Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s)

Study Overview
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Brief Summary
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This long term, placebo-controlled trial is intended to assess the efficacy and safety of exenatide, dosed twice a day, in Japanese patients with Type 2 Diabetes who are treated with oral antidiabetic(s) but not well controlled.

Official Title
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Efficacy and Safety of LY2148568 in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s) But Not Well Controlled

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: exenatide
* Drug: exenatide
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with type 2 diabetes. Has been treated by sulfonylurea (SU) alone, SU and biguanide, or SU and thiazolidinedione for at least 90 days prior to study start. In a patient receiving SU alone, the dose must be within the dose range from maximum maintenance dose to maximum approved dose. The patients with concomitant use of alpha glucosidase inhibitors (acarbose, voglibose or miglitol) or meglitinide derivatives (mitiglinide or nateglinide) can be included in this study, but these drugs must be discontinued at study start. Have HbA1c 7.0% to 10% at study start. Have a body weight >=50 kg. Exclusion Criteria: 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. Have participated in this study previously or any other study using exenatide or glucagon-like peptide-1 (GLP-1) analogs within the last 90 days. Have been treated with any exogenous insulin within 90 days before study start. Have been continuously treated with any drug that directly affects gastrointestinal motility for more than a total of 21 days in the 90 days prior to study start. The combination therapy of sulfonylurea, biguanide and thiazolidinedione is not allowed.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: exenatide<br>* subcutaneous injection, 5mcg, twice a day<br>* Other names: Byetta;|
| Experimental: 2<br> | Drug: exenatide<br>* subcutaneous injection, 10mcg, twice a day<br>* Other names: Byetta;|
| Placebo Comparator: 3<br> | Drug: placebo<br>* subcutaneous injection, volume equivalent to 5mcg or 10mcg exenatide, twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24 | Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0) | baseline, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Achieving HbA1c < 7.0% | Percentage of subjects whose HbA1c was >=7.0% at baseline who achieved an HbA1c < 7.0% at endpoint (i.e., number of eligible subjects who achieved HbA1c < 7.0% divided by total number of eligible subjects times 100) | 24 weeks | 
| Percentage of Patients Achieving HbA1c < 6.5% | Percentage of subjects whose HbA1c was >=6.5% at baseline who achieved an HbA1c < 6.5% at endpoint (i.e., number of eligible subjects who achieved HbA1c < 6.5% divided by total number of eligible subjects times 100) | 24 weeks | 
| Change in Fasting Blood Glucose | Change in fasting blood glucose from baseline to endpoint (i.e., fasting blood glucose at week 24 minus fasting blood glucose at week 0) | baseline, week 24 | 
| Change in Body Weight | Change in body weight form baseline to endpoint (i.e., body weight at week 24 minus body weight at week 0) | baseline, week 24 | 
| Change in Total Cholesterol | Change in total cholesterol from baseline to endpoint (i.e., total cholesterol at week 24 minus total cholesterol at week 0) | baseline, week 24 | 
| Change in Low Density Lipoprotein Cholesterol (LDL-C) | Change in LDL-C from baseline to endpoint (i.e., LDL-C at week 24 minus LDL-C at week 0) | baseline, week 24 | 
| Change in High Density Lipoprotein Cholesterol (HDL-C) | Change in HDL-C from baseline to endpoint (i.e., HDL-C at week 24 minus HDL-C at week 0) | baseline, week 24 | 
| Change in Triglycerides | Change in triglycerides from baseline to endpoint (i.e., triglycerides at week 24 minus triglycerides at week 0) | baseline, week 24 | 
| Change in Waist Size | Change in waist size from baseline to endpoint (i.e., waist size at week 24 minus waist size at week 0) | baseline, week 24 | 
| Change in Waist-to-hip Ratio | Change in waist-to-hip ratio from baseline to endpoint (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio is waist circumference divided by hip circumference. | baseline, week 24 | 
| 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | Self-monitored blood glucose at 7 different time points during the day (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime). | baseline, week 24 | 
| Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B) | Change in HOMA-B from baseline to endpoint (i.e., HOMA-B at week 24 minus HOMA-B at week 0). HOMA-B is a measurement of beta cell function. | baseline, week 24 | 
| Change in Homeostasis Model Assessment - Insulin Resistance (HOMA-R) | Change in HOMA-R from baseline to endpoint (i.e., HOMA-R at week 24 minus HOMA-R at week 0). HOMA-R is a measurement of insulin resistance. | baseline, week 24 | 
| Change in Serum Insulin | Change in serum insulin from baseline to endpoint (i.e., serum insulin at week 24 minus serum insulin at week 0) | baseline, week 24 | 
| Change in C-peptide | Change in C-peptide from baseline to endpoint (i.e., C-peptide at week 24 minus C-peptide at week 0) | baseline, week 24 | 
| Change in 1,5-anhydroglucitol | Change in 1,5-anhydroglucitol from baseline to endpoint (i.e., 1,5-anhydroglucitol at week 24 minus 1,5-anhydroglucitol at week 0) | baseline, week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, exenatide, LY2148568, Byetta, Lilly, Amylin