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Type 2 Diabetes MellitusPhase 4GOAL-RCTNCT02682680

Randomized Trial Comparing Colesevelam vs. Ezetimibe

A Phase 4 study testing Colesevelam and Ezetimibe in people with Type 2 Diabetes Mellitus, run by LMC Diabetes & Endocrinology Ltd. at 9 sites in Canada.

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 24-week, randomized, open-label study investigating the efficacy, safety and tolerability of colesevelam 3.75 g daily compared to ezetimibe 10 mg daily, as an add-on to baseline statin therapy in patients with type 2 diabetes mellitus (T2DM) who are not at target for glycated hemoglobin (HbA1c) (> 7.0%) and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Colesevelam and Ezetimibe
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
9 sitesCanada
Study dates
11 Jan 2016to 25 May 2017
Phase
Phase 4
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of type 2 diabetes > 6 months
  • HbA1c level between 7.1 to 10.0% (inclusive) within three months of study enrollment
  • LDL cholesterol > 2.0 mmol/L within three months of study enrollment
  • Receiving a stable dose of statin for a minimum of three months, which the investigator does not plan to change over the 24-week trial period. If patient has documented statin intolerance, may be on a fibrate and/or niacin, or on no lipid lowering therapy
  • Stable diabetes medications for previous three months (apart from adjustment of insulin dose)
  • Informed consent

Who cannot join

  • Use of a second lipid lowering therapy other than statin within three months of study enrolment, unless on a fibrate and/or niacin if patient has statin intolerance
  • Triglycerides ≥ 5.0 mmol/L or incalculable LDL cholesterol
  • Significant liver enzyme or CK elevation defined as CK or ALT ≥ 3x upper limit of normal (ULN)
  • 5) Pregnant or breast feeding or planning to become pregnant or breast feed during the study 6) Chronic kidney disease (CKD) stage ≥4 or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m-squared 7) Severe gastroparesis or history of significant bowel resection 8) Current use of any Investigational Product

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Canada9 sites

  • LMC Barrie

    Barrie, Ontario

  • LMC Brampton

    Brampton, Ontario, L6S 0C9

  • LMC Calgary

    Calgary, Alberta

  • LMC Etobicoke

    Etobicoke, Ontario

  • LMC Markham

    Markham, Ontario

  • LMC Oakville

    Oakville, Ontario

  • LMC Thornhill

    Thornhill, Ontario

  • Manna Toronto

    Toronto, Ontario, M9W 4L6

  • LMC Bayview

    Toronto, Ontario

Other trials in Canada

About this study

Official title: Goal Achievement of A1c and LDL in a Randomized Trial Comparing Colesevelam vs. Ezetimibe as Add-on to Baseline Statin Therapy: The GOAL-RCT Trial

A 24-week, randomized, open-label study investigating the efficacy, safety and tolerability of colesevelam 3.75 g daily compared to ezetimibe 10 mg daily, as an add-on to baseline statin therapy in patients with type 2 diabetes mellitus (T2DM) who are not at target for glycated hemoglobin (HbA1c) (> 7.0%) and low-density lipoprotein (LDL) cholesterol (> 2.0 mmol/L).

Read the detailed description

This study will enroll 200 adult patients with T2DM who are not at target for HbA1c and LDL cholesterol. Patients who are on baseline statin therapy will be randomly assigned in a 1:1 ratio to colesevelam 3.75 g daily for 24 weeks, or ezetimibe 10 mg daily for 24 weeks. If a patient has statin intolerance, they may be on a fibrate and/or niacin, or on no lipid lowering therapy. The primary efficacy objectives are

  1. to demonstrate that colesevelam 3.75 g daily is non-inferior to ezetimibe 10 mg daily as add-on to statin therapy for patients achieving a composite target of HbA1c (≤ 7.0%) and LDL cholesterol (≤ 2.0 mmol/L) at week 24, and
  2. to compare the proportion of patients achieving a composite target of HbA1c (≤ 7.0%) and LDL cholesterol (≤ 2.0 mmol/L) at week 24.

This study will also assess the primary composite outcome in a sub-group of patients on sodium/glucose cotransporter 2 inhibitor (SGLT2i) therapy.

Being tested
Colesevelam, Ezetimibe
Keywords
diabetes, hyperlipidaemia, colesevelam, ezetimibe, LDL cholesterol, glycated hemoglobin
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus, Hyperlipidemias

What participants receive

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

  • ColesevelamDrug

    Also called Lodalis, Welchol

    Colesevelam 3.75 g daily for 24 weeks

  • EzetimibeDrug

    Also called Ezetrol, Zetia

    Ezetimibe 10 mg daily for 24 weeks

Study groups in NCT02682680
Study groupRoleWhat they receive
ColesevelamExperimentalColesevelam 3.75 g daily (tablets or oral suspension) for 24 weeks
Receives: Drug: Colesevelam
EzetimibeActive comparatorEzetimibe 10 mg once daily for 24 weeks
Receives: Drug: Ezetimibe

What is being measured

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

  1. Proportion of subjects who achieve target HbA1c and LDL cholesterol

    target HbA1c: ≤ 7.0%; target LDL cholesterol: ≤ 2.0 mmol/L

    Measured: 24 weeks

Secondary outcomes (23)

  1. Proportion of subjects who achieve the primary outcome measure in the sub-group of subjects on sodium/glucose cotransporter 2 inhibitor (SGLT2i) therapy

    Measured: 24 weeks

  2. Absolute change in LDL cholesterol

    Measured: 24 weeks

  3. Absolute change in non-high-density lipoprotein (non-HDL) cholesterol

    Measured: 24 weeks

  4. Absolute change in fasting plasma glucose (FPG)

    Measured: 24 weeks

  5. Absolute change in HbA1c

    Measured: 24 weeks

  6. Absolute change in LDL cholesterol in sub-group of subjects on SGLT2i therapy

    Measured: 24 weeks

  7. Absolute change in non-HDL cholesterol in sub-group of subjects on SGLT2i therapy

    Measured: 24 weeks

  8. Absolute change in FPG in sub-group of subjects on SGLT2i therapy

    Measured: 12 weeks and 24 weeks

  9. Absolute change in HbA1c in sub-group of subjects on SGLT2i therapy

    Measured: 12 weeks and 24 weeks

  10. Proportion of subjects achieving a composite target of glycemic control, LDL cholesterol control and blood pressure control

    glycemic control: A1c ≤ 7.0%; LDL cholesterol control: ≤ 2.0 mmol/L; blood pressure control: ≤ 130/80 mm Hg

    Measured: 24 weeks

  11. Proportion of subjects achieving a composite target of glycemic control with no hypoglycemia and no weight gain

    Measured: 24 weeks

  12. Proportion of subjects with ≥ 0.3% reduction in HbA1c and ≥ 10% reduction in LDL cholesterol from baseline

    Measured: 24 weeks

  13. Proportion of subjects with ≥ 0.5% reduction in HbA1c and ≥ 15% reduction in LDL cholesterol

    Measured: 24 weeks

  14. Absolute change in high-sensitivity C-reactive protein (hs-CRP) levels from baseline

    Measured: 24 weeks

  15. Absolute change in triglyceride levels from baseline

    Measured: 24 weeks

  16. Proportion of subjects achieving target HbA1c and LDL cholesterol in the sub-group of subjects on non-insulin therapies

    Measured: 24 weeks

  17. Absolute change in FPG in the sub-group of subjects on non-insulin therapies

    Measured: 24 weeks

  18. Absolute change in HbA1c in the sub-group of subjects on non-insulin therapies

    Measured: 24 weeks

  19. Absolute change in LDL cholesterol in the sub-group of subjects on non-insulin therapies

    Measured: 24 weeks

  20. Absolute change in non-HDL cholesterol in the sub-group of subjects on non-insulin therapies

    Measured: 24 weeks

  21. Rate of non-severe and severe hypoglycemia

    Severe hypoglycemia is defined as hypoglycemia requiring third party intervention of another person to actively administer carbohydrate, glucagon or other resuscitative actions.

    Measured: 24 weeks

  22. Absolute change in alanine aminotransferase (ALT)

    Measured: 24 weeks

  23. Absolute change in creatine kinase (CK)

    Measured: 24 weeks

Timeline

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

  1. First posted15 Feb 2016 (estimated)
  2. Study start11 Jan 2016
  3. Primary completion25 May 2017
  4. Study completion25 May 2017

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02682680
Sponsor's protocol ID
GOAL RCT
Acronym
GOAL-RCT
Status last verified
Nov 2019
First submitted
8 Feb 2016
Last updated
26 Nov 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Colesevelam and Ezetimibe in people with Type 2 Diabetes Mellitus, run by LMC Diabetes & Endocrinology Ltd. at 9 sites in Canada.

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 6 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 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Proportion of subjects who achieve target HbA1c and LDL cholesterol (time frame: 24 weeks). 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 NCT02682680.

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 26 Nov 2019.

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