Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy

Efficacy of Exenatide Compared With Insulin Glargine in Patients With Type 2 Diabetes Using Metformin or Sulfonylurea for Whom Insulin is the Next Appropriate Therapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00099619

Enrollment

138

Registered

2004-12-20

Start date

2004-09-30

Completion date

2005-08-31

Last updated

2015-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

exenatide, exendin-4, diabetes, Amylin, Lilly

Brief summary

This is a study with two treatment sequences and two treatment periods that will assess the safety and efficacy of exenatide treatment in patients with type 2 diabetes who have inadequate glycemic control using metformin or sulfonylurea and for whom insulin is the next appropriate step in diabetes treatment.

Interventions

DRUGexenatide/insulin glargine

Subcutaneously injected exenaide 10 mcg twice daily for 16 weeks; then insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels

DRUGinsulin glargine/exenatide

Subcutaneously injected insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels; then exenaide 10 mcg twice daily for 16 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Inclusion criteria

Main Inclusion Criteria: * Treated with a stable dose of metformin or sulfonylurea for at least 3 months prior to screening. * HbA1c between 7.1% and 11.0%, inclusive. * Insulin therapy should be the next appropriate step of diabetes treatment. * Body Mass Index (BMI) \>25 kg/m2 and \<40 kg/m2. Main

Exclusion criteria

* Patient previously in a study involving exenatide or glucagon-like peptide-1 analogs. * Treated with insulin, thiazolidinediones, alpha-glucosidase inhibitors, or meglitinides within 3 months prior to screening.

Design outcomes

Primary

Measure	Time frame	Description
Change in HbA1c (glycosylated hemoglobin) from the baseline of the first period (16-weeks of exenatide or insulin) to the end of each 16-week period.	Baseline, Week 16, Week 32	Change in HbA1c from Baseline to the end of each 16-week period. There is one 16-week period of exenatide treatment and one 16-week period of insulin glargine.

Secondary

Measure	Time frame	Description
Change in patient-reported outcomes from Baseline to the end of each 16-week period	Baseline, Week 16, Week 32	Change in patient-based outcomes (Hypoglycemic Fear Survey, patient-preference questionnaires \[Treatment Evaluation and Treatment Preference questionnaires), Diabetes Symptom Checklist-Revised, Diabetes Treatment Flexibility Scale, Psychological General Well-Being Index, and the EuroQol (EQ-5D) instrument\] from Baseline to the end of each 16-week exenatide or insulin glargine period

Countries

Australia, Greece, Hungary, Italy, Mexico, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026