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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
Not provided
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The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide (BET) | Experimental | Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) |
|
| Insulin Lispro (BBT) | Active Comparator | Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exenatide | Drug | subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (26 weeks), twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30 | Change in HbA1c from baseline following 30 weeks of therapy (i.e. HbA1c at week 30 minus HbA1c at baseline). | Baseline, 30 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving HbA1C < 7.0% | Percentage of participants achieving HbA1C < 7.0% | Week 30 |
| Percent of Participants Achieving HbA1c ≤ 6.5%. | Percent of participants achieving HbA1c ≤ 6.5%. |
Not provided
Inclusion Criteria:
Have been taking a basal insulin Glargine, at dose of ≥ 20 units/day, for at least 3 months prior to study start.
Have been taking basal insulin Glargine at dose of ≥ 20 units/day, in combination with 1 of the following oral antidiabetic medication (OAM) regimens, for at least 3 months prior to study start:
Have an HbA1C > 7.0% and ≤ 10.0%.
Have a body mass index (BMI) between ≥ 25 and ≤ 45 kg/m2.
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer, MD | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Buenos Aires | Argentina | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25011946 | Result | Diamant M, Nauck MA, Shaginian R, Malone JK, Cleall S, Reaney M, de Vries D, Hoogwerf BJ, MacConell L, Wolffenbuttel BH; 4B Study Group. Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes. Diabetes Care. 2014 Oct;37(10):2763-73. doi: 10.2337/dc14-0876. Epub 2014 Jul 10. |
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1036 patients entered the study, 637 were assigned to the two interventional study groups. 10 patients assigned to treatment groups did not receive study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled | Patients who enrolled in the basal insulin optimization (BIO) phase |
| FG001 | Exenatide (BET) | Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Basal Insulin Optimization Phase (BIO) |
|
Not provided
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Not provided
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| insulin lispro | Drug | titrated based on pre-meal glucose level; three times a day |
|
|
| Metformin | Drug |
|
| Insulin/ Glargine | Drug |
|
| Week 30 |
| Change in Fasting Blood Glucose (FBG) From Baseline to Week 30. | Change in fasting blood glucose (FBG) from Baseline to Week 30 using MMRM model. The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects. | Baseline, Week 30 |
| Change in Total Cholesterol From Baseline to Week 30 | Change in total cholesterol from baseline to Week 30 using ANCOVA model. The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate. | Baseline, week 30 |
| Change in High Density Lipoprotein (HDL) From Baseline to Week 30 | Change in High Density Lipoprotein (HDL) from baseline to Week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate. | Baseline, week 30 |
| Change in Low Density Lipoprotein (LDL) From Baseline to Week 30 | Change in Low Density Lipoprotein (LDL) from baseline to week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate. | Baseline, Week 30 |
| Change in Body Weight From Baseline to Week 30. | Change in body weight from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects. | baseline, week 30 |
| Change in Systolic Blood Pressure (SBP) From Baseline to Week 30 | Change in Systolic Blood Pressure (SBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects. | Baseline, Week 30 |
| Change in Diastolic Blood Pressure (DBP) From Baseline to Week 30 | Change in Diastolic Blood Pressure (DBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects. | baseline, Week 30 |
| Daily Insulin Glargine Dose at Baseline and at Week 30 | Daily Insulin Glargine Dose at baseline and at Week 30 | Baseline, week 30 |
| Major Hypoglycemia Rate Per Year | Mean (standard deviation) of major hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Major hypoglycemia was defined as any symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and requiring the assistance of another person because of severe impairment in consciousness or behavior. | 30 weeks |
| Minor Hypoglycemia Rate Per Year | Mean (standard deviation) of minor hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Minor hypoglycemia was defined as any time a participant feels that he or she is experiencing a sign or symptom associated with hypoglycemia that is either self-treated by the participant or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) | 30 weeks |
| Caba |
| Argentina |
| Research Site | Capital Federal | Argentina |
| Research Site | Ciudad Autonoma de Buenos Aire | Argentina |
| Research Site | Ciudad de Buenos Aires | Argentina |
| Research Site | Corrientes | Argentina |
| Research Site | Rosario | Argentina |
| Research Site | San Rafael | Argentina |
| Research Site | Arlon | Belgium |
| Research Site | Bonheiden | Belgium |
| Research Site | Edegem | Belgium |
| Research Site | Merksem | Belgium |
| Research Site | Tallinn | Estonia |
| Research Site | Tartu | Estonia |
| Research Site | Helsinki | Finland |
| Research Site | Oulu | Finland |
| Research Site | Vantaa | Finland |
| Research Site | Angers | France |
| Research Site | Auxerre | France |
| Research Site | Bar-le-Duc | France |
| Research Site | Douai | France |
| Research Site | La Roche-sur-Yon | France |
| Research Site | La Rochelle | France |
| Research Site | Le Creuzot | France |
| Research Site | Lille | France |
| Research Site | Marseille | France |
| Research Site | Montpellier | France |
| Research Site | Nanterre | France |
| Research Site | Pessac | France |
| Research Site | Rennes | France |
| Research Site | Strasbourg | France |
| Research Site | Toulouse | France |
| Research Site | Vénissieux | France |
| Research Site | Bad Lauterberg im Harz | Germany |
| Research Site | Dippoldiswalde | Germany |
| Research Site | Friedrichsthal | Germany |
| Research Site | Goch | Germany |
| Research Site | Grevenbroich | Germany |
| Research Site | Hamburg | Germany |
| Research Site | Mainz | Germany |
| Research Site | Saarbrücken | Germany |
| Research Site | Athens | Greece |
| Research Site | Thessaloniki | Greece |
| Research Site | Florence | Italy |
| Research Site | Naples | Italy |
| Research Site | Olbia | Italy |
| Research Site | Perugia | Italy |
| Research Site | Trieste | Italy |
| Research Site | Verona | Italy |
| Research Site | Aguascalientes | Mexico |
| Research Site | Cuernavaca | Mexico |
| Research Site | Mexico City | Mexico |
| Research Site | Monterrey | Mexico |
| Research Site | Almere Stad | Netherlands |
| Research Site | Amsterdam | Netherlands |
| Research Site | Beek | Netherlands |
| Research Site | Groningen | Netherlands |
| Research Site | Heerlen | Netherlands |
| Research Site | Hoogeveen | Netherlands |
| Research Site | Sittard-Geleen | Netherlands |
| Research Site | The Hague | Netherlands |
| Research Site | Coimbra | Portugal |
| Research Site | Lisbon | Portugal |
| Research Site | Portugal | Portugal |
| Research Site | Hato Rey | Puerto Rico |
| Research Site | Bucharest | Romania |
| Research Site | Cluj-Napoca | Romania |
| Research Site | Constanța | Romania |
| Research Site | Craiova | Romania |
| Research Site | Oradea | Romania |
| Research Site | Ploieşti | Romania |
| Research Site | Arkhangelsk | Russia |
| Research Site | Rostov-on-Don | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Seoul | South Korea |
| Research Site | Ulsan | South Korea |
| Research Site | Wŏnju | South Korea |
| Research Site | A Coruña | Spain |
| Research Site | Alicante | Spain |
| Research Site | Barcelona | Spain |
| Research Site | Dos Hermanas | Spain |
| Research Site | Santander | Spain |
| Research Site | Valencia | Spain |
| Research Site | Halmstad | Sweden |
| Research Site | Karlstad | Sweden |
| Research Site | Lund | Sweden |
| Research Site | Malmö | Sweden |
| Research Site | Solna | Sweden |
| Research Site | Stockholm | Sweden |
| Research Site | Umeå | Sweden |
| Research Site | Bournemouth | United Kingdom |
| Research Site | Ipswich | United Kingdom |
| Research Site | Leicester | United Kingdom |
| Research Site | Penarth | United Kingdom |
| Research Site | Wakefield | United Kingdom |
| FG002 | Insulin Lispro (BBT) | Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Interventional Phase |
|
|
per protocol population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Exenatide (BET) | Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) |
| BG001 | Insulin Lispro (BBT) | Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| prior use of Sulfonylurea (SU) | Number | participants |
| ||||||||||||||||||
| Glycosylated hemoglobin (HbA1c) | Mean | Standard Deviation | Percent |
|
| 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 Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30 | Change in HbA1c from baseline following 30 weeks of therapy (i.e. HbA1c at week 30 minus HbA1c at baseline). | Participants analyzed for this endpoint included the per protocol population, 247 and 263, respectively. | Posted | Least Squares Mean | Standard Error | percent of hemoglobin | Baseline, 30 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving HbA1C < 7.0% | Percentage of participants achieving HbA1C < 7.0% | Participants included in the analysis = 244 and 263, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (244, 263, respectively). | Posted | Number | Percentage of participants | Week 30 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Participants Achieving HbA1c ≤ 6.5%. | Percent of participants achieving HbA1c ≤ 6.5%. | Participants included in the analysis = 244 and 263, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (244, 263, respectively). | Posted | Number | percentage of participants | Week 30 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Fasting Blood Glucose (FBG) From Baseline to Week 30. | Change in fasting blood glucose (FBG) from Baseline to Week 30 using MMRM model. The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects. | Participants included in the analysis = 243 and 262, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (243, 262, respectively). | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Week 30 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Total Cholesterol From Baseline to Week 30 | Change in total cholesterol from baseline to Week 30 using ANCOVA model. The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate. | Participants included in the analysis = 237 and 254, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (237, 254, respectively). | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, week 30 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in High Density Lipoprotein (HDL) From Baseline to Week 30 | Change in High Density Lipoprotein (HDL) from baseline to Week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate. | Participants included in the analysis = 237 and 254, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (237, 254, respectively). | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, week 30 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Low Density Lipoprotein (LDL) From Baseline to Week 30 | Change in Low Density Lipoprotein (LDL) from baseline to week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate. | Participants included in the analysis = 232 and 245, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (232, 245, respectively). | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Week 30 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Body Weight From Baseline to Week 30. | Change in body weight from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects. | Participants analyzed were 247 and 263, respectively. These were from the per protocol population (247, 263, respectively) with no missing data (247, 263, respectively). | Posted | Least Squares Mean | Standard Error | kg | baseline, week 30 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Systolic Blood Pressure (SBP) From Baseline to Week 30 | Change in Systolic Blood Pressure (SBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects. | Participants included in the analysis = 207 and 227, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (207, 227, respectively). | Posted | Least Squares Mean | Standard Error | mmHg | Baseline, Week 30 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Diastolic Blood Pressure (DBP) From Baseline to Week 30 | Change in Diastolic Blood Pressure (DBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects. | Participants included in the analysis = 207 and 227, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (207, 227, respectively). | Posted | Least Squares Mean | Standard Error | mmHg | baseline, Week 30 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Daily Insulin Glargine Dose at Baseline and at Week 30 | Daily Insulin Glargine Dose at baseline and at Week 30 | Participants analyzed were from the per protocol population (247, 263) with no missing data for this endpoint (247, 263, respectively). | Posted | Mean | Standard Deviation | IU/day | Baseline, week 30 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Major Hypoglycemia Rate Per Year | Mean (standard deviation) of major hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Major hypoglycemia was defined as any symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and requiring the assistance of another person because of severe impairment in consciousness or behavior. | The As-treated population includes all randomized participants who had taken at least one dose of study drug. | Posted | Mean | Standard Deviation | rate per year | 30 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Minor Hypoglycemia Rate Per Year | Mean (standard deviation) of minor hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Minor hypoglycemia was defined as any time a participant feels that he or she is experiencing a sign or symptom associated with hypoglycemia that is either self-treated by the participant or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) | The As-treated population includes all randomized participants who had taken at least one dose of study drug. | Posted | Mean | Standard Deviation | rate per year | 30 weeks |
|
|
Not provided
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exenatide (BET) | Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) | 23 | 315 | 228 | 315 | ||
| EG001 | Insulin Lispro (BBT) | Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) | 26 | 312 | 175 | 312 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders |
| |||
| Angina unstable | Cardiac disorders |
| |||
| Cardiac failure congestive | Cardiac disorders |
| |||
| Coronary artery disease | Cardiac disorders |
| |||
| Acute myocardial infarction | Cardiac disorders |
| |||
| Angina pectoris | Cardiac disorders |
| |||
| Cardiac failure | Cardiac disorders |
| |||
| Myocardial ischaemia | Cardiac disorders |
| |||
| Vitreous haemorrhage | Eye disorders |
| |||
| Diabetic retinopathy | Eye disorders |
| |||
| Cataract | Eye disorders |
| |||
| Glaucoma | Eye disorders |
| |||
| Abdominal pain | Gastrointestinal disorders |
| |||
| Gastrooesophageal reflux disease | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Cholecystitis acute | Hepatobiliary disorders |
| |||
| Cholecystitis chronic | Hepatobiliary disorders |
| |||
| Osteomyelitis | Infections and infestations |
| |||
| Pyelonephritis | Infections and infestations |
| |||
| Urinary tract infection | Infections and infestations |
| |||
| Bacterial infection | Infections and infestations |
| |||
| Escherichia urinary tract infection | Infections and infestations |
| |||
| Pneumonia | Infections and infestations |
| |||
| Post procedural infection | Infections and infestations |
| |||
| Pyelonephritis acute | Infections and infestations |
| |||
| Ankle fracture | Injury, poisoning and procedural complications |
| |||
| Fall | Injury, poisoning and procedural complications |
| |||
| Lower limb fracture | Injury, poisoning and procedural complications |
| |||
| Meniscus lesion | Injury, poisoning and procedural complications |
| |||
| Ureteroscopy | Investigations |
| |||
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders |
| |||
| Exostosis | Musculoskeletal and connective tissue disorders |
| |||
| Osteoarthritis | Musculoskeletal and connective tissue disorders |
| |||
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders |
| |||
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Carotid artery thrombosis | Nervous system disorders |
| |||
| Encephalopathy | Nervous system disorders |
| |||
| Haemorrhagic stroke | Nervous system disorders |
| |||
| Ischaemic stroke | Nervous system disorders |
| |||
| Cerebral haemorrhage | Nervous system disorders |
| |||
| Hypoglycaemic coma | Nervous system disorders |
| |||
| Calculus ureteric | Renal and urinary disorders |
| |||
| Calculus urinary | Renal and urinary disorders |
| |||
| Renal failure acute | Renal and urinary disorders |
| |||
| Nephrolithiasis | Renal and urinary disorders |
| |||
| Rash | Skin and subcutaneous tissue disorders |
| |||
| Diabetic foot | Skin and subcutaneous tissue disorders |
| |||
| Arterial bypass operation | Surgical and medical procedures |
| |||
| Percutaneous coronary intervention | Surgical and medical procedures |
| |||
| Hypertensive crisis | Vascular disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders |
| |||
| Dyspepsia | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Bronchitis | Infections and infestations |
| |||
| Influenza | Infections and infestations |
| |||
| Nasopharyngitis | Infections and infestations |
| |||
| Headache | Nervous system disorders |
| |||
| Back Pain | Musculoskeletal and connective tissue disorders |
| |||
| Decreased appetite | Metabolism and nutrition disorders |
| |||
| Abdominal pain | Gastrointestinal disorders |
| |||
| Urinary tract infection | Infections and infestations |
| |||
| Dizziness | Nervous system disorders |
| |||
| Pharyngitis | Infections and infestations |
| |||
| Gastroenteritis | Infections and infestations |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Gastritis | Gastrointestinal disorders |
| |||
| Abdominal pain upper | Gastrointestinal disorders |
| |||
| pain in extremity | General disorders |
| |||
| Cough | Respiratory, thoracic and mediastinal disorders |
| |||
| seasonal allergy | Immune system disorders |
| |||
| arthralgia | Musculoskeletal and connective tissue disorders |
| |||
| musculoskeletal pain | Musculoskeletal and connective tissue disorders |
| |||
| upper respiratory tract infection | Infections and infestations |
| |||
| tooth infection | Infections and infestations |
| |||
| hypertension | Vascular disorders |
| |||
| Osteoarthritis | Musculoskeletal and connective tissue disorders |
| |||
| anxiety | Psychiatric disorders |
| |||
| toothache | Gastrointestinal disorders |
| |||
| anemia | Blood and lymphatic system disorders |
|
Not provided
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077270 | Exenatide |
| D061268 | Insulin Lispro |
| D008687 | Metformin |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D049528 | Insulin, Long-Acting |
Not provided
Not provided
| Lost to Follow-up |
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| entry criteria not met |
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| Protocol Violation |
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| Withdrawal by Subject |
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| Physician Decision |
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| sponsor decision |
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| Lack of Efficacy |
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| >=65 years |
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| Male |
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| NO |
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Non inferiority was concluded if the upper limit of the 95% confidence interval (CI) for the treatment contrast (BET minus BBT) at week 30 was less than the non inferiority margin.
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