NCT00044668

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2002

Longer than P75 for phase_3 diabetes-mellitus-type-2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 3, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2002

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

February 20, 2015

Status Verified

January 1, 2015

Enrollment Period

3.1 years

First QC Date

September 3, 2002

Last Update Submit

February 19, 2015

Conditions

Diabetes Mellitus, Type 2

Keywords

exenatideexendin-4diabetesAmylinLilly

Outcome Measures

Primary Outcomes (2)

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

    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)

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

  • 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

    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)

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

Study Arms (1)

AC2993

EXPERIMENTAL

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

Drug: AC2993

Interventions

AC2993DRUG

Subjects will receive 5 μg AC2993, subcutaneously injected twice daily, for 4 weeks followed by 10 μg AC2993, subcutaneously injected twice daily, during a maintenance period that is expected to continue for at least 11 months.

Also known as: synthetic exendin-4
AC2993

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Diagnostic Units Hungary Kft.

Budapest, Hungary, H 1036, Hungary

Location

Peterfy Teaching Hospital

Budapest, Hungary, H 1076, Hungary

Location

Uzsoki Street Municipal Hospital

Budapest, Hungary, H 1145, Hungary

Location

Related Publications (2)

  • Ivanyi T, Fovenyi J, Faludi P, Han J, Macconell L, Wille S, Kiljanski J. 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. Clin Ther. 2012 Jun;34(6):1301-13. doi: 10.1016/j.clinthera.2012.04.022. Epub 2012 May 16.

    PMID: 22608106DERIVED

  • Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.

    PMID: 22236356DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Study Officials

  • Lisa Porter, MD

    Amylin Pharmaceuticals, LLC.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2002

First Posted

September 5, 2002

Study Start

August 1, 2002

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

February 20, 2015

Record last verified: 2015-01

Locations

HU(3)