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

Hoffmann-La Roche22 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus Type 2

Interventions

PlaceboDRUG

single oral dose

RO4998452DRUG

single oral doses

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Strasbourg, France

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)

Time frame: 25 hours

Mean daily blood glucose concentration, pre-meal plasma glucose concentration, plasma insulin concentration

Time frame: Assessments up to 25 hours after dosing

Urinary glucose excretion

Time frame: 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

Data from ClinicalTrials.gov

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