Effects on Colesevelam HC1 (WelChol®) on Insulin Sensitivity in Subjects With Type 2 Diabetes Mellitus
This study has been completed.
Sponsor:
Daiichi Sankyo Inc.
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00361153
First received: August 3, 2006
Last updated: June 24, 2008
Last verified: June 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Colesevelam hydrochloride Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Effects on Colesevelam HC1 (WelChol®) on Insulin Sensitivity in Subjects With Type 2 Diabetes Mellitus |
Resource links provided by NLM:
Further study details as provided by Daiichi Sankyo Inc.:
Primary Outcome Measures:
- To evaluate the effect of 8 weeks treatment with WelChol on insulin sensitivity,as measured by the hyperinsulinemic-euglycemic clamp method, i.e., placebo-corrected change from baseline in M-value. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the effect of 2 weeks treatment with WelChol on insulin sensitivity,as measured by the hyperinsulinemic-euglycemic clamp method. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- To evaluate acute and chronic effects of treatment with WelChol on plasma glucose after ingestion of a standard meal replacement. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- To evaluate the effect of treatment with WelChol on HbA1C, insulin, fasting plasma glucose, and fructosamine. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 35 |
| Study Start Date: | May 2006 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Colesevelam hydrochloride
|
Drug: Colesevelam hydrochloride
Welchol tablet 625mg
Other Name: Welchol
|
|
Placebo Comparator: 2
placebo
|
Drug: placebo
placebo
Other Name: placebo
|
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. A screening period may be up to 18 weeks to withdraw non sulfonylurea antidiabetic treatment or withdraw or adjust sulfonylurea antidiabetic treatment. To evaluate hepatic and peripheral insulin sensitivity, subjects will undergo a two-step hyperinsulinemic-euglycemic clamp with a tritiated glucose infusion at pre randomization and after 8 weeks of treatment. To evaluate oral glucose absorption, subjects will undergo two oral glucose tolerance tests (OGTT) at pre randomization, one without colesevelam and one with colesevelam, and one OGTT at the end of the treatment period..
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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 Criteria:
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00361153
Locations
| United States, Texas | |
| Diabetes and Glandular Research Associates | |
| San Antonio, Texas, United States, 78229 | |
Sponsors and Collaborators
Daiichi Sankyo Inc.
Investigators
| Study Director: | Director Clinical Development | Daiichi Sankyo Inc. |
More Information
No publications provided by Daiichi Sankyo Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Vice President Clinical Development, Daiichi Sankyo |
| ClinicalTrials.gov Identifier: | NCT00361153 History of Changes |
| Other Study ID Numbers: | WEL-202 |
| Study First Received: | August 3, 2006 |
| Last Updated: | June 24, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Insulin Resistance Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Hyperinsulinism Colesevelam |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013