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

NCT ID: NCT00111670

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

291 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-07-31

Brief Summary

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This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor compared to placebo in patients with type 2 diabetes. The anticipated time on study treatment is \< 3 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 or qd

2

Group Type EXPERIMENTAL

DPP-IV Inhibitor

Intervention Type DRUG

Escalating doses po bid or qd

3

Group Type EXPERIMENTAL

DPP-IV Inhibitor

Intervention Type DRUG

Escalating doses po bid or qd

4

Group Type EXPERIMENTAL

DPP-IV Inhibitor

Intervention Type DRUG

Escalating doses po bid or qd

5

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

po bid or qd

Interventions

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DPP-IV Inhibitor

Escalating doses po bid or qd

Intervention Type DRUG

Placebo

po bid or qd

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;
* no previous treatment, or previous treatment with no more than 2 oral medications.

Exclusion Criteria

* type 1 diabetes;
* type 2 diabetes treated with insulin or a PPAR gamma agonist during the 3 months before screening;
* patients who are pregnant, breastfeeding or not using a reliable contraceptive method.
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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Salinas, California, United States

Site Status

Clearwater, Florida, United States

Site Status

Hialeah, Florida, United States

Site Status

Pembroke Pines, Florida, United States

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Blue Ridge, Georgia, United States

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Aurora, Illinois, United States

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Elkton, Maryland, United States

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Oxon Hill, Maryland, United States

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Troy, Michigan, United States

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Pahrump, Nevada, United States

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Cincinnati, Ohio, United States

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Portland, Oregon, 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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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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San José, , Costa Rica

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Tartu, , Estonia

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Tartu, , Estonia

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Ogre, , Latvia

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Riga, , Latvia

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Klaipėda, , Lithuania

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Vilnius, , Lithuania

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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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Mexico City, , Mexico

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Monterrey, , Mexico

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Pachuca, , Mexico

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Ponce, , Puerto Rico

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Ploieşti, , Romania

Site Status

Târgu Mureş, , Romania

Site Status

Countries

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United States Bulgaria Costa Rica Estonia Latvia Lithuania Mexico Puerto Rico Romania

Other Identifiers

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BM18102

Identifier Type: -

Identifier Source: org_study_id