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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01017302
First received: November 19, 2009
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


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

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety and Tolerability of various doses of RO5095932 [ Time Frame: Weeks 1-4, 6, 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 32
Study Start Date: December 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RO5095932
Escalating subcutaneous doses once weekly over a 4 weeks period
Placebo Comparator: 2 Drug: Placebo
Subcutenaous once weekly for 4 weeks
Experimental: 3 Drug: RO5095932
Single subcutenaous dose in week 5
Placebo Comparator: 4 Drug: Placebo
Single subcutaneous dose in week 5

  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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017302

Locations
United States, Texas
San Antonio, Texas, United States, 78229
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: NCT01017302     History of Changes
Other Study ID Numbers: NP22709
Study First Received: November 19, 2009
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 21, 2014