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

This study has been completed.
Sponsor:
Collaborators:
International Diabetes Center at Park Nicollet
Daiichi Sankyo Inc.
Information provided by (Responsible Party):
Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT00993824
First received: October 12, 2009
Last updated: June 16, 2014
Last verified: February 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 Park Nicollet 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993824

Locations
United States, Minnesota
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
Sponsors and Collaborators
Park Nicollet 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: Park Nicollet Institute
ClinicalTrials.gov Identifier: NCT00993824     History of Changes
Other Study ID Numbers: 03901-09-C
Study First Received: October 12, 2009
Results First Received: September 5, 2013
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 29, 2014