A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients

Study Overview
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Brief Summary
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This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs.

Official Title
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An Open Label Study Comparing Exenatide With Basal Insulin in Achieving an HbA1c of ≤ 7.4% With Minimum Weight Gain, in Type 2 Diabetes Patients Who Are Not Achieving Adequate HbA1c Control on Oral Anti Diabetic Therapies Alone

Conditions
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Type 2 Diabetes

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with type 2 diabetes Currently being treated with the following: Dual or triple oral therapy - on a stable combination and dose for at least 3 months. HbA1c between 7.5% and 10.0%. BMI >27. Exclusion Criteria: Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to study. Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study. Treatment with the following medications: *Insulin as outpatient therapy within last 3 months; *Meglitinides, or acarbose within the last 3 months; *Regular use of any drugs that directly affect gastrointestinal motility; *Any previous (study) therapy with exenatide or glucagon-like peptide-1 (GLP-1) analogue; *Anti-obesity agent use within the last 3 months. Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: exenatide<br>* subcutaneous injection, 5mcg or 10mcg, twice a day<br>* Other names: Byetta;|
| Active Comparator: 2<br> | Drug: insulin glargine<br>* subcutaneous injection, titrated to target blood glucose level, once a day<br>* Other names: Lantus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg) | Composite endpoint evaluating effect of treatment on glycemic control and weight | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg | Composite endpoint evaluating effect of treatment on glycemic control and weight | 26 weeks | 
| Change in Fasting Serum Glucose | Change in fasting serum glucose from baseline (week 0) to endpoint (week 26) | 26 weeks | 
| Percent of Patients Achieving HbA1c ≤ 7.4% | Percent of patients achieving specified HbA1c target at endpoint | 26 weeks | 
| Percent of Patients Achieving HbA1c < 7% | Percent of patients achieving specified HbA1c target at endpoint | 26 weeks | 
| Percent of Patients Achieving HbA1c < 6.5% | Percent of patients achieving specified HbA1c target at endpoint | 26 weeks | 
| Change in 7 Point Self Monitored Blood Glucose Profile | Change from baseline to endpoint in self monitored blood glucose levels measured at 7 time points during the day | 26 weeks | 
| Change in Body Mass Index (BMI) | Change in BMI from baseline to endpoint | 26 weeks | 
| Change in Waist Circumference | Change in waist circumference from baseline to endpoint | 26 Weeks | 
| Change in Waist-to-hip Ratio | Change in waist-to-hip ratio from baseline to endpoint | 26 weeks | 
| Change in Body Weight | Change in body weight from baseline to endpoint | 26 weeks | 
| Percent Change in Body Weight | Percent change in baseline body weight at endpoint | 26 Weeks | 
| Percent of Patients Achieving 5% Weight Loss | Percent of patients who lost at least 5% of baseline body weight at endpoint | 26 weeks | 
| Percent of Patients Achieving 10% Weight Loss | Percent of patients who lost at least 10% of baseline body weight at endpoint | 26 weeks | 
| Change in Systolic Blood Pressure | Change in systolic blood pressure from baseline to endpoint | 26 weeks | 
| Change in Diastolic Blood Pressure | Change in diastolic blood pressure from baseline to endpoint | 26 weeks | 
| Change in Fasting Serum Total Cholesterol (TC) | Change in TC from baseline to endpoint | 26 weeks | 
| Change in High Density Lipoprotein (HDL) Cholesterol | Change in HDL cholesterol from baseline to endpoint | 26 weeks | 
| Change in TC to HDL Cholesterol Ratio | Change in TC to HDL cholesterol ratio from baseline to endpoint | 26 weeks | 
| Change in Fasting Serum Triglycerides | Change in fasting serum triglycerides from baseline to endpoint | 26 weeks | 
| Change in Low Density Lipoprotein (LDL) Cholesterol | Change in LDL cholesterol from baseline to endpoint | 26 weeks | 
| Change in Apolipoprotein-B | Change in apolipoprotein-B from baseline to endpoint | 26 weeks | 
| Incidence of Hypoglycemic Episodes | Percent of total patients in each arm experiencing hypoglycemia at any point in the 26 week study | 26 weeks | 
| Incidence of Nocturnal Hypoglycemic Episodes | Percent of total patients in each arm experiencing nocturnal hypoglycemia at any point in the 26 week study | 26 weeks | 
| Incidence of Severe Hypoglycemic Episodes | Percent of total patients in each arm experiencing severe hypoglycemia at any point during the 26 week study | 26 weeks | 
| Hypoglycemic Rate Per 30 Days | Number of hypoglycemic episodes per patient adjusted per 30 days | 26 weeks | 
| Nocturnal Hypoglycemic Rate Per 30 Days | Number of nocturnal hypoglycemic episodes per patient adjusted per 30 days | 26 weeks | 
| Severe Hypoglycemic Rate Per 30 Days | Number of severe hypoglycemic episodes per patient adjusted per 30 days | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, exenatide, insulin glargine, Lilly, Amylin