Skip to main content
OpenTrials
Completed

NCT Number: NCT01092663

The Effects of Co-admin of Colesevelam and Sitagliptin on Glucose Metabolism in Subjects With Type 2 Diabetes Mellitus

This study will assess the effects of colesevelam, alone or in combination with sitagliptin, on glucose metabolism in subjects with T2DM inadequately controlled by diet and exercise

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco, San Francisco, California, United States

Loading trial locations.

About this study

The hypothesis is that co-administrationof colesevelam plus sitagliptin results in a greater reduction in HbA1c compared to colesevelam HCl treatment by

  • improving the effects of colesevelam on fasting glucose metabolism
  • improving the effects of colsevelam on postprandial glucose metabolism

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or Female
  • Females of childbearing potential are on approved birth control method
  • Negative pregnancy testing for females of childbearing potential
  • Previously diagnosed or newly diagnosed with T2DM drug naïve subjects
  • HbA1c: 6.7-10%
  • Age 18 - 80 years
  • BMI ≥ 18.5 kg/m2 and ≤ 40 kg/m2
  • Fasting serum glucose < 300 mg/dL
  • Normal liver function, normal thyroid function, no history of liver, biliary or intestinal disease
  • Normal TSH
  • On stable diet and exercise routine for at least 4 weeks prior to screening
  • Has had a stable weight (+/-5%) for ≥3 months before screening

Exclusion criteria

  • A history of type 1 diabetes mellitus or history of diabetic ketoacidosis
  • History of chronic (required daily for > 2 months) use of insulin therapy
  • Treatment with blood pressure lowering therapy that has not been stable for three months before screening
  • Treatment with lipid lowering medication other than statins
  • Treatment with statins that has not been stable for three months before screening
  • Treatment with a DPP-4 inhibitor or and GLP1 agonists at any time
  • Treatment with a thiazolidinedione (TZD) within the last 6 months of screening
  • History of an allergic or toxic reaction to sitagliptin or colesevelam
  • History of dysphagia, swallowing disorders, bowel obstruction, intestinal motility disorder, and gastrointestinal disorders
  • History of major gastrointestinal surgery
  • History of kidney problems
  • Fasting plasma triglycerides > 300 mg/dL
  • Serum LDL-C <60 mg/dL
  • Positive toxicology test
  • Known hypersensitivity to colesevelam HCl or sitagliptin.
  • Any contraindications to a study medication (colesevelam HCl or sitagliptin).

Treatment and study plan

Colesevelam HCl

Drug

Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.

Other names: Welchol

Sitagliptin

Drug

Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks.

Other names: Januvia

Primary outcomes

  1. Hemoglobin A1C

    Time frame: Baseline and 12 weeks

    Change from baseline in hemoglobin A1C after 12 weeks of colesevelam or colesevelam plus sitagliptin treatments

  2. Fasting Plasma Glucose

    Time frame: Baseline and 12 weeks

    Change from baseline in fasting plasma glucose concentrations after 12 weeks of colesevelam or colesevelam plus sitagliptin treatments.

  3. Fasting Endogenous Glucose Production

    Time frame: baseline and 12 weeks

    Change from baseline in fasting endogenous glucose production after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment

  4. Fasting Gluconeogenesis

    Time frame: baseline and 12 weeks

    Change from baseline in fasting gluconeogenesis after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment

  5. Fasting Glycogenolysis

    Time frame: baseline and 12 weeks

    Change from baseline in fasting glycogenolysis after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment

  6. Fasting Plasma Glucose Clearance

    Time frame: baseline and 12 weeks

    Change from baseline in fasting plasma glucose clearance after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments.

  7. Appearance Rate of Oral Glucose

    Time frame: baseline and 12 weeks

    Change from baseline in appearance rate of oral glucose after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments

  8. Postprandial Endogenous Glucose Production

    Time frame: baseline and 12 weeks

    Change from baseline in postprandial endogenous glucose production after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments

    Mean value was calculated using all results measured between 10 and 300 min post meal.

  9. Postprandial Rate of Total Glucose Disposal Area Under the Curve (AUC)

    Time frame: baseline and 12 weeks

    Change from baseline in postprandial rate of total glucose disposal (AUC) after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments

    AUC was calculated by the trapezoid method using all results measured between 0 and 300 min during the meal tolerance test.

  10. Whole-body Glycolytic Disposal of Oral Glucose

    Time frame: baseline and 12 weeks

    Change in baseline in whole-body glycolytic disposal of oral glucose after 12 weeks of colesevelam alone or colesevelam plus glucose treatments

  11. Postprandial Glucose (AUC)

    Time frame: Baseline and 12 weeks

    Comparison between baseline and 12 weeks values of postrandial glucose (AUC).

Secondary outcomes

  1. Fasting Plasma C-peptide

    Time frame: Baseline and 12 weeks

    To evaluate the effect of treatments on plamsa C-peptide concentrations.

  2. Fasting Plamsa Glucagon

    Time frame: Baseline and 12 weeks

    To evaluate the effect of treatments on plasma glucagon concentrations.

  3. Fasting Active Plasma Glucagon Like-Peptide 1 (GLP-1)

    Time frame: Baseline and 12 weeks

    To evaluate the effect of treatments on plasma GLP-1 concentrations.

  4. Fasting Plasma Total Glucose-dependent Insulinotropic Peptide (GIP)

    Time frame: Baseline and 12 weeks

    To evaluate the effect of treatments on plasma Glucose-dependent Insulinotropic Peptide (GIP) concentrations.

  5. Fasting Insulin

    Time frame: Baseline and 12 weeks

    To evaluate the effect of treatments on fasting insulin concentrations

  6. Postprandial Insulin (AUC)

    Time frame: Baseline and 12 weeks

    To evaluate the effect of treatments on postprandial insulin (AUC)

  7. Postprandial C-peptide (AUC)

    Time frame: Baseline and 12 weeks

    To evaluate the effect of treatments on postprandial C-peptide (AUC)

  8. Postprandial Active GLP-1 (AUC)

    Time frame: Baseline and 12 weeks

    To evaluate the effects of treatments on postprandial active GLP-1 (AUC)

  9. Postprandial Total GIP (AUC)

    Time frame: Baseline and 12 weeks

    To evaluate the effects of treatment on postprandial total GIP (AUC)

  10. Postprandial Glucagon (AUC)

    Time frame: Baseline and 12 weeks

    To evaluate the effects of treatment on postprandial glucagon (AUC)

Sponsors and collaborators

Lead sponsor

KineMed

Industry

Registry information

Official study title

The Effects of Co-administration of Colesevelam and Sitagliptin on Glucose Metabolism in Patients With Type 2 Diabetes

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 25, 2010
Registry last updated
Jan 17, 2013

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.