] 0 0
Turkey
State/province [113] 0 0
Izmir
Country [114] 0 0
Turkey
State/province [114] 0 0
Kayseri
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Berks
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Leicestershire
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Surrey
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Wales

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01435616