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

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

colesevelam HCl

placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

International Diabetes Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Arm Label

Welchol then Placebo

Placebo then Welchol

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Sleep Norm AUC Average by Group (Normalized)

Overnight glucose captured by CGM.

Wake Norm AUC Average by Group (Normalized)

Wake glucose captured by continuous glucose monitoring (CGM).

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT00993824

First Posted

October 12, 2009

Last Updated

November 25, 2015

Sponsor

HealthPartners Institute

Collaborators

International Diabetes Center at Park Nicollet, Daiichi Sankyo, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00993824

Brief Title

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

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HealthPartners Institute

Collaborators

International Diabetes Center at Park Nicollet, Daiichi Sankyo, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Welchol then Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Placebo then Welchol

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

colesevelam HCl

Other Intervention Name(s)

Welchol

Intervention Description

3.75 grams of colesevelam HCl (6 tablets)

Intervention Type

Drug

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

Total Norm AUC Average by Group (Normalized)

Description

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.

Time Frame

2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.

Title

Sleep Norm AUC Average by Group (Normalized)

Description

Overnight glucose captured by CGM.

Time Frame

2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.

Title

Wake Norm AUC Average by Group (Normalized)

Description

Wake glucose captured by continuous glucose monitoring (CGM).

Time Frame

2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.

Title

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

Description

Ambulatory glucose profile (AGP) reports were examined for the changes in the incidence of hypoglycemia (CGM<70 mg/dL)

Time Frame

2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roger S. Mazze, PhD

Organizational Affiliation

International Diabetes Center at Park Nicollet

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Elinor S. Strock, APRN, BC

Organizational Affiliation

International Diabetes Center at Park Nicollet

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Robert M. Cuddihy, MD

Organizational Affiliation

International Diabetes Center at Park Nicollet

Official's Role

Principal Investigator

Facility Information:

Facility Name

International Diabetes Center

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55416

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18852398

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.

Results Reference

result

PubMed Identifier

18473688

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.

Results Reference

result

PubMed Identifier

18663165

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.

Results Reference

result

PubMed Identifier

19132850

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.

Results Reference

result

PubMed Identifier

17379048

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.

Results Reference

result

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

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