A Study of Single Doses of RO4998452 in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01044017
First received: November 17, 2009
Last updated: August 26, 2014
Last verified: August 2014

November 17, 2009
August 26, 2014
December 2009
August 2010   (final data collection date for primary outcome measure)
Effect on postprandial plasma glucose concentration [ Time Frame: Following meal 13 hours after dosing ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01044017 on ClinicalTrials.gov Archive Site
  • Mean postprandial daily plasma glucose concentration (3 consecutive meals) [ Time Frame: 25 hours ] [ Designated as safety issue: No ]
  • Mean daily blood glucose concentration, pre-meal plasma glucose concentration, plasma insulin concentration [ Time Frame: Assessments up to 25 hours after dosing ] [ Designated as safety issue: No ]
  • Urinary glucose excretion [ Time Frame: Assessments up to 25 hours after dosing ] [ Designated as safety issue: No ]
  • Safety and tolerability: AEs, laboratory parameters [ Time Frame: AEs throughout study, laboratory assessments on 3 treatment days and on follow-up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Single Doses of RO4998452 in Patients With Type 2 Diabetes
A Single-center, Double-blind, Randomized, Cross-over, Placebo-controlled, Single-dose Study to Investigate Glycemic Parameters of Efficacy During 24 Hours, Safety/ Tolerability and Pharmacokinetics of Two Dose Levels of RO4998452 in Patients With Type 2 Diabetes Mellitus

This randomized, double-blind, placebo-controlled, cross-over study will evaluat e the glucose concentration and other glycemic parameters of efficacy, and the s afety and tolerability and pharmacokinetics of single oral doses of RO4998452 in patients with diabetes mellitus type 2. On 3 treatment days a week apart, patie nts will each receive orally one of 2 dose levels of RO4998452 or placebo. Antic ipated time of study treatment is 3 weeks. Target sample size is <50.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Diabetes Mellitus, Type 2
  • Drug: Placebo
    single oral dose
  • Drug: RO4998452
    single oral doses
  • Experimental: A
    Intervention: Drug: RO4998452
  • Experimental: B
    Intervention: Drug: RO4998452
  • Placebo Comparator: C
    Intervention: 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
22
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, 18-75 years of age
  • Type 2 diabetes mellitus, diagnosed for at least 3 months at screening
  • Treatment with diet and exercise
  • BMI between 27 and 40 kg/m2

Exclusion Criteria:

  • Type 1 diabetes
  • History of ketoacidosis, hyperosmolar coma, or lactic acidosis
  • Renal disease or renal dysfunction
  • Evidence of significant diabetic complication
  • Currently or within 3 months prior to screening treated with any oral or injectable anti-diabetic agents (exception: insulin injection in emergency situation)
  • History of anti-diabetic triple therapy
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01044017
BP22764, 2009-013124-23
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

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