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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Drugs - Glargine
Treatment: Drugs - LY2605541

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


Treatment: Drugs: Glargine


Treatment: Drugs: LY2605541
Intervention code [1] 0 0
Treatment: Drugs
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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United States of America
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Alabama
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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/ct2/show/NCT01435616
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01435616