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

NCT ID: NCT00993824

Last Updated: 2015-11-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-09-30

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Welchol then Placebo

3.75 grams of colesevelam HCl (Welchol) at evening meal for 12 weeks, and then crossover to placebo at evening meal for 12 weeks.

Group Type PLACEBO_COMPARATOR

colesevelam HCl

Intervention Type DRUG

3.75 grams of colesevelam HCl (6 tablets)

placebo

Intervention Type DRUG

Placebo then Welchol

Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal fro 12 weeks.

Group Type PLACEBO_COMPARATOR

colesevelam HCl

Intervention Type DRUG

3.75 grams of colesevelam HCl (6 tablets)

placebo

Intervention Type DRUG

Interventions

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colesevelam HCl

3.75 grams of colesevelam HCl (6 tablets)

Intervention Type DRUG

placebo

Intervention Type DRUG

Other Intervention Names

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Welchol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International Diabetes Center at Park Nicollet

OTHER

Sponsor Role collaborator

Daiichi Sankyo

INDUSTRY

Sponsor Role collaborator

HealthPartners Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roger S. Mazze, PhD

Role: STUDY_DIRECTOR

International Diabetes Center at Park Nicollet

Elinor S. Strock, APRN, BC

Role: PRINCIPAL_INVESTIGATOR

International Diabetes Center at Park Nicollet

Robert M. Cuddihy, MD

Role: PRINCIPAL_INVESTIGATOR

International Diabetes Center at Park Nicollet

Locations

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International Diabetes Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 18852398 (View on PubMed)

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.

Reference Type RESULT
PMID: 18473688 (View on PubMed)

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.

Reference Type RESULT
PMID: 18663165 (View on PubMed)

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.

Reference Type RESULT
PMID: 19132850 (View on PubMed)

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.

Reference Type RESULT
PMID: 17379048 (View on PubMed)

Other Identifiers

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03901-09-C

Identifier Type: -

Identifier Source: org_study_id