Completed
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 T2D Inadequately Controlled With Metformin Monotherapy
Led by Hoffmann-La Roche · Updated on 2017-02-23
200
Participants Needed
31
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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 metformin in patients with type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks.
CONDITIONS
Brief Title
A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Alone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
Trial Site Locations
Total: 31 locations
1
Chino, California, United States, 91710
Status Unknown
2
Hawaiian Gardens, California, United States, 90716
Status Unknown
3
Los Angeles, California, United States, 90057
Status Unknown
4
Santa Ana, California, United States, 92701
Status Unknown
5
Thousand Oaks, California, United States, 91360
Status Unknown
6
West Hills, California, United States, 91307
Status Unknown
7
Kissimmee, Florida, United States, 34741
Status Unknown
8
Atlanta, Georgia, United States, 30338
Status Unknown
9
Chicago, Illinois, United States, 60607
Status Unknown
10
Avon, Indiana, United States, 46123
Status Unknown
11
Bethesda, Maryland, United States, 20817
Status Unknown
12
Springfield, Missouri, United States, 65807
Status Unknown
13
Toms River, New Jersey, United States, 08753
Status Unknown
14
Altoona, Pennsylvania, United States, 16602
Status Unknown
15
Beaver, Pennsylvania, United States, 15009
Status Unknown
16
Morrisville, Pennsylvania, United States, 19067
Status Unknown
17
Scranton, Pennsylvania, United States, 18510
Status Unknown
18
Tipton, Pennsylvania, United States, 16684
Status Unknown
19
Knoxville, Tennessee, United States, 37919
Status Unknown
20
Dallas, Texas, United States, 75230
Status Unknown
21
Richmond, Virginia, United States, 23249
Status Unknown
22
Spokane, Washington, United States, 99202
Status Unknown
23
Buenos Aires, Argentina, 1056
Status Unknown
24
Caba, Argentina, C1428DCO
Status Unknown
25
Rosario, Argentina, S2000CXP
Status Unknown
26
Cuernavaca, Mexico, 62250
Status Unknown
27
Culiacán, Mexico, 80020
Status Unknown
28
Guadalajara, Mexico, 44650
Status Unknown
29
Mexico City, Mexico, 11650
Status Unknown
30
Pachuca, Mexico, 42060
Status Unknown
31
Tampico, Mexico, 89000
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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