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Trial · Interventional

CompletedPhase 3Registry data

Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes

NCTNCT00111540 (opens ClinicalTrials.gov in a new tab)Other id2993-119
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
456 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Nov 2002
Primary completion
Sept 2006
Completion
Sept 2006
First posted
24 May 2005 (estimated)
Last update posted
23 Feb 2015 (estimated)
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200220032004200520062007
  1. Ph 3

    Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes

    NCT00111540

    Nov 2002 to Sept 2006

Registry summary

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

This open label study is designed to assess long term glucose control, as measured by hemoglobin A1c (HbA1c) and to evaluate long term safety and tolerability in subjects with type 2 diabetes mellitus who receive subcutaneously injected exenatide administered twice a day.

Interventions

  • exenatideDrug

Arms1

  • Experimental

    Exenatide

    Exenatide 5 mcg for 4 weeks (transition) then 10 mcg to study termination

Primary outcomes4

Outcomes the sponsor listed as primary.

  1. Change in HbA1c (glycosylated hemoglobin) from Visit 1 to each protocol visit

    Time frame · Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)

    Registry description

    Change in HbA1c from Visit 1 to each visit up to open-ended study termination

  2. Change in body weight from Visit 1 to each protocol visit

    Time frame · Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)

    Registry description

    Change in body weight (kg) from Visit 1 to each visit up to open-ended study termination

  3. Change in fasting plasma glucose from Visit 1 to each protocol visit

    Time frame · Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)

    Registry description

    Change in fasting plasma glucose from Visit 1 to each visit up to open-ended study termination

  4. Change in lipids from Visit 1 to each protocol visit

    Time frame · Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)

    Registry description

    Change in lipids from Visit 1 to each visit up to open-ended study termination

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

Studies5

Studies that cite this trial.

Studies with results

5 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 · 2008

16 results

Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years.

Klonoff et al. 2008Current medical research and opinioncited by 508

PMID 18053320DOI 10.1185/030079908x253870PUB-18053320

Full text at the publisher16 results
Publisher pageSee results (16)

Indexing hint: Randomized controlled trial · 2007

13 results

Metabolic effects of two years of exenatide treatment on diabetes, obesity, and hepatic biomarkers in patients with type 2 diabetes: an interim analysis of data from the open-label, uncontrolled extension of three double-blind, placebo-controlled trials.

Buse et al. 2007Clinical therapeuticscited by 194

PMID 17379054DOI 10.1016/j.clinthera.2007.01.015PUB-17379054

Full text at the publisher13 results
Publisher pageSee results (13)

Indexing hint: Randomized controlled trial · 2007

12 results

The incretin mimetic exenatide as a monotherapy in patients with type 2 diabetes.

Nelson et al. 2007Diabetes technology & therapeuticscited by 27

PMID 17705687DOI 10.1089/dia.2006.0024PUB-17705687

Full text at the publisher12 results
Publisher pageSee results (12)

Indexing hint: Randomized controlled trial · 2006

10 results

Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes.

Blonde et al. 2006Diabetes, obesity & metabolismcited by 308

PMID 16776751DOI 10.1111/j.1463-1326.2006.00602.xPUB-16776751

Rights unknown10 results
Source linkSee 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: * The subject has an HbA1c value \<=11.0% * The subject has a body mass index (BMI) of 25 kg/m\^2 to 45 kg/m\^2, inclusive Exclusion Criteria: * Is currently treated with certain medications, including exogenous insulin

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