Skip to content

Trial · Interventional

CompletedPhase 3Registry data

Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy

NCTNCT00099619 (opens ClinicalTrials.gov in a new tab)Other idH8O-MC-GWAO
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
138 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Open label (no masking)
Countries
6 countries

Australia, Greece, Hungary, Italy, Mexico, Poland

Start
Sept 2004
Primary completion
Aug 2005
Completion
Aug 2005
First posted
20 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 3

    Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy

    NCT00099619

    Sept 2004 to Aug 2005

Registry summary

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

This is a study with two treatment sequences and two treatment periods that will assess the safety and efficacy of exenatide treatment in patients with type 2 diabetes who have inadequate glycemic control using metformin or sulfonylurea and for whom insulin is the next appropriate step in diabetes treatment.

Interventions

  • exenatide/insulin glargineDrug
  • insulin glargine/exenatideDrug

Arms2

  • Experimental

    exenatide/insulin glargine

    Arm that first receives exenatide, then crosses over to insulin glargine

  • Experimental

    Insulin glargine/exenatide

    Arm that first receives insulin glargine, then crosses over to exenatide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in HbA1c (glycosylated hemoglobin) from the baseline of the first period (16-weeks of exenatide or insulin) to the end of each 16-week period.

    Time frame · Baseline, Week 16, Week 32

    Registry description

    Change in HbA1c from Baseline to the end of each 16-week period. There is one 16-week period of exenatide treatment and one 16-week period of insulin glargine.

Secondary outcomes(1)

  1. Change in patient-reported outcomes from Baseline to the end of each 16-week period

    Time frame · Baseline, Week 16, Week 32

    Registry description

    Change in patient-based outcomes (Hypoglycemic Fear Survey, patient-preference questionnaires \[Treatment Evaluation and Treatment Preference questionnaires), Diabetes Symptom Checklist-Revised, Diabetes Treatment Flexibility Scale, Psychological General Well-Being Index, and the EuroQol (EQ-5D) instrument\] from Baseline to the end of each 16-week exenatide or insulin glargine period

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

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)

Eligibility

Who could join, as posted.

Sex
All
Age
from 30 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Main Inclusion Criteria: * Treated with a stable dose of metformin or sulfonylurea for at least 3 months prior to screening. * HbA1c between 7.1% and 11.0%, inclusive. * Insulin therapy should be the next appropriate step of diabetes treatment. * Body Mass Index (BMI) \>25 kg/m2 and \<40 kg/m2. Main Exclusion Criteria: * Patient previously in a study involving exenatide or glucagon-like peptide-1 analogs. * Treated with insulin, thiazolidinediones, alpha-glucosidase inhibitors, or meglitinides within 3 months prior to screening.

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