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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 (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01017302
First received: November 19, 2009
Last updated: November 1, 2016
Last verified: November 2016
  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: Placebo Drug: RO5095932 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, 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

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 ]

Secondary Outcome Measures:
  • Safety and Tolerability of a single dose of RO5095932 [ Time Frame: Week 5, 6, 8 ]
  • Pharmacokinetics: blood concentration [ Time Frame: Weeks 1-4, 6, 8 ]
  • Pharmacodynamics: glucose, insulin, C-peptide [ Time Frame: Weeks 1-4, 6, 8 ]

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   (Adult)
Sexes Eligible for Study:   All
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
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: 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

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: November 1, 2016

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

ClinicalTrials.gov processed this record on June 27, 2017