Skip to main content
OpenTrials
Completed

NCT Number: NCT00682097

A Multiple Ascending Dose Study of RO4998452 in Patients With Type 2 Diabetes Mellitus.

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Successive cohorts of patients will be randomized to receive either active drug, at escalating doses, or placebo. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Neuss, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients, 18-65 years of age;
  • type 2 diabetes;
  • either treated by diet and exercise alone or with metformin.

Exclusion criteria

  • type 1 diabetes mellitus;
  • uncontrolled hypertension;
  • clinically severe diabetic complications.

Treatment and study plan

RO4998452

Drug

Escalating oral doses

Placebo

Drug

Oral doses

Primary outcomes

  1. AEs, laboratory parameters, vital signs.

    Time frame: Throughout study

  2. AUC0-24h, Cmax

    Time frame: Days 1 and 14

Secondary outcomes

  1. Parameters of glucose metabolism

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Double-Blind, Multiple-Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO4998452 Following Oral Administrations in Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 22, 2008
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.