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WelChol® With Metformin in Treating Patients With Type 2 Diabetes

Sponsor
Daiichi Sankyo, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00147719
Collaborator
(none)
300
Enrollment
48
Locations
25
Duration (Months)
6.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Colesevelam hydrochloride
 Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Start Date :
Jun 1, 2004
Actual Primary Completion Date :
Jul 1, 2006
Actual Study Completion Date :
Jul 1, 2006

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. To assess the fasting plasma glucose and fructosamine lowering effect; []

  2. To assess the glycemic control response rate; []

  3. To assess the improvement in insulin sensitivity; []

  4. To assess the effect on high sensitivity C-reactive protein; []

  5. To assess the improvement in lipids, and lipoproteins; []

  6. To assess the safety and tolerability of colesevelam hydrochloride when added on to current therapy []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CRO Jonesboro Arkansas United States
2 Beverly Hills California United States
3 Carmichael California United States
4 Fresno California United States
5 Irvine California United States
6 La Jolla California United States
7 Los Gatos California United States
8 San Diego California United States
9 Spring Valley California United States
10 West Hills California United States
11 Washington District of Columbia United States
12 Coco Beach Florida United States
13 Largo Florida United States
14 Miami Florida United States
15 Pembroke Pines Florida United States
16 West Palm Beach Florida United States
17 Atlanta Georgia United States
18 Evansville Indiana United States
19 Louisville Kentucky United States
20 Detroit Michigan United States
21 Troy Michigan United States
22 Edina Minnesota United States
23 Chesterfield Missouri United States
24 Bozeman Montana United States
25 Butte Montana United States
26 Las Vegas Nevada United States
27 Rochester New York United States
28 Charlotte North Carolina United States
29 Winston-Salem North Carolina United States
30 Cincinnati Ohio United States
31 Cleveland Ohio United States
32 Lyndhurst Ohio United States
33 Marion Ohio United States
34 Oklahoma City Oklahoma United States
35 Tulsa Oklahoma United States
36 Portland Oregon United States
37 Beaver Pennsylvania United States
38 Charleston South Carolina United States
39 Columbia South Carolina United States
40 Morristown Tennessee United States
41 Corpus Christi Texas United States
42 Dallas Texas United States
43 Pharr Texas United States
44 San Antonio Texas United States
45 Arlington Virginia United States
46 Richmond Virginia United States
47 Mexico DF Mexico
48 Lima Peru

Sponsors and Collaborators

  • Daiichi Sankyo, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier:
NCT00147719
Other Study ID Numbers:
  • WEL-301
First Posted:
Sep 7, 2005
Last Update Posted:
Jan 18, 2012
Last Verified:
Jan 1, 2012
Keywords provided by Daiichi Sankyo, Inc.
Diabetes Mellitus
Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Colesevelam Hydrochloride

Study Results

No Results Posted as of Jan 18, 2012