Status:
COMPLETED
A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Diabetes Mellitus Type 2
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This randomized, double-blind, placebo-controlled study will assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in patients with type 2 diabetes mellitus. Pa...
Eligibility Criteria
Inclusion
- adult patients, 18-65 years of age
- females who are either surgically sterile or post-menopausal
- type 2 diabetes treated with a stable dose of metformin
- BMI between 25-39kg/m2
- HbA1c between 7 and 10%
- fasting plasma glucose between 7 and 13.3mmol/L
Exclusion
- history of clinically significant cardiovascular disease
- history of clinically significant hepatic or renal disease or impairment
- recent therapy with insulin, thiazolidinedione, glucagon-like peptide-1 analogues, amylin analogues and/or DPP-IV inhibitors
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00961909
Start Date
June 1 2009
End Date
October 1 2010
Last Update
November 2 2016
Active Locations (6)
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1
Anaheim, California, United States, 92801
2
Chula Vista, California, United States, 91911
3
Fort Myers, Florida, United States, 33901
4
Miramar, Florida, United States, 33025