Status:
COMPLETED
A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Monotherapy
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Diabetes Mellitus Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 m...
Eligibility Criteria
Inclusion
- 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 \</= 9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
- Fasting plasma glucose \</= 13.3 mmol/L (\</= 240 mg/dL) at pre-randomization visit
- Agreement to maintain diet and exercise habits implemented during the run-in phase during the full course of the study
Exclusion
- 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:
- Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01871415
Start Date
May 1 2013
End Date
August 1 2013
Last Update
November 2 2016
Active Locations (7)
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1
Shanghai, China, 200003
2
Shenyang, China, 110004
3
Shiyan, China, 442000
4
Suzhou, China, 215004