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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: exenatide/insulin glargine
* Drug: insulin glargine/exenatide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exenatide/insulin glargine<br>Arm that first receives exenatide, then crosses over to insulin glargine | Drug: exenatide/insulin glargine<br>* 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<br>* Other names: syntheitc exenden-4;|
| Experimental: Insulin glargine/exenatide<br>Arm that first receives insulin glargine, then crosses over to exenatide | Drug: insulin glargine/exenatide<br>* 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<br>* Other names: synthetic exenden-4;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline, Week 16, Week 32 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient-reported outcomes from Baseline to the end of each 16-week period | 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 | Baseline, Week 16, Week 32 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exenatide, exendin-4, diabetes, Amylin, Lilly