Status:
COMPLETED
Effects on Colesevelam HC1 (WelChol®) on Insulin Sensitivity in Subjects With Type 2 Diabetes Mellitus
Lead Sponsor:
Daiichi Sankyo
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study is designed to test whether WelChol (colesevelam HC1) improves blood sugar control in patients with type 2 diabetes by making their own insulin work more efficiently.
Detailed Description
Single-center, randomized, parallel, double-blind, placebo controlled, 8-week trial in subjects with type 2 diabetes mellitus. Two parallel treatment groups include double-blind colesevelam or placebo...
Eligibility Criteria
Inclusion
- Subjects meeting the following criteria at the Screening Visit will be eligible to participate in the trial:
- Have given written informed consent
- Ages 18 to 75 years, inclusive
- Diagnosis of type 2 diabetes mellitus of at least 3 months duration
- HbA1C 7.0- 10.0%, inclusive
- Antidiabetic treatment may include oral agents; all antidiabetic agents must be withdrawn before randomization
- Women may be enrolled if they are not pregnant (negative serum βHCG at the Screening Visit), are not breast-feeding, and do not plan to become pregnant during the trial. In addition, they must either have had a hysterectomy or tubal ligation at least 6 months before signing informed consent, be post-menopausal for 1 year, or practicing an acceptable method of birth control. An acceptable method of birth control may be oral, injectable or implantable hormonal contraceptives, intrauterine device, diaphragm plus spermicide, or female condom plus spermicide. Abstinence, partner's use of condoms, and partner's vasectomy are NOT acceptable methods of contraception
- BMI 25 - 45 kg/M sq, inclusive
Exclusion
- Subjects are excluded from participation in the study if any of the following criteria apply:
- Type 1 diabetes mellitus or history of diabetic ketoacidosis
- Treatment with lipid or blood pressure lowering therapy that has not been stable for three months before randomization
- Treatment with WelChol, cholestyramine or colestipol for hyperlipidemia within the last 3 months
- Treatment with thiazolidinediones
- History of dysphagia, swallowing disorders, or intestinal motility disorder
- Serum triglyceride \>500 mg/dL at Visit 1
- Serum LDL-C \<60 mg/dL at Visit 1
- Any condition or therapy which, in the opinion of the investigator, poses a risk to the subject or makes participation not in the subject's best interest
- Use of any investigational drug within 30 days before randomization
- Chronic treatment with oral corticosteroids
- History of hyperthyroidism and/or treatment with thyroid hormone/ levothyroxine
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00361153
Start Date
May 1 2006
End Date
March 1 2007
Last Update
June 25 2008
Active Locations (1)
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1
Diabetes and Glandular Research Associates
San Antonio, Texas, United States, 78229