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A Study With RO5095932 in Patients With Type 2 Diabetes on Stable Metformin Therapy.

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01017302
First received: November 19, 2009
Last updated: November 15, 2011
Last verified: November 2011
History of Changes

November 19, 2009
November 15, 2011
December 2009
August 2011   (final data collection date for primary outcome measure)
Safety and Tolerability of various doses of RO5095932 [ Time Frame: Weeks 1-4, 6, 8 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01017302 on ClinicalTrials.gov Archive Site
  • Safety and Tolerability of a single dose of RO5095932 [ Time Frame: Week 5, 6, 8 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: blood concentration [ Time Frame: Weeks 1-4, 6, 8 ] [ Designated as safety issue: No ]
  • Pharmacodynamics: glucose, insulin, C-peptide [ Time Frame: Weeks 1-4, 6, 8 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study With RO5095932 in Patients With Type 2 Diabetes on Stable Metformin Therapy.
A Randomized, Double-blind, Placebo-controlled, Titration Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose and Escalating Doses of RO5095932 in Patients With Type 2 Diabetes Mellitus on Stable Background Therapy

This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in adult patients with type 2 diabetes mellitus. Patients that are on stable metformin therapy are eligible to enter the study. There will be a 5-weeks exenatide run in period and a 5-weeks period when co-administered with the study drug. RO5095932 will be administered subcutaneously as a single dose or as escalating doses. Patients will be randomized to receive either active drug or placebo in weeks 1 to 4. Active drug or placebo will be administered once weekly for 4 weeks. Patients who received active drug in weeks 1 to 4 will receive placebo in week 5. Patients who received a single dose of placebo in weeks 1 to 4, will receive a single dose of active drug in week 5. The anticipated time of study treatment is <6 months. The target sample size is <100 patients.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: RO5095932
    Escalating subcutaneous doses once weekly over a 4 weeks period
  • Drug: Placebo
    Subcutenaous once weekly for 4 weeks
  • Drug: RO5095932
    Single subcutenaous dose in week 5
  • Drug: Placebo
    Single subcutaneous dose in week 5
  • Experimental: 1
    Intervention: Drug: RO5095932
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
  • Experimental: 3
    Intervention: Drug: RO5095932
  • Placebo Comparator: 4
    Intervention: 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
32
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, 18-65 years of age
  • Diabetes mellitus, type 2 for at least 6 months before screening
  • On treatment with stable doses of metformin for at least 3 months before screening
  • BMI between >/=25 and </=39

Exclusion Criteria:

  • Type 1 diabetes
  • Pancreatitis
  • Treatment with insulin for more than one week within 3 months prior to study start
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01017302
NP22709
Not Provided
Disclosures Group, Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2011

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