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Trial · Interventional

CompletedPhase 3Registry data

Evaluation of the Effect on Glucose Control and Safety of AC2993 in Patients With Type 2 Diabetes Treated With Metformin, Sulfonylurea, or Metformin and Sulfonylurea Combination

NCTNCT00044668 (opens ClinicalTrials.gov in a new tab)Other id2993-117
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
155 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

Hungary

Start
Aug 2002
Primary completion
Sept 2005
Completion
Sept 2005
First posted
5 Sept 2002 (estimated)
Last update posted
20 Feb 2015 (estimated)
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20022003200420052006
  1. Ph 3

    Evaluation of the Effect on Glucose Control and Safety of AC2993 in Patients With Type 2 Diabetes Treated With Metformin, Sulfonylurea, or Metformin and Sulfonylurea Combination

    NCT00044668

    Aug 2002 to Sept 2005

Registry summary

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

This multi-center, open-label study is designed to examine the effects on long-term glucose control and safety of AC2993 in patients with type 2 diabetes treated with metformin, sulfonylurea, or metformin and sulfonylurea combination.

Interventions

  • AC2993Drug

Arms1

  • Experimental

    AC2993

    5 μg AC2993, twice daily, for 4 weeks followed by 10 μg AC2993, twice daily, during a maintenance period

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24, Week 52, and to each intermediate visit

    Time frame · Baseline, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52

    Registry description

    Change in HbA1c from Baseline to Week 24, Week 52, and to each intermediate visit (Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)

  2. Change in concentrations of fasting plasma glucose and lipids from Baseline Visit 2 (Day 1) to Week 24, to Week 52, and to each intermediate visit

    Time frame · Baseline, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52

    Registry description

    Change in concentrations of fasting plasma glucose and lipids from Baseline Visit 2 (Day 1) to Visit 10 (Week 24), to Visit 14 (Week 52) and to each intermediate visit (Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)

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 pageSee results (15)

More studies

1 study on this page

Indexing hint: Clinical trial · 2012

Long-term effects of adding exenatide to a regimen of metformin and/or sulfonylurea in type 2 diabetes: an uncontrolled, open-label trial in Hungary.

Iványi et al. 2012Clinical therapeuticscited by 4

PMID 22608106DOI 10.1016/j.clinthera.2012.04.022PUB-22608106

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 20 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Subjects with type 2 diabetes * Treated for at least 3 months prior to screening either with metformin, sulfonylurea, or metformin and sulfonylurea combination * BMI 25-45 kg/m\^2 * HbA1c between 7.5 % and 12.0 %, inclusive Exclusion Criteria: * Treated with other oral anti-diabetic agents other than metformin and sulfonylureas within 3 months of screening * Patients previously treated with AC2993 * Patients presently treated with insulin

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