A Study in Patients With Type 2 Diabetes Mellitus | Completed
A Study in Patients With Type 2 Diabetes Mellitus
IMAGINE 2
Trial Source

There is no location for this trial

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Health Conditions
  • Diabetes Mellitus, Type 2
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01435616
Primary Trial ID Number
Summary
The purpose of this study is: - To compare the blood sugar control on LY2605541 with insulin glargine after 52 weeks of treatment. - To compare the number of night time low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment. - To compare the number of patients 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 total number of low blood sugar episodes on LY2605541 with insulin glargine after 52 weeks of treatment
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Glargine, Drug : LY2605541

Study Arm Groups : Glargine, LY2605541

Intervention Type
See Interventions above
Primary Outcome Measures
  • Change from baseline to 52 week endpoint in hemoglobin A1c (HbA1c); Baseline, 52 weeks
Secondary Outcome Measures
  • Rate of total and nocturnal hypoglycemia events; 0 to 52 weeks; Percentage of patients with hemoglobin A1c equal or less than 6.5% and less than 7.0 %; 52 weeks; Fasting serum glucose (by laboratory measurement) and fasting blood glucose (by patient self monitored blood glucose readings); 52 weeks; 6 point self-monitored blood glucose (SMBG); 52 weeks; Change in Body weight; Baseline, 52 weeks; Hemoglobin A1c; 52 weeks; Insulin dose per Body Weight; 52 weeks; Number of Insulin Dose Adjustments to Steady-State; 0 to 26 weeks; European Quality of Life -5 dimension (EuroQol-5 dimension); 52 weeks; Insulin Treatment Satisfaction Questionnaire; 52 weeks; Adult Low Blood Sugar Survey; 52 weeks; Change in Triglycerides,Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C); Baseline, 52 weeks; Percentage of patients with equal or above 2-, and 3- fold upper limits of normal (ULN) for total bilirubin; 52 weeks; Change in Anti-LY2605541 Antibodies; Baseline, 52 weeks; Intra-patient variability of the Fasting Blood Glucose (FBG); 52 weeks; Incidence of total and nocturnal hypoglycemic events; 0 to 52 weeks; Percentage of patients with hemoglobin A1c equal or less than 6.5% and less than 7.0 % and without nocturnal hypoglycemia; 52 weeks; Percentage of patients with equal or above 2-, and 3-fold upper limits of normal (ULN) for Alanine transaminase (ALT/SGPT), aspartate transaminase (AST/SGOT); 52 weeks
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
1516
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - Have type 2 diabetes mellitus, not treated with insulin, for at least one year prior
  • to the study
  • - Have been receiving at least 2 oral antihyperglycemic medication for at least 3
  • months before entering the study
  • - Have hemoglobin A1c 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
  • - Woman of Childbearing potential only: are not breastfeeding, have a negative
  • pregnancy test at the time of screening and randomization and 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
  • 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, 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 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
  • hemoglobin A1c
  • - Have active or untreated malignancy, have been in remission from clinically
  • significant malignancy for less than 5 years
  • - Have fasting or nonfasting triglycerides greater than 400 mg/dL (greater than 4.5
  • 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Leicester General Hospital
Leicester
England
LE5 4PW
The Royal Surrey County Hospital NHS Foundation Trust
Guildford
Surrey
GU2 7XX
Clinical Trials Unit
Swansea
Wales
SA6 6NL
Mortimer
RG7 3SQ
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United States, Argentina, Australia, Brazil, Canada, Finland, Germany, Greece, Hungary, Israel, Italy, Lithuania, Mexico, New Zealand, Poland, Puerto Rico, Romania, Russian Federation, Slovakia, South Africa, Spain, Turkey, United Kingdom
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
EudraCT Number
Not available for this trial
Funder(s)
  • Boehringer Ingelheim
Other Study ID Numbers
12141
Sponsor(s)
Eli Lilly and Company
Key Dates

Recruitment Start Date

Oct 2011

Recruitment End Date

Jan 2014

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

09 Sep 2011

Last Updated

14 Apr 2014