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This clincial trial is evaluating if the co-administration of saxagliptin and dapagliflozin, in addition to metformin, results in better glycemic control, as measured by HbA1c, over a treatment period of 52 weeks, compared to the addition of glimepiride to metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on Metformin Alone. We will compare the change from baseline in HbA1c achieved with saxagliptin, in co-administration with dapagliflozin, added to current background therapy with metformin compared to glimepiride added to current background therapy with metformin ≥1500 mg at Week 52.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saxagliptin 5 mg/ dapagliflozin 10mg or Placebo | Experimental | Saxagliptin 5 mg /dapagliflozin 10 mg Placebo once a day orally |
|
| Glimepiride or Placebo | Experimental | Glimepiride or placebo 1mg or 2mg or 3mg or 4mg or 6mg once a day orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saxagliptin | Drug |
| ||
| Dapagliflozin |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52 | To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment. | Baseline and Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Body Weight at Week 52 | To examine whether the mean change from baseline in total body weight with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment. | Baseline and Week 52 |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35211 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32052516 | Derived | Frias JP, Gonzalez-Galvez G, Johnsson E, Maaske J, Testa MA, Simonson DC, Dronamraju N, Garcia-Sanchez R, Peters AL. Efficacy and safety of dual add-on therapy with dapagliflozin plus saxagliptin versus glimepiride in patients with poorly controlled type 2 diabetes on a stable dose of metformin: Results from a 52-week, randomized, active-controlled trial. Diabetes Obes Metab. 2020 Jul;22(7):1083-1093. doi: 10.1111/dom.13997. Epub 2020 Mar 9. |
| Label | URL |
|---|---|
| CV181365\_CSP\_redacted | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
The study duration was up to 160 weeks, consisting of a 2-week screening period, 2-week lead-in period, 52-week short-term treatment period, and 104-week long-term treatment period (156-week treatment period). One subject did not start the short-term treatment period and so only 443 subjects received treatment.
A total of 444 subjects were randomized in this international, multi-center study which was conducted at 88 centers in 10 countries between 14 Aug 2015 and 18 September 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dapagliflozin 10mg and Saxagliptin 5mg | Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day |
| FG001 | Titrated Glimepiride |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Short-term Treatment Period |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 8, 2018 | Jul 12, 2018 |
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| Drug |
|
| Glimepiride | Drug |
|
| Placebo | Other |
|
| Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 52 |
Therapeutic glycemic response was defined as HbA1c <7.0%. Subjects rescued or discontinued prior to, and subjects with missing measurements at Week 52 were treated as non-responders. The percentage of subjects with a therapeutic glycemic response is based on the logistic regression method with adjustment for baseline HbA1c. |
| At Week 52 |
| Change From Baseline in Systolic Blood Pressure (SBP) at Week 52 | To examine whether the change from baseline in SBP with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment. | Baseline and Week 52 |
| Percentage of Subjects With Treatment Intensification During the 52-week Short-term Treatment Period | Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after the 52-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 52 were counted as having an event for the analysis. The values presented are the percentage of subjects requiring the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control during the 52-week short -term treatment period. | Up to Week 52 |
| Percentage of Subjects With Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period. | Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after 156-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 156 were counted as having an event for the analysis. The values presented are the percentage of subjects requiring the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control during the 156-week treatment period. | Up to Week 156 |
| Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 156 | Therapeutic glycemic response was defined as HbA1c <7.0%. Subjects rescued or discontinued prior to, and subjects with missing measurements at Week 156 were treated as non-responders. The percentage of subjects with a therapeutic glycemic response is based on the logistic regression method with adjustment for baseline HbA1c. | At Week 156 |
| Time to Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period. | Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after 156-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 156 were counted as having an event for the analysis. Time to treatment intensification curves were generated using Kaplan-Meier estimates and compared using a Cox proportional hazards model. | Up to Week 156 |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Research Site | Tempe | Arizona | 85283 | United States |
| Research Site | Huntington Park | California | 90255 | United States |
| Research Site | Los Angeles | California | 90057 | United States |
| Research Site | Sacramento | California | 95823 | United States |
| Research Site | Tarzana | California | 91356 | United States |
| Research Site | Waterbury | Connecticut | 06708 | United States |
| Research Site | Jacksonville | Florida | 32207 | United States |
| Research Site | Jacksonville | Florida | 32277 | United States |
| Research Site | Kissimmee | Florida | 34744 | United States |
| Research Site | Miami | Florida | 33126 | United States |
| Research Site | Miami | Florida | 33174 | United States |
| Research Site | New Port Richey | Florida | 34652 | United States |
| Research Site | Palm Harbor | Florida | 34684 | United States |
| Research Site | Edina | Minnesota | 55435 | United States |
| Research Site | Las Vegas | Nevada | 89128 | United States |
| Research Site | Greer | South Carolina | 29651 | United States |
| Research Site | Bristol | Tennessee | 37620 | United States |
| Research Site | Knoxville | Tennessee | 37912 | United States |
| Research Site | Dallas | Texas | 75230 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | Cheb | 350 02 | Czechia |
| Research Site | Hradec Králové | 503 41 | Czechia |
| Research Site | Krnov | 794 01 | Czechia |
| Research Site | KroměřÞ | 767 01 | Czechia |
| Research Site | Náchod | 54701 | Czechia |
| Research Site | Prague | 140 00 | Czechia |
| Research Site | Prague | 149 00 | Czechia |
| Research Site | Dresden | 01307 | Germany |
| Research Site | Leipzig | 04249 | Germany |
| Research Site | Ajka | 8400 | Hungary |
| Research Site | Balatonfüred | 8230 | Hungary |
| Research Site | Budapest | 1033 | Hungary |
| Research Site | Budapest | 1089 | Hungary |
| Research Site | Budapest | Hungary |
| Research Site | Debrecen | 4032 | Hungary |
| Research Site | Eger | 3300 | Hungary |
| Research Site | Gyula | 5700 | Hungary |
| Research Site | Kaposvár | 7400 | Hungary |
| Research Site | Kecskemét | 6000 | Hungary |
| Research Site | NyÃregyháza | 4405 | Hungary |
| Research Site | Zalaegerszeg | 8900 | Hungary |
| Research Site | Aguascalientes | 20230 | Mexico |
| Research Site | Chihuahua City | 31237 | Mexico |
| Research Site | Cuautla | 62746 | Mexico |
| Research Site | Guadalajara | 44600 | Mexico |
| Research Site | Guanajuato City | 38000 | Mexico |
| Research Site | Monterrey | 64460 | Mexico |
| Research Site | Veracruz | 91910 | Mexico |
| Research Site | Bialystok | 15-351 | Poland |
| Research Site | Katowice | 40-648 | Poland |
| Research Site | Krakow | 31-156 | Poland |
| Research Site | Krakow | 31-261 | Poland |
| Research Site | Lodz | 90-242 | Poland |
| Research Site | Opole | 45-367 | Poland |
| Research Site | Oświęcim | 32-600 | Poland |
| Research Site | Poznan | 61-655 | Poland |
| Research Site | Warsaw | 00-465 | Poland |
| Research Site | Warsaw | 02-507 | Poland |
| Research Site | Wroclaw | 50-349 | Poland |
| Research Site | Brasov | 500269 | Romania |
| Research Site | Bucharest | 020045 | Romania |
| Research Site | Bucharest | 020359 | Romania |
| Research Site | Buzău | 120203 | Romania |
| Research Site | Galati | 800291 | Romania |
| Research Site | Oradea | 410032 | Romania |
| Research Site | Oradea | 410169 | Romania |
| Research Site | PloieÅŸti | 100163 | Romania |
| Research Site | PloieÅŸti | 100342 | Romania |
| Research Site | Satu Mare | 440055 | Romania |
| Research Site | Târgu Gânguleşti | 540142 | Romania |
| Research Site | Timișoara | 300736 | Romania |
| Research Site | Novosibirsk | 630087 | Russia |
| Research Site | Saint Petersburg | 190013 | Russia |
| Research Site | Saint Petersburg | 194354 | Russia |
| Research Site | Saint Petersburg | 195176 | Russia |
| Research Site | Saint Petersburg | 195257 | Russia |
| Research Site | Saint Petersburg | 196084 | Russia |
| Research Site | Smolensk | 214018 | Russia |
| Research Site | Gothenburg | 413 45 | Sweden |
| Research Site | Helsingborg | 25220 | Sweden |
| Research Site | Rättvik | 79530 | Sweden |
| Research Site | Dundee | DD1 9SY | United Kingdom |
Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day. |
| Recevied Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Long-term Treatment Period |
|
|
Baseline characteristics are presented for the randomized subjects data set which included all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dapagliflozin 10mg and Saxagliptin 5mg | Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day |
| BG001 | Titrated Glimepiride | Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day. |
| 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, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52 | To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment. | The randomized subject data set included all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period. Of these, only subjects with an evaluable baseline measurement for a given endpoint were analysed. | Posted | Least Squares Mean | 95% Confidence Interval | % HbA1c | Baseline and Week 52 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Body Weight at Week 52 | To examine whether the mean change from baseline in total body weight with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment. | The randomized subject data set included all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period. Of these, only subjects with an evaluable baseline measurement for a given endpoint were analysed. | Posted | Least Squares Mean | 95% Confidence Interval | kilogram (kg) | Baseline and Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 52 | Therapeutic glycemic response was defined as HbA1c <7.0%. Subjects rescued or discontinued prior to, and subjects with missing measurements at Week 52 were treated as non-responders. The percentage of subjects with a therapeutic glycemic response is based on the logistic regression method with adjustment for baseline HbA1c. | The randomized subject data set included all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period. | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) at Week 52 | To examine whether the change from baseline in SBP with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment. | The randomized subject data set included all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period. Of these, only subjects with an evaluable baseline measurement for a given endpoint were analysed. | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | Baseline and Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Treatment Intensification During the 52-week Short-term Treatment Period | Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after the 52-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 52 were counted as having an event for the analysis. The values presented are the percentage of subjects requiring the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control during the 52-week short -term treatment period. | The randomized subject data set included all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period. | Posted | Number | Percentage of Subjects | Up to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period. | Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after 156-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 156 were counted as having an event for the analysis. The values presented are the percentage of subjects requiring the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control during the 156-week treatment period. | The randomized subject data set included all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period. | Posted | Number | Percentage of Subjects | Up to Week 156 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 156 | Therapeutic glycemic response was defined as HbA1c <7.0%. Subjects rescued or discontinued prior to, and subjects with missing measurements at Week 156 were treated as non-responders. The percentage of subjects with a therapeutic glycemic response is based on the logistic regression method with adjustment for baseline HbA1c. | The randomized subject data set included all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period. | Posted | Number | 95% Confidence Interval | Percentage of Subjects | At Week 156 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period. | Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after 156-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 156 were counted as having an event for the analysis. Time to treatment intensification curves were generated using Kaplan-Meier estimates and compared using a Cox proportional hazards model. | The randomized subject data set included all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period. | Posted | Median | 95% Confidence Interval | Weeks | Up to Week 156 |
|
All adverse events (AEs), including serious adverse events (SAEs), were collected on or after the date of first dose of short-term study medication and up to and including 4 days (other AEs) or 30 days (SAEs) after last dose. Up to a total of 160 weeks.
The treated subjects data set for the short-tem plus long-term treatment period consisted of all subjects who received at least 1 dose of double-blind study medication during the short-term double-blind treatment period.
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 | Dapagliflozin 10mg and Saxagliptin 5mg | Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day | 1 | 227 | 29 | 227 | 99 | 227 |
| EG001 | Titrated Glimepiride | Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day. | 3 | 216 | 24 | 216 | 106 | 216 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Chronic inflammatory demyelinating polyradiculoneuropathy | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Guillain-Barre syndrome | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal wall infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hormone level abnormal | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 22.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | +1 877-240-9479 | information.center@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 8, 2019 | Jun 8, 2020 | SAP_002.pdf |
| ID | Term |
|---|---|
| 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 |
|---|---|
| C502994 | saxagliptin |
| C529054 | dapagliflozin |
| C057619 | glimepiride |
Not provided
Not provided
Not provided
| Lack of Efficacy |
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| Death |
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| Adverse Event |
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| Other |
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| Subject Decision |
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| Withdrawal by Subject |
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| Male |
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| Black Or African American |
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| Native Hawaiian Or Other Pacific Islander |
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| Other |
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| White |
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| Participants |
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| Participants |
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