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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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: April 14, 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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014