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Trial · Interventional

CompletedPhase 2Registry data

Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients With Type 2 Diabetes Mellitus

NCTNCT00044694 (opens ClinicalTrials.gov in a new tab)Other id2993-116
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States

Start
Aug 2002
Primary completion
May 2003
Completion
May 2003
First posted
5 Sept 2002 (estimated)
Last update posted
20 Feb 2015 (estimated)
Conditions
Diabetes Mellitus, Non-Insulin-Dependent

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200220032004
  1. Ph 2

    Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients With Type 2 Diabetes Mellitus

    NCT00044694

    Aug 2002 to May 2003

Registry summary

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

This is a multicenter, randomized, blinded, placebo-controlled, short-term, dose-response study to examine the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be individuals with type 2 diabetes treated with metformin for at least 3 months prior to screening. Patients whose diabetes management consists of diet and exercise will also be eligible for this study.

Interventions

  • Placebo 0.01 mLDrug
  • Placebo 0.02 mLDrug
  • Placebo 0.03 mLDrug
  • Placebo 0.04 mLDrug
  • AC2993 2.5 mcgDrug
  • AC2993 5.0 mcgDrug
  • AC2993 7.5 mcgDrug
  • AC2993 10.0 mcgDrug

Arms8

  • Placebo comparator

    Placebo 0.01 mL

    2 week placebo lead-in followed by Placebo 0.01 mL

  • Placebo comparator

    Placebo 0.02 mL

    2 week placebo lead-in followed by Placebo 0.02 mL

  • Placebo comparator

    Placebo 0.03 mL

    2 week placebo lead-in followed by Placebo 0.03 mL

  • Placebo comparator

    Placebo 0.04 mL

    2 week placebo lead-in followed by Placebo 0.04 mL

  • Experimental

    AC2993 2.5 mcg

    2 week placebo lead-in (0.01 mL) followed by AC2993 2.5 mcg; 0.01 mL

  • Experimental

    AC2993 5.0 mcg

    2 week placebo lead-in followed by AC2993 5.0 mcg; 0.01 mL

  • Experimental

    AC2993 7.5 mcg

    2 week placebo lead-in followed by AC2993 7.5 mcg; 0.03 mL

  • Experimental

    AC2993 10.0 mcg

    2 week placebo lead-in period followed by AC2993 10.0 mcg; 0.04 mL

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Baseline (Day 1) to Day 28

    Registry description

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

Secondary outcomes(3)

  1. Change in HbA1c from Baseline to Day 14

    Time frame · Baseline, Day 14

    Registry description

    Change in HbA1c from Baseline (Day 1) to Day 14

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

    Time frame · Baseline, Day 14, Day28

    Registry description

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

  3. Change in serum fructosamine from Baseline (Day 1) to Day 14 and to Day 28

    Time frame · Baseline, Day 14, Day 28

    Registry description

    Change in serum fructosamine from baseline (Day 1) to Visit 4 (Day 14) and 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 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Subjects with type 2 diabetes * Treated with diet and exercise alone or with metformin for at least 3 months prior to screening * BMI 27-45 kg/m\^2 * HbA1c between 7.0 % and 8.0 % Exclusion Criteria: * Treated with other oral anti-diabetic agents other than metformin within 3 months of screening * Patients previously treated with AC2993 * Patients presently treated with insulin

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