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: July 7, 2014
Last verified: July 2014

November 17, 2009
July 7, 2014
December 2009
Not Provided
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: RO4998452
    single oral doses
  • Drug: Placebo
    single oral dose
  • 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
March 2010
Not Provided

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
July 2014

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