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Completed

NCT Number: NCT00151762

Long-Term Study of Safety and Efficacy of WelChol® as an Additional Therapy in Patients With Type 2 Diabetes

This extension study is designed to evaluate the long-term safety and tolerability of colesevelam hydrochloride (WelChol®) in patients with type 2 diabetes.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mexico City, Mexico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion/Rollover Criteria:

  • Patients who have completed studies WEL-301, WEL-302, or WEL-303 with treatment compliance at least 80%
  • Patients who have completed studies WEL-301, WEL-302, or WEL-303 who have not met withdrawal criteria

Treatment and study plan

Colesevelam hydrochloride

Drug

Primary outcomes

  1. To evaluate safety and tolerability of colesevelam hydrochloride as add-on therapy

Secondary outcomes

  1. To assess the long-term effect on hemoglobin A1c

  2. To assess the long-term effect on fasting plasma glucose

  3. To assess effects on lipids and lipoproteins

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

A Multi-Center, 52-Week, Open-Label Extension Study (From Studies WEL-301, WEL-302, and WEL-303) to Evaluate the Long-Term Safety and Tolerability of WelChol® in Type 2 Diabetic Patients

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 9, 2005
Registry last updated
Jan 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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