Effects of Colesevelam HCl, Rosiglitazone, Sitagliptin on Control of Blood Glucose and Lipids in Type 2 Diabetes Patients Whose Blood Glucose Isn't Completely Controlled With Metformin

NCT ID: NCT00484419

Last Updated: 2016-10-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-04-30

Brief Summary

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A 16 week open-label study with subjects receiving background metformin monotherapy. 150 subjects randomized 1:1:1 to receive 1 of the following: open-label colesevelam HCl, open label rosiglitazone, or open-label sitagliptin.

Detailed Description

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Conditions

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Type 2 Diabetes Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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colesevelam

colesevelam tablets 625 mg

Group Type EXPERIMENTAL

Colesevelam HCl

Intervention Type DRUG

coleveselam tablets 625 mg; 6 tablets/day

rosiglitazone

rosiglitazone maleate 4mg

Group Type ACTIVE_COMPARATOR

rosiglitazone maleate

Intervention Type DRUG

rosiglitazone tablets 4mg

sitagliptin

sitagliptin phosphate tablets

Group Type ACTIVE_COMPARATOR

sitagliptin phosphate

Intervention Type DRUG

sitagliptin phosphate tablets 100mg/day

Interventions

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Colesevelam HCl

coleveselam tablets 625 mg; 6 tablets/day

Intervention Type DRUG

rosiglitazone maleate

rosiglitazone tablets 4mg

Intervention Type DRUG

sitagliptin phosphate

sitagliptin phosphate tablets 100mg/day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HbA1C 7.0 % to 10.0% on metformin monotherapy; may be withdrawn from other (non-metformin) drugs if HbA1C is 6.5% to 9.5 % at screening.

Exclusion Criteria

* Subjects currently treated with a thiazolidinedione are excluded.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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La Mesa, California, United States

Site Status

Los Angeles, California, United States

Site Status

Los Gatos, California, United States

Site Status

San Antonio, California, United States

Site Status

Chiefland, Florida, United States

Site Status

Gary, Indiana, United States

Site Status

Baltimore, Maryland, United States

Site Status

Dearborn, Michigan, United States

Site Status

West Bloomfield, Michigan, United States

Site Status

Las Vegas, Nevada, United States

Site Status

Yonkers, New York, United States

Site Status

Lexington, North Carolina, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Munroe Falls, Ohio, United States

Site Status

Zaneville, Ohio, United States

Site Status

Portland, Oregon, United States

Site Status

Jersey Shore, Pennsylvania, United States

Site Status

Clemson, South Carolina, United States

Site Status

Harriman, Tennessee, United States

Site Status

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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Wel-409

Identifier Type: -

Identifier Source: org_study_id

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