A Study of Single Doses of RO4998452 in Patients With Type 2 Diabetes

November 1, 2016 updated by: Hoffmann-La Roche

A Single-center, Double-blind, Randomized, Cross-over, Placebo-controlled, Single-dose Study to Investigate Glycemic Parameters of Efficacy During 24 Hours, Safety/ Tolerability and Pharmacokinetics of Two Dose Levels of RO4998452 in Patients With Type 2 Diabetes Mellitus

This randomized, double-blind, placebo-controlled, cross-over study will evaluate the glucose concentration and other glycemic parameters of efficacy, and the safety and tolerability and pharmacokinetics of single oral doses of RO4998452 in patients with diabetes mellitus type 2. On 3 treatment days a week apart, patients will each receive orally one of 2 dose levels of RO4998452 or placebo. Anticipated time of study treatment is 3 weeks. Target sample size is <50.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

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

  • France
      • Strasbourg, France, 67064

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients, 18-75 years of age
  • Type 2 diabetes mellitus, diagnosed for at least 3 months at screening
  • Treatment with diet and exercise
  • BMI between 27 and 40 kg/m2

Exclusion Criteria:

  • Type 1 diabetes
  • History of ketoacidosis, hyperosmolar coma, or lactic acidosis
  • Renal disease or renal dysfunction
  • Evidence of significant diabetic complication
  • Currently or within 3 months prior to screening treated with any oral or injectable anti-diabetic agents (exception: insulin injection in emergency situation)
  • History of anti-diabetic triple therapy

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: C
Drug: Placebo
single oral dose
Experimental: A
Drug: RO4998452
single oral doses
Experimental: B
Drug: RO4998452
single oral doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect on postprandial plasma glucose concentration
Time Frame: Following meal 13 hours after dosing
Following meal 13 hours after dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean postprandial daily plasma glucose concentration (3 consecutive meals)
Time Frame: 25 hours
25 hours
Mean daily blood glucose concentration, pre-meal plasma glucose concentration, plasma insulin concentration
Time Frame: Assessments up to 25 hours after dosing
Assessments up to 25 hours after dosing
Urinary glucose excretion
Time Frame: Assessments up to 25 hours after dosing
Assessments up to 25 hours after dosing
Safety and tolerability: AEs, laboratory parameters
Time Frame: AEs throughout study, laboratory assessments on 3 treatment days and on follow-up
AEs throughout study, laboratory assessments on 3 treatment days and on follow-up

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, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

November 17, 2009

First Submitted That Met QC Criteria

January 6, 2010

First Posted (Estimate)

January 7, 2010

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

  • BP22764
  • 2009-013124-23

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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