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AzTrials

Type 2 DiabetesPhase 3NCT00484419

Effects of Colesevelam HCl, Rosiglitazone, Sitagliptin on Control of Blood Glucose and Lipids in Type 2 Diabetes Patients Whose Blood Glucose Isn't Completely Controlled With Metformin

A Phase 3 study testing Colesevelam HCl, rosiglitazone maleate and sitagliptin phosphate in people with Type 2 Diabetes and Hyperlipidemia, run by Daiichi Sankyo at 20 sites 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

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Type 2 Diabetes, Hyperlipidemia
What is being tested?
Colesevelam HCl, rosiglitazone maleate and sitagliptin phosphate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
169 participants
Where
20 sitesUnited States
Study dates
May 2007to Apr 2008
Phase
Phase 3
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HbA1C 7.0 % to 10.0% on metformin monotherapy; may be withdrawn from other (non-metformin) drugs if HbA1C is 6.5% to 9.5 % at screening.

Who cannot join

  • Subjects currently treated with a thiazolidinedione are excluded.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Study site

    Baltimore, Maryland

  • Study site

    Chiefland, Florida

  • Study site

    Clemson, South Carolina

  • Study site

    Dallas, Texas

  • Study site

    Dearborn, Michigan

  • Study site

    Gary, Indiana

  • Study site

    Harriman, Tennessee

  • Study site

    Jersey Shore, Pennsylvania

  • Study site

    La Mesa, California

  • Study site

    Las Vegas, Nevada

  • Study site

    Lexington, North Carolina

  • Study site

    Los Angeles, California

  • Study site

    Los Gatos, California

  • Study site

    Munroe Falls, Ohio

  • Study site

    Portland, Oregon

  • Study site

    San Antonio, California

  • Study site

    West Bloomfield, Michigan

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Yonkers, New York

  • Study site

    Zaneville, Ohio

Other trials in United States

About this study

Official title: Effects of Colesevelam HCl, Avandia® (Rosiglitazone Maleate), or JanuviaTM (Sitagliptin) on Glycemic Parameters and Lipid Profiles in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Monotherapy

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.

Being tested
Colesevelam HCl, rosiglitazone maleate, sitagliptin phosphate
Keywords
Colesevelam HCl,, rosiglitazone, sitagliptin, Type 2 diabetes, metformin
Medical subject headings
Diabetes Mellitus, Type 2, Hyperlipidemias

What participants receive

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

  • Colesevelam HClDrug

    coleveselam tablets 625 mg; 6 tablets/day

  • rosiglitazone maleateDrug

    rosiglitazone tablets 4mg

  • sitagliptin phosphateDrug

    sitagliptin phosphate tablets 100mg/day

Study groups in NCT00484419
Study groupRoleWhat they receive
colesevelamExperimentalcolesevelam tablets 625 mg
Receives: Drug: Colesevelam HCl
rosiglitazoneActive comparatorrosiglitazone maleate 4mg
Receives: Drug: rosiglitazone maleate
sitagliptinActive comparatorsitagliptin phosphate tablets
Receives: Drug: sitagliptin phosphate

What is being measured

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

  1. Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint

    Change in HbA1c from Week 0(baseline) to Week 16 endpoint mean with standard deviation change = week 16 - week 0.

    Measured: 16 weeks change = week 16 - week 0.

Secondary outcomes (17)

  1. Mean Percentage of Change in Glycosylated Hemoglobin (HbA1c) From Week 0(Baseline) to Week 16 Endpoint Least Squares Mean

    Change in HbA1c from Week 0(baseline)to Week 16 endpoint least squares mean with 95% confidence intervals, change = week 16 - week 0.

    Measured: 16 weeks change = week 16 - week 0.

  2. Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8

    change in HbA1c from Week 0(baseline) to week 8 mean and standard deviation change = week 8 - week 0.

    Measured: 8 weeks change = week 8- week 0.

  3. Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean

    change in FPG from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0.

    Measured: 8 weeks change = week 8- week 0.

  4. Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean

    change in FPG from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0.

    Measured: 16 weeks change = week 16 - week 0.

  5. Mean Change in FPG From Week 0(Baseline) to Week 8

    mean change in FPG from Week 0(baseline) to Week 8 with standard deviation change = week 8 - week 0.

    Measured: 8 weeks change = week 8- week 0.

  6. Mean Change in FPG From Week 0(Baseline) to Week 16

    change in FPG from Week 0(baseline) to week 16 mean and standard deviation change = week 16 - week 0.

    Measured: 16 weeks change = week 16 - week 0.

  7. Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean

    change in fasting insulin from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0.

    Measured: 8 weeks change = week 8- week 0.

  8. Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean

    change in fasting insulin from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0.

    Measured: 16 weeks change = week 16 - week 0.

  9. Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8

    mean change in fasting insulin from Week 0(baseline) to week 8 with standard deviation change = week 8 - week 0.

    Measured: 8 weeks change = week 8- week 0.

  10. Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16

    mean change in fasting insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.

    Measured: 16 weeks change = week 16 - week 0.

  11. Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean

    change in post-prandial glucose from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0.

    Measured: 16 weeks change = week 16 - week 0.

  12. Mean Change in Post-prandial Glucose From Week 0(Baseline) to Week 16

    mean change in post-prandial glucose from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.

    Measured: 16 weeks change = week 16 - week 0.

  13. Mean Change in Post-prandial Insulin From Week 0(Baseline) to Week 16

    mean change in post-prandial insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.

    Measured: 16 weeks change = week 16 - week 0.

  14. Change in Low-Density Lipoprotein-C(LDL-C) From Week 0(Baseline) to Week 16 Least Squares Mean

    change in LDL-C from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0.

    Measured: 16 weeks change = week 16 - week 0.

  15. Mean Change in LDL-C From Week 0(Baseline) to Week 16

    mean change in LDL-C from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.

    Measured: 16 weeks change = week 16 - week 0.

  16. Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16

    mean percent change in LDL-C levels from Week 0(baseline) to Week 16 mean with standard deviation change = week 16 - week 0.

    Measured: 16 weeks change = week 16 - week 0.

  17. Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 (Least Squares Mean)

    percent change in LDL-C levels from Week 0(baseline) to Week 16 (least squares mean with 95% confidence interval)

    Measured: 16 weeks change = week 16 - week 0.

Timeline

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

  1. First posted8 Jun 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionApr 2008
  4. Study completionApr 2008

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00484419
Sponsor's protocol ID
Wel-409
Status last verified
Aug 2016
First submitted
7 Jun 2007
Last updated
4 Oct 2016

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Colesevelam HCl, rosiglitazone maleate and sitagliptin phosphate in people with Type 2 Diabetes and Hyperlipidemia, run by Daiichi Sankyo at 20 sites 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 1 inclusion and 1 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 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 17 Jun 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?

Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint (time frame: 16 weeks change = week 16 - week 0.). 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 NCT00484419.

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 4 Oct 2016.

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