WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes

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Daiichi Sankyo

Status and phase

Completed
Phase 3

Conditions

Type 2 Diabetes

Treatments

Drug: Colesevelam hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00147758
WEL-303

Details and patient eligibility

About

The purpose of the study is to see how safe and effective and tolerable the use of colesevelam hydrochloride is for type 2 diabetes when added to sulfonylurea alone or in combination with other anti-diabetic drugs.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* Age 18-75 years, inclusive * Diagnosed with type 2 diabetes * Stable dose of sulfonylurea alone or in combination with other anti-diabetic medications for 90 days * Hemoglobin A1c value 7.5% to 9.5%, inclusive * C peptide \> 0.5 ng/mL * Prescribed ADA diet

Exclusion criteria

* History of type 1 diabetes or ketoacidosis * History of pancreatitis * Uncontrolled hypertension * Allergy or toxic response to colesevelam or any of its components * Serum LDL-C \< 60 mg/dL * Serum TG \> 500 mg/dL * Body mass index (BMI) \> 45 kg/m2

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

47

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Data sourced from clinicaltrials.gov

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