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| Name | Class |
|---|---|
| Astra Zeneca, Bristol-Myers Squibb | OTHER |
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To obtain safety and tolerability information in patients with type 1 diabetes where Dapagliflozin is added on to Insulin (for 14 days)
Study Classification : Safety, Pharmacokinetics and Pharmacodynamics
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Dapagliflozin (1 mg) | Experimental |
| |
| Arm 2: Dapagliflozin (2.5 mg) | Experimental |
| |
| Arm 3: Dapagliflozin (5 mg) | Experimental |
| |
| Arm 4: Dapagliflozin (10 mg) | Experimental |
| |
| Arm 5: Placebo matching Dapagliflozin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Tablets, Oral, 1 mg, Once daily, 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in 7-Point Glucose Monitoring (7-PGM) at Day 7 | 7-PGM was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the assessment on Day -1, prior to the start date and time of the first dose of the double-blind study medication. 7-PGM included the average of all available glucose values before and 2-hour (hr) after each meal (breakfast, lunch, dinner) as well as bedtime. Measurements were on Day -1, and Day 7 in the double-blind period. | From Baseline to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Dapagliflozin Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax) | Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Cmax was recorded directly from experimental observations. |
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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 |
|---|---|---|---|---|---|---|
| Profil Institute For Clinical Research, Inc. | Chula Vista | California | 91911 | United States | ||
| Va San Diego Healthcare System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35403243 | Derived | Melin J, Tang W, Rekic D, Hamren B, Penland RC, Boulton DW, Parkinson J. Dapagliflozin Pharmacokinetics Is Similar in Adults With Type 1 and Type 2 Diabetes Mellitus. J Clin Pharmacol. 2022 Oct;62(10):1227-1235. doi: 10.1002/jcph.2062. Epub 2022 May 2. | |
| 25271207 | Derived | Henry RR, Rosenstock J, Edelman S, Mudaliar S, Chalamandaris AG, Kasichayanula S, Bogle A, Iqbal N, List J, Griffen SC. Exploring the potential of the SGLT2 inhibitor dapagliflozin in type 1 diabetes: a randomized, double-blind, placebo-controlled pilot study. Diabetes Care. 2015 Mar;38(3):412-9. doi: 10.2337/dc13-2955. Epub 2014 Sep 30. |
| Label | URL |
|---|---|
| MB102072\_Clinical\_Study\_Protocol | View source |
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Of 171 participants enrolled, 76 completed a screening period. Of these 76 participants, 70 were randomized and received treatment. Of these 70 participants, 62 completed double-blind treatment period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + Insulin | Tablets, oral, once daily for 2 weeks |
| FG001 | Dapagliflozin 1 mg + Insulin | Tablets, oral, once daily for 2 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Placebo matching Dapagliflozin | Drug | Tablets, Oral, 0 mg, Once daily, 14 days |
|
| Day 7 (0 hr to 24 hr post dose) |
| Dapagliflozin Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax) | Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Tmax was recorded directly from experimental observations. | Day 7 (0 hr to 24 hr post dose) |
| Dapagliflozin Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The concentrations below the lower limit of quantitation (\ | Day 7 (0 hr to 24 hr post dose) |
| Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax) | Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Cmax was recorded directly from experimental observations. | Day 7 (0 hr to 24 hr post dose) |
| Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax) | Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Tmax was recorded directly from experimental observations. | Day 7 (0 hr to 24 hr post dose) |
| Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The concentrations below the lower limit of quantitation (\ | Day 7 (0 hr to 24 hr post dose) |
| Pharmacokinetic Parameters on Day 7 - Ratio of Metabolite (RM) to Parent AUC[TAU] | Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The concentrations below the lower limit of quantitation (\ | Day 7 (0 hr to 24 hr post dose) |
| San Diego |
| California |
| 92161 |
| United States |
| La Biomed Research Inst. At Harbor Ucla Med Ctr. | Torrance | California | 90502 | United States |
| Compass Research Phase 1, Llc | Orlando | Florida | 32806 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Vince And Associates Clinical Research | Overland Park | Kansas | 66212 | United States |
| Central Kentucky Research Associates, Inc. | Lexington | Kentucky | 40509 | United States |
| Louisiana Research Associates, Inc. | New Orleans | Louisiana | 70114 | United States |
| Jasper Clinic, Inc. | Kalamazoo | Michigan | 49007 | United States |
| Kansas City University Of Medicine And Biosciences | Kansas City | Missouri | 64106 | United States |
| Regional Medical Clinic-Endocrinology | Rapid City | South Dakota | 57701 | United States |
| Dallas Diabetes & Endocrine Center | Dallas | Texas | 75230 | United States |
| FG002 | Dapagliflozin 2.5 mg + Insulin | Tablets, oral, once daily for 2 weeks |
| FG003 | Dapagliflozin 5 mg + Insulin | Tablets, oral, once daily for 2 weeks |
| FG004 | Dapagliflozin 10 mg + Insulin | Tablets, oral, once daily for 2 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants who received at least 1 dose of study medication
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + Insulin | Tablets, oral, once daily for 2 weeks |
| BG001 | Dapagliflozin 1 mg + Insulin | Tablets, oral, once daily for 2 weeks |
| BG002 | Dapagliflozin 2.5 mg + Insulin | Tablets, oral, once daily for 2 weeks |
| BG003 | Dapagliflozin 5 mg + Insulin | Tablets, oral, once daily for 2 weeks |
| BG004 | Dapagliflozin 10 mg + Insulin | Tablets, oral, once daily for 2 weeks |
| BG005 | 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 |
| |||||||||||||||
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex/Gender, Customized | Number | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | 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 | Mean Change From Baseline in 7-Point Glucose Monitoring (7-PGM) at Day 7 | 7-PGM was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the assessment on Day -1, prior to the start date and time of the first dose of the double-blind study medication. 7-PGM included the average of all available glucose values before and 2-hour (hr) after each meal (breakfast, lunch, dinner) as well as bedtime. Measurements were on Day -1, and Day 7 in the double-blind period. | All randomized participants who received study medication and had nonmissing values at baseline and Day 7 | Posted | Mean | Standard Error | mg/dL | From Baseline to Day 7 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Dapagliflozin Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax) | Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Cmax was recorded directly from experimental observations. | Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 7 (0 hr to 24 hr post dose) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Dapagliflozin Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax) | Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Tmax was recorded directly from experimental observations. | Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles | Posted | Mean | Full Range | hour | Day 7 (0 hr to 24 hr post dose) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Dapagliflozin Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The concentrations below the lower limit of quantitation (\ | Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Day 7 (0 hr to 24 hr post dose) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax) | Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Cmax was recorded directly from experimental observations. | Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 7 (0 hr to 24 hr post dose) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax) | Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Tmax was recorded directly from experimental observations. | Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles | Posted | Mean | Full Range | hour | Day 7 (0 hr to 24 hr post dose) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The concentrations below the lower limit of quantitation (\ | Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Day 7 (0 hr to 24 hr post dose) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameters on Day 7 - Ratio of Metabolite (RM) to Parent AUC[TAU] | Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The concentrations below the lower limit of quantitation (\ | Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles | Posted | Geometric Mean | Geometric Coefficient of Variation | (ng*h/mL):(ng*h/mL) | Day 7 (0 hr to 24 hr post dose) |
|
Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
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 | Tablets, oral, once daily for 2 weeks | 0 | 13 | 8 | 13 | ||
| EG001 | Dapagliflozin 1 mg + Insulin | Tablets, oral, once daily for 2 weeks | 0 | 13 | 5 | 13 | ||
| EG002 | Dapagliflozin 2.5 mg + Insulin | Tablets, oral, once daily for 2 weeks | 0 | 15 | 7 | 15 | ||
| EG003 | Dapagliflozin 5 mg + Insulin | Tablets, oral, once daily for 2 weeks | 1 | 14 | 7 | 14 | ||
| EG004 | Dapagliflozin 10 mg + Insulin | Tablets, oral, once daily for 2 weeks | 0 | 15 | 6 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IMPAIRED GASTRIC EMPTYING | Gastrointestinal disorders | MedDRA Version: 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| CATHETER SITE PAIN | General disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA Version: 15.1 | Systematic Assessment |
| |
| BED BUG INFESTATION | Infections and infestations | MedDRA Version: 15.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA Version: 15.1 | Systematic Assessment |
| |
| VAGINAL INFECTION | Infections and infestations | MedDRA Version: 15.1 | Systematic Assessment |
| |
| VULVOVAGINAL MYCOTIC INFECTION | Infections and infestations | MedDRA Version: 15.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| MICTURITION URGENCY | Renal and urinary disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| EYE IRRITATION | Eye disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| VITREOUS FLOATERS | Eye disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA Version: 15.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| ABNORMAL DREAMS | Psychiatric disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| DYSMENORRHOEA | Reproductive system and breast disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA Version: 15.1 | Systematic Assessment |
| |
| FLUSHING | Vascular disorders | MedDRA Version: 15.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Maria Langkilde | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C529054 | dapagliflozin |
Not provided
Not provided
Not provided
| 45 years and older |
|
| Female |
|
| Black/African American |
|
| Asian |
|
| Other |
|
| Descriptive statistics |
No formal statistical testing was performed to compare between treatment groups. |
| Mean Difference (Final Values) |
| -0.77 |
| Standard Error of the Mean |
| 16.7228 |
| 2-Sided |
| 95 |
| -35.36 |
| 33.82 |
| No |
| Superiority or Other |
| Descriptive statistics | No formal statistical testing was performed to compare between treatment groups. | Mean Difference (Final Values) | -6.88 | Standard Error of the Mean | 17.1548 | 2-Sided | 95 | -42.21 | 28.45 | No | Superiority or Other |
| Descriptive statistics | No formal statistical testing was performed to compare between treatment groups. | Mean Difference (Final Values) | -1.03 | Standard Error of the Mean | 18.4617 | 2-Sided | 95 | -39.22 | 37.16 | No | Superiority or Other |
| OG003 | Dapagliflozin 10 mg + Insulin | Tablets, oral, once daily for 2 weeks |
|
|
| OG003 | Dapagliflozin 10 mg + Insulin | Tablets, oral, once daily for 2 weeks |
|
|
| Dapagliflozin 5 mg + Insulin |
Tablets, oral, once daily for 2 weeks |
| OG003 | Dapagliflozin 10 mg + Insulin | Tablets, oral, once daily for 2 weeks |
|
|
| OG003 | Dapagliflozin 10 mg + Insulin | Tablets, oral, once daily for 2 weeks |
|
|
| OG003 | Dapagliflozin 10 mg + Insulin | Tablets, oral, once daily for 2 weeks |
|
|
| Dapagliflozin 5 mg + Insulin |
Tablets, oral, once daily for 2 weeks |
| OG003 | Dapagliflozin 10 mg + Insulin | Tablets, oral, once daily for 2 weeks |
|
|
| OG002 |
| Dapagliflozin 5 mg + Insulin |
Tablets, oral, once daily for 2 weeks |
| OG003 | Dapagliflozin 10 mg + Insulin | Tablets, oral, once daily for 2 weeks |
|
|