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

November 1, 2016 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Drug: Placebo
Subcutenaous once weekly for 4 weeks
Drug: Placebo
Single subcutaneous dose in week 5
EXPERIMENTAL: 1
Drug: RO5095932
Escalating subcutaneous doses once weekly over a 4 weeks period
Drug: RO5095932
Single subcutenaous dose in week 5
EXPERIMENTAL: 3
Drug: RO5095932
Escalating subcutaneous doses once weekly over a 4 weeks period
Drug: RO5095932
Single subcutenaous dose in week 5
PLACEBO_COMPARATOR: 4
Drug: Placebo
Subcutenaous once weekly for 4 weeks
Drug: Placebo
Single subcutaneous dose in week 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and Tolerability of various doses of RO5095932
Time Frame: Weeks 1-4, 6, 8
Weeks 1-4, 6, 8

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

November 19, 2009

First Submitted That Met QC Criteria

November 19, 2009

First Posted (ESTIMATE)

November 20, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP22709

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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