A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes

NCT ID: NCT00111631

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

PHASE2

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2006-10-31

Brief Summary

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This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients with type 2 diabetes receiving a stable 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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1

Group Type EXPERIMENTAL

DPP-IV Inhibitor

Intervention Type DRUG

Escalating doses po bid

Metformin

Intervention Type DRUG

As prescribed

2

Group Type EXPERIMENTAL

DPP-IV Inhibitor

Intervention Type DRUG

Escalating doses po bid

Metformin

Intervention Type DRUG

As prescribed

3

Group Type EXPERIMENTAL

DPP-IV Inhibitor

Intervention Type DRUG

Escalating doses po bid

Metformin

Intervention Type DRUG

As prescribed

4

Group Type PLACEBO_COMPARATOR

Metformin

Intervention Type DRUG

As prescribed

Placebo

Intervention Type DRUG

po bid

Interventions

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DPP-IV Inhibitor

Escalating doses po bid

Intervention Type DRUG

Metformin

As prescribed

Intervention Type DRUG

Placebo

po bid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients 18-75 years of age;
* type 2 diabetes;
* stable metformin therapy for \>=3 months before screening.

Exclusion Criteria

* women who are pregnant, breast-feeding, or not using an adequate contraceptive method;
* type 1 diabetes;
* any anti-hyperglycemic medication other than metformin in the 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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Concord, California, United States

Site Status

Salinas, California, United States

Site Status

San Diego, California, United States

Site Status

Boulder, Colorado, United States

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Newark, Delaware, United States

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Wilmington, Delaware, United States

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Clearwater, Florida, United States

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Miami, Florida, United States

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Chicago, Illinois, United States

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Detroit, Michigan, United States

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Buffalo, New York, United States

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Rochester, New York, United States

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Durham, North Carolina, United States

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Mogadore, Ohio, United States

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Portland, Oregon, United States

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Connellsville, Pennsylvania, United States

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Warminster, Pennsylvania, United States

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Dallas, Texas, United States

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Midland, Texas, United States

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San Antonio, Texas, United States

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Adelaide, , Australia

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Sydney, , Australia

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Winnipeg, Manitoba, Canada

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Halifax, Nova Scotia, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Bad Lauterberg im Harz, , Germany

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Berlin, , Germany

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Dresden, , Germany

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Görlitz, , Germany

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Mainz, , Germany

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Neuss, , Germany

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Ancona, , Italy

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Florence, , Italy

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Napoli, , Italy

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Udine, , Italy

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Ponce, , Puerto Rico

Site Status

Countries

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United States Australia Canada Germany Italy Puerto Rico

Other Identifiers

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BM18106

Identifier Type: -

Identifier Source: org_study_id