Clinical trial NCT00993824: Glycemic Effect of Colesevelam HCl (Welchol) in Patients With Type 2 Diabetes
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: International Diabetes Center at Park Nicollet
name: Daiichi Sankyo
First posted: 2009-10-14
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Total Norm AUC Average by Group (Normalized)
timeFrame: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.
measure: Sleep Norm AUC Average by Group (Normalized)
timeFrame: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.
measure: Wake Norm AUC Average by Group (Normalized)
timeFrame: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.
measure: Hypoglycemia Percentage of Time <70 mg/dL Average by Group
timeFrame: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
Study officials:
affiliation: International Diabetes Center at Park Nicollet
name: Roger S. Mazze, PhD
role: STUDY_DIRECTOR
affiliation: International Diabetes Center at Park Nicollet
name: Elinor S. Strock, APRN, BC
role: PRINCIPAL_INVESTIGATOR
affiliation: International Diabetes Center at Park Nicollet
name: Robert M. Cuddihy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. 2008 Jun;10(3):149-59. doi: 10.1089/dia.2007.0293.
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.168.14.1531.
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.2008.0041.
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 subjects with type 2 diabetes. Clin Ther. 2007 Jan;29(1):74-83. doi: 10.1016/j.clinthera.2007.01.003.