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: February 19, 2014
Last verified: February 2014
  Purpose

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

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Glargine
Drug: LY2605541
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from baseline to 52 week endpoint in hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1516
Study Start Date: October 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: LY2605541
Administered by subcutaneous injection
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
Drug: Glargine
Administered by subcutaneous injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435616

  Show 167 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Boehringer Ingelheim
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01435616     History of Changes
Other Study ID Numbers: 12141, I2R-MC-BIAJ
Study First Received: September 9, 2011
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Brazil: Ethics Committee
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Canada: Health Canada
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
European Union: European Medicines Agency
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
Greece: Ethics Committee
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: Ethics Committee
Lithuania: State Medicine Control Agency - Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
New Zealand: Medsafe
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: Ethics Committee
Romania: National Medicines Agency
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
South Africa: Department of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Turkey: Ethics Committee
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Eli Lilly and Company:
diabetes mellitus
type 2 diabetes mellitus
insulin naive
insulin treatment

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014