A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus

November 1, 2016 updated by: Hoffmann-La Roche

A Multi-Center, Randomized, Double-Blind, Multiple Ascending Dose, Placebo-Controlled, Parallel Group, 2-Part Study to Investigate the Safety, Tolerability, PK, and PD of Once Weekly RO5095932 in Patients With Type 2 Diabetes Mellitus on a Stable Dose of Metformin

This randomized, double-blind, placebo-controlled study will assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in patients with type 2 diabetes mellitus. Patients will be randomized to receive either RO5095932 subcutaneously once weekly or placebo for 4 weeks (part 1) or 6 weeks (part 2), in addition to their current stable doses of metformin.

Study Overview

Study Type

Interventional

Enrollment (Actual)

122

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

    • California
      • Anaheim, California, United States, 92801
      • Chula Vista, California, United States, 91911
    • Florida
      • Ft. Myers, Florida, United States, 33901
      • Miramar, Florida, United States, 33025
    • Texas
      • San Antonio, Texas, United States, 78209
      • San Antonio, Texas, United States, 78229-4801

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
  • females who are either surgically sterile or post-menopausal
  • type 2 diabetes treated with a stable dose of metformin
  • BMI between 25-39kg/m2
  • HbA1c between 7 and 10%
  • fasting plasma glucose between 7 and 13.3mmol/L

Exclusion Criteria:

  • history of clinically significant cardiovascular disease
  • history of clinically significant hepatic or renal disease or impairment
  • recent therapy with insulin, thiazolidinedione, glucagon-like peptide-1 analogues, amylin analogues and/or DPP-IV inhibitors

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
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1active
cohorts receiving multiple ascending doses, sc once weekly for 4 weeks
dose titration to target dose, sc once weekly for 6 weeks
stable dose
Placebo Comparator: 1placebo
stable dose
sc once weekly for 4 weeks
Experimental: 2active
cohorts receiving multiple ascending doses, sc once weekly for 4 weeks
dose titration to target dose, sc once weekly for 6 weeks
stable dose
Placebo Comparator: 2placebo
stable dose
sc once weekly for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability: AEs, laboratory parameters, ECG, body weight, vital signs
Time Frame: monitored throughout study, with weekly ECG and 2x weekly to 2-weekly laboratory assessments on study treatment and at intervals during follow-up
monitored throughout study, with weekly ECG and 2x weekly to 2-weekly laboratory assessments on study treatment and at intervals during follow-up
Change in hemoglobin A1c (HbA1c)
Time Frame: from baseline to week 6
from baseline to week 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics: blood concentration of RO5095932 after multiple dosing
Time Frame: multiple sampling weeks 1-4 or 1-6 respectively, and weekly during follow-up
multiple sampling weeks 1-4 or 1-6 respectively, and weekly during follow-up
Change in metabolic parameters: glucose, insulin, C-peptide
Time Frame: assessed after 4 or 6 weeks on study treatment
assessed after 4 or 6 weeks on study treatment

Collaborators and Investigators

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

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

June 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

August 18, 2009

First Submitted That Met QC Criteria

August 18, 2009

First Posted (Estimate)

August 19, 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

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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