NCT00099333

Brief Summary

This study will look at the safety of substituting exenatide for insulin in patients with type 2 diabetes who are currently taking insulin and oral antidiabetic agent(s).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Feb 2004

Typical duration for phase_2 type-2-diabetes-mellitus

Geographic Reach
1 country

5 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

February 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2004

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

February 23, 2015

Status Verified

January 1, 2015

Enrollment Period

1.5 years

First QC Date

December 10, 2004

Last Update Submit

February 20, 2015

Conditions

Type 2 Diabetes Mellitus

Keywords

exenatideexendin-4AmylinEli Lillydiabetes

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16

    Change in HbA1c from Baseline study termination (Week 16)

    Baseline, Week 16

Study Arms (2)

Exenatide

EXPERIMENTAL

The subjects will discontinue their insulin and substitute it with exenatide. Subjects will remain on their existing oral diabetic therapy.

Drug: exenatide

Insulin

ACTIVE COMPARATOR

The subjects will remain on their current insulin therapy. Subjects will also remain on their existing oral diabetic therapy.

Drug: Insulin

Interventions

exenatideDRUG

Exenatide 5 mcg subcutaneously injected twice daily for 4 weeks; then 10 mcg subcutaneously injected twice daily for 12 weeks.

Also known as: synthetic exendin-4, AC2993, Byetta
Exenatide
InsulinDRUG

Insulin will be taken according to the subject's current regimen

Insulin

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients have been treated with insulin for \>=3 months up to 12 years.
  • HbA1c \<=10.5%.
  • Body mass index (BMI) between 27 kg/m2 and 40 kg/m2.

You may not qualify if:

  • Patients previously received exenatide or GLP-1 analogs.
  • Patients have been treated for greater than 2 weeks with thiazolidinediones or alpha-glucosidase inhibitors within 3 months prior to screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Research Site

Chula Vista, California, United States

Location

Research Site

Butte, Montana, United States

Location

Research Site

Portland, Oregon, United States

Location

Research Site

Nashville, Tennessee, United States

Location

Research Site

San Antonio, Texas, United States

Location

Related Publications (2)

  • 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

  • Davis SN, Johns D, Maggs D, Xu H, Northrup JH, Brodows RG. Exploring the substitution of exenatide for insulin in patients with type 2 diabetes treated with insulin in combination with oral antidiabetes agents. Diabetes Care. 2007 Nov;30(11):2767-72. doi: 10.2337/dc06-2532. Epub 2007 Jun 26.

    PMID: 17595353DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

ExenatideInsulin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological FactorsProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • James Malone, MD

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2004

First Posted

December 13, 2004

Study Start

February 1, 2004

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

February 23, 2015

Record last verified: 2015-01

Locations

US(5)