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Completed

NCT Number: NCT01017302

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

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Subcutenaous once weekly for 4 weeks

RO5095932

Drug

Escalating subcutaneous doses once weekly over a 4 weeks period

Primary outcomes

  1. Safety and Tolerability of various doses of RO5095932

    Time frame: Weeks 1-4, 6, 8

Secondary outcomes

  1. Safety and Tolerability of a single dose of RO5095932

    Time frame: Week 5, 6, 8

  2. Pharmacokinetics: blood concentration

    Time frame: Weeks 1-4, 6, 8

  3. Pharmacodynamics: glucose, insulin, C-peptide

    Time frame: Weeks 1-4, 6, 8

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 20, 2009
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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