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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00682097
Recruitment Status : Completed
First Posted : May 22, 2008
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: RO4998452 Drug: placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2008
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ]
  2. AUC0-24h, Cmax [ Time Frame: Days 1 and 14 ]

Secondary Outcome Measures :
  1. Parameters of glucose metabolism [ Time Frame: Throughout study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00682097     History of Changes
Other Study ID Numbers: BP21549
2007-007120-18
First Posted: May 22, 2008    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

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