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

January 15, 2013 updated by: KineMed

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

  1. improving the effects of colesevelam on fasting glucose metabolism
  2. improving the effects of colsevelam on postprandial glucose metabolism

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • University of California, San Francisco
    • Florida
      • Miami, Florida, United States, 33014
        • Clinical Pharmacology of Miami
    • Texas
      • San Antonio, Texas, United States, 78209
        • Healthcare Discoveries, Llc D/B/A Icon Development Solutions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Colesevelam HCl: 3 tablets, 2x/day
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.
Drug: Colesevelam HCl
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
Active Comparator: Colesevelam plus Sitagliptin

Colesevelam: 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.

Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks.
Drug: Colesevelam HCl
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
Drug: Sitagliptin
Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks.
Other Names:
  • Januvia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1C
Time Frame: Baseline and 12 weeks
Change from baseline in hemoglobin A1C after 12 weeks of colesevelam or colesevelam plus sitagliptin treatments
Baseline and 12 weeks
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.
Baseline and 12 weeks
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
baseline and 12 weeks
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
baseline and 12 weeks
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
baseline and 12 weeks
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.
baseline and 12 weeks
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
baseline and 12 weeks
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.
baseline and 12 weeks
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.
baseline and 12 weeks
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
baseline and 12 weeks
Postprandial Glucose (AUC)
Time Frame: Baseline and 12 weeks
Comparison between baseline and 12 weeks values of postrandial glucose (AUC).
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting Plasma C-peptide
Time Frame: Baseline and 12 weeks
To evaluate the effect of treatments on plamsa C-peptide concentrations.
Baseline and 12 weeks
Fasting Plamsa Glucagon
Time Frame: Baseline and 12 weeks
To evaluate the effect of treatments on plasma glucagon concentrations.
Baseline and 12 weeks
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.
Baseline and 12 weeks
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.
Baseline and 12 weeks
Fasting Insulin
Time Frame: Baseline and 12 weeks
To evaluate the effect of treatments on fasting insulin concentrations
Baseline and 12 weeks
Postprandial Insulin (AUC)
Time Frame: Baseline and 12 weeks
To evaluate the effect of treatments on postprandial insulin (AUC)
Baseline and 12 weeks
Postprandial C-peptide (AUC)
Time Frame: Baseline and 12 weeks
To evaluate the effect of treatments on postprandial C-peptide (AUC)
Baseline and 12 weeks
Postprandial Active GLP-1 (AUC)
Time Frame: Baseline and 12 weeks
To evaluate the effects of treatments on postprandial active GLP-1 (AUC)
Baseline and 12 weeks
Postprandial Total GIP (AUC)
Time Frame: Baseline and 12 weeks
To evaluate the effects of treatment on postprandial total GIP (AUC)
Baseline and 12 weeks
Postprandial Glucagon (AUC)
Time Frame: Baseline and 12 weeks
To evaluate the effects of treatment on postprandial glucagon (AUC)
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KineMed

Investigators

  • Principal Investigator: Carine Beysen, DPhil, KineMed, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

March 23, 2010

First Submitted That Met QC Criteria

March 23, 2010

First Posted (Estimate)

March 25, 2010

Study Record Updates

Last Update Posted (Estimate)

January 17, 2013

Last Update Submitted That Met QC Criteria

January 15, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KM-29

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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