Type 2 DiabetesPhase 2NCT00147745

Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes

A Phase 2 study testing Colesevelam and Insulin glargine (Lantus) in people with Type 2 Diabetes, run by Daiichi Sankyo at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Colesevelam and Insulin glargine (Lantus)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 1 siteUnited States
Study dates: Jun 2005to Jan 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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Antidiabetic treatments may include sulfonylurea agents (non-sulfonylurea agents must be withdrawn)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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

San Diego VMC
San Diego, California, 92161

Other trials in United States

About this study

Official title: Effects of Colesevelam on Insulin Sensitivity in Type 2 Diabetes Mellitus

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

Conditions: Type 2 Diabetes
Being tested: Colesevelam, Colesevelam matching placebo, Insulin glargine (Lantus)
Keywords: Mechanism of action insulin sensitivity
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ColesevelamDrug
Colesevelam 3.8g for 12 weeks
Colesevelam matching placeboDrug
Colesevelam matching placebo for 12 weeks
Insulin glargine (Lantus)Drug
Insulin glargine for 12 weeks

Study groups in NCT00147745
Study group	Role	What they receive
1	Experimental	colesevelam 3.8g administered daily for 12 weeks Receives: Drug: Colesevelam
2	Placebo comparator	Colesevelam matching placebo for 12 weeks Receives: Drug: Colesevelam matching placebo
3	Active comparator	open-label Insulin Glargine for 12 weeks Receives: Drug: Insulin glargine (Lantus)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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
The parameter measured is the change in area under the curve for glucose(AUCg) after an oral glucose tolerance test. A decrease in AUCg indicative of drug effect on glucose absorption.
Measured: Baseline to 12 weeks
Change in Hemoglobin A1C Due to Effect of Colesevelam From Baseline to 12 Weeks
The parameter measured is the percent of hemoglobin A that is glycosylated. A decrease in this parameter is indicative of improved glucose control.
Measured: Baseline to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2005Jan 2008

First posted7 Sep 2005 (estimated)
Study startJun 2005
Primary completionJan 2008
Study completionJan 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by Daiichi SankyoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00147745
Sponsor's protocol ID: WEL-201
Status last verified: Mar 2014
First submitted: 2 Sep 2005
Last updated: 2 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Colesevelam on Insulin Sensitivity in Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT00147745
Acronym / sponsor ID: WEL-201
Conditions: Type 2 Diabetes
Keywords: Mechanism of action insulin sensitivity
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Daiichi SankyoIndustry (pharma, biotech, devices)
Study start: Jun 2005
Primary completion: Jan 2008 (actual)
Study completion: Jan 2008 (actual)
First posted: 7 Sep 2005 (estimated)
Results: Posted 4 Dec 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: Colesevelamcolesevelam 3.8g administered daily for 12 weeks
2	Placebo comparator	Drug: Colesevelam matching placeboColesevelam matching placebo for 12 weeks
3	Active comparator	Drug: Insulin glargine (Lantus)open-label Insulin Glargine for 12 weeks

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ColesevelamColesevelam 3.8g for 12 weeks	Drug	1
Colesevelam matching placeboColesevelam matching placebo for 12 weeks	Drug	2
Insulin glargine (Lantus)Insulin glargine for 12 weeks	Drug	3

Primary outcome

Difference in Endogenous (Hepatic) Glucose Output During a High-dose Insulin Infusion From Baseline to After 12 Weeks of Treatment.
Time frame: Baseline to 12 weeks
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.
Difference in Endogenous (Hepatic) Glucose Output During a Low-dose Insulin Infusion From Baseline to Week 12.
Time frame: Baseline to 12 weeks
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.
Acute Effect of a Single Dose of Colesevelam on Oral Glucose Absorption From Baseline to First Dose
Time frame: Baseline (Day -4) to first dose (Day 1)
Change in area under the curve for glucose (AUCg) after a glucose tolerance test. A decrease in AUCg is indicative of a drug effect.

2 secondary outcomes

The Acute Effect of Colesevelam (Multiple Doses) on Oral Glucose Absorption From Baseline to 12 Weeks
Time frame: Baseline to 12 weeks
Change in Hemoglobin A1C Due to Effect of Colesevelam From Baseline to 12 Weeks
Time frame: Baseline to 12 weeks

Results and safety

Results posted to the registry on 4 Dec 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Colesevelam 3.8g	16	15
Colesevelam Matching Placebo	14	14
Open-label Insulin Glargine	6	6

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

Time frame: Baseline to 12 weeks. Least squares mean (Standard Error). Unit: mg/kg/min

Measure	Colesevelam 3.8g n = 15	Colesevelam Matching Placebo n = 13	Open-label Insulin Glargine n = 6
Value	-0.06 (0.048)	-0.011 (0.051)	-0.01 (0.076)

Colesevelam 3.8g vs Colesevelam Matching Placebo: Mean Difference (Final Values): 0.04 (95% CI -0.10 to 0.19), p = 0.5499, ANCOVA
Colesevelam 3.8g vs Open-label Insulin Glargine: Mean Difference (Final Values): -0.05 (95% CI -0.23 to 0.13), p = 0.5723, ANCOVA
Colesevelam Matching Placebo vs Open-label Insulin Glargine: Mean Difference (Final Values): 0.09 (95% CI -0.09 to 0.28), p = 0.3138, ANCOVA

Population analysed: The population analyzed was all randomized subjects who received medication and had a baseline and at least 1 post-randomization assessment of an efficacy variable. One placebo participant did not have a valid post-randomization insulin clamp study. Therefore, the number included in the placebo group for this analysis was 13.

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

Time frame: Baseline to 12 weeks. Least squares mean (Standard Error). Unit: mg/kg/min

Measure	Colesevelam 3.8g n = 15	Colesevelam Matching Placebo n = 13	Open-label Insulin Glargine n = 6
Value	-0.08 (0.044)	-0.16 (0.048)	-0.04 (0.070)

Colesevelam 3.8g vs Colesevelam Matching Placebo: Mean Difference (Final Values): 0.08 (95% CI -0.05 to 0.22), p = 0.2042, ANCOVA
Colesevelam 3.8g vs Open-label Insulin Glargine: Mean Difference (Final Values): -0.03 (95% CI -0.20 to 0.14), p = 0.6855, ANCOVA
Colesevelam Matching Placebo vs Open-label Insulin Glargine: Mean Difference (Final Values): 0.12 (95% CI -0.05 to 0.29), p = 0.1727, ANCOVA

Primary outcome: Acute Effect of a Single Dose of Colesevelam on Oral Glucose Absorption From Baseline to First Dose

Time frame: Baseline (Day -4) to first dose (Day 1). Mean (Standard Deviation). Unit: mg*hr/dL

Measure	Colesevelam 3.8g n = 36
Value	-38.4 (105.75)

Colesevelam 3.8g: p = 0.0362, t-test, 2 sided

Population analysed: The entire study population was included in this analysis

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 week treatment period plus 30 days after the last dose of study medication.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Colesevelam 3.8g	0 of 16 (0%)	14 of 16 (87.5%)	Not reported
Colesevelam Matching Placebo	0 of 14 (0%)	10 of 14 (71.4%)	Not reported
Open-label Insulin Glargine	0 of 6 (0%)	4 of 6 (66.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Colesevelam and Insulin glargine (Lantus) in people with Type 2 Diabetes, run by Daiichi Sankyo at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in Endogenous (Hepatic) Glucose Output During a High-dose Insulin Infusion From Baseline to After 12 Weeks of Treatment. (time frame: Baseline to 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00147745.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2014.