Skip to content

Trial · Interventional

CompletedPhase 2Registry data

Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus

NCTNCT00085969 (opens ClinicalTrials.gov in a new tab)Other id2993-120
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
99 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
Sept 2003
Primary completion
Jan 2004
Completion
Jan 2004
First posted
22 Jun 2004 (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
200320042005
  1. Ph 2

    Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus

    NCT00085969

    Sept 2003 to Jan 2004

Registry summary

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

The purpose of this study is to evaluate the safety and efficacy of a 28-day regimen of exenatide (AC2993), given as a monotherapy to subjects with type 2 diabetes mellitus.

Interventions

  • Placebo 0.04 mL twice dailyDrug
  • Placebo 0.04 mL once dailyDrug
  • Placebo 0.08 mL once dailyDrug
  • B - Exenatide 10 mcg twice dailyDrug
  • C - Exenatide 10 mcg once dailyDrug
  • Exenatide 20 mcg once dailyDrug

Arms6

  • Placebo comparator

    A1 - Placebo 0.04 mL twice daily

  • Placebo comparator

    A2 - Placebo 0.04 mL once daily

  • Placebo comparator

    A3 - Placebo 0.08 mL once daily

  • Experimental

    B - Exenatide 10 mcg twice daily

  • Experimental

    C - Exenatide 10 mcg once daily

  • Experimental

    D - Exenatide 20 mcg once daily

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28

    Time frame · Baseline, Day 28

    Registry description

    Change in HbA1c from Baseline Visit 3 (Day 1) to study termination (Day 28)

Secondary outcomes(4)

  1. Change in serum fructosamine concentration from Baseline to Day 14 and to Day 28

    Time frame · Baseline, Day 14, Day 28

    Registry description

    Change in serum fructosamine concentration from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)

  2. Change in body weight from Baseline to Day 14 and to Day 28

    Time frame · Baseline, Day 14, Day28

    Registry description

    Change in body weight from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)

  3. Change in fasting plasma glucose concentration from Baseline to Day 14 and to Day 28

    Time frame · Baseline, Day 14, Day 28

    Registry description

    Change in fasting plasma glucose concentration from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)

  4. Change in postprandial blood glucose concentrations from Baseline to Day 28

    Time frame · Baseline, Week 28

    Registry description

    Change in postprandial blood glucose concentrations from Baseline Visit 3 (Day 1) to study termination (Day 28)

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

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)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Subject has type 2 diabetes mellitus treated with diet and exercise modification alone or in combination with one oral antidiabetic agent for no longer than 4 years. Exclusion Criteria: * Subject has a clinically significant history or presence of any of the following conditions: (a) Hepatic disease, (b) Renal disease, (c) Central nervous system disease, (d) Gastrointestinal disease (e) Pulmonary disease (f) Hematologic disease. * Subject is currently treated with any of the following excluded medications: (a) Metformin/sulfonylurea combination therapy (b) Thiazolidinediones (c) Insulin as outpatient therapy (d) Regular use of drugs that directly affect gastrointestinal motility (e) Regular use of systemic corticosteroids by oral, intravenous (IV), or intramuscular (IM) route, or potent, inhaled, intrapulmonary, or intranasal steroids known to have a high rate of systemic absorption (f) Regular use of medications with addictive potential such as opiates, narcotics and tranquilizers (g) Antineoplastic agents (h) Transplantation medications (i) Prescription weight-loss medications.

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