A Study of Dipeptidyl-peptidase IV (DPP-IV) RO4876904 in Patients With Type 2 Diabetes.

NCT ID: NCT00502710

Last Updated: 2016-08-05

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

PHASE2

Total Enrollment

289 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-04-30

Brief Summary

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This 5 arm study will assess the efficacy, pharmacokinetics, safety and tolerability of a DPP-IV inhibitor compared to placebo in patients with type 2 diabetes. Patients will be randomized to receive DPP-IV(3) at one of 4 doses (of 12.5mg and above), or placebo p.o. Patients receiving metformin before the study will continue on the same dose of metformin. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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RO4876904 1

Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.

Group Type EXPERIMENTAL

RO4876904

Intervention Type DRUG

Escalating doses, at a starting dose of 12.5mg po daily.

RO4876904 2

Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.

Group Type EXPERIMENTAL

RO4876904

Intervention Type DRUG

Escalating doses, at a starting dose of 12.5mg po daily.

RO4876904 3

Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.

Group Type EXPERIMENTAL

RO4876904

Intervention Type DRUG

Escalating doses, at a starting dose of 12.5mg po daily.

RO4876904 4

Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.

Group Type EXPERIMENTAL

RO4876904

Intervention Type DRUG

Escalating doses, at a starting dose of 12.5mg po daily.

Placebo

Placebo po daily. Patients receiving metformin before the study will continue on the same dose of metformin.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo po daily.

Interventions

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Placebo

Placebo po daily.

Intervention Type DRUG

RO4876904

Escalating doses, at a starting dose of 12.5mg po daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, 18-75 years of age;
* type 2 diabetes diagnosed \>= 1 month before screening;
* drug-naive, or pretreated with maximum tolerated dose (MTD) of metformin;
* BMI 25-45kg/m2.

Exclusion Criteria

* type 1 diabetes;
* any anti-hyperglycemic medication other than metformin, or weight-lowering drug, during last 3 months.
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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Hot Springs, Arkansas, United States

Site Status

Concord, California, United States

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Los Angeles, California, United States

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Chicago, Illinois, United States

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Avon, Indiana, United States

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Indianapolis, Indiana, United States

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Oxon Hill, Maryland, United States

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Troy, Michigan, United States

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Omaha, Nebraska, United States

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Binghamton, New York, United States

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Charlotte, North Carolina, United States

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Beaver, Pennsylvania, United States

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Adelaide, , Australia

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Canberra, , Australia

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St Leonards, , Australia

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São Paulo, , Brazil

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São Paulo, , Brazil

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Guatemala City, , Guatemala

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Hong Kong, , Hong Kong

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Aguascalientes, , Mexico

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Chihuahua City, , Mexico

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Guadalajara, , Mexico

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Guadalajara, , Mexico

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Mexico City, , Mexico

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Pachuca, , Mexico

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Tampico, , Mexico

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Yaroslavl, , Russia

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Yaroslavl, , Russia

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Alzira, , Spain

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Bacarot Alicant, , Spain

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Badalona, , Spain

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Barcelona, , Spain

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Ferrol, , Spain

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Bath, , United Kingdom

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Frome, , United Kingdom

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Glasgow, , United Kingdom

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Liverpool, , United Kingdom

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Motherwell, , United Kingdom

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Countries

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United States Australia Brazil Guatemala Hong Kong Mexico Russia Spain United Kingdom

Other Identifiers

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BC20779

Identifier Type: -

Identifier Source: org_study_id

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