A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects
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|ClinicalTrials.gov Identifier: NCT00917267|
Recruitment Status : Completed
First Posted : June 10, 2009
Results First Posted : December 31, 2012
Last Update Posted : April 9, 2015
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|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: exenatide once weekly Drug: exenatide twice daily||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||691 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Comparator-Controlled Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control (HbA1c) and Safety in Asian Subjects With Type 2 Diabetes Mellitus Managed With Oral Antidiabetic Medications|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||April 2011|
Drug: exenatide once weekly
2.0mg subcutaneous injection, once a week
|Active Comparator: 2||
Drug: exenatide twice daily
5mcg subcutaneous injection twice a day (4 weeks), 10mcg subcutaneous injection twice a day (22 weeks)
Other Name: Byetta
- Change in HbA1c From Baseline to Week 26. [ Time Frame: Baseline, Week 26 ]Change in HbA1c from baseline to Week 26.
- Percentage of Patients Achieving HbA1c Targets <=7% at Week 26 [ Time Frame: Baseline, Week 26 ]Percentage of patients achieving HbA1c <=7% at Week 26 (for patients with HbA1c >7% at baseline).
- Percentage of Patients Achieving HbA1c Targets <=6.5% at Week 26 [ Time Frame: Baseline, Week 26 ]Percentage of patients achieving HbA1c <=6.5% at Week 26 (for patients with HbA1c >6.5% at baseline).
- Change in Fasting Serum Glucose (FSG) From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]Change in FSG from baseline to Week 26.
- Change in Body Weight (BW) From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]Change in BW from baseline to Week 26.
- Change in Total Cholesterol (TC) From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]Change in TC from baseline to Week 26.
- Change in High-Density Lipoprotein (HDL) From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]Change in HDL from baseline to Week 26.
- Ratio of Triglycerides (TG) at Week 26 to Baseline [ Time Frame: Baseline, Week 26 ]Ratio of TG (measured in mg/dL) at Week 26 to baseline. Log(Post-baseline TG) - log(Baseline TG); change from baseline to Week 26 is presented as ratio of Week 26 to baseline.
- Change in Blood Pressure From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]Change in systolic blood pressure and diastolic blood pressure from baseline to Week 26.
- Assessment of Event Rate of Treatment-emergent Hypoglycemic Events [ Time Frame: Baseline to Week 26 ]Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT.
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|Ages Eligible for Study:||20 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Have been diagnosed with type 2 diabetes.
- Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 11.0% inclusive.
- Have a body mass index (BMI) of >21 kg/m2 and <35 kg/m2, inclusive.
- Have a history of stable body weight (not varying by >5% for at least 90 days prior to study start).
- Have been treated with a stable dose regimen of Met, SU, TZD, Met plus SU, Met plus TZD, or SU plus TZD for at least 90 days prior to study start.
- Have any contraindication for the OAD(s) that they use.
- Have a known allergy or hypersensitivity to exenatide BID, exenatide QW, or excipients contained in these agents.
- Have received chronic >14 consecutive days) systemic glucocorticoid therapy by oral, intravenous (IV), or intramuscular (IM) route or intra-articular steroid injection within 4 weeks prior to study start or are regularly treated with potent, inhaled steroids that are known to have a high rate of systemic absorption.
- Have been treated with drugs that promote weight loss (for example, GLP-1 analogue, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 90 days of study start.
Have been treated for >2 weeks with any of the following excluded medications within 90 days prior to study start:
- Dipeptidyl peptidase (DPP)-4 inhibitors (for example, sitagliptin or vildagliptin)
- Pramlintide acetate
- Drugs that directly affect gastrointestinal motility, including, but not limited to: Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.
- Have had prior exposure to exenatide
- Have previously completed or withdrawn from this study or any other study investigating exenatide BID or QW.
- 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.
- Are currently enrolled in any other clinical study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00917267
|Uttar Pradesh, India|
|Korea, Republic of|
|Bucheon, Korea, Republic of|
|Daegu, Korea, Republic of|
|Seoul, Korea, Republic of|
|Study Director:||Chief Medical Officer Officer, MD||Eli Lilly and Company|
|Other Study ID Numbers:||
|First Posted:||June 10, 2009 Key Record Dates|
|Results First Posted:||December 31, 2012|
|Last Update Posted:||April 9, 2015|
|Last Verified:||March 2015|
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists