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WelChol® With Metformin in Treating Patients With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Colesevelam hydrochloride
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Diabetes Mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-75 years, inclusive Diagnosed with type 2 diabetes Hemoglobin (HbA1c) between 7.5% to 9.5% Prescribed an ADA accepted diet Receiving stable dose of metformin alone or in combination with other oral anti-diabetic medications for 90 days before Visit 1 Exclusion Criteria: History of type 1 diabetes or ketoacidosis History of chronic (more than 2 months) insulin therapy or the initiation of insulin for chronic treatment History of pancreatitis Uncontrolled hypertension Recent severe cardiovascular disease Allergy or toxic response to colesevelam or any of its components Body mass index (BMI) >45 kg/m2

Sites / Locations

  • CRO

Outcomes

Primary Outcome Measures

To assess the additional lowering of HbA1C achieved by addition of colesevelam hydrochloride to current antidiabetic therapy

Secondary Outcome Measures

To assess the fasting plasma glucose and fructosamine lowering effect;
To assess the glycemic control response rate;
To assess the improvement in insulin sensitivity;
To assess the effect on high sensitivity C-reactive protein;
To assess the improvement in lipids, and lipoproteins;
To assess the safety and tolerability of colesevelam hydrochloride when added on to current therapy

Full Information

First Posted
September 2, 2005
Last Updated
January 16, 2012
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00147719
Brief Title
WelChol® With Metformin in Treating Patients With Type 2 Diabetes
Official Title
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Type 2 Diabetics With Inadequate Glycemic Control on Metformin Monotherapy or Metformin Therapy in Combination With Other Oral Anti-Diabetic Agents
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

5. Study Description

Brief Summary
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 metformin alone or in combination with other anti-diabetic drugs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Colesevelam hydrochloride
Primary Outcome Measure Information:
Title
To assess the additional lowering of HbA1C achieved by addition of colesevelam hydrochloride to current antidiabetic therapy
Secondary Outcome Measure Information:
Title
To assess the fasting plasma glucose and fructosamine lowering effect;
Title
To assess the glycemic control response rate;
Title
To assess the improvement in insulin sensitivity;
Title
To assess the effect on high sensitivity C-reactive protein;
Title
To assess the improvement in lipids, and lipoproteins;
Title
To assess the safety and tolerability of colesevelam hydrochloride when added on to current therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-75 years, inclusive Diagnosed with type 2 diabetes Hemoglobin (HbA1c) between 7.5% to 9.5% Prescribed an ADA accepted diet Receiving stable dose of metformin alone or in combination with other oral anti-diabetic medications for 90 days before Visit 1 Exclusion Criteria: History of type 1 diabetes or ketoacidosis History of chronic (more than 2 months) insulin therapy or the initiation of insulin for chronic treatment History of pancreatitis Uncontrolled hypertension Recent severe cardiovascular disease Allergy or toxic response to colesevelam or any of its components Body mass index (BMI) >45 kg/m2
Facility Information:
Facility Name
CRO
City
Jonesboro
State/Province
Arkansas
Country
United States
City
Beverly Hills
State/Province
California
Country
United States
City
Carmichael
State/Province
California
Country
United States
City
Fresno
State/Province
California
Country
United States
City
Irvine
State/Province
California
Country
United States
City
La Jolla
State/Province
California
Country
United States
City
Los Gatos
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Spring Valley
State/Province
California
Country
United States
City
West Hills
State/Province
California
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Coco Beach
State/Province
Florida
Country
United States
City
Largo
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Pembroke Pines
State/Province
Florida
Country
United States
City
West Palm Beach
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Evansville
State/Province
Indiana
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Troy
State/Province
Michigan
Country
United States
City
Edina
State/Province
Minnesota
Country
United States
City
Chesterfield
State/Province
Missouri
Country
United States
City
Bozeman
State/Province
Montana
Country
United States
City
Butte
State/Province
Montana
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Lyndhurst
State/Province
Ohio
Country
United States
City
Marion
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Tulsa
State/Province
Oklahoma
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Beaver
State/Province
Pennsylvania
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Columbia
State/Province
South Carolina
Country
United States
City
Morristown
State/Province
Tennessee
Country
United States
City
Corpus Christi
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Pharr
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Arlington
State/Province
Virginia
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Mexico DF
Country
Mexico
City
Lima
Country
Peru

12. IPD Sharing Statement

Citations:
PubMed Identifier
18852398
Citation
Bays HE, Goldberg RB, Truitt KE, Jones MR. Colesevelam hydrochloride therapy in patients with type 2 diabetes mellitus treated with metformin: glucose and lipid effects. Arch Intern Med. 2008 Oct 13;168(18):1975-83. doi: 10.1001/archinte.168.18.1975.
Results Reference
derived

Learn more about this trial

WelChol® With Metformin in Treating Patients With Type 2 Diabetes

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