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

NCT ID: NCT01044017

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type EXPERIMENTAL

RO4998452

Intervention Type DRUG

single oral doses

B

Group Type EXPERIMENTAL

RO4998452

Intervention Type DRUG

single oral doses

C

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

single oral dose

Interventions

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Placebo

single oral dose

Intervention Type DRUG

RO4998452

single oral doses

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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2009-013124-23

Identifier Type: -

Identifier Source: secondary_id

BP22764

Identifier Type: -

Identifier Source: org_study_id