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| ID | Type | Description | Link |
|---|---|---|---|
| Eudract-2008-001089-10 |
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The purpose of this study is to compare the effects of saxagliptin with those of placebo as add-on therapy to insulin and insulin with metformin in improving glycemic control at 24 and 52 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saxagliptin, 5 mg + insulin | Experimental | Saxagliptin, 5 mg, plus insulin, administered to participants with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin |
|
| Placebo + insulin | Placebo Comparator | Placebo administered to participants with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saxagliptin, 5 mg + insulin | Drug | Saxagliptin, 5-mg tablets (plus stable insulin dose), given orally once daily (24 weeks short-term, 28 weeks long-term); participants stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue) |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF]) | Change from baseline: post-pre. Adjusted for baseline (value and metformin use). ANCOVA model: difference between week t and baseline values=baseline values + treatment + metformin use | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Meal Tolerance Test (MTT) | An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Abnormal Changes From Baseline in Electrocardiogram (ECG) Results | ECG abnormalities included those in nonspecific "other" categories (Other nonspecific ST/T, Other intraventricular conduction defect, Other, and Other rhythm abnormalities)and nonspecific findings, such as sinus bradycardia, sinus arrythmia, sinus tachycardia, poor R-wave progression, and ventricular premature contractions. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Advantage, Inc | Tempe | Arizona | 85282 | United States | ||
| Valley Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27402391 | Derived | Perl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11. | |
| 25414932 | Derived | Cook W, Minervini G, Bryzinski B, Hirshberg B. Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. Postgrad Med. 2014 Oct;126(6):19-32. doi: 10.3810/pgm.2014.10.2818. |
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Of 455 participants randomized, 402 received treatment and completed the 24-week phase. Two participants were mistakenly identified as not completing the short-term (ST) treatment period, although they did. The discrepancy was identified after the ST phase database lock. In reality, 404 completed the ST phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Saxagliptin, 5 mg + Insulin | Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes |
| FG001 | Placebo + Insulin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1: Short-term (24-week) Phase |
|
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|
| Placebo + insulin | Drug | Placebo tablets given orally once daily for 24 weeks (short-term period)+ insulin with metformin |
|
| Change From Baseline in 120-minute PPG Values During an MTT | An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal. | Baseline to Week 24 |
| Change From Baseline in Fasting Plasma Glucose Values | Baseline to Week 24 |
| Percentage of Participants Achieving a Therapeutic Glycemic Response | Therapeutic glycemic response is defined as an A1C<7%. Significance was not interpreted with a p value. | Baseline to Week 24 |
| Change From Baseline in Mean Total Daily Dose of Insulin (MTDDI) (LOCF) | Based on information recorded in the participant's daily diary. The MTDDI was calculated at every visit using the values patients recorded since the last regularly scheduled visit (minimum of 80% of days with a value). At every visit, the MTDDI was compared with the participant's baseline MTDDI (measured during a 4-week lead-in period) to identify any changes in insulin use at that visit compared with insulin use at baseline. | Baseline to Week 24 |
| Baseline to Week 52 |
| Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF) | Absolute lymphocyte count=value*10^3 c/uL | Baseline and Weeks 24 and 52 |
| Number of Participants With at Least 1 Adverse Event (AE), at Least 1 Treatment-related AE, Death as Outcome, at Least 1 Serious Adverse Event (SAE), at Least 1 Treatment-related SAE, Discontinuations Due to SAEs, and Discontinuations Due to AEs | An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment. | Baseline to Week 52, continuously |
| Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings | Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52 |
| Mean Changes From Baseline in Heart Rate | Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52 |
| Shift in Platelet Counts From Baseline to Selected Visits (LOCF) | Platelet count=value*10^9 c/L | Baseline and Weeks 24 and 52 |
| Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period | Marked abnormality=a laboratory value lying outside the predefined criteria and more extreme (farther from the limit)on-treatment than at baseline. ULN=upper limit of normal; LLN=lower limit of normal; prx=pre-RX=pretreatment. Criteria 1: if prx=0 use >=2, if prx=0.5 or 1 use >=3, if prx=2 use 4. | Baseline and during and up to 14 days after last dose of study drug (in Week 52) |
| Percentage of Participants With Reported and Confirmed Hypoglycemia | Confirmed hypoglycemia=fingerstick glucose measurement of ≤50 mg/dL with associated symptoms/ | Baseline to Week 52 |
| Fresno |
| California |
| 93720 |
| United States |
| Torrance-Lomita Medical Center | Lomita | California | 90717 | United States |
| Diabetes Medical Center Of California | Northridge | California | 91325 | United States |
| Ritchken & First M.D.'S | San Diego | California | 92117 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| Central Florida Clinical Trials, Inc. | Altamonte Springs | Florida | 32701 | United States |
| Family Care Associates Of Nw Florida | Chipley | Florida | 32428 | United States |
| Panhandle Family Care Assoc. & Coastal Palms Res. Grp Inc. | Marianna | Florida | 32446 | United States |
| Endocrine Research Solutions, Inc. | Roswell | Georgia | 30076 | United States |
| Danny W. Jackson P.A. | Rolling Fork | Mississippi | 39159 | United States |
| Southgate Medical Group | West Seneca | New York | 14224 | United States |
| Southeastern Research Associates, Inc. | Taylors | South Carolina | 29687 | United States |
| Texas Center For Drug Development | Houston | Texas | 77081 | United States |
| Dgd Research, Inc. | San Antonio | Texas | 78229 | United States |
| Aurora Advanced Healthcare | Milwaukee | Wisconsin | 53209 | United States |
| Local Institution | Calgary | Alberta | T3B 0M3 | Canada |
| Local Institution | Vancouver | British Columbia | V6E 1M7 | Canada |
| Local Institution | Bathurst | New Brunswick | E2A 4X7 | Canada |
| Local Institution | London | Ontario | N6A 4V2 | Canada |
| Local Institution | Charlottetown | Prince Edward Island | C1A 5Y9 | Canada |
| Local Institution | Gatineau | Quebec | J8V 2P5 | Canada |
| Local Institution | Laval | Quebec | H7T 2P5 | Canada |
| Local Institution | Sherbrooke | Quebec | J1G 5K2 | Canada |
| Local Institution | Regina | Saskatchewan | S4P 0W5 | Canada |
| Local Institution | Besançon | 25030 | France |
| Local Institution | Montpellier | 34295 | France |
| Local Institution | Nantes | 44093 | France |
| Local Institution | Valenciennes | 59300 | France |
| Local Institution | Balatonfüred | 8230 | Hungary |
| Local Institution | Budapest | 1041 | Hungary |
| Local Institution | Budapest | 1083 | Hungary |
| Local Institution | Budapest | 1212 | Hungary |
| Local Institution | Szentes | 6600 | Hungary |
| Local Institution | Zalaegerszeg-Pozva | 8900 | Hungary |
| Local Institution | Indore | Madhya Pradesh | 452001 | India |
| Local Institution | Hariyāna | 132001 | India |
| Local Institution | Mumbai | 400007 | India |
| Local Institution | Pune | 411 030 | India |
| Local Institution | Pune | 411011 | India |
| Local Institution | Pune | 411037 | India |
| Local Institution | Vellore | 632004 | India |
| Local Institution | Aguascalientes | Aguascalientes | 20127 | Mexico |
| Local Institution | Aguascalientes | Aguascalientes | 20230 | Mexico |
| Local Institution | Zapopan, Jal. | Jalisco | 45150 | Mexico |
| Local Institution | Mexico City | Mexico City | 06700 | Mexico |
| Local Institution | Mexico City | Mexico City | 14000 | Mexico |
| Local Institution | Monterrey | Nuevo León | 64060 | Mexico |
| Local Institution | Monterrey | Nuevo León | 64240 | Mexico |
| Local Institution | Monterrey | Nuevo León | 64710 | Mexico |
| Local Institution | Monterrrey | Nuevo León | 64700 | Mexico |
| Local Institution | Veracruz | Veracruz | 91700 | Mexico |
| Local Institution | Elblag | 82-300 | Poland |
| Local Institution | Gdansk | 80-286 | Poland |
| Local Institution | Krakow | 30-510 | Poland |
| Local Institution | Lodz | 90-153 | Poland |
| Local Institution | Lublin | 20-950 | Poland |
| Local Institution | Sopot | 81-756 | Poland |
| Local Institution | Szczecin | 71-455 | Poland |
| Local Institution | Wroclaw | 50-088 | Poland |
| Local Institution | Zabrze | 41-800 | Poland |
| Local Institution | Kursk | 305035 | Russia |
| Local Institution | Saint Petersburg | 191015 | Russia |
| Local Institution | Saint Petersburg | 194156 | Russia |
| Local Institution | Saint Petersburg | 195257 | Russia |
| Local Institution | Saint Petersburg | 197022 | Russia |
| Local Institution | Saint Petersburg | 198013 | Russia |
| Local Institution | Saratov | 410031 | Russia |
| Local Institution | Smolensk | 214018 | Russia |
| Local Institution | Yaroslaval | 150062 | Russia |
| Local Institution | Parktown | Gauteng | 2193 | South Africa |
| Local Institution | Durban | KwaZulu-Natal | 4001 | South Africa |
| Local Institution | Umhlanga | KwaZulu-Natal | 4319 | South Africa |
| Local Institution | Goodwood | Western Cape | 7460 | South Africa |
| Local Institution | Tygerberg | Western Cape | 7505 | South Africa |
| Local Institution | Middlesbrough | Cleveland | TS4 3BW | United Kingdom |
| Local Institution | Salford | Greater Manchester | M6 8HD | United Kingdom |
| Local Institution | Newcastle upon Tyne | Tyne and Wear | NE4 6BE | United Kingdom |
| Local Institution | Birmingham | West Midlands | B9 5SS | United Kingdom |
| Local Institution | Sheffield | Yorkshire | S5 7AU | United Kingdom |
| 23949898 | Derived | Barnett AH, Charbonnel B, Li J, Donovan M, Fleming D, Iqbal N. Saxagliptin add-on therapy to insulin with or without metformin for type 2 diabetes mellitus: 52-week safety and efficacy. Clin Drug Investig. 2013 Oct;33(10):707-17. doi: 10.1007/s40261-013-0107-8. |
| 22313154 | Derived | Barnett AH, Charbonnel B, Donovan M, Fleming D, Chen R. Effect of saxagliptin as add-on therapy in patients with poorly controlled type 2 diabetes on insulin alone or insulin combined with metformin. Curr Med Res Opin. 2012 Apr;28(4):513-23. doi: 10.1185/03007995.2012.665046. Epub 2012 Mar 1. |
Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2: Long-term (52-week) Phase |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Saxagliptin, 5 mg + Insulin | Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes |
| BG001 | Placebo + Insulin | Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes |
| 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, Customized | Median | Full Range | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Age, Customized | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF]) | Change from baseline: post-pre. Adjusted for baseline (value and metformin use). ANCOVA model: difference between week t and baseline values=baseline values + treatment + metformin use | Randomized participants who received at least 1 dose of double-blind study medication. Participants must also have had both a baseline and at least 1 postrandomization measurement in the 24- and 52-week periods. | Posted | Mean | Standard Error | Percentage of change | Baseline to Week 24 |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Meal Tolerance Test (MTT) | An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal | Posted | Mean | Standard Error | mg*min/dL | Baseline to Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 120-minute PPG Values During an MTT | An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal. | Posted | Mean | Standard Error | mg/dL | Baseline to Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Plasma Glucose Values | Posted | Mean | Standard Error | mg/dL | Baseline to Week 24 |
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| Secondary | Percentage of Participants Achieving a Therapeutic Glycemic Response | Therapeutic glycemic response is defined as an A1C<7%. Significance was not interpreted with a p value. | Randomized participants who received at least 1 dose of double-blind study medication. Participants must also have had both a baseline and at least 1 postrandomization measurement in the 24-week period. | Posted | Number | Percentage of participants | Baseline to Week 24 |
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| Secondary | Change From Baseline in Mean Total Daily Dose of Insulin (MTDDI) (LOCF) | Based on information recorded in the participant's daily diary. The MTDDI was calculated at every visit using the values patients recorded since the last regularly scheduled visit (minimum of 80% of days with a value). At every visit, the MTDDI was compared with the participant's baseline MTDDI (measured during a 4-week lead-in period) to identify any changes in insulin use at that visit compared with insulin use at baseline. | Randomized participants who received at least 1 dose of double-blind study medication. Participants must also have had both a baseline and at least 1 postrandomization measurement in the 24-week period. | Posted | Mean | Standard Error | Units | Baseline to Week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Abnormal Changes From Baseline in Electrocardiogram (ECG) Results | ECG abnormalities included those in nonspecific "other" categories (Other nonspecific ST/T, Other intraventricular conduction defect, Other, and Other rhythm abnormalities)and nonspecific findings, such as sinus bradycardia, sinus arrythmia, sinus tachycardia, poor R-wave progression, and ventricular premature contractions. | Participants who had normal ECG findings at baseline and who received at least 1 dose of study medication. | Posted | Number | Participants | Baseline to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF) | Absolute lymphocyte count=value*10^3 c/uL | All participants who received at least 1 dose of double-blind study medication. | Posted | Number | Participants | Baseline and Weeks 24 and 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With at Least 1 Adverse Event (AE), at Least 1 Treatment-related AE, Death as Outcome, at Least 1 Serious Adverse Event (SAE), at Least 1 Treatment-related SAE, Discontinuations Due to SAEs, and Discontinuations Due to AEs | An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment. | All participants who received at least 1 dose of double-blind study medication. | Posted | Number | Participants | Baseline to Week 52, continuously |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings | All participants who received at least 1 dose of double-blind study medication. | Posted | Number | 95% Confidence Interval | mm Hg | Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Mean Changes From Baseline in Heart Rate | All participants who received at least 1 dose of double-blind study medication. | Posted | Number | 95% Confidence Interval | Beats per minute | Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Shift in Platelet Counts From Baseline to Selected Visits (LOCF) | Platelet count=value*10^9 c/L | All participants who received at least 1 dose of double-blind study medication. | Posted | Number | Participants | Baseline and Weeks 24 and 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period | Marked abnormality=a laboratory value lying outside the predefined criteria and more extreme (farther from the limit)on-treatment than at baseline. ULN=upper limit of normal; LLN=lower limit of normal; prx=pre-RX=pretreatment. Criteria 1: if prx=0 use >=2, if prx=0.5 or 1 use >=3, if prx=2 use 4. | All participants who received at least 1 dose of double-blind study medication. | Posted | Number | Participants | Baseline and during and up to 14 days after last dose of study drug (in Week 52) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Reported and Confirmed Hypoglycemia | Confirmed hypoglycemia=fingerstick glucose measurement of ≤50 mg/dL with associated symptoms/ | Posted | Number | Percentage of Participants | Baseline to Week 52 |
|
|
Baseline to Week 52
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 | Placebo + Insulin | Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes | 13 | 151 | 64 | 151 | ||
| EG001 | Saxagliptin, 5 mg + Insulin | Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes | 25 | 304 | 96 | 304 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIABETIC RETINOPATHY | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| LIVER FUNCTION TEST ABNORMAL | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CORONARY ARTERY OCCLUSION | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| PERIPHERAL ISCHAEMIA | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| PERIPHERAL VASCULAR DISORDER | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| THROMBOPHLEBITIS SUPERFICIAL | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| JAUNDICE | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CHOLANGITIS | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CHOLANGITIS ACUTE | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| SCIATICA | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| THALAMIC INFARCTION | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CROHN'S DISEASE | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| PANCREATITIS CHRONIC | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| ABSCESS LIMB | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| DENGUE FEVER | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| ARTHRITIS INFECTIVE | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| INTESTINAL GANGRENE | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ANAEMIA VITAMIN B12 DEFICIENCY | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| PITUITARY TUMOUR | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| UTERINE LEIOMYOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| PANCREATIC CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| PROSTATE CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HYPERTENSION | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boaz Hirschberg | AstraZeneca Pharmaceuticals | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C502994 | saxagliptin |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Poor or noncompliance |
|
| Pregnancy |
|
| No longer meets study criteria |
|
| Other |
|
| 65 years to younger than 75 years |
|
| 75 years and older |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|