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The aim of this study is to evaluate safety and efficacy of therapy with saxagliptin 5mg co-administered with dapagliflozin 5mg, compared to therapy with saxagliptin 5mg or dapagliflozin 5mg in patients who are inadequately controlled on ≥1500mg/day of metformin monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saxagliptin+Dapagliflozin+Metformin | Active Comparator | 5 mg Tablets, Oral, Once daily, 24 weeks for Saxagliptin and Dapagliflozin |
|
| Dapagliflozin+Saxagliptin placebo+Metformin | Active Comparator | 5 mg Tablets, Oral, Once daily, 24 weeks for Dapagliflozin and Saxagliptin Placebo |
|
| Saxagliptin+Dapagliflozin placebo+metformin | Active Comparator | 5 mg Tablets, Oral, Once daily, 24 weeks for Saxagliptin and Dapagliflozin placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | 5mg, orally, Green, plain, diamond-shaped, film-coated tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c at Week 24 | To demonstrate the superiority of the change from baseline HbA1c achieved with the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to either agent individually after 24 weeks. Results were presented for the modified full analysis set. Note: Baseline was defined as the last assessment on or prior to the date of the first dose of the study medication. | Baseline and week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Achieving HbA1c <7.0% at 24 Weeks | To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to either agent individually on proportion of participants achieving therapeutic glycaemic response after 24 weeks. Therapeutic glycaemic response was defined as an HbA1c value at Week 24 <7.0% irrespective of whether participant received rescue medication. Risk difference for each treatment was calculated as adjusted response rate. Participants who did not had an HbA1c measurement at Week 24 were regarded as non-responders. Results were presented for the modified full analysis set. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Saraland | Alabama | 36571 | United States | ||
| Research Site |
Not provided
| Label | URL |
|---|---|
| d1683c00005 csp Redacted | View source |
| D1683C00005 SAP redacted | View source |
Not provided
All participants had screening (Visit 0) at 1 week prior to enrolment to screen the eligibility based on non-fasting sample of Glycated haemoglobin (Hb A1c); results of HbA1c determined enrolment based on inclusion/exclusion criteria. An abbreviated informed consent was signed and review of concomitant or other medications/therapies were performed.
The study was conducted at 119 sites in 6 countries: Canada, Czech Republic, Germany, Mexico, Russia, and United States (US). Approximately 900 participants were to be randomized. Participants with Type 2 Diabetes (T2DM) inadequately controlled on metformin alone were randomized in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dapagliflozin + Saxagliptin + Metformin | Randomized participants received orally once daily (QD) dapagliflozin 5 mg and saxagliptin 5 mg film coated tablets as an add-on to metformin (≥1500 mg/day orally) |
| FG001 | Dapagliflozin + Metformin |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| 1 -Modified Enrolled Participants Set |
|
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 | Aug 4, 2016 | Jul 6, 2018 |
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|
| Placebo for Dapagliflozin | Drug | Does not contain active ingredient, orally, Green, plain, diamond-shaped, film-coated tablet |
|
| Saxagliptin | Drug | 5mg, orally, Plain, yellow, biconvex, round, film-coated tablet |
|
|
| Placebo for Saxagliptin | Drug | Does not contain active ingredient, orally, Plain, yellow, biconvex, round, film-coated tablet |
|
| Baseline and week 24 |
| Change in Fasting Plasma Glucose at 24 Weeks | To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5mg to either agent individually on fasting plasma glucose after 24 weeks. Results were presented for the modified full analysis set. | Baseline and week 24 |
| Change in Total Body Weight at 24 Weeks | To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to saxagliptin 5 mg on total body weight after 24 weeks. Results were presented for the modified full analysis set. | Baseline and week 24 |
| Fresno |
| California |
| 93702 |
| United States |
| Research Site | Harbor City | California | 90710 | United States |
| Research Site | Hawaiian Gardens | California | 90716 | United States |
| Research Site | Lancaster | California | 93534 | United States |
| Research Site | Los Angeles | California | 90057 | United States |
| Research Site | Montclair | California | 91763 | United States |
| Research Site | Pomona | California | 91767 | United States |
| Research Site | Spring Valley | California | 91978 | United States |
| Research Site | Vallejo | California | 94592 | United States |
| Research Site | Denver | Colorado | 80220 | United States |
| Research Site | Northglenn | Colorado | 80234 | United States |
| Research Site | Wheat Ridge | Colorado | 80033 | United States |
| Research Site | Waterbury | Connecticut | 06708 | United States |
| Research Site | Cooper City | Florida | 33024 | United States |
| Research Site | Doral | Florida | 33166 | United States |
| Research Site | Hialeah | Florida | 33012 | United States |
| Research Site | Miami | Florida | 33176 | United States |
| Research Site | Miami | Florida | 33186 | United States |
| Research Site | Miami Lakes | Florida | 33016 | United States |
| Research Site | Buford | Georgia | 30518 | United States |
| Research Site | Chicago | Illinois | 60607 | United States |
| Research Site | Hazel Crest | Illinois | 60429 | United States |
| Research Site | New Orleans | Louisiana | 70115 | United States |
| Research Site | Zachary | Louisiana | 70791 | United States |
| Research Site | Biloxi | Mississippi | 39531 | United States |
| Research Site | Florissant | Missouri | 63031 | United States |
| Research Site | Albany | New York | 12203 | United States |
| Research Site | The Bronx | New York | 10459 | United States |
| Research Site | Asheville | North Carolina | 28801 | United States |
| Research Site | Mooresville | North Carolina | 28117 | United States |
| Research Site | Fargo | North Dakota | 58103 | United States |
| Research Site | Columbus | Ohio | 43201 | United States |
| Research Site | Maumee | Ohio | 43537 | United States |
| Research Site | East Providence | Rhode Island | 02914 | United States |
| Research Site | West Columbia | South Carolina | 29169 | United States |
| Research Site | Dallas | Texas | 75208 | United States |
| Research Site | Dallas | Texas | 75230 | United States |
| Research Site | El Paso | Texas | 79935 | United States |
| Research Site | Fort Worth | Texas | 76132 | United States |
| Research Site | Houston | Texas | 77004 | United States |
| Research Site | Houston | Texas | 77036 | United States |
| Research Site | Houston | Texas | 77040 | United States |
| Research Site | Odessa | Texas | 79761 | United States |
| Research Site | Sugar Land | Texas | 77479 | United States |
| Research Site | Waco | Texas | 76710 | United States |
| Research Site | Salt Lake City | Utah | 84102 | United States |
| Research Site | Norfolk | Virginia | 23510 | United States |
| Research Site | Moncton | New Brunswick | E1G 1A7 | Canada |
| Research Site | Bridgewater | Nova Scotia | B4V 3N2 | Canada |
| Research Site | Brampton | Ontario | L7A 3P1 | Canada |
| Research Site | Etobicoke | Ontario | M9W 4L6 | Canada |
| Research Site | Greater Sudbury | Ontario | P3E 6C3 | Canada |
| Research Site | London | Ontario | N5W 6A2 | Canada |
| Research Site | Scarborough Village | Ontario | M1P 2T7 | Canada |
| Research Site | Toronto | Ontario | M3J 2C5 | Canada |
| Research Site | Chicoutimi | Quebec | G7H 7K9 | Canada |
| Research Site | Lévis | Quebec | G6W 0M5 | Canada |
| Research Site | Mirabel | Quebec | J7J 2K8 | Canada |
| Research Site | Pointe-Claire | Quebec | H9R 3J1 | Canada |
| Research Site | Saint-Marc-des-Carrieres | Quebec | G0A 4B0 | Canada |
| Research Site | Chrudim III | 537 01 | Czechia |
| Research Site | České Budějovice | 370 01 | Czechia |
| Research Site | Jílové u Prahy | 254 01 | Czechia |
| Research Site | Ostrava | 710 00 | Czechia |
| Research Site | Pardubice | 530 02 | Czechia |
| Research Site | Pilsen | 301 66 | Czechia |
| Research Site | Prague | 100 00 | Czechia |
| Research Site | Prague | 140 46 | Czechia |
| Research Site | Prague | 149 00 | Czechia |
| Research Site | Prague | 181 00 | Czechia |
| Research Site | Praha Klanovice | 190 14 | Czechia |
| Research Site | Uherské Hradiště | 686 01 | Czechia |
| Research Site | Berlin | 10787 | Germany |
| Research Site | Bünde | 32257 | Germany |
| Research Site | Essen | 45359 | Germany |
| Research Site | Giengen an der Brenz | 89537 | Germany |
| Research Site | Großheirath | 96269 | Germany |
| Research Site | Hof | 95030 | Germany |
| Research Site | Hohenmölsen | 06679 | Germany |
| Research Site | Karlsruhe | 76199 | Germany |
| Research Site | Lichtenfels | 96215 | Germany |
| Research Site | Meine | 38527 | Germany |
| Research Site | Münster | 48153 | Germany |
| Research Site | Rehburg-Loccum | 31547 | Germany |
| Research Site | Stolberg | 52222 | Germany |
| Research Site | Villingen-Schwenningen | 78048 | Germany |
| Research Site | Guadalajara | 44160 | Mexico |
| Research Site | Guadalajara | 44600 | Mexico |
| Research Site | Guadalajara | 44670 | Mexico |
| Research Site | México | 03800 | Mexico |
| Research Site | Monterrey | 64460 | Mexico |
| Research Site | Monterrey | 64465 | Mexico |
| Research Site | Zapopan | 45116 | Mexico |
| Research Site | Arkhangelsk | 163001 | Russia |
| Research Site | Izhevsk | 426063 | Russia |
| Research Site | Kazan' | 420008 | Russia |
| Research Site | Moscow | 119991 | Russia |
| Research Site | Moscow | 127473 | Russia |
| Research Site | Perm | 614056 | Russia |
| Research Site | Perm | 6144090 | Russia |
| Research Site | Rostov-on-Don | 344022 | Russia |
| Research Site | Saint Petersburg | 196143 | Russia |
| Research Site | Saint Petersburg | 196601 | Russia |
| Research Site | Saint Petersburg | 198013 | Russia |
| Research Site | Tver' | 170036 | Russia |
| Research Site | Ufa | 450071 | Russia |
| Research Site | Vladikavkaz | 362007 | Russia |
| Research Site | Yekaterinburg | 620039 | Russia |
| Research Site | Yekaterinburg | 620219 | Russia |
Randomized participants received orally QD dapagliflozin 5 mg film coated tablet and placebo for saxagliptin as an add-on to metformin (≥1500 mg/day orally) |
| FG002 | Saxagliptin + Metformin | Randomized participants received orally QD saxagliptin 5 mg film coated tablet and placebo for dapagliflozin as an add-on to metformin (≥1500 mg/day orally) |
|
| Participants Completed Treatment Period |
|
| COMPLETED | Participants who completed study treatment |
|
| NOT COMPLETED |
|
|
| 2 - Enrolled Participants Set |
|
|
Full analysis set (FAS): All randomized participants who took at least 1 dose of study drug & had baseline value for HbA1c. Analysis was based on randomized treatment. Modified FAS - all participants from FAS with the exception of participants from one site (United States; excluded due to serious Good Clinical Practice [GCP] violations).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dapagliflozin + Saxagliptin + Metformin | Randomized participants received orally once daily (QD) dapagliflozin 5 mg and saxagliptin 5 mg film coated tablets as an add-on to metformin (≥1500 mg/day orally) |
| BG001 | Dapagliflozin + Metformin | Randomized participants received orally QD dapagliflozin 5 mg film coated tablet and placebo for saxagliptin as an add-on to metformin (≥1500 mg/day orally) |
| BG002 | Saxagliptin + Metformin | Randomized participants received orally QD saxagliptin 5 mg film coated tablet and placebo for dapagliflozin as an add-on to metformin (≥1500 mg/day orally) |
| 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, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | 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 | Change From Baseline in HbA1c at Week 24 | To demonstrate the superiority of the change from baseline HbA1c achieved with the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to either agent individually after 24 weeks. Results were presented for the modified full analysis set. Note: Baseline was defined as the last assessment on or prior to the date of the first dose of the study medication. | FAS: All randomized participants who took at least one dose of the study medication and had a baseline value for HbA1c. Analysis of the FAS was based on the randomized treatment. The modified FAS included all participants from FAS with the exception of participants from one site (excluded due to serious GCP violations). | Posted | Least Squares Mean | Standard Error | Percentage (%) | Baseline and week 24 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants Achieving HbA1c <7.0% at 24 Weeks | To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to either agent individually on proportion of participants achieving therapeutic glycaemic response after 24 weeks. Therapeutic glycaemic response was defined as an HbA1c value at Week 24 <7.0% irrespective of whether participant received rescue medication. Risk difference for each treatment was calculated as adjusted response rate. Participants who did not had an HbA1c measurement at Week 24 were regarded as non-responders. Results were presented for the modified full analysis set. | FAS: All randomized participants who took at least one dose of the study medication and had a baseline value for HbA1c. Analysis of the FAS was based on the randomized treatment. The modified FAS included all participants from FAS with the exception of participants from one site (excluded due to serious GCP violations). | Posted | Number | Participants | Baseline and week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Fasting Plasma Glucose at 24 Weeks | To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5mg to either agent individually on fasting plasma glucose after 24 weeks. Results were presented for the modified full analysis set. | FAS: All randomized participants who took at least one dose of the study medication and had a baseline value for HbA1c. Analysis of the FAS was based on the randomized treatment. The modified FAS included all participants from FAS with the exception of participants from one site (excluded due to serious GCP violations). | Posted | Least Squares Mean | Standard Error | Milligrams per deciliter (mg/dL) | Baseline and week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Total Body Weight at 24 Weeks | To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to saxagliptin 5 mg on total body weight after 24 weeks. Results were presented for the modified full analysis set. | FAS: All randomized participants who took at least one dose of the study medication and had a baseline value for HbA1c. Analysis of the FAS was based on the randomized treatment. The modified FAS included all participants from FAS with the exception of participants from one site (excluded due to serious GCP violations). | Posted | Least Squares Mean | Standard Error | Kilograms (Kg) | Baseline and week 24 |
|
|
From time of randomization, and throughout the treatment period and until end of treatment (Visit 5)/early termination + 4 days for non serious AEs and 30 days for SAEs.
An undesirable medical condition could be symptoms (eg, nausea, chest pain), signs (eg, tachycardia, enlarged liver)/abnormal results of an investigation (eg, laboratory findings, electrocardiogram). One participant was randomized but did not receive treatment in Dapagliflozin+Metformin and Saxagliptin + Metformin groups.
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 + Saxagliptin + Metformin | Randomized participants received orally once daily (QD) dapagliflozin 5 mg and saxagliptin 5 mg film coated tablets as an add-on to metformin (≥1500 mg/day orally) | 1 | 293 | 7 | 293 | 41 | 293 |
| EG001 | Dapagliflozin + Metformin | Randomized participants received orally QD dapagliflozin 5 mg film coated tablet and placebo for saxagliptin as an add-on to metformin (≥1500 mg/day orally) | 2 | 293 | 8 | 293 | 39 | 293 |
| EG002 | Saxagliptin + Metformin | Randomized participants received orally QD saxagliptin 5 mg film coated tablet and placebo for dapagliflozin as an add-on to metformin (≥1500 mg/day orally) | 0 | 295 | 7 | 295 | 29 | 295 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Basal ganglia haemorrhage | Nervous system disorders | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Lumbosacral radiculopathy | Nervous system disorders | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Arteritis | Vascular disorders | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA version 20.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Glomerular filtration rate decreased | Investigations | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 20.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 20.0 | Non-systematic Assessment |
|
All clinical study findings and documents will be regarded as confidential. The investigator and members of his/her research team must not disclose such information without prior written approval from the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Leader | AstraZeneca | +46 766 346712 | clinicaltrialtransparency@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 9, 2017 | Jul 6, 2018 | SAP_001.pdf |
| 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 |
|---|---|
| C529054 | dapagliflozin |
| C502994 | saxagliptin |
Not provided
Not provided
Not provided
| Severe non-compliance to protocol |
|
| Lack of therapeutic response |
|
| Study specific discontinuation criteria |
|
| Other |
|
| No treatment given |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| LS mean difference |
| -0.34 |
| 2-Sided |
| 95 |
| -0.50 |
| -0.19 |
| Superiority |
| OG002 | Saxagliptin + Metformin | Randomized participants received orally QD saxagliptin 5 mg film coated tablet and placebo for dapagliflozin as an add-on to metformin (≥1500 mg/day orally) |
|
|
|
|
|
|
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|
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