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

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Hyperlipidemia; Type 2 Diabetes

Treatments: Drug: Colesevelam HCl; Drug: rosiglitazone maleate; Drug: sitagliptin phosphate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00484419

Wel-409

Details and patient eligibility

About

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.

Enrollment: 169 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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• HbA1C 7.0 % to 10.0% on metformin monotherapy; may be withdrawn from other (non-metformin) drugs if HbA1C is 6.5% to 9.5 % at screening.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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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169 participants in 3 patient groups

colesevelam

Experimental group

Description:

colesevelam tablets 625 mg

Treatment:

Drug: Colesevelam HCl

rosiglitazone

Active Comparator group

Description:

rosiglitazone maleate 4mg

Treatment:

Drug: rosiglitazone maleate

sitagliptin

Active Comparator group

Description:

sitagliptin phosphate tablets

Treatment:

Drug: sitagliptin phosphate