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

Diabetes Mellitus Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01044017
• Other study ID #: BP22764
• Secondary ID: 2009-013124-23
• Status: Completed
• Phase: Phase 1
• First received: November 17, 2009
• Last updated: November 1, 2016
• Start date: December 2009
• Est. completion date: August 2010

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Placebo
single oral dose
• RO4998452
single oral doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on postprandial plasma glucose concentration		Following meal 13 hours after dosing	No
Secondary	Mean postprandial daily plasma glucose concentration (3 consecutive meals)		25 hours	No
Secondary	Mean daily blood glucose concentration, pre-meal plasma glucose concentration, plasma insulin concentration		Assessments up to 25 hours after dosing	No
Secondary	Urinary glucose excretion		Assessments up to 25 hours after dosing	No
Secondary	Safety and tolerability: AEs, laboratory parameters		AEs throughout study, laboratory assessments on 3 treatment days and on follow-up	No