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Glycemic Effect of Colesevelam HCl (Welchol) in Patients With Type 2 Diabetes

Information source: Park Nicollet Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes

Intervention: colesevelam HCl (Drug); placebo (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Park Nicollet Institute

Official(s) and/or principal investigator(s):
Roger S. Mazze, PhD, Study Director, Affiliation: International Diabetes Center at Park Nicollet
Elinor S. Strock, APRN, BC, Principal Investigator, Affiliation: International Diabetes Center at Park Nicollet
Robert M. Cuddihy, MD, Principal Investigator, Affiliation: International Diabetes Center at Park Nicollet

Summary

The purpose of this study is to obtain continuous glucose monitoring (CGM) data from individuals taking Welchol compared to placebo. The CGM data will determine the effect on glucose control of adding Welchol to an anti-diabetic medication regimen.

Clinical Details

Official title: Use of Continuous Glucose Monitoring With Ambulatory Glucose Profile Analysis to Demonstrate the Glycemic Effect of Colesevelam HCl (Welchol) in Patients With Type 2 Diabetes

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Total Norm AUC Average by Group (Normalized)

Sleep Norm AUC Average by Group (Normalized)

Wake Norm AUC Average by Group (Normalized)

Hypoglycemia Percentage of Time <70 mg/dL Average by Group

Detailed description: To understand the effect of the addition of colesevelam HCl to oral agent therapy in individuals with type 2 diabetes on glycemic control by utilizing a novel technology, continuous glucose monitoring with ambulatory glucose profile analysis. To date there are no studies of this compound that have employed continuous glucose monitoring (CGM) with ambulatory glucose profile (AGP) analysis to obtain data that will detail the diurnal glucose patterns associated with this therapy. We plan to employ CGM at critical points throughout the study. AGP analysis will enable rapid assessment of the clinical status of the subject. Using statistically stable estimates of hourly values represented by five percentile curves AGP depicts glucose exposure, variability and stability. Previously, we have used AGP analysis to characterize glucose perturbations in individuals ranging from normal glucose tolerance to overt type 2 diabetes.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female subjects ≥18 and ≤75 years of age

- Clinical diagnosis of type 2 diabetes

- Currently treated with metformin, a sulfonylurea, or combination

metformin/sulfonylurea; stable dose for ≥3 months

- HbA1c of 7. 0-9. 0% inclusive

- If taking lipid lowering medications, stable dose for >30 days

Exclusion Criteria:

- Taken oral or injected prednisone or cortisone medications in the previous 30 days.

(Topical or inhaled steroids will not be considered excluded medications.)

- Current use of insulin or TZD's, or incretins

- LDL <70 mg/dL

- Serum triglycerides >500 mg/dL

- History of hypertriglyceridemia-induced pancreatitis

- History of gastrointestinal disorder such as dysphagia, swallowing disorder,

intestinal motility disorder or prior bowel obstruction

- History or presence of any severe medical or psychological condition or chronic

conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study

- Unable to follow the study protocol

- Unable to speak, read and write in English

- Pregnant, planning to become pregnant, breast feeding

Locations and Contacts

International Diabetes Center, Minneapolis, Minnesota 55416, United States
Additional Information

Starting date: September 2009
Last updated: June 16, 2014

Page last updated: August 23, 2015

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