NCT02682680

Brief 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 low-density lipoprotein (LDL) cholesterol (\> 2.0 mmol/L).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

9 active sites

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

January 11, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2017

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

1.4 years

First QC Date

February 8, 2016

Last Update Submit

November 22, 2019

Conditions

Type 2 Diabetes Mellitus

Keywords

diabeteshyperlipidaemiacolesevelamezetimibeLDL cholesterolglycated hemoglobin

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects who achieve target HbA1c and LDL cholesterol

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

    24 weeks

Secondary Outcomes (23)

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

    24 weeks

  • Absolute change in LDL cholesterol

    24 weeks

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

    24 weeks

  • Absolute change in fasting plasma glucose (FPG)

    24 weeks

  • Absolute change in HbA1c

    24 weeks

  • +18 more secondary outcomes

Other Outcomes (7)

  • Change in body weight

    24 weeks

  • Change in body mass index (BMI)

    24 weeks

  • Change in waist circumference

    24 weeks

  • +4 more other outcomes

Study Arms (2)

Colesevelam

EXPERIMENTAL

Colesevelam 3.75 g daily (tablets or oral suspension) for 24 weeks

Drug: Colesevelam

Ezetimibe

ACTIVE COMPARATOR

Ezetimibe 10 mg once daily for 24 weeks

Drug: Ezetimibe

Interventions

ColesevelamDRUG

Colesevelam 3.75 g daily for 24 weeks

Also known as: Lodalis, Welchol
Colesevelam
EzetimibeDRUG

Ezetimibe 10 mg daily for 24 weeks

Also known as: Ezetrol, Zetia
Ezetimibe

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • \) 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

LMC Calgary

Calgary, Alberta, Canada

Location

LMC Barrie

Barrie, Ontario, Canada

Location

LMC Brampton

Brampton, Ontario, L6S 0C9, Canada

Location

LMC Etobicoke

Etobicoke, Ontario, Canada

Location

LMC Markham

Markham, Ontario, Canada

Location

LMC Oakville

Oakville, Ontario, Canada

Location

LMC Thornhill

Thornhill, Ontario, Canada

Location

Manna Toronto

Toronto, Ontario, M9W 4L6, Canada

Location

LMC Bayview

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusHyperlipidemias

Interventions

Colesevelam HydrochlorideEzetimibe

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDyslipidemiasLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

AllylamineAminesOrganic ChemicalsAllyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsAzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Harpreet Bajaj, MD

    LMC Diabetes & Endocrinology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Endocrinologist

Study Record Dates

First Submitted

February 8, 2016

First Posted

February 15, 2016

Study Start

January 11, 2016

Primary Completion

May 25, 2017

Study Completion

May 25, 2017

Last Updated

November 26, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(9)