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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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Previous studies have suggested that a once-weekly formulation of exenatide may provide sustained glycemic control. These previous studies of exenatide once weekly have been conducted in non-Asian populations, so this study has been developed to support the local regulatory requirements of China, Korea, Japan, India, and Taiwan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exenatide once weekly | Drug | 2.0mg subcutaneous injection, once a week |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c From Baseline to Week 26. | Change in HbA1c from baseline to Week 26. | Baseline, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving HbA1c Targets <=7% at Week 26 | Percentage of patients achieving HbA1c <=7% at Week 26 (for patients with HbA1c >7% at baseline). | Baseline, Week 26 |
| Percentage of Patients Achieving HbA1c Targets <=6.5% at Week 26 |
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Inclusion Criteria:
Exclusion Criteria:
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:
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Have previously completed or withdrawn from this study or any other study investigating exenatide BID or QW.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.
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer Officer, MD | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | China | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24843650 | Derived | Onishi Y, Koshiyama H, Imaoka T, Haber H, Scism-Bacon J, Boardman MK. Safety of exenatide once weekly for 52 weeks in Japanese patients with type 2 diabetes mellitus. J Diabetes Investig. 2013 Mar 18;4(2):182-9. doi: 10.1111/jdi.12000. Epub 2012 Oct 22. | |
| 24843631 | Derived | Ji L, Onishi Y, Ahn CW, Agarwal P, Chou CW, Haber H, Guerrettaz K, Boardman MK. Efficacy and safety of exenatide once-weekly vs exenatide twice-daily in Asian patients with type 2 diabetes mellitus. J Diabetes Investig. 2013 Jan 29;4(1):53-61. doi: 10.1111/j.2040-1124.2012.00238.x. Epub 2012 Sep 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exenatide Once Weekly | Subcutaneous injection of 2 mg exenatide, once a week |
| FG001 | Exenatide Twice Daily | Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| exenatide twice daily |
| Drug |
5mcg subcutaneous injection twice a day (4 weeks), 10mcg subcutaneous injection twice a day (22 weeks) |
|
|
Percentage of patients achieving HbA1c <=6.5% at Week 26 (for patients with HbA1c >6.5% at baseline).
| Baseline, Week 26 |
| Change in Fasting Serum Glucose (FSG) From Baseline to Week 26 | Change in FSG from baseline to Week 26. | Baseline, Week 26 |
| Change in Body Weight (BW) From Baseline to Week 26 | Change in BW from baseline to Week 26. | Baseline, Week 26 |
| Change in Total Cholesterol (TC) From Baseline to Week 26 | Change in TC from baseline to Week 26. | Baseline, Week 26 |
| Change in High-Density Lipoprotein (HDL) From Baseline to Week 26 | Change in HDL from baseline to Week 26. | Baseline, Week 26 |
| Ratio of Triglycerides (TG) at Week 26 to Baseline | 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. | Baseline, Week 26 |
| Change in Blood Pressure From Baseline to Week 26 | Change in systolic blood pressure and diastolic blood pressure from baseline to Week 26. | Baseline, Week 26 |
| Assessment of Event Rate of Treatment-emergent Hypoglycemic Events | 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. | Baseline to Week 26 |
| Chengdu |
| China |
| Research Site | Chongqin | China |
| Research Site | Guangzhou | China |
| Research Site | Shanghai | China |
| Research Site | Ahmedabad | India |
| Research Site | Aligarh | India |
| Research Site | Bangalore | India |
| Research Site | Ghaziabad | India |
| Research Site | Hyderabaad | India |
| Research Site | Indore | India |
| Research Site | Kolkata | India |
| Research Site | Mumbai | India |
| Research Site | Pune | India |
| Research Site | Trivandrum | India |
| Research Site | Uttar Pradesh | India |
| Research Site | Varanasi | India |
| Research Site | Ageo | Japan |
| Research Site | Chiyoda-ku | Japan |
| Research Site | Izumisano | Japan |
| Research Site | Kashiwara | Japan |
| Research Site | Kitaazumi-gun | Japan |
| Research Site | Kumamoto | Japan |
| Research Site | Kurume | Japan |
| Research Site | Matsumoto | Japan |
| Research Site | Matsuyama | Japan |
| Research Site | Miyazaki | Japan |
| Research Site | Osaka | Japan |
| Research Site | Ōita | Japan |
| Research Site | Ōta-ku | Japan |
| Research Site | Shinjuku-ku | Japan |
| Research Site | Takatsuki | Japan |
| Research Site | Yokohama | Japan |
| Research Site | Bucheon-si | South Korea |
| Research Site | Daegu | South Korea |
| Research Site | Seoul | South Korea |
| Research Site | Changhua | Taiwan |
| Research Site | Chiayi City | Taiwan |
| Research Site | Kaohsiung City | Taiwan |
| Research Site | Tainan | Taiwan |
| Research Site | Taipei | Taiwan |
| Research Site | Taoyuan | Taiwan |
| Intent to Treat (ITT) |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Exenatide Once Weekly | Subcutaneous injection of 2 mg exenatide, once a week |
| BG001 | Exenatide Twice Daily | Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Glycosylated hemoglobin (HbA1c) | Mean | Standard Deviation | percentage of total hemoglobin |
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| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||||
| Background Oral Antidiabetic Agent (OAD) | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in HbA1c From Baseline to Week 26. | Change in HbA1c from baseline to Week 26. | ITT Population: Randomized patients received at least one dose of study drug. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. | Posted | Least Squares Mean | Standard Error | percentage of total hemoglobin | Baseline, Week 26 |
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| Secondary | Percentage of Patients Achieving HbA1c Targets <=7% at Week 26 | Percentage of patients achieving HbA1c <=7% at Week 26 (for patients with HbA1c >7% at baseline). | ITT Population. Only patients with baseline HbA1c > target were included in calculation. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach. | Posted | Number | percentage of patients | Baseline, Week 26 |
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| Secondary | Percentage of Patients Achieving HbA1c Targets <=6.5% at Week 26 | Percentage of patients achieving HbA1c <=6.5% at Week 26 (for patients with HbA1c >6.5% at baseline). | ITT Population. Only patients with baseline HbA1c > target were included in calculation. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using LOCF approach. | Posted | Number | percentage of patients | Baseline, Week 26 |
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| Secondary | Change in Fasting Serum Glucose (FSG) From Baseline to Week 26 | Change in FSG from baseline to Week 26. | ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, Week 26 |
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| Secondary | Change in Body Weight (BW) From Baseline to Week 26 | Change in BW from baseline to Week 26. | ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. | Posted | Least Squares Mean | Standard Error | kg | Baseline, Week 26 |
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| Secondary | Change in Total Cholesterol (TC) From Baseline to Week 26 | Change in TC from baseline to Week 26. | ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, Week 26 |
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| Secondary | Change in High-Density Lipoprotein (HDL) From Baseline to Week 26 | Change in HDL from baseline to Week 26. | ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, Week 26 |
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| Secondary | Ratio of Triglycerides (TG) at Week 26 to Baseline | 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. | ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. | Posted | Least Squares Mean | Standard Error | ratio | Baseline, Week 26 |
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| Secondary | Change in Blood Pressure From Baseline to Week 26 | Change in systolic blood pressure and diastolic blood pressure from baseline to Week 26. | ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was not imputed. | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 26 |
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| Secondary | Assessment of Event Rate of Treatment-emergent Hypoglycemic Events | 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. | ITT Population. | Posted | Mean | Standard Error | events per subject-year | Baseline to Week 26 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exenatide Once Weekly | Subcutaneous injection of 2 mg exenatide, once a week | 13 | 340 | 131 | 340 | ||
| EG001 | Exenatide Twice Daily | Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks) | 8 | 338 | 150 | 338 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral infarction | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Atrial tachycardia | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Blood calcitonin increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
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| Bronchopneumonia | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
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| Cerebral artery occlusion | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Chronic sinusitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Diplegia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Pneumonia haemophilus | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
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| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
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| Aortic aneurysm | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
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| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
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| Transient global amnesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Vitreous haemorrhage | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site induration | General disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Injection site nodule | General disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Ohman, Medical Science Director | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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| >=65 years |
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| Male |
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| MET+Sulfonylurea (SU) |
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| MET+SU+Thiazolidinedione (TZD) |
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| MET+TZD |
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| SU |
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| SU+TZD |
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| TZD |
|
Superiority of exenatide once weekly to exenatide twice daily concluded if upper limit of the 2-sided 95% confidence interval for treatment difference is <0; noninferiority concluded if upper limit is <0.4%. |
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| OG002 |
| Exenatide Once Weekly Without SU Use at Screening |
Subcutaneous injection of 2 mg exenatide, once a week and without SU use at Screening |
| OG003 | Exenatide Twice Daily Without SU Use at Screening | Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks) and without SU use at Screening |
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