Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will compare the benefits of exenatide once weekly treatment to those achieved by the approved antidiabetic therapies sitagliptin and pioglitazone in subjects whose type 2 diabetes is managed with metformin therapy alone. The safety and tolerability of the three treatment regimens will also be compared.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
| |
| 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exenatide once weekly | Drug | subcutaneous injection, 2.0mg, once a week |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c From Baseline to Week 26 | Absolute change in HbA1c from baseline (Day 1) to Week 26 [Week 26 - Baseline]. | Day 1, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Achieving HbA1c Target of <7% at Week 26 | Percentages of subjects achieving HbA1c target values of <7% at Week 26. | Week 26 |
| Percentage of Subjects Achieving HbA1c Target of <=6.5% at Week 26 |
Not provided
Inclusion Criteria:
Has been diagnosed with type 2 diabetes mellitus
Has a hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at study start
Has a body mass index (BMI)of 25 kg/m2 to 45 kg/m2, inclusive, at study start
Has been on a stable treatment regimen of metformin for a minimum of 2 months prior to study start
Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start:
Exclusion Criteria:
Has been previously exposed to exenatide once weekly
Has donated blood within 60 days of study start or is planning to donate blood during the study
Currently being treated, or is expected to require or undergo treatment with any of the following treatment-excluded medications:
Has received any investigational drug within 1 month (or five half-lives of investigational drug, whichever is greater) of study start
Has previously experienced a clinically significant adverse event (e.g., significant edema) related to TZD or DPP-4 inhibitor use
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lisa Porter, MD | Amylin Pharmaceuticals, LLC. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Peoria | Arizona | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32306296 | Derived | Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18. | |
| 23748507 | Derived | Malloy J, Meloni A, Han J. Efficacy and tolerability of exenatide once weekly versus sitagliptin in patients with type 2 diabetes mellitus: a retrospective analysis of pooled clinical trial data. Postgrad Med. 2013 May;125(3):58-67. doi: 10.3810/pgm.2013.05.2661. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Exenatide Once Weekly | Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning |
| FG001 | Sitagliptin | Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| sitagliptin |
| Drug |
oral tablet, 100mg, once a day |
|
|
| pioglitazone | Drug | oral tablet, 45mg, once a day |
|
| placebo tablet | Drug | oral tablet, once a day |
|
| placebo once weekly | Drug | subcutaneous injection, once a week |
|
Percentages of subjects achieving HbA1c target values of <=6.5% at Week 26.
| Week 26 |
| Percentage of Subjects Achieving HbA1c Target of <=6.0% at Week 26 | Percentages of subjects achieving HbA1c target values of <=6.0% at Week 26. | Week 26 |
| Change in Body Weight From Baseline to Week 26 | Change in body weight from baseline (Day 1) to Week 26. | Day 1, Week 26 |
| Change in Fasting Plasma Glucose From Baseline to Week 26 | Change in fasting plasma glucose from baseline (Day 1) to Week 26. | Day 1, Week 26 |
| Change in Systolic Blood Pressure From Baseline to Week 26 | Change in systolic blood pressure from baseline (Day 1) to Week 26. | Day 1, Week 26 |
| Change in Diastolic Blood Pressure From Baseline to Week 26 | Change in diastolic blood pressure from baseline (Day 1) to Week 26. | Day 1, Week 26 |
| Change in Fasting Total Cholesterol From Baseline to Week 26 | Change in fasting total cholesterol from baseline (Day 1) to Week 26. | Day 1, Week 26 |
| Change in Fasting High-density Lipoprotein (HDL) From Baseline to Week 26 | Change in fasting HDL from baseline (Day 1) to Week 26. | Day 1, Week 26 |
| Ratio of Fasting Triglycerides at Week 26 to Baseline | Ratio of triglycerides (measured in mg/dL) at Week 26 to baseline (Day 1). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline. | Day 1, Week 26 |
| Assessment on Event Rate of Treatment-emergent Hypoglycemic Events | Major hypoglycemia: events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration < 54 mg/dL prior to treatment. Minor hypoglycemia: symptoms consistent with hypoglycemia and blood glucose concentration < 54 mg/dL prior to treatment and not classified as major hypoglycemia. | Day 1 to Week 26 |
| Artesia |
| California |
| United States |
| Research Site | Concord | California | United States |
| Research Site | Encino | California | United States |
| Research Site | Greenbrae | California | United States |
| Research Site | La Mesa | California | United States |
| Research Site | Orange | California | United States |
| Research Site | Walnut Creek | California | United States |
| Research Site | Whittier | California | United States |
| Research Site | Colorado Springs | Colorado | United States |
| Research Site | Washington D.C. | District of Columbia | United States |
| Research Site | Coral Gables | Florida | United States |
| Research Site | DeLand | Florida | United States |
| Research Site | Melbourne | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Site | New Port Richey | Florida | United States |
| Research Site | Decatur | Georgia | United States |
| Research Site | Avon | Indiana | United States |
| Research Site | Wichita | Kansas | United States |
| Research Site | Paducah | Kentucky | United States |
| Research Site | Baton Rouge | Louisiana | United States |
| Research Site | New Orleans | Louisiana | United States |
| Research Site | Oxon Hill | Maryland | United States |
| Research Site | Boston | Massachusetts | United States |
| Research Site | Chelsea | Michigan | United States |
| Research Site | Ypsilanti | Michigan | United States |
| Research Site | Saint Louis Park | Minnesota | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Butte | Montana | United States |
| Research Site | Lincoln | Nebraska | United States |
| Research Site | Las Vegas | Nevada | United States |
| Research Site | New Hyde Park | New York | United States |
| Research Site | New Windsor | New York | United States |
| Research Site | New York | New York | United States |
| Research Site | Rochester | New York | United States |
| Research Site | Durham | North Carolina | United States |
| Research Site | Statesville | North Carolina | United States |
| Research Site | Winston-Salem | North Carolina | United States |
| Research Site | Athens | Ohio | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Dayton | Ohio | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Rapid City | South Dakota | United States |
| Research Site | Memphis | Tennessee | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | Olympia | Washington | United States |
| Research Site | Spokane | Washington | United States |
| Research Site | Tacoma | Washington | United States |
| Research Site | Bangalore | India |
| Research Site | Indore | India |
| Research Site | Karnāl | India |
| Research Site | Mumbai | India |
| Research Site | Pune | India |
| Research Site | Guadalajara | Jalisco | Mexico |
| Research Site | Zapopan | Jalisco | Mexico |
| Research Site | Mexico City | Mexico City | Mexico |
| Research Site | Cuernavaca | Morelos | Mexico |
| Research Site | Monterrey | NuevoLeon | Mexico |
| Research Site | Toluca | State of Mexico | Mexico |
| 23748506 | Derived | Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660. |
| 23522121 | Derived | Meloni AR, DeYoung MB, Han J, Best JH, Grimm M. Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals. Cardiovasc Diabetol. 2013 Mar 23;12:48. doi: 10.1186/1475-2840-12-48. |
| 23039868 | Derived | Peyrot M, Bushnell DM, Best JH, Martin ML, Cameron A, Patrick DL. Development and validation of the self-management profile for type 2 diabetes (SMP-T2D). Health Qual Life Outcomes. 2012 Oct 5;10:125. doi: 10.1186/1477-7525-10-125. |
| 22236356 | Derived | Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10. |
| 21434995 | Derived | Wysham C, Bergenstal R, Malloy J, Yan P, Walsh B, Malone J, Taylor K. DURATION-2: efficacy and safety of switching from maximum daily sitagliptin or pioglitazone to once-weekly exenatide. Diabet Med. 2011 Jun;28(6):705-14. doi: 10.1111/j.1464-5491.2011.03301.x. |
| 20580422 | Derived | Bergenstal RM, Wysham C, Macconell L, Malloy J, Walsh B, Yan P, Wilhelm K, Malone J, Porter LE; DURATION-2 Study Group. Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. Lancet. 2010 Aug 7;376(9739):431-9. doi: 10.1016/S0140-6736(10)60590-9. Epub 2010 Jun 26. |
| FG002 | Pioglitazone | Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly |
| Intent to Treat (ITT) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Exenatide Once Weekly | Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning |
| BG001 | Sitagliptin | Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly |
| BG002 | Pioglitazone | Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly |
| BG003 | 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 |
| ||||||||||||||||
| Glycosylated hemoglobin (HbA1c) | Mean | Standard Deviation | percentage of total hemoglobin |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kg |
|
| 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 | Absolute change in HbA1c from baseline (Day 1) to Week 26 [Week 26 - Baseline]. | The ITT Population included randomized subjects who received at least one injection of study medication. Missing data up to Week 26 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. | Posted | Least Squares Mean | Standard Error | percentage of total hemoglobin | Day 1, Week 26 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Achieving HbA1c Target of <7% at Week 26 | Percentages of subjects achieving HbA1c target values of <7% at Week 26. | ITT Population. Missing data up to Week 26 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline HbA1c measurement were categorized as not achieving goal. | Posted | Number | percentage of subjects | Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Achieving HbA1c Target of <=6.5% at Week 26 | Percentages of subjects achieving HbA1c target values of <=6.5% at Week 26. | ITT Population. Missing data up to Week 26 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline HbA1c measurement were categorized as not achieving goal. | Posted | Number | percentage of subjects | Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Achieving HbA1c Target of <=6.0% at Week 26 | Percentages of subjects achieving HbA1c target values of <=6.0% at Week 26. | ITT Population. Missing data up to Week 26 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline HbA1c measurement were categorized as not achieving goal. | Posted | Number | percentage of subjects | Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Body Weight From Baseline to Week 26 | Change in body weight from baseline (Day 1) to Week 26. | ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. | Posted | Least Squares Mean | Standard Error | kg | Day 1, Week 26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Fasting Plasma Glucose From Baseline to Week 26 | Change in fasting plasma glucose from baseline (Day 1) to Week 26. | ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. | Posted | Least Squares Mean | Standard Error | mg/dL | Day 1, Week 26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Systolic Blood Pressure From Baseline to Week 26 | Change in systolic blood pressure from baseline (Day 1) to Week 26. | ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. | Posted | Least Squares Mean | Standard Error | mmHg | Day 1, Week 26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Diastolic Blood Pressure From Baseline to Week 26 | Change in diastolic blood pressure from baseline (Day 1) to Week 26. | ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. | Posted | Least Squares Mean | Standard Error | mmHg | Day 1, Week 26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Fasting Total Cholesterol From Baseline to Week 26 | Change in fasting total cholesterol from baseline (Day 1) to Week 26. | ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. | Posted | Least Squares Mean | Standard Error | mg/dL | Day 1, Week 26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Fasting High-density Lipoprotein (HDL) From Baseline to Week 26 | Change in fasting HDL from baseline (Day 1) to Week 26. | ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. | Posted | Least Squares Mean | Standard Error | mg/dL | Day 1, Week 26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Ratio of Fasting Triglycerides at Week 26 to Baseline | Ratio of triglycerides (measured in mg/dL) at Week 26 to baseline (Day 1). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline. | ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. | Posted | Least Squares Mean | Standard Error | ratio | Day 1, Week 26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Assessment on Event Rate of Treatment-emergent Hypoglycemic Events | Major hypoglycemia: events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration < 54 mg/dL prior to treatment. Minor hypoglycemia: symptoms consistent with hypoglycemia and blood glucose concentration < 54 mg/dL prior to treatment and not classified as major hypoglycemia. | ITT Population. | Posted | Mean | Standard Error | rate per subject-year | Day 1 to Week 26 |
|
Not provided
Not provided
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 Once Weekly | Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning | 4 | 160 | 81 | 160 | ||
| EG001 | Sitagliptin | Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly | 5 | 166 | 59 | 166 | ||
| EG002 | Pioglitazone | Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly | 10 | 165 | 61 | 165 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cryptogenic organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Viral pericarditis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Bacterial pyelonephritis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pancreatic abscess | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pancreatitis necrotising | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
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 |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| No |
| Superiority or Other |
| Null hypothesis: no difference across treatments. Alternative hypothesis: a difference exists between exenatide once weekly and at least one comparator group (sitagliptin or pioglitazone). Power: Assuming 10% dropout, delta=0.5%, and common SD=1.2%, 450 subjects would provide >90% power to detect a treatment difference (alpha=0.05, two-sided) in the change in HbA1c between exenatide once weekly and sitagliptin or pioglitazone, with Hochberg's multiplicity adjustment method. | ANOVA | Analysis of Variance (ANOVA) model includes treatment, country, and baseline HbA1c stratum (<9.0% or >=9.0%) as factors. | 0.0165 | Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons. | Least Squares Mean Difference | 0.32 | Standard Error of the Mean | 0.131 | 2-Sided | 95 | 0.06 | 0.57 | No | Superiority or Other |
| Participants |
|
|
|
| Participants |
|
|
|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|