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

Roche

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: Placebo; Drug: RO4998452

Study type: Interventional

Funder types: Industry

Identifiers

NCT01044017

2009-013124-23

BP22764

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 3 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: RO4998452

B

Experimental group

Treatment:

Drug: RO4998452

C

Placebo Comparator group

Treatment:

Drug: Placebo