Trial · Interventional

CompletedPhase 3Registry data

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

NCTNCT00099320Other idH8O-MC-GWAP

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 182 participants (actual)
Sponsor: AstraZeneca · Industry
Design: Randomized · Double masking
Countries: 3 countries
United States, Canada, Spain
Start: May 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

Ph 3
Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin
NCT00099320
May 2004 to Aug 2005

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, as measured by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate glycemic control with OAD alone.

Interventions

exenatideDrug
PlaceboDrug

Arms2

Experimental
Exenatide
After a 2-week placebo lead-in period, exenatide will be given in an esclating dose along with the subject's current therapy regimen
Placebo comparator
Placebo
After a 2-week placebo lead-in period, subjects will be given placebo (in equivalent amounts to exenatide) in addition to their current therapy regimen.

Primary outcomes2

Outcomes the sponsor listed as primary.

Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16, and if measured, any visits in between
Time frame · Baseline, Week 4, Week 8, Week 12, Week 16
Registry description
Change in HbA1c from Baseline (Visit 3) to study termination at Week 16, and at all study visits in between
Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose
Time frame · Baseline, Week 16
Registry description
Change from Baseline to Week 16 in FSG and glucose measured at different times throughout the day derived from 7-point self-monitored glucose (SMG) profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)

Secondary outcomes(5)

Percentage of subjects reaching the target HbA1c (<7%)
Time frame · Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Registry description
The percentage of subjects reaching the target HbA1c (\<7%) will be summarized and compared by treatment
Change in body weight from Baseline to Week 16
Time frame · Baseline, Week 16
Registry description
Change in body weight (kg) from Baseline to Week 16
Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose
Time frame · Baseline, Week 16
Registry description
Change from Baseline to Week 16 in FSG and glucose measured at different times throughout the day derived from 7-point self-monitored glucose (SMG) profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)
Changes in beta cell function and insulin sensitivity between Baseline and Week 16
Time frame · Baseline, Week 16
Registry description
Changes in beta cell function and insulin sensitivity as assessed by homeostasis model assessment (HOMA) analyses and the proinsulin/insulin ratio Between Baseline and Week 16
Changes in lipids between Baseline and Week 16
Time frame · Baseline, Week 16
Registry description
Changes from Baseline to Week 16 in serum lipids (total cholesterol \[TC\], high-density lipoprotein cholesterol \[HDL-C\], fasting triglycerides, calculated low-density lipoprotein cholesterol \[LDL-C\]

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

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 page See results (15)

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2007

Corrected

The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes: a randomized trial.

Zinman et al. 2007Annals of internal medicinecited by 301

PMID 17404349DOI 10.7326/0003-4819-146-7-200704030-00003PUB-17404349

Full text at the publisher

Publisher page Read the notice

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 thiazolidinedione (TZD) alone or in combination with metformin. TZD dose stable for at least 120 days prior to screening, and those patients on metformin must have been on a stable dose for at least 30 days prior to screening. * HbA1c between 7.1% and 10.0%, inclusive. * Body mass index (BMI) between 25 kg/m\^2 and 45 kg/m\^2. Exclusion Criteria: * Patient previously in a study using exenatide or GLP-1 analogs. * Treated with oral anti-diabetic medications other than TZD and metformin within 3 months of screening. * Treated with oral insulin within 3 months of screening.

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