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: August 26, 2014
Last verified: August 2014

August 18, 2009
August 26, 2014
June 2009
October 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • Safety and tolerability: AEs, laboratory parameters, ECG, body weight, vital signs [ Time Frame: monitored throughout study, with ECG and laboratory assessments 2x weekly on study treatment and at intervals during follow-up ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose [ Time Frame: assessed on days 1-4 each week on study treament and at intervals during follow-up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00961909 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Pharmacokinetics: blood concentration of RO5095932 after multiple dosing [ Time Frame: multiple sampling weeks 1-4, and weekly during follow-up ] [ Designated as safety issue: No ]
  • Change in metabolic parameters: glucose, insulin, C-peptide [ Time Frame: assessed after 4 weeks on study treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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: metformin
    stable dose
  • Drug: placebo
    sc once weekly for 4 weeks
  • Experimental: 1active
    Interventions:
    • Drug: RO5095932
    • Drug: metformin
  • Placebo Comparator: 1placebo
    Interventions:
    • Drug: metformin
    • Drug: placebo
  • Experimental: 2active
    Interventions:
    • Drug: RO5095932
    • Drug: metformin
  • Placebo Comparator: 2placebo
    Interventions:
    • Drug: metformin
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00961909
NP22340
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP