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colesevelam for Type 2 Diabetes

Phase 3
Waitlist Available
Research Sponsored by Daiichi Sankyo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* HbA1C 7.0 % to 10.0% on metformin monotherapy; may be withdrawn from other (non-metformin) drugs if HbA1C is 6.5% to 9.5 % at screening.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks change = week 16 - week 0.
Awards & highlights
Approved for 5 Other Conditions
Pivotal Trial
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

A 16 week open-label study with subjects receiving background metformin monotherapy. 150 subjects randomized 1:1:1 to receive 1 of the following: open-label colesevelam HCl, open label rosiglitazone, or open-label sitagliptin.

Eligible Conditions
  • Type 2 Diabetes
  • High Cholesterol

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks change = week 16 - week 0.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks change = week 16 - week 0. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint
Secondary study objectives
Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean
Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean
Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean
+14 more

Side effects data

From 2010 Phase 4 trial • 42 Patients • NCT01122108
5%
Gas
5%
Diarrhea
5%
Mild Indigestion
2%
Bloating
2%
Increased Urination
2%
Abdominal Cramps
2%
Belching
2%
Intermittent R Back Thigh Pain
2%
Moderate Indigestion
2%
Severe Indigestion
2%
Headache
2%
Moderate Nausea
2%
Vomitting
100%
80%
60%
40%
20%
0%
Study treatment Arm
More Than 30 Minutes After Last Beverage
Cholestyramine (12g)
Colesevelam HCl (3.75 Grams)

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: colesevelamExperimental Treatment1 Intervention
colesevelam tablets 625 mg
Group II: sitagliptinActive Control1 Intervention
sitagliptin phosphate tablets
Group III: rosiglitazoneActive Control1 Intervention
rosiglitazone maleate 4mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Colesevelam
FDA approved

Find a Location

Who is running the clinical trial?

Daiichi SankyoLead Sponsor
418 Previous Clinical Trials
468,398 Total Patients Enrolled
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
422,751 Total Patients Enrolled
~9 spots leftby Dec 2025
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