A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Monotherapy
Overview[ - collapse ][ - ]
| Purpose | This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of aleglitazar in combination with metformin in patients with Type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy. Patients will be randomized to receive either aleglitazar 150 mcg orally daily or placebo for 26 weeks in combination with their pre-existing metformin regimen and dose. |
|---|---|
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: aleglitazar Drug: placebo Drug: metformin |
| Phase | Phase 3 |
| Sponsor | Hoffmann-La Roche |
| Responsible Party | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier | NCT01871415 |
| First Received | June 4, 2013 |
| Last Updated | April 7, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | June 4, 2013 |
|---|---|
| Last Updated Date | April 7, 2014 |
| Start Date | May 2013 |
| Estimated Primary Completion Date | August 2013 |
| Current Primary Outcome Measures | Change in HbA1c [Time Frame: from baseline to Week 26] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Monotherapy |
|---|---|
| Official Title | A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF ALEGLITAZAR PLUS METFORMIN COMBINATION THERAPY COMPARED WITH PLACEBO PLUS METFORMIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS INADEQUATELY CONTROLLED WITH METFORMIN MONOTHERAPY |
| Brief Summary | This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of aleglitazar in combination with metformin in patients with Type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy. Patients will be randomized to receive either aleglitazar 150 mcg orally daily or placebo for 26 weeks in combination with their pre-existing metformin regimen and dose. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: aleglitazar 150 mcg orally daily Drug: placebo matching aleglitazar placebo orally daily Drug: metformin pre-existing background regimen and dose |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 7 |
| Estimated Completion Date | August 2013 |
| Estimated Primary Completion Date | August 2013 |
| Eligibility Criteria | Inclusion Criteria: - Adult patient, >/= 18 years of age - Type 2 diabetes mellitus treated with stable metformin monotherapy for at least 12 weeks prior to screening; metformin dose should be >/= 1500 mg/day (or individual maximum tolerated dose), but no more than the maximum dose specified in the label - HbA1c >/= 7% and pre-randomization visit - Fasting plasma glucose - Agreement to maintain diet and exercise habits implemented during the run-in phase during the full course of the study Exclusion Criteria: - Pregnant women, women intending to become pregnant during the study period, currently lactating women, or women of child-bearing potential not using highly effective, medically approved birth control methods - Diagnosis or history of: 1. Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes 2. Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months - Any previous treatment with thiazolidinedione or with a dual PPAR agonist - Any body weight lowering or lipoprotein-modifying therapy (e.g. fibrates) within 12 weeks prior to screening with the exception of stable (>= 1 month) statin therapy - Prior intolerance to fibrate - Treatment with anti-diabetic medication other than metformin in the last 12 weeks prior to screening - Triglycerides (fasting) > 4.5 mmol/L (> 400 mg/dL) at screening or within 4 weeks prior to screening - Clinically apparent liver disease - Anemia at or within 4 weeks prior to screening - Inadequate renal function - Symptomatic congestive heart failure NYHA Class II-IV at screening - Myocardial infarction, acute coronary syndrome or transient ischemic attack/stroke within 6 months prior to screening visit - Known macular edema at screening or prior to screening visit - Diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years - Uncontrolled hypertension - History of active substance abuse (including alcohol) within the past 2 years |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | China, Korea, Republic of |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01871415 |
|---|---|
| Other Study ID Numbers | YC28036 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Hoffmann-La Roche |
| Study Sponsor | Hoffmann-La Roche |
| Collaborators | Not Provided |
| Investigators | Study Director: Clinical Trials Hoffmann-La Roche |
| Verification Date | April 2014 |
Locations[ + expand ][ + ]
| China | Shanghai, China, 200003 |
|---|---|
| China | Shen Yang, China, 110004 |
| China | Shiyan, China, 442000 |
| China | Suzhou, China, 215004 |
| Korea, Republic of | Gyeonggi-do, Korea, Republic of, 463-712 |
| Korea, Republic of | Incheon, Korea, Republic of, 405-760 |
| Korea, Republic of | Seoul, Korea, Republic of, 150-950 |