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: March 9, 2015
Last verified: March 2015
  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: placebo
Drug: RO4998452
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

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: placebo
Oral doses
Drug: RO4998452
Escalating oral doses
Experimental: 2 Drug: placebo
Oral doses
Drug: RO4998452
Escalating oral doses
Experimental: 3 Drug: placebo
Oral doses
Drug: RO4998452
Escalating oral doses
Experimental: 4 Drug: placebo
Oral doses
Drug: RO4998452
Escalating oral doses
Experimental: 5 Drug: placebo
Oral doses
Drug: RO4998452
Escalating oral doses
Experimental: 6 Drug: placebo
Oral doses
Drug: RO4998452
Escalating oral doses
Experimental: 7 Drug: placebo
Oral doses
Drug: RO4998452
Escalating 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: March 9, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on March 31, 2015