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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 1, 2016
Last verified: November 2016
May 20, 2008
November 1, 2016
May 2008
March 2009   (Final data collection date for primary outcome measure)
  • AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ]
  • AUC0-24h, Cmax [ Time Frame: Days 1 and 14 ]
Same as current
Complete list of historical versions of study NCT00682097 on ClinicalTrials.gov Archive Site
Parameters of glucose metabolism [ Time Frame: Throughout study ]
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 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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United States
 
 
NCT00682097
BP21549
2007-007120-18
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

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