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

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ClinicalTrials.gov Identifier: NCT01044017
Recruitment Status : Completed
First Posted : January 7, 2010
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Placebo Drug: RO4998452 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
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
Study Start Date : December 2009
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A Drug: RO4998452
single oral doses
Experimental: B Drug: RO4998452
single oral doses
Placebo Comparator: C Drug: Placebo
single oral dose


Outcome Measures

Primary Outcome Measures :
  1. Effect on postprandial plasma glucose concentration [ Time Frame: Following meal 13 hours after dosing ]

Secondary Outcome Measures :
  1. Mean postprandial daily plasma glucose concentration (3 consecutive meals) [ Time Frame: 25 hours ]
  2. Mean daily blood glucose concentration, pre-meal plasma glucose concentration, plasma insulin concentration [ Time Frame: Assessments up to 25 hours after dosing ]
  3. Urinary glucose excretion [ Time Frame: Assessments up to 25 hours after dosing ]
  4. Safety and tolerability: AEs, laboratory parameters [ Time Frame: AEs throughout study, laboratory assessments on 3 treatment days and on follow-up ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01044017


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01044017     History of Changes
Other Study ID Numbers: BP22764
2009-013124-23
First Posted: January 7, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

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