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
2 other identifiers
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 diabetes-mellitus-type-2
Started Dec 2009
Typical duration for phase_1 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedFirst Posted
Study publicly available on registry
January 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedNovember 2, 2016
November 1, 2016
8 months
November 17, 2009
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Effect on postprandial plasma glucose concentration
Following meal 13 hours after dosing
Secondary Outcomes (4)
Mean postprandial daily plasma glucose concentration (3 consecutive meals)
25 hours
Mean daily blood glucose concentration, pre-meal plasma glucose concentration, plasma insulin concentration
Assessments up to 25 hours after dosing
Urinary glucose excretion
Assessments up to 25 hours after dosing
Safety and tolerability: AEs, laboratory parameters
AEs throughout study, laboratory assessments on 3 treatment days and on follow-up
Study Arms (3)
A
EXPERIMENTALB
EXPERIMENTALC
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Strasbourg, 67064, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2009
First Posted
January 7, 2010
Study Start
December 1, 2009
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
November 2, 2016
Record last verified: 2016-11