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A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00961909
First received: August 18, 2009
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

This randomized, double-blind, placebo-controlled study will assess the efficacy

, safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in pa tients with type 2 diabetes mellitus. Patients will be randomized to receive eit her RO5095932 subcutaneously once weekly or placebo for 4 weeks (part 1) or 6 we eks (part 2), in addition to their current stable doses of metformin.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: RO5095932
Drug: metformin
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

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 ]

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 ]

Enrollment: 122
Study Start Date: June 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1active Drug: RO5095932
cohorts receiving multiple ascending doses, sc once weekly for 4 weeks
Drug: metformin
stable dose
Placebo Comparator: 1placebo Drug: metformin
stable dose
Drug: placebo
sc once weekly for 4 weeks
Experimental: 2active Drug: RO5095932
dose titration to target dose, sc once weekly for 6 weeks
Drug: metformin
stable dose
Placebo Comparator: 2placebo Drug: metformin
stable dose
Drug: placebo
sc once weekly for 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00961909

Locations
United States, California
Anaheim, California, United States, 92801
Chula Vista, California, United States, 91911
United States, Florida
Ft. Myers, Florida, United States, 33901
Miramar, Florida, United States, 33025
United States, Texas
San Antonio, Texas, United States, 78229-4801
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00961909     History of Changes
Other Study ID Numbers: NP22340
Study First Received: August 18, 2009
Last Updated: November 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014