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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01044017
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 3
• Duration (Months): 8
• Patients Per Site Per Month: 2.8

Study Details

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
• 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: Dec 1, 2009
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

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 [Following meal 13 hours after dosing]

Secondary Outcome Measures

1. Mean postprandial daily plasma glucose concentration (3 consecutive meals) [25 hours]

2. Mean daily blood glucose concentration, pre-meal plasma glucose concentration, plasma insulin concentration [Assessments up to 25 hours after dosing]

3. Urinary glucose excretion [Assessments up to 25 hours after dosing]

4. Safety and tolerability: AEs, laboratory parameters [AEs throughout study, laboratory assessments on 3 treatment days and on follow-up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1		Strasbourg		France	67064

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01044017
• Other Study ID Numbers: BP22764; 2009-013124-23
• First Posted: Jan 7, 2010
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Nov 2, 2016