A Study in Patients With Type 2 Diabetes Mellitus (IMAGINE 2)
This study is ongoing, but not recruiting participants.
Sponsor:
Eli Lilly and Company
Collaborator:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01435616
First received: September 9, 2011
Last updated: January 22, 2013
Last verified: January 2013
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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 |
| Estimated Study Completion Date: | January 2014 |
| Estimated 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
Show 167 Study LocationsSponsors and Collaborators
Eli Lilly and Company
Boehringer Ingelheim Pharmaceuticals
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: | January 22, 2013 |
| 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 May 21, 2013