Skip to content

Trial · Interventional

CompletedPhase 3Registry data

Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin

NCTNCT00324363 (opens ClinicalTrials.gov in a new tab)Other idH8O-MC-GWBA
Open at ClinicalTrials.govAsk about this trial

Overview

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

China, India, South Korea, Taiwan

Start
Jan 2006
Primary completion
Apr 2007
Completion
Apr 2007
First posted
11 May 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 in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin

    NCT00324363

    Jan 2006 to Apr 2007

Registry summary

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

This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control.

Interventions

  • exenatideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Exenatide

    Placebo lead-in; exenatide 5 mcg for 4 weeks; exenatide 10 mcg for 12 weeks

  • Placebo comparator

    Placebo

    Placebo in volume equal to exenatide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. To test the hypothesis that exenatide (before morning and evening meals) produces a greater decrease in HbA1c than placebo in patients with type 2 diabetes and inadequate glycemic control taking metformin alone or metformin and sulfonylureas.

    Time frame · 16 weeks

Secondary outcomes(1)

  1. To compare exenatide and placebo groups with respect to: *safety and tolerability; *proportion of patients achieving HbA1c<=7%; *body weight; *incidence and rate of hypoglycemic events; *glucose measurements

    Time frame · 16 weeks

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 · 2009

7 results

Efficacy and safety of exenatide in patients of Asian descent with type 2 diabetes inadequately controlled with metformin or metformin and a sulphonylurea.

Gao et al. 2009Diabetes research and clinical practicecited by 69

PMID 19019476DOI 10.1016/j.diabres.2008.09.037PUB-19019476

Full text at the publisher7 results
Publisher pageSee results (7)

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Treated with a stable dose of one of the following for at least 3 months prior to screening: \* \>=1000 mg/day immediate-release metformin; or metformin \>=1000 mg/day and sulfonylurea; or sulfonylurea/metformin combination therapy. * HbA1c between 7.1% and 11.0%, inclusive. * Body Mass Index (BMI) \>21 kg/m\^2 and \<35 kg/m\^2. Exclusion Criteria: * Have participated in this study previously, or any other study using exenatide or GLP-1 analogs. * Have participated in an interventional, medical, surgical, or pharmaceutical study within 30 days of screening. * Have characteristics contraindicating metformin or sulfonylurea use. * Have been treated with exogenous insulin for more than 1 week within the 3 months prior to screening. * Have used drugs for weight loss within 1 month of screening.

PepBank is a research reference. Talk to a doctor before you use any peptide.