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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001702-33 | EudraCT Number |
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This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM) will compare the glycemic control (measured by HbA1c) in subjects co-administered saxagliptin and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects receiving insulin glargine, in addition to metformin with or without sulfonylurea, over a treatment period of 52 weeks.
CV181-369; A 24 Week International, Open-Label Trial With a 28 Week Extension to Evaluate the Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects With Type 2 Diabetes on Metformin With or Without Sulfonylurea Therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saxagliptin/Dapagliflozin/Metformin | Experimental | Oral route. Saxagliptin/Dapa adminsitered once daily for 24 weeks at a dose of 5 mg Saxagliptin and 10 mg Dapagliflozin |
|
| Insulin Glargine, Lantos/Metformin | Active Comparator | Insulin glargine administered once a day with starting dose of 0.2 Unit per kg or 10 units. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saxagliptin, Onglyza | Drug | Tablets, Oral, 5mg , Once daily, 24 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in HbA1c at Week 24 | To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior (noninferiority margin of 0.3%) to titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment. | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Total Body Weight at Week 24 | To compare the mean change from baseline in total body weight with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment | Baseline and Week 24 |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Anaheim | California | 92801 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31167892 | Derived | Vilsboll T, Ekholm E, Johnsson E, Dronamraju N, Jabbour S, Lind M. Dapagliflozin Plus Saxagliptin Add-on Therapy Compared With Insulin in Patients With Type 2 Diabetes Poorly Controlled by Metformin With or Without Sulfonylurea Therapy: A Randomized Clinical Trial. Diabetes Care. 2019 Aug;42(8):1464-1472. doi: 10.2337/dc18-1988. Epub 2019 Jun 4. |
| Label | URL |
|---|---|
| cv181-369 SAP redacted | View source |
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The study duration was up to 56 weeks, consisting of a 2-week screening period, 2-week lead-in period, 24-week short-term treatment period, and 28-week long-term treatment period.
This study was conducted at 112 centers in 11 countries from 20 Oct 2015 to 10 Nov 2017. There were 2 data cut-offs for this study: 8 May 2017 for analyses of the short-term study period (after 24 weeks of open-label treatment) and 10 Nov 2017 for analyses of the short-term plus long-term study period (after 52 weeks of open-label treatment).
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| ID | Title | Description |
|---|---|---|
| FG000 | Dapagliflozin + Saxagliptin + Metformin | Subjects received dapagliflozin 10 milligrams (mg) and saxagliptin 5 mg, administered orally once daily (QD) in the morning for the 52-week treatment period (24-week short-term period and 28-week long term period). Subjects continued to receive their stable dose of metformin with or without sulfonylurea (SU) throughout the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 21, 2017 | Aug 20, 2018 |
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| Dapagliflozin, Farxiga | Drug | Tablets, Oral, 10mg , Once daily, 24 weeks |
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| Glargine insulin | Drug | 100 Units/ml solution for injection in a prefilled SoloStar pen |
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| Metformin | Drug | Tablets, Oral, ≥ 1500mg/≤ 2500mg, Once daily, 24 weeks |
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| Percentage of Subjects With Confirmed Hypoglycaemia at Week 24 | Hypoglycemia defined as plasma glucose ≤70 mg/dL (3.9 mmol/L) | Baseline and Week 24 |
| Percentage of Subjects Achieving a Therapeutic Glycemic Response, Without Hypoglycaemia, at Week 24 | To compare the percentage of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, without any reported hypoglycemia, with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment. | Baseline and Week 24 |
| Percentage of Subjects Achieving a Therapeutic Glycemic Response at Week 24 | To examine whether the percentage of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior (noninferiority margin of 10%) to titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment. | Baseline and Week 24 |
| Change From Baseline in the Mean Value of 24-hour Glucose at Week 2 | Change from baseline in the mean value of 24-hour glucose readings measured by Continuous Glucose Monitoring with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior to titrated insulin glargine plus metformin with or without SU after 2 weeks of open-label treatment. | Baseline and Week 2 |
| Los Angeles |
| California |
| 90057 |
| United States |
| Research Site | Miami | Florida | 33144 | United States |
| Research Site | Miami | Florida | 33155 | United States |
| Research Site | St. Petersburg | Florida | 33709 | United States |
| Research Site | Norcross | Georgia | 30071 | United States |
| Research Site | Chicago | Illinois | 60612 | United States |
| Research Site | Lexington | Kentucky | 40502 | United States |
| Research Site | Quincy | Massachusetts | 02169 | United States |
| Research Site | Beavercreek | Ohio | 45432 | United States |
| Research Site | Norman | Oklahoma | 73069 | United States |
| Research Site | Barto | Pennsylvania | 19504 | United States |
| Research Site | Columbia | South Carolina | 29204 | United States |
| Research Site | Bristol | Tennessee | 37620 | United States |
| Research Site | Kingsport | Tennessee | 37660 | United States |
| Research Site | Houston | Texas | 77004 | United States |
| Research Site | Mesquite | Texas | 74194 | United States |
| Research Site | San Antonio | Texas | 78230 | United States |
| Research Site | San Antonio | Texas | 78258 | United States |
| Research Site | Bountiful | Utah | 84010 | United States |
| Research Site | Karlovy Vary | 360 01 | Czechia |
| Research Site | Olomouc | 772 00 | Czechia |
| Research Site | Copenhagen | 2400 | Denmark |
| Research Site | Budapest | 1032 | Hungary |
| Research Site | Budapest | 1097 | Hungary |
| Research Site | Budapest | 1171 | Hungary |
| Research Site | Guadalajara | 44670 | Mexico |
| Research Site | México | 03800 | Mexico |
| Research Site | Monterrey | 64460 | Mexico |
| Research Site | Zapopan, Jalisco | 45200 | Mexico |
| Research Site | Lodz | 92-003 | Poland |
| Research Site | Nowy Duninów | 09-505 | Poland |
| Research Site | Sochaczew | 96-500 | Poland |
| Research Site | Craiova | 200349 | Romania |
| Research Site | PloieÅŸti | 100018 | Romania |
| Research Site | Timișoara | 300125 | Romania |
| Research Site | Timișoara | 300456 | Romania |
| Research Site | Lenasia | 1827 | South Africa |
| Research Site | A Coruña | 15006 | Spain |
| Research Site | Uddevalla | 451 80 | Sweden |
| cv181-369 CSP redacted | View source |
| FG001 | Titrated Insulin + Metformin | Subjects were to administer insulin glargine subcutaneously QD at the same time every day for the 52-week treatment period (24-week short-term period and 28-week long term period), following investigator instructions and training. All subjects started with an initial dose of 0.2 units/kilogram (kg) body weight or at least 10 units of insulin per day. Subjects self-titrated the dose of insulin glargine over the first 8 weeks of the study based on daily glucose monitoring. The investigator had the discretion to modify insulin dose based on his/her assessment between Week 8 and Week 12 with the goal to reach an acceptable and stable insulin dose by Week 12. Subjects continued to receive their stable dose of metformin with or without SU throughout the study. |
| Received Treatment in Short-term Study |
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| Entered Long-term Study |
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| Received Treatment in Long-term Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dapagliflozin + Saxagliptin + Metformin | Subjects received dapagliflozin 10 mg and saxagliptin 5 mg, administered orally QD in the morning for the 52-week treatment period (24-week short-term period and 28-week long term period). Subjects continued to receive their stable dose of metformin with or without SU throughout the study. |
| BG001 | Titrated Insulin + Metformin | Subjects were to administer insulin glargine subcutaneously QD at the same time every day for the 52-week treatment period (24-week short-term period and 28-week long term period), following investigator instructions and training. All subjects started with an initial dose of 0.2 units/kg body weight or at least 10 units of insulin per day. Subjects self-titrated the dose of insulin glargine over the first 8 weeks of the study based on daily glucose monitoring. The investigator had the discretion to modify insulin dose based on his/her assessment between Week 8 and Week 12 with the goal to reach an acceptable and stable insulin dose by Week 12. Subjects continued to receive their stable dose of metformin with or without SU throughout the study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | Mean Change From Baseline in HbA1c at Week 24 | To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior (noninferiority margin of 0.3%) to titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment. | The randomized subjects data set consisted of all randomized subjects who received at least 1 dose of study medication. | Posted | Least Squares Mean | 95% Confidence Interval | % HbA1c | Baseline and Week 24 |
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| Secondary | Mean Change From Baseline in Total Body Weight at Week 24 | To compare the mean change from baseline in total body weight with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment | The number of participants is the number of subjects in the randomized subject data set with non-missing baseline assessments and at least one post-baseline assessment. | Posted | Least Squares Mean | 95% Confidence Interval | kg | Baseline and Week 24 |
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| Secondary | Percentage of Subjects With Confirmed Hypoglycaemia at Week 24 | Hypoglycemia defined as plasma glucose ≤70 mg/dL (3.9 mmol/L) | The randomized subject data set consisted of all randomized subjects who received at least 1 dose of study medication. | Posted | Number | 95% Confidence Interval | Adjusted % Participants | Baseline and Week 24 |
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| Secondary | Percentage of Subjects Achieving a Therapeutic Glycemic Response, Without Hypoglycaemia, at Week 24 | To compare the percentage of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, without any reported hypoglycemia, with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment. | The randomized subject data set consisted of all randomized subjects who received at least 1 dose of study medication. | Posted | Number | 95% Confidence Interval | Adjusted % Participants | Baseline and Week 24 |
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| Secondary | Percentage of Subjects Achieving a Therapeutic Glycemic Response at Week 24 | To examine whether the percentage of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior (noninferiority margin of 10%) to titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment. | The randomized subject data set consisted of all randomized subjects who received at least 1 dose of study medication. | Posted | Number | 95% Confidence Interval | Adjusted % Participants | Baseline and Week 24 |
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| Secondary | Change From Baseline in the Mean Value of 24-hour Glucose at Week 2 | Change from baseline in the mean value of 24-hour glucose readings measured by Continuous Glucose Monitoring with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior to titrated insulin glargine plus metformin with or without SU after 2 weeks of open-label treatment. | The randomized subject data set consisted of all randomized subjects who received at least 1 dose of study medication. | Posted | Least Squares Mean | 95% Confidence Interval | mg/deciliter (dL) | Baseline and Week 2 |
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From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
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| 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 | Subjects received dapagliflozin 10 mg and saxagliptin 5 mg, administered orally QD in the morning for the 52-week treatment period (24-week short-term period and 28-week long term period). Subjects continued to receive their stable dose of metformin with or without SU throughout the study. | 2 | 324 | 20 | 324 | 55 | 324 |
| EG001 | Titrated Insulin + Metformin | Subjects were to administer insulin glargine subcutaneously QD at the same time every day for the 52-week treatment period (24-week short-term period and 28-week long term period), following investigator instructions and training. All subjects started with an initial dose of 0.2 units/kg body weight or at least 10 units of insulin per day. Subjects self-titrated the dose of insulin glargine over the first 8 weeks of the study based on daily glucose monitoring. The investigator had the discretion to modify insulin dose based on his/her assessment between Week 8 and Week 12 with the goal to reach an acceptable and stable insulin dose by Week 12. Subjects continued to receive their stable dose of metformin with or without SU throughout the study. | 0 | 319 | 13 | 319 | 73 | 319 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Femoral hernia incarcerated | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Postoperative hernia | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Post-traumatic stress disorder | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Urinary bladder polyp | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Gangrene | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Vitreous haemorrhage | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
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| Prostatomegaly | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
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| Inflammation | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Lisfranc fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | +46 (0)31 7761000 | ClinicalTrialTransparency@astrazeneca.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 17, 2016 | Aug 20, 2018 | Prot_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 |
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| ID | Term |
|---|---|
| C502994 | saxagliptin |
| C529054 | dapagliflozin |
| D000069036 | Insulin Glargine |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| 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 |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Asian |
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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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