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Completed

NCT Number: NCT00993824

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colesevelam HCl

Drug

3.75 grams of colesevelam HCl (6 tablets)

Other names: Welchol

Placebo

Drug

Primary outcomes

  1. 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.

  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.

  3. 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).

  4. 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)

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • Daiichi Sankyo
  • International Diabetes Center at Park Nicollet

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 14, 2009
Registry last updated
Nov 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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