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Trial · Interventional

CompletedPhase 3Registry data

Safety and Efficacy of Exenatide as Monotherapy

NCTNCT00381342 (opens ClinicalTrials.gov in a new tab)Other idH8O-MC-GWBJ
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
233 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Double masking
Countries
5 countries

United States, India, Puerto Rico, Romania, Russia

Start
Sept 2006
Primary completion
Sept 2007
Completion
Sept 2007
First posted
27 Sept 2006 (estimated)
Last update posted
23 Feb 2015 (estimated)
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200620072008
  1. Ph 3

    Safety and Efficacy of Exenatide as Monotherapy

    NCT00381342

    Sept 2006 to Sept 2007

Registry summary

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

This Phase 3 trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo with respect to glycemic control in drug-naive patients with type 2 diabetes treated with diet and exercise.

Interventions

  • exenatideDrug
  • exenatideDrug
  • placeboDrug

Arms3

  • Experimental

    Exenatide 5 mcg/exenatide 5 mcg

    Exenatide 5 mcg; then exenatide 5 mcg

  • Experimental

    Exenatide 5 mcg/exenatide 10 mcg

    Exenatide 5 mcg, then exenatide 10 mcg

  • Placebo comparator

    Placebo

    Placebo in volumes equivalent to exenatide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24

    Time frame · Baseline, Week 24

    Registry description

    Change in HbA1c from Baseline to Week 24

Secondary outcomes(6)

  1. Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less

    Time frame · Baseline, Weeks 4, 8, 12, 16, 24

    Registry description

    Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less

  2. Change in fasting serum glucose (FSG) from Baseline to Week 24

    Time frame · Baseline, Weeks 4, 8, 12, 16, and 24

    Registry description

    Change in fasting serum glucose (FSG) from Baseline to Week 24 and, if measured, at all visits in between

  3. Change in body weight from Baseline to Week 24

    Time frame · Baseline, Weeks 4, 8, 12, 16, and 24

    Registry description

    Change in body weight (kg) from Baseline to Week 24 and, if measured, at all visits in between

  4. Change in glucose measurements from Baseline to Week 24

    Time frame · Baseline, Weeks 4, 8, 12, 16, 24

    Registry description

    Change in fasting SMBG profiles (glucose measurements before and 2 hours after meals) from Baseline to Week 24 and, if measured, at all visits in between

  5. Changes in beta-cell function and insulin sensitivity from Baseline to Week 24

    Time frame · Baseline, Weeks 4, 8, 12, 16, and 24

    Registry description

    Changes in beta-cell function and insulin sensitivity as assessed by homeostasis model assessment (HOMA) analyses from Baseline to Week 24 and, if measured, at all visits in between

  6. Changes in fasting and 30, 60, 120 and 180-minute glucose measurements

    Time frame · Immediately before glucose load, then 30, 60, 120, and 180 minutes post

    Registry description

    Changes in fasting and 30, 60, 120, 180-minute post glucose load blood concentrations of glucose and insulin

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

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

PubMed tag: none · 2012

15 results

Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment.

Fineman et al. 2012Diabetes, obesity & metabolismcited by 117

PMID 22236356DOI 10.1111/j.1463-1326.2012.01561.xPUB-22236356

Full text at the publisher15 results
Publisher pageSee results (15)

PubMed tag: none · 2012

11 results

Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index.

Pencek et al. 2012Postgraduate medicinecited by 45

PMID 22913891DOI 10.3810/pgm.2012.07.2567PUB-22913891

Full text at the publisher11 results
Publisher pageSee results (11)

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2008

Corrected

Efficacy and tolerability of exenatide monotherapy over 24 weeks in antidiabetic drug-naive patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, parallel-group study.

Moretto et al. 2008Clinical therapeuticscited by 268

PMID 18803987DOI 10.1016/j.clinthera.2008.08.006PUB-18803987

Full text at the publisher
Publisher pageRead the notice

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Diagnosed with type 2 diabetes * Treating diabetes with diet and exercise * HbA1c between 6.5% and 10.0%, inclusive * Body Mass Index (BMI) between 25 kg/m\^2 and 45 kg/m\^2, inclusive Exclusion Criteria: * Have previously completed or withdrawn from this study * Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry * Have been treated with any antidiabetic agent * Have used drugs for weight loss (for example, Xenical, Meridia, Acutrim, or similar over-the counter medications) within 3 months of screening * Are currently treated with any of the following excluded medications: \* drugs that directly affect gastrointestinal motility; \* systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous, or intramuscular route used regularly (longer than 2 weeks) or used within 2 weeks immediately prior to screening for this study

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