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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993824
• Other study ID #: 03901-09-C
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 12, 2009
• Last updated: November 25, 2015
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: February 2014
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• colesevelam HCl
3.75 grams of colesevelam HCl (6 tablets)
• placebo

Locations

Country	Name	City	State
United States	International Diabetes Center	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
HealthPartners Institute	Daiichi Sankyo Inc., International Diabetes Center at Park Nicollet

Country where clinical trial is conducted

United States, 

References & Publications (5)

Bays HE, Goldberg RB, Truitt KE, Jones MR. Colesevelam hydrochloride therapy in patients with type 2 diabetes mellitus treated with metformin: glucose and lipid effects. Arch Intern Med. 2008 Oct 13;168(18):1975-83. doi: 10.1001/archinte.168.18.1975. — View Citation

Goldberg RB, Fonseca VA, Truitt KE, Jones MR. Efficacy and safety of colesevelam in patients with type 2 diabetes mellitus and inadequate glycemic control receiving insulin-based therapy. Arch Intern Med. 2008 Jul 28;168(14):1531-40. doi: 10.1001/archinte — View Citation

Mazze RS, Strock E, Borgman S, Wesley D, Stout P, Racchini J. Evaluating the accuracy, reliability, and clinical applicability of continuous glucose monitoring (CGM): Is CGM ready for real time? Diabetes Technol Ther. 2009 Jan;11(1):11-8. doi: 10.1089/dia — View Citation

Mazze RS, Strock E, Wesley D, Borgman S, Morgan B, Bergenstal R, Cuddihy R. Characterizing glucose exposure for individuals with normal glucose tolerance using continuous glucose monitoring and ambulatory glucose profile analysis. Diabetes Technol Ther. 2 — View Citation

Zieve FJ, Kalin MF, Schwartz SL, Jones MR, Bailey WL. Results of the glucose-lowering effect of WelChol study (GLOWS): a randomized, double-blind, placebo-controlled pilot study evaluating the effect of colesevelam hydrochloride on glycemic control in sub — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Norm AUC Average by Group (Normalized)	Double Blinded CGM used for 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.	2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.	No
Primary	Sleep Norm AUC Average by Group (Normalized)	Overnight glucose captured by CGM.	2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.	No
Primary	Wake Norm AUC Average by Group (Normalized)	Wake glucose captured by continuous glucose monitoring (CGM).	2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.	No
Primary	Hypoglycemia Percentage of Time <70 mg/dL Average by Group	Ambulatory glucose profile (AGP) reports were examined for the changes in the incidence of hypoglycemia (CGM<70 mg/dL)	2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.	Yes