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WelChol® and Insulin 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: Ages 18 - 75 years, inclusive Diagnosed with type 2 diabetes Stable insulin therapy for 6 weeks Stable dose of any other antidiabetic medications for 90 days Hemoglobin A1c value between 7.5% to 9.5% C peptide greater than 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 less than 60 mg/dL Serum TG greater than 500 mg/dL Body mass index (BMI) greater than 45 kg/m2-

Sites / Locations

Outcomes

Primary Outcome Measures

- To assess the additional lowering of HbA1c achieved by
addition of WelChol® to current antidiabetic therapy

Secondary Outcome Measures

To assess: the effects on fasting plasma glucose and
fructosamine; glycemic control response rate; effect on adiponectin; the effect on c-peptide; effect on c-reactive protein; effects on lipids and lipoproteins; the safety and tolerability of WelChol® as add-
on therapy to patients receiving insulin alone or with
other oral drugs

Full Information

First Posted
September 7, 2005
Last Updated
January 16, 2012
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00151749
Brief Title
WelChol® and Insulin 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 Diabetes With Inadequate Glycemic Control on Insulin Therapy Alone or Insulin Therapy 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
December 2005 (Actual)
Study Completion Date
December 2005 (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 WelChol® is for type 2 diabetes when added to insulin 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
260 (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
Title
addition of WelChol® to current antidiabetic therapy
Secondary Outcome Measure Information:
Title
To assess: the effects on fasting plasma glucose and
Title
fructosamine; glycemic control response rate; effect on adiponectin; the effect on c-peptide; effect on c-reactive protein; effects on lipids and lipoproteins; the safety and tolerability of WelChol® as add-
Title
on therapy to patients receiving insulin alone or with
Title
other oral drugs

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: Ages 18 - 75 years, inclusive Diagnosed with type 2 diabetes Stable insulin therapy for 6 weeks Stable dose of any other antidiabetic medications for 90 days Hemoglobin A1c value between 7.5% to 9.5% C peptide greater than 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 less than 60 mg/dL Serum TG greater than 500 mg/dL Body mass index (BMI) greater than 45 kg/m2-
Facility Information:
City
Tuscumbia
State/Province
Alabama
Country
United States
City
Sierra Vista
State/Province
Arizona
Country
United States
City
Jonesboro
State/Province
Arkansas
Country
United States
City
Searcy
State/Province
Arkansas
Country
United States
City
Carmichael
State/Province
California
Country
United States
City
Concord
State/Province
California
Country
United States
City
Fullerton
State/Province
California
Country
United States
City
La Jolla
State/Province
California
Country
United States
City
San Diego
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
Largo
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
New Port Richey
State/Province
Florida
Country
United States
City
West Palm Beach
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
City
Boston
State/Province
Massachusetts
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
Kansas City
State/Province
Missouri
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Bozeman
State/Province
Montana
Country
United States
City
Butte
State/Province
Montana
Country
United States
City
Englewood
State/Province
New Jersey
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Hickory
State/Province
North Carolina
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Statesville
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
Marion
State/Province
Ohio
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
Bristol
State/Province
Tennessee
Country
United States
City
Morristown
State/Province
Tennessee
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Midland
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Mexico DF
Country
Mexico
City
Lima
Country
Peru

12. IPD Sharing Statement

Citations:
PubMed Identifier
18663165
Citation
Goldberg RB, Fonseca VA, Truitt KE, Jones MR. Efficacy and safety of colesevelam in patients with type 2 diabetes mellitus and inadequate glycemic control receiving insulin-based therapy. Arch Intern Med. 2008 Jul 28;168(14):1531-40. doi: 10.1001/archinte.168.14.1531.
Results Reference
derived

Learn more about this trial

WelChol® and Insulin in Treating Patients With Type 2 Diabetes

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