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Trial · Interventional

CompletedPhase 2Registry data

Study of the Safety of Substituting Exenatide for Insulin in Patients Using Insulin and Oral Antidiabetic Agents

NCTNCT00099333 (opens ClinicalTrials.gov in a new tab)Other idH8O-MC-GWAK
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
49 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Feb 2004
Primary completion
Aug 2005
Completion
Aug 2005
First posted
13 Dec 2004 (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
200420052006
  1. Ph 2

    Study of the Safety of Substituting Exenatide for Insulin in Patients Using Insulin and Oral Antidiabetic Agents

    NCT00099333

    Feb 2004 to Aug 2005

Registry summary

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

This study will look at the safety of substituting exenatide for insulin in patients with type 2 diabetes who are currently taking insulin and oral antidiabetic agent(s).

Interventions

  • exenatideDrug
  • InsulinDrug

Arms2

  • Experimental

    Exenatide

    The subjects will discontinue their insulin and substitute it with exenatide. Subjects will remain on their existing oral diabetic therapy.

  • Active comparator

    Insulin

    The subjects will remain on their current insulin therapy. Subjects will also remain on their existing oral diabetic therapy.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16

    Time frame · Baseline, Week 16

    Registry description

    Change in HbA1c from Baseline study termination (Week 16)

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

Studies2

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)

Indexing hint: Randomized controlled trial · 2007

4 results

Exploring the substitution of exenatide for insulin in patients with type 2 diabetes treated with insulin in combination with oral antidiabetes agents.

Davis et al. 2007Diabetes carecited by 62

PMID 17595353DOI 10.2337/dc06-2532PUB-17595353

Rights unknown4 results
Source linkSee results (4)

Eligibility

Who could join, as posted.

Sex
All
Age
from 35 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Patients have been treated with insulin for \>=3 months up to 12 years. * HbA1c \<=10.5%. * Body mass index (BMI) between 27 kg/m2 and 40 kg/m2. Exclusion Criteria: * Patients previously received exenatide or GLP-1 analogs. * Patients have been treated for greater than 2 weeks with thiazolidinediones or alpha-glucosidase inhibitors within 3 months prior to screening.

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