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

Hoffmann-La Roche0 sites22 target enrollmentDecember 2009

ConditionsDiabetes Mellitus Type 2

InterventionsRO4998452 Placebo

DrugsPlacebo RO4998452

Overview

Phase: Phase 1
Intervention: RO4998452
Conditions: Diabetes Mellitus Type 2
Sponsor: Hoffmann-La Roche
Enrollment: 22
Primary Endpoint: Effect on postprandial plasma glucose concentration
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

August 2010

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

A

Intervention: RO4998452

B

Intervention: RO4998452

C

Intervention: Placebo

Outcomes

Primary Outcomes

Effect on postprandial plasma glucose concentration

Time Frame: Following meal 13 hours after dosing

Secondary Outcomes

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