NCT00147745

Brief Summary

This study is designed to assess the potential mechanism of action by which WelChol® (colesevelam) may improve blood glucose control in patients with type 2 diabetes

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_2 type-2-diabetes

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_2 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

December 4, 2009

Completed
Last Updated

April 2, 2014

Status Verified

March 1, 2014

Enrollment Period

2.6 years

First QC Date

September 2, 2005

Results QC Date

July 15, 2009

Last Update Submit

March 5, 2014

Conditions

Type 2 Diabetes

Keywords

Mechanism of action insulin sensitivity

Outcome Measures

Primary Outcomes (3)

  • Difference in Endogenous (Hepatic) Glucose Output During a High-dose Insulin Infusion From Baseline to After 12 Weeks of Treatment.

    The parameter measured is the endogenous (hepatic) glucose output during a high-dose insulin infusion. A decrease after treatment with colesevelam is indicative of greater sensitivity of the liver to insulin.

    Baseline to 12 weeks

  • Difference in Endogenous (Hepatic) Glucose Output During a Low-dose Insulin Infusion From Baseline to Week 12.

    The parameter measured is the endogenous (hepatic) glucose output during a low-dose insulin infusion. A decrease is indicative of greater senstitivity of the liver to insulin.

    Baseline to 12 weeks

  • Acute Effect of a Single Dose of Colesevelam on Oral Glucose Absorption From Baseline to First Dose

    Change in area under the curve for glucose (AUCg) after a glucose tolerance test. A decrease in AUCg is indicative of a drug effect.

    Baseline (Day -4) to first dose (Day 1)

Secondary Outcomes (2)

  • The Acute Effect of Colesevelam (Multiple Doses) on Oral Glucose Absorption From Baseline to 12 Weeks

    Baseline to 12 weeks

  • Change in Hemoglobin A1C Due to Effect of Colesevelam From Baseline to 12 Weeks

    Baseline to 12 weeks

Study Arms (3)

1

EXPERIMENTAL

colesevelam 3.8g administered daily for 12 weeks

Drug: Colesevelam

2

PLACEBO COMPARATOR

Colesevelam matching placebo for 12 weeks

Drug: Colesevelam matching placebo

3

ACTIVE COMPARATOR

open-label Insulin Glargine for 12 weeks

Drug: Insulin glargine (Lantus)

Interventions

ColesevelamDRUG

Colesevelam 3.8g for 12 weeks

1
Colesevelam matching placeboDRUG

Colesevelam matching placebo for 12 weeks

2
Insulin glargine (Lantus)DRUG

Insulin glargine for 12 weeks

3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between the ages of 18 - 75, inclusive
  • Diagnosed with type 2 diabetes
  • Hemoglobin A1c value greater than or equal to 8.0%
  • Antidiabetic treatments may include sulfonylurea agents (non-sulfonylurea agents must be withdrawn)
  • Overweight, obese (body mass index 25-45 kg/m2)

You may not qualify if:

  • Change of dose of lipid or blood pressure lowering therapy within past three months
  • Previous treatment with colesevelam for hyperlipidemia
  • Serum triglyceride greater than 500 mg/dL
  • Serum low density lipoprotein-cholesterol less than 60 mg/dL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego VMC

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Colesevelam HydrochlorideInsulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AllylamineAminesOrganic ChemicalsAllyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsInsulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
John Raia, Senior Director, Professional Affairs
Organization
Daiichi Sankyo, Inc
jraia@dsi.com
(973) 944-2683

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 7, 2005

Study Start

June 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

April 2, 2014

Results First Posted

December 4, 2009

Record last verified: 2014-03

Locations

US(1)