A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus | RxWiki

A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus

Overview[ - collapse ][ - ]

Purpose	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. Patients will be randomized to receive either RO5095932 subcutaneously once weekly or placebo for 4 weeks (part 1) or 6 weeks (part 2), in addition to their current stable doses of metformin.
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: RO5095932 Drug: RO5095932 Drug: placebo Drug: metformin
Phase	Phase 1
Sponsor	Hoffmann-La Roche
Responsible Party	Hoffmann-La Roche
ClinicalTrials.gov Identifier	NCT00961909
First Received	August 18, 2009
Last Updated	April 7, 2014
Last verified	April 2014

Tracking Information[ + expand ][ + ]

First Received Date	August 18, 2009
Last Updated Date	April 7, 2014
Start Date	June 2009
Estimated Primary Completion Date	October 2010
Current Primary Outcome Measures	Safety and tolerability: AEs, laboratory parameters, ECG, body weight, vital signs [Time Frame: monitored throughout study, with weekly ECG and 2x weekly to 2-weekly laboratory assessments on study treatment and at intervals during follow-up] [Designated as safety issue: No] Change in hemoglobin A1c (HbA1c) [Time Frame: from baseline to week 6] [Designated as safety issue: No]
Current Secondary Outcome Measures	Pharmacokinetics: blood concentration of RO5095932 after multiple dosing [Time Frame: multiple sampling weeks 1-4 or 1-6 respectively, and weekly during follow-up] [Designated as safety issue: No] Change in metabolic parameters: glucose, insulin, C-peptide [Time Frame: assessed after 4 or 6 weeks on study treatment] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus
Official Title	A Multi-Center, Randomized, Double-Blind, Multiple Ascending Dose, Placebo-Controlled, Parallel Group, 2-Part Study to Investigate the Safety, Tolerability, PK, and PD of Once Weekly RO5095932 in Patients With Type 2 Diabetes Mellitus on a Stable Dose of Metformin
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. Patients will be randomized to receive either RO5095932 subcutaneously once weekly or placebo for 4 weeks (part 1) or 6 weeks (part 2), in addition to their current stable doses of metformin.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 1
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: RO5095932 cohorts receiving multiple ascending doses, sc once weekly for 4 weeks Drug: RO5095932 dose titration to target dose, sc once weekly for 6 weeks Drug: placebo sc once weekly for 4 weeks Drug: metformin stable dose
Study Arm (s)	Experimental: 1active Placebo Comparator: 1placebo Experimental: 2active Placebo Comparator: 2placebo

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	122
Estimated Completion Date	October 2010
Estimated Primary Completion Date	October 2010
Eligibility Criteria	Inclusion Criteria: - 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 Criteria: - 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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00961909
Other Study ID Numbers	NP22340
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 ][ + ]

United States, California	Anaheim, California, United States, 92801
United States, California	Chula Vista, California, United States, 91911
United States, Florida	Ft. Myers, Florida, United States, 33901
United States, Florida	Miramar, Florida, United States, 33025
United States, Texas	San Antonio, Texas, United States, 78229-4801
United States, Texas	San Antonio, Texas, United States, 78209