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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo
Drug: RO4998452
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Effect on postprandial plasma glucose concentration [ Time Frame: Following meal 13 hours after dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 22
Study Start Date: December 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: RO4998452
single oral doses
Experimental: B Drug: RO4998452
single oral doses
Placebo Comparator: C Drug: Placebo
single oral dose

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01044017

Locations
France
Strasbourg, France, 67064
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01044017     History of Changes
Other Study ID Numbers: BP22764, 2009-013124-23
Study First Received: November 17, 2009
Last Updated: August 26, 2014
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 26, 2014