Status:
COMPLETED
A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Alone
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 assess the efficacy, safety and tolerability of aleglitazar plus metformin combination therapy compared with placebo plus metf...
Eligibility Criteria
Inclusion Criteria:
- Adult patients, >/=18 years of age
- Diagnosis of diabetes mellitus type 2
- Patients treated with stable metformin monotherapy for at least 12 weeks prior to screening
- HbA1c >/=7% and </=9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
- Fasting plasma glucose </=240 mg/dL at pre-randomization visit
- Agreement to maintain diet and exercise habits during the study
Exclusion Criteria:
- Patients with Type 1 diabetes mellitus, secondary diabetes, diabetes resulting from pancreatic injury, or acute metabolic diabetic complications within the past 6 months
- Any previous treatment with thiazolidinedione or a dual PPAR agonist
- Any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin)
- Symptomatic congestive heart failure classified as New York Heart Association class II-IV at screening
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01691846
Start Date
October 1 2012
End Date
September 1 2013
Last Update
February 23 2017
Active Locations (31)
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1
Chino, California, United States, 91710
2
Hawaiian Gardens, California, United States, 90716
3
Los Angeles, California, United States, 90057
4
Santa Ana, California, United States, 92701