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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is:

* To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of treatment.
* To compare the rate of night time low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment.
* To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 52 weeks of treatment.
* To compare the rate of low blood sugar episodes on LY2605541 with insulin glargine after 52 weeks of treatment
Trial website
https://clinicaltrials.gov/study/NCT01435616
Trial related presentations / publications
Sanyal A, Cusi K, Hartman ML, Zhang S, Bastyr EJ 3rd, Bue-Valleskey JM, Chang AM, Haupt A, Jacober SJ, Konrad RJ, Zhang Q, Hoogwerf BJ. Cytokeratin-18 and enhanced liver fibrosis scores in type 1 and type 2 diabetes and effects of two different insulins. J Investig Med. 2018 Mar;66(3):661-668. doi: 10.1136/jim-2017-000609. Epub 2017 Nov 21.
Orchard TJ, Cariou B, Connelly MA, Otvos JD, Zhang S, Antalis CJ, Ivanyi T, Hoogwerf BJ. The effects of basal insulin peglispro vs. insulin glargine on lipoprotein particles by NMR and liver fat content by MRI in patients with diabetes. Cardiovasc Diabetol. 2017 Jun 6;16(1):73. doi: 10.1186/s12933-017-0555-1.
Cusi K, Sanyal AJ, Zhang S, Hartman ML, Bue-Valleskey JM, Hoogwerf BJ, Haupt A. Non-alcoholic fatty liver disease (NAFLD) prevalence and its metabolic associations in patients with type 1 diabetes and type 2 diabetes. Diabetes Obes Metab. 2017 Nov;19(11):1630-1634. doi: 10.1111/dom.12973. Epub 2017 Jun 22.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01435616