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A Study in Patients With Type 2 Diabetes Mellitus (IMAGINE 2)

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01435616
First received: September 9, 2011
Last updated: April 14, 2014
Last verified: February 2014

September 9, 2011
April 14, 2014
October 2011
January 2014   (final data collection date for primary outcome measure)
Change from baseline to 52 week endpoint in hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01435616 on ClinicalTrials.gov Archive Site
  • Rate of total and nocturnal hypoglycemia events [ Time Frame: 0 to 52 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with hemoglobin A1c equal or less than 6.5% and less than 7.0 % [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Fasting serum glucose (by laboratory measurement) and fasting blood glucose (by patient self monitored blood glucose readings) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • 6 point self-monitored blood glucose (SMBG) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change in Body weight [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Hemoglobin A1c [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Insulin dose per Body Weight [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Number of Insulin Dose Adjustments to Steady-State [ Time Frame: 0 to 26 weeks ] [ Designated as safety issue: No ]
  • European Quality of Life -5 dimension (EuroQol-5 dimension) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Insulin Treatment Satisfaction Questionnaire [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Adult Low Blood Sugar Survey [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change in Triglycerides,Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of patients with equal or above 2-, and 3- fold upper limits of normal (ULN) for total bilirubin [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Change in Anti-LY2605541 Antibodies [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
  • Intra-patient variability of the Fasting Blood Glucose (FBG) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Incidence of total and nocturnal hypoglycemic events [ Time Frame: 0 to 52 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with hemoglobin A1c equal or less than 6.5% and less than 7.0 % and without nocturnal hypoglycemia [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study in Patients With Type 2 Diabetes Mellitus
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

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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Glargine
    Administered by subcutaneous injection
  • Drug: LY2605541
    Administered by subcutaneous injection
  • Experimental: LY2605541
    LY2605541 titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 pre-study oral antihyperglycemic medications (OAMs) prescribed by their personal physician, for 52 or 78 weeks
    Intervention: Drug: LY2605541
  • Active Comparator: Glargine
    Glargine titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 pre-study oral antihyperglycemic medications (OAMs) prescribed by their personal physician, for 52 or 78 weeks
    Intervention: Drug: Glargine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1516
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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
 
NCT01435616
12141, I2R-MC-BIAJ
Yes
Eli Lilly and Company
Eli Lilly and Company
Boehringer Ingelheim
Study Director: 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) Eli Lilly and Company
Eli Lilly and Company
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP