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Trial · Interventional

CompletedPhase 4Registry data

A Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus

NCTNCT00477581 (opens ClinicalTrials.gov in a new tab)Other idBCA403
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
102 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Triple masking
Countries
1 country

United States

Start
May 2007
Primary completion
Sept 2007
Completion
Sept 2007
First posted
23 May 2007 (estimated)
Last update posted
26 Aug 2015 (estimated)
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20072008
  1. Ph 4

    A Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus

    NCT00477581

    May 2007 to Sept 2007

Registry summary

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

This purpose of this study is to compare the effect of exenatide to that of sitagliptin on 2-hour postprandial glucose in subjects with type 2 diabetes mellitus.

Interventions

  • exenatideDrug
  • sitagliptinDrug

Arms2

  • Experimental

    Sequence A

  • Experimental

    Sequence B

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Effect of Exenatide on postprandial glucose

    Time frame · 28 days

    Registry description

    To compare the effect of exenatide to that of sitagliptin on 2-hour postprandial glucose in subjects with type 2 diabetes mellitus

Secondary outcomes(1)

  1. Assessment of effect of exenatide to the effect of sitagliptin the acetaminophen absorption test, and 6-point self-monitored blood glucose (SMBG) profiles

    Time frame · 28 days

    Registry description

    To compare the effect of exenatide to the effect of sitagliptin on the following endpoints in subjects with type 2 diabetes mellitus: postprandial glucose, insulin, insulin secretion rate, glucagon, and triglycerides; gastric emptying, as assessed by the acetaminophen absorption test, and 6-point self-monitored blood glucose (SMBG) profiles

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 · 2008

10 results

Effects of exenatide versus sitagliptin on postprandial glucose, insulin and glucagon secretion, gastric emptying, and caloric intake: a randomized, cross-over study.

DeFronzo et al. 2008Current medical research and opinioncited by 286

PMID 18786299DOI 10.1185/03007990802418851PUB-18786299

Full text at the publisher10 results
Publisher pageSee results (10)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Treatment with metformin for at least 2 months * Has HbA1c 7.0% to 11.0%, inclusive, at screening * Body mass index (BMI)25 kg/m\^2 to 45 kg/m\^2, inclusive * List of medications that are not allowed or the patient has been on stable treatment for at least 2 months: * Hormone replacement therapy (female subjects) * Oral contraceptives (female subjects) * Antihypertensive agents * Lipid-lowering agents * Thyroid replacement therapy Exclusion Criteria * Has been treated with exenatide (BYETTA®) or any DPP-4 inhibitor prior to screening * Received any study medication or participated in any type of clinical trial within 30 days prior to screening * Has donated blood within 60 days of screening visit or is planning to donate blood during the study * Treated with any of the following medications: * Sulfonylurea or Thiazolidinedione within 3 months of screening; * Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®)within 30 days of screening; * Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 6 months of screening; * Drugs that directly affect gastrointestinal motility, including but not limited to, anticholinergics, macrolide antibiotics, dopamine antagonists, opioids, and Reglan®(metoclopramide); * Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption;

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