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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00993824
First Posted: October 14, 2009
Last Update Posted: November 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
International Diabetes Center at Park Nicollet
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
HealthPartners Institute
  Purpose
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.

Condition Intervention Phase
Type 2 Diabetes Drug: colesevelam HCl Drug: placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by HealthPartners Institute:

Primary Outcome Measures:
  • Total Norm AUC Average by Group (Normalized) [ Time Frame: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2. ]
    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) [ Time Frame: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2. ]
    Overnight glucose captured by CGM.

  • Wake Norm AUC Average by Group (Normalized) [ Time Frame: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2. ]
    Wake glucose captured by continuous glucose monitoring (CGM).

  • Hypoglycemia Percentage of Time <70 mg/dL Average by Group [ Time Frame: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2. ]
    Ambulatory glucose profile (AGP) reports were examined for the changes in the incidence of hypoglycemia (CGM<70 mg/dL)


Enrollment: 21
Study Start Date: September 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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.
Drug: colesevelam HCl
3.75 grams of colesevelam HCl (6 tablets)
Other Name: Welchol
Drug: placebo
Placebo Comparator: 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.
Drug: colesevelam HCl
3.75 grams of colesevelam HCl (6 tablets)
Other Name: Welchol
Drug: placebo

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993824


Locations
United States, Minnesota
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
Sponsors and Collaborators
HealthPartners Institute
International Diabetes Center at Park Nicollet
Daiichi Sankyo, Inc.
Investigators
Study Director: Roger S. Mazze, PhD International Diabetes Center at Park Nicollet
Principal Investigator: Elinor S. Strock, APRN, BC International Diabetes Center at Park Nicollet
Principal Investigator: Robert M. Cuddihy, MD International Diabetes Center at Park Nicollet
  More Information

Publications:
Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT00993824     History of Changes
Other Study ID Numbers: 03901-09-C
First Submitted: October 12, 2009
First Posted: October 14, 2009
Results First Submitted: September 5, 2013
Results First Posted: June 17, 2014
Last Update Posted: November 30, 2015
Last Verified: February 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Colesevelam Hydrochloride
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents