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Trial · Interventional

CompletedPhase 4Results postedRegistry data

The Vascular Effects of Exenatide Versus Metformin in Patients With Pre-Diabetes

NCTNCT00546728 (opens ClinicalTrials.gov in a new tab)Other idSPHC 2007-02
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
50 participants (actual)
Sponsor
St. Paul Heart Clinic · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Oct 2007
Primary completion
Jul 2011
Completion
Jul 2011
First posted
19 Oct 2007 (estimated)
Last update posted
8 Nov 2013 (estimated)
Conditions
Impaired Glucose Tolerance

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200720082009201020112012
  1. Ph 4

    The Vascular Effects of Exenatide Versus Metformin in Patients With Pre-Diabetes

    NCT00546728

    Oct 2007 to Jul 2011

Registry summary

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

The purpose of this study is to compare the effects of exenatide versus metformin on vascular health with chronic (3-month) therapy and during a 2-hour period following a meal in patients with pre-diabetes. It is predicted that exenatide will improve vascular health to a greater degree compared to metformin.

Interventions

  • ExenatideDrug
  • MetforminDrug

Arms2

  • Experimental

    Exenatide

    Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily.

  • Active comparator

    Metformin

    Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Reactive Hyperemic Index Over the 3-month Treatment Period

    Time frame · Change from baseline to 3 months

    Registry description

    Change in reactive hyperemic index over the 3-month treatment period, which is a measure of endothelial (inner lining of blood vessels) function. This is measured as a ratio of post-occlusion blood flow volume versus baseline blood flow volume in fingertips. Higher ratio values are considered indicative of better arterial health.

Posted results

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

Primary outcome results

Primary outcomeMean· Change from baseline to 3 months

Change in Reactive Hyperemic Index Over the 3-month Treatment Period

GroupValue (ratio)Spread
Exenatide0.010.68
Metformin-0.170.72

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
ExenatideThree months of Exenatide therapy. Exenatide was initiated at 5 mcg, twice a day for one month and then up titrated to 10 mcg, twice a day for the remaining two months.–0 / 250 / 25
MetforminThree months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months.–0 / 250 / 25

Each cell reads participants affected / participants at risk, as the registry posted them.

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 · 2012

6 results

Effects of exenatide vs. metformin on endothelial function in obese patients with pre-diabetes: a randomized trial.

Kelly et al. 2012Cardiovascular diabetologycited by 82

PMID 22681705PMC3434036DOI 10.1186/1475-2840-11-64PUB-22681705

CC BY6 results
Download PDFSee results (6)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Greater than or equal to 18 years old * Impaired glucose tolerance: 2-hr oral glucose tolerance test (OGTT) plasma glucose \>140 mg/dL OR impaired fasting glucose: fasting glucose \> or = 100 mg/dL OR elevated glycosylated hemoglobin: Hemoglobin A1c \> or = 5.7% * Abdominal obesity: waist circumference \>102 cm (men) and \>88 cm (women) * Stable cardiovascular medication regimen (or other medications known to affect endothelial function) at least 1 month prior to enrollment and throughout the study Exclusion Criteria: * Type 2 diabetes * Current use of glycemic control medications within one month of randomization * Fasting glucose \>126 mg/dL * Current use of weight loss medication * Previous weight loss surgery * History of severe gastrointestinal disease * Standard clinical contraindications to exenatide or metformin therapy * Unstable angina * Heart failure * Stroke or coronary artery bypass graft within 3 months of screening * Women who are currently pregnant or planning to become pregnant * Breastfeeding women * Clinically significant liver disease * Creatinine \> 1.5 mg/dL * Hepatic function greater than 3 times upper limit of normal * Patients who are mentally incompetent and cannot sign a Patient Informed Consent

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