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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01044017

Enrollment

Registered

2010-01-07

Start date

2009-12-31

Completion date

2010-08-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

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.

Interventions

DRUGPlacebo

single oral dose

DRUGRO4998452

single oral doses

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Effect on postprandial plasma glucose concentration	Following meal 13 hours after dosing

Secondary

Measure	Time frame
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
Urinary glucose excretion	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026