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Trial · Interventional

CompletedPhase 3Registry data

Preserving Beta-cell Function in Type 2 Diabetes With Exenatide and Insulin (PREVAIL)

Short name PREVAIL

NCTNCT02194595 (opens ClinicalTrials.gov in a new tab)Other id14-0128-A
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
105 participants (actual)
Sponsor
Mount Sinai Hospital, Canada · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Canada

Start
Sept 2014
Primary completion
Dec 2021
Completion
Feb 2022
First posted
18 Jul 2014 (estimated)
Last update posted
11 Apr 2022
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142016201820202022
  1. Ph 3

    PREVAIL

    NCT02194595

    Sept 2014 to Feb 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Type 2 diabetes mellitus is a chronic metabolic disorder characterized by progressive deterioration in the function of the pancreatic beta-cells, which are the cells that produce and secrete insulin (the hormone primarily responsible for the handling of glucose in the body). The investigators propose a randomized controlled trial to determine whether combining basal insulin with a new medication called exenatide is a therapeutic strategy that can preserve beta-cell function early in the course of type 2 diabetes.

Interventions

  • Basal insulin and exenatideDrug
  • Basal insulin onlyDrug
  • Basal insulin and bolus insulinDrug

Arms3

  • Experimental

    Basal insulin and exenatide

    Participants in this arm will undergo an 8-week course of treatment with exenatide and insulin glargine. Exenatide will be initiated at 5ug subcutaneous (sc) bid (before breakfast and before dinner) for the first 4 weeks, followed by 10ug bid for the next 4 weeks. Glargine sc injection at bedtime will be titrated to fasting glucose.

  • Active comparator

    Basal insulin only

    Participants in this arm will undergo an 8-week course of treatment with glargine sc injection at bedtime, titrated to target fasting glucose.

  • Active comparator

    Basal Insulin and bolus insulin

    Participants in this arm will undergo an 8-week course of multiple daily insulin injection therapy, consisting of titrated basal insulin glargine at bedtime and insulin lispro before each meal.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Mean beta-cell function over the 8-week treatment period, measured using the Insulin Secretion-Sensitivity Index-2 (ISSI-2)

    Time frame · 8 weeks

    Registry description

    ISSI-2 is an established measure of beta-cell function. ISSI-2 is defined as the product of (i) insulin secretion measured by the ratio of the area-under-the-insulin-curve to the area-under-the-glucose curve and (ii) insulin sensitivity measured by the Matsuda index. The primary outcome comparison is between the glargine/exenatide and glargine only arms.

Secondary outcomes(4)

  1. Baseline-adjusted beta-cell function at 20 weeks

    Time frame · 20 weeks

    Registry description

    The secondary outcome of baseline-adjusted beta-cell function at 20 weeks will be measured with the Insulin Secretion-Sensitivity Index-2 (ISSI-2)

  2. Baseline-adjusted glycemic control at 20 weeks

    Time frame · 20 weeks

    Registry description

    The secondary outcome of baseline-adjusted glycemic control at 20 weeks will be assessed by A1c (glycated hemoglobin)

  3. Endothelial function at 8 weeks

    Time frame · 8 weeks

    Registry description

    Endothelial function will be assessed as the digital endothelial vasomotor function in response to reactive hyperemia using pulse amplitude tonometry, which will be measured by the pulse amplitude response to hyperemia (PAT ratio)

  4. Baseline-adjusted glycemic control at 8 weeks

    Time frame · 8 weeks

    Registry description

    Baseline-adjusted glycemic control at 8 weeks will be measured by A1c

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2023

16 results

The vascular function effects of adding exenatide or meal insulin to basal insulin therapy in early type 2 diabetes.

Retnakaran et al. 2023Cardiovascular diabetologycited by 2

PMID 36894921PMC9998007DOI 10.1186/s12933-023-01781-zPUB-36894921

CC BY16 results
Download PDFSee results (16)

Eligibility

Who could join, as posted.

Sex
All
Age
from 30 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Men and women between the ages of 30 and 80 years inclusive 2. T2DM diagnosed by a physician ≤7 years prior to enrolment 3. On 0-2 anti-diabetic medications, with no change in dose/regimen in the preceding 4 weeks 4. A1c at screening between 5.5% and 9.0% inclusive if on anti-diabetic medications, or between 6.0% and 9.5% inclusive if on no oral anti-diabetic medication 5. BMI ≥ 23 kg/m2 6. Negative pregnancy test at recruitment for all women with childbearing potential Exclusion Criteria: 1. Current anti-diabetic treatment with insulin or a glucagon-like peptide-1 (GLP-1) agonist 2. Type 1 diabetes or secondary forms of diabetes 3. History of hypoglycemia unawareness or severe hypoglycemia requiring assistance 4. Hypersensitivity to insulin, exenatide, or the formulations of these products 5. Renal dysfunction as evidenced by estimated glomerular filtration rate (eGFR)\<30 ml/min by Modification of Diet in Renal Disease (MDRD) formula 6. History of pancreatitis 7. Family or personal history of Multiple Endocrine Neoplasia type 2 (MEN-2) or familial medullary thyroid carcinoma (MTC) 8. Personal history of non-familial medullary thyroid carcinoma (MTC) 9. Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer) 10. Unwillingness to perform capillary glucose monitoring at least 4 times a day during treatment 11. Pregnancy or unwillingness to use reliable contraception. Women should not be planning pregnancy for the duration of the study or the first 3 months after the study. Reliable contraception includes birth control pill, intra-uterine device, abstinence, tubal ligation, partner vasectomy, or condoms with spermicide. 12. Any factor likely to limit adherence to the protocol, in the opinion of investigator

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