NCT00097500

Brief Summary

This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus using metformin.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
69

participants targeted

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

Timeline
Completed

Started Sep 2004

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

Geographic Reach
3 countries

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

September 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2004

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 10, 2011

Completed
Last Updated

April 7, 2015

Status Verified

March 1, 2015

Enrollment Period

5.3 years

First QC Date

November 24, 2004

Results QC Date

December 24, 2010

Last Update Submit

March 19, 2015

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetesexenatideexendin-4AmylinLilly

Outcome Measures

Primary Outcomes (1)

  • Beta-cell Function After 52 Weeks of Therapy

    Treatment effect on beta-cell function as measured by the ratio of Week 52 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period \[i.e., clamp time 290 min to 300 min\]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 52 divided by arginine-stimulated insulin secretion at baseline \[week -2\]).

    Baseline (week -2) and 52 weeks

Secondary Outcomes (8)

  • Beta-cell Function 4 Weeks After Cessation of Therapy

    Baseline (week -2) and 56 weeks

  • Change in First Phase C-peptide Release

    baseline (week -2), 52 weeks, and 56 weeks

  • Change in Second Phase C-peptide Release

    baseline (-2 weeks), 52 weeks, and 56 weeks

  • Change in Glycosylated Hemoglobin (HbA1c)

    Week 0 and week 52

  • Change in Fasting Plasma Glucose

    0 weeks and 52 weeks

  • +3 more secondary outcomes

Study Arms (2)

Exenatide Arm

EXPERIMENTAL

Exenatide and Metformin

Drug: exenatideDrug: Metformin

Insulin Glargine Arm

ACTIVE COMPARATOR

Insulin Glargine and Metformin

Drug: Insulin glargineDrug: Metformin

Interventions

exenatideDRUG

subcutaneous injection, titrated up to a maximum of 20mcg three times a day in order to meet defined blood glucose targets

Also known as: Byetta
Exenatide Arm
Insulin glargineDRUG

subcutaneous injection, once a day, titrated as necessary in order to meet defined blood glucose targets

Also known as: Lantus
Insulin Glargine Arm
MetforminDRUG

Patients usual dosage

Exenatide ArmInsulin Glargine Arm

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of type 2 diabetes, but otherwise healthy
  • HbA1c between 6.6% and 9.5%, inclusive.
  • Body mass index (BMI) of 25 kg/m2 to 40 kg/m2, inclusive.
  • Treated with a stable dose of metformin for at least 2 months prior to screening.

You may not qualify if:

  • Patients previously in a study using exenatide.
  • Treated with oral anti-diabetic medications other than metformin within 2 months of screening (thiazolidinediones within 5 months of screening).
  • Treated with insulin within 3 months of screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Helsinki, Finland

Location

Research Site

Amsterdam, Netherlands

Location

Research Site

Gothenburg, Sweden

Location

Related Publications (5)

  • Bunck MC, Diamant M, Corner A, Eliasson B, Malloy JL, Shaginian RM, Deng W, Kendall DM, Taskinen MR, Smith U, Yki-Jarvinen H, Heine RJ. One-year treatment with exenatide improves beta-cell function, compared with insulin glargine, in metformin-treated type 2 diabetic patients: a randomized, controlled trial. Diabetes Care. 2009 May;32(5):762-8. doi: 10.2337/dc08-1797. Epub 2009 Feb 5.

    PMID: 19196887RESULT

  • Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.

    PMID: 39963952DERIVED

  • Muskiet MHA, Bunck MC, Heine RJ, Corner A, Yki-Jarvinen H, Eliasson B, Joles JA, Diamant M, Tonneijck L, van Raalte DH. Exenatide twice-daily does not affect renal function or albuminuria compared to titrated insulin glargine in patients with type 2 diabetes mellitus: A post-hoc analysis of a 52-week randomised trial. Diabetes Res Clin Pract. 2019 Jul;153:14-22. doi: 10.1016/j.diabres.2019.05.001. Epub 2019 May 9.

    PMID: 31078666DERIVED

  • Bunck MC, Corner A, Eliasson B, Heine RJ, Shaginian RM, Taskinen MR, Smith U, Yki-Jarvinen H, Diamant M. Effects of exenatide on measures of beta-cell function after 3 years in metformin-treated patients with type 2 diabetes. Diabetes Care. 2011 Sep;34(9):2041-7. doi: 10.2337/dc11-0291.

    PMID: 21868779DERIVED

  • Bunck MC, Corner A, Eliasson B, Heine RJ, Shaginian RM, Wu Y, Yan P, Smith U, Yki-Jarvinen H, Diamant M, Taskinen MR. One-year treatment with exenatide vs. insulin glargine: effects on postprandial glycemia, lipid profiles, and oxidative stress. Atherosclerosis. 2010 Sep;212(1):223-9. doi: 10.1016/j.atherosclerosis.2010.04.024. Epub 2010 Apr 29.

    PMID: 20494360DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

ExenatideInsulin GlargineMetformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological FactorsInsulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsBiguanidesGuanidinesAmidinesOrganic Chemicals

Results Point of Contact

Title
Peter Ohman, Medical Science Director
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Study Officials

  • Vice President, Research and Development, MD

    Amylin Pharmaceuticals, LLC.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

November 24, 2004

First Posted

November 25, 2004

Study Start

September 1, 2004

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

April 7, 2015

Results First Posted

January 10, 2011

Record last verified: 2015-03

Locations

FI(1)NL(1)SE(1)