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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: November 17, 2009
Last updated: November 1, 2016
Last verified: November 2016
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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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

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 ]

Secondary Outcome Measures:
  • 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 ]

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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01044017

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

Responsible Party: Hoffmann-La Roche Identifier: NCT01044017     History of Changes
Other Study ID Numbers: BP22764
Study First Received: November 17, 2009
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on September 19, 2017