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

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. Identifier: NCT01044017
Recruitment Status : Completed
First Posted : January 7, 2010
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

November 17, 2009
January 7, 2010
November 2, 2016
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 ]
Same as current
Complete list of historical versions of study NCT01044017 on Archive Site
  • Mean postprandial daily plasma glucose concentration (3 consecutive meals) [ Time Frame: 25 hours ]
  • Mean daily blood glucose concentration, pre-meal plasma glucose concentration, plasma insulin concentration [ Time Frame: Assessments up to 25 hours after dosing ]
  • Urinary glucose excretion [ Time Frame: Assessments up to 25 hours after dosing ]
  • Safety and tolerability: AEs, laboratory parameters [ Time Frame: AEs throughout study, laboratory assessments on 3 treatment days and on follow-up ]
Same as current
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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 evaluate the glucose concentration and other glycemic parameters of efficacy, and the safety and tolerability and pharmacokinetics of single oral doses of RO4998452 in patients with diabetes mellitus type 2. On 3 treatment days a week apart, patients will each receive orally one of 2 dose levels of RO4998452 or placebo. Anticipated time of study treatment is 3 weeks. Target sample size is <50.
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Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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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