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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00682097
First received: May 20, 2008
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: RO4998452
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • AUC0-24h, Cmax [ Time Frame: Days 1 and 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parameters of glucose metabolism [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: May 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RO4998452
Escalating oral doses
Drug: placebo
Oral doses
Experimental: 2 Drug: RO4998452
Escalating oral doses
Drug: placebo
Oral doses
Experimental: 3 Drug: RO4998452
Escalating oral doses
Drug: placebo
Oral doses
Experimental: 4 Drug: RO4998452
Escalating oral doses
Drug: placebo
Oral doses
Experimental: 5 Drug: RO4998452
Escalating oral doses
Drug: placebo
Oral doses
Experimental: 6 Drug: RO4998452
Escalating oral doses
Drug: placebo
Oral doses
Experimental: 7 Drug: RO4998452
Escalating oral doses
Drug: placebo
Oral doses

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682097

Locations
United States, California
Chula Vista, California, United States, 91911
United States, Texas
San Antonio, Texas, United States, 78229
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00682097     History of Changes
Other Study ID Numbers: BP21549, 2007-007120-18
Study First Received: May 20, 2008
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014