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A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00961909
First Posted: August 19, 2009
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
August 18, 2009
August 19, 2009
November 2, 2016
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 ]
  • Change in hemoglobin A1c (HbA1c) [ Time Frame: from baseline to week 6 ]
  • 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 ]
  • Change in fasting plasma glucose [ Time Frame: assessed on days 1-4 each week on study treament and at intervals during follow-up ]
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 ]
  • Change in metabolic parameters: glucose, insulin, C-peptide [ Time Frame: assessed after 4 or 6 weeks on study treatment ]
  • Pharmacokinetics: blood concentration of RO5095932 after multiple dosing [ Time Frame: multiple sampling weeks 1-4, and weekly during follow-up ]
  • Change in metabolic parameters: glucose, insulin, C-peptide [ Time Frame: assessed after 4 weeks on study treatment ]
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 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.
Not Provided
Interventional
Phase 1
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00961909
NP22340
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

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