Back to resultsA Study of Single Doses of RO4998452 in Patients With Type 2 Diabetes
Primary Purpose
Diabetes Mellitus Type 2
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Placebo
RO4998452
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes Mellitus Type 2
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
A
B
C
Arm Description
Outcomes
Primary Outcome Measures
Effect on postprandial plasma glucose concentration
Secondary Outcome Measures
Mean postprandial daily plasma glucose concentration (3 consecutive meals)
Mean daily blood glucose concentration, pre-meal plasma glucose concentration, plasma insulin concentration
Urinary glucose excretion
Safety and tolerability: AEs, laboratory parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01044017
Brief Title
A Study of Single Doses of RO4998452 in Patients With Type 2 Diabetes
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 Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Arm Title
C
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
single oral dose
Intervention Type
Drug
Intervention Name(s)
RO4998452
Intervention Description
single oral doses
Primary Outcome Measure Information:
Title
Effect on postprandial plasma glucose concentration
Time Frame
Following meal 13 hours after dosing
Secondary Outcome Measure Information:
Title
Mean postprandial daily plasma glucose concentration (3 consecutive meals)
Time Frame
25 hours
Title
Mean daily blood glucose concentration, pre-meal plasma glucose concentration, plasma insulin concentration
Time Frame
Assessments up to 25 hours after dosing
Title
Urinary glucose excretion
Time Frame
Assessments up to 25 hours after dosing
Title
Safety and tolerability: AEs, laboratory parameters
Time Frame
AEs throughout study, laboratory assessments on 3 treatment days and on follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Strasbourg
ZIP/Postal Code
67064
Country
France
12. IPD Sharing Statement
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A Study of Single Doses of RO4998452 in Patients With Type 2 Diabetes
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