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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: November 24, 2014
Last verified: November 2014

May 20, 2008
November 24, 2014
May 2008
March 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00682097 on ClinicalTrials.gov Archive Site
Parameters of glucose metabolism [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Multiple Ascending Dose Study of RO4998452 in Patients With Type 2 Diabetes Mellitus.
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

This study will evaluate the safety, tolerability, pharmacokinetics and pharmaco dynamics of multiple ascending doses of RO4998452 compared to placebo in patient s with type 2 diabetes mellitus. Successive cohorts of patients will be randomiz ed to receive either active drug, at escalating doses, or placebo. The anticipat ed time on study treatment is <3 months, and the target sample size is <100 indi viduals.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: RO4998452
    Escalating oral doses
  • Drug: placebo
    Oral doses
  • Experimental: 1
    Interventions:
    • Drug: RO4998452
    • Drug: placebo
  • Experimental: 2
    Interventions:
    • Drug: RO4998452
    • Drug: placebo
  • Experimental: 3
    Interventions:
    • Drug: RO4998452
    • Drug: placebo
  • Experimental: 4
    Interventions:
    • Drug: RO4998452
    • Drug: placebo
  • Experimental: 5
    Interventions:
    • Drug: RO4998452
    • Drug: placebo
  • Experimental: 6
    Interventions:
    • Drug: RO4998452
    • Drug: placebo
  • Experimental: 7
    Interventions:
    • Drug: RO4998452
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
March 2009
March 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT00682097
BP21549, 2007-007120-18
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP