Effects on Colesevelam HC1 (WelChol®) on Insulin Sensitivity in Subjects With Type 2 Diabetes Mellitus
1 other identifier
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 type-2-diabetes-mellitus
Started May 2006
Shorter than P25 for phase_2 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 3, 2006
CompletedFirst Posted
Study publicly available on registry
August 7, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedJune 25, 2008
June 1, 2008
5 months
August 3, 2006
June 24, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
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.
8 weeks
Secondary Outcomes (3)
To evaluate the effect of 2 weeks treatment with WelChol on insulin sensitivity,as measured by the hyperinsulinemic-euglycemic clamp method.
2 weeks
To evaluate acute and chronic effects of treatment with WelChol on plasma glucose after ingestion of a standard meal replacement.
8 weeks
To evaluate the effect of treatment with WelChol on HbA1C, insulin, fasting plasma glucose, and fructosamine.
8 weeks
Study Arms (2)
1
ACTIVE COMPARATORColesevelam hydrochloride
2
PLACEBO COMPARATORplacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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- Antidiabetic treatment may include oral agents; all antidiabetic agents must be withdrawn before randomization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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (1)
Diabetes and Glandular Research Associates
San Antonio, Texas, 78229, United States
Related Publications (1)
Schwartz SL, Lai YL, Xu J, Abby SL, Misir S, Jones MR, Nagendran S. The effect of colesevelam hydrochloride on insulin sensitivity and secretion in patients with type 2 diabetes: a pilot study. Metab Syndr Relat Disord. 2010 Apr;8(2):179-88. doi: 10.1089/met.2009.0049.
PMID: 20059361DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Director Clinical Development
Daiichi Sankyo
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 3, 2006
First Posted
August 7, 2006
Study Start
May 1, 2006
Primary Completion
October 1, 2006
Study Completion
March 1, 2007
Last Updated
June 25, 2008
Record last verified: 2008-06