A Study of RO5093151 and RO5027838 in Patients With Type 2 Diabetes Mellitus on a Stable Dose of Metformin

July 26, 2016 updated by: Hoffmann-La Roche

Multi-center, Randomized, Double-blind, 5-arm Parallel Group, Placebo Controlled 4 Week Study to Investigate the Safety, Tolerability and Efficacy of Two Doses Each (Near to Maximum Tolerated Dose and Lower Dose) of RO5093151 Administered Twice Daily (BID Regimen) and RO5027838 Administered Once da

This 5 arm study will evaluate the efficacy and safety of RO5093151 and RO5027838 in patients with type 2 diabetes mellitus on a stable dose of metformin. After a 4 week pre-randomization period for glucose control, patients will be randomized to one of 5 groups to receive a)RO5093151 400mg po bid b)RO5093151 10mg po bid c)RO5027838 200mg po qd d)RO5027838 50mg po qd or e)placebo po bid for 4 weeks. The anticipated time on study treatment is < 3 months, and the target sample size is 100-500 individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 2

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

  • Austria
      • Graz, Austria, 8036
  • Germany
      • München, Germany, 80636
      • Neuss, Germany, 41460
  • United States
    • California
      • Chula Vista, California, United States, 91911
    • Florida
      • Miami, Florida, United States, 330014

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

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients, 35-65 years of age;
  • type 2 diabetes for >=3 months;
  • treated for >=3 months with stable dose of metformin >=1.5g/day or maximum tolerated dose.

Exclusion Criteria:

  • history of diabetic ketoacidosis;
  • currently or previously treated with insulin;
  • currently or within previous 6 months treated with a thiazolidinedione or dual peroxisome proliferator activated receptor (PPAR) agonist;
  • treated with lipoprotein-modifying therapy within a month before screening.

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
po bid for 4 weeks
Experimental: RO5027838 200mg
Drug: RO5027838
200mg po qd for 4 weeks
Drug: RO5027838
50mg po bid for 4 weeks
Experimental: RO5027838 50mg
Drug: RO5027838
200mg po qd for 4 weeks
Drug: RO5027838
50mg po bid for 4 weeks
Experimental: RO5093151 10mg
Drug: RO5093151
400mg po bid for 4 weeks
Drug: RO5093151
10mg po bid for 4 weeks
Experimental: RO5093151 400mg
Drug: RO5093151
400mg po bid for 4 weeks
Drug: RO5093151
10mg po bid for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute change in mean daily plasma glucose
Time Frame: From baseline to day 27
From baseline to day 27

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting plasma glucose
Time Frame: Baseline, and weeks 1, 2, 3 and 4
Baseline, and weeks 1, 2, 3 and 4
Post-prandial glucose and insulin
Time Frame: Baseline, weeks 2 and 4
Baseline, weeks 2 and 4
Insulin sensitivity, beta cell function, lipid profile, HbA1C
Time Frame: At baseline, and at planned visits up to week 4
At baseline, and at planned visits up to week 4
Adverse events, lab parameters, vital signs, body weight
Time Frame: At baseline, and at planned visits up to week 4
At baseline, and at planned visits up to week 4

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

April 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

January 15, 2009

First Submitted That Met QC Criteria

January 15, 2009

First Posted (Estimate)

January 16, 2009

Study Record Updates

Last Update Posted (Estimate)

July 28, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP21850
  • 2008-001122-13

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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