Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No 2007-002685-36 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary objective: safety and tolerability of BI 10773 in male and female patients with type 2 diabetes Secondary objective: pharmacokinetics and pharmacodynamics of BI 10773
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| BI 10773 low dose | Experimental |
| |
| BI 10773 medium dose | Experimental |
| |
| BI 10773 high dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 10773 low dose | Drug |
| ||
| placebo to BI 10773 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Drug Related Adverse Events | number of subjects with investigator-defined drug-related adverse events. | from drug administration up to 6 weeks |
| Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG | Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. | from drug administration up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Empagliflozin | maximum concentration of the analyte in plasma after first dose (Cmax, Day 1 ) and at steady state over a uniform dosing interval (Cmax,ss, Day 28). | 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 hours(h) after drug administration on day 1 and 28 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1245.4.49003 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||||
| 1245.4.49002 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35472672 | Derived | Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034. | |
| 23940010 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Oral administration in the fasted state once daily |
| FG001 | 10mg Empagliflozin | Oral administration in the fasted state once daily. |
| FG002 | 25mg Empagliflozin | Oral administration in the fasted state once daily. |
| FG003 | 100mg Empagliflozin | Oral administration in the fasted state once daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | oral administration in the fasted state once daily. |
| BG001 | 10mg Empagliflozin | oral administration in the fasted state once daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Subjects With Drug Related Adverse Events | number of subjects with investigator-defined drug-related adverse events. | treated set: comprised all 78 patients who received at least one dose of study medication | Posted | Number | participants | from drug administration up to 6 weeks |
|
From screening (35 to 15 days before treatment administration) until the end of study examination (35 to 41 days after treatment administration)
Patients were required to report spontaneously any AEs, including the time of onset, duration and intensity of these events. Each patient could be assessed by the investigator whenever necessary.
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 | oral administration in the fasted state once daily |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular extrasystoles | Cardiac disorders | MEDDRA 11.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C570240 | empagliflozin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| BI 10773 medium dose | Drug |
|
| BI 10773 high dose | Drug |
|
| Tmax of Empagliflozin |
time from last dosing to maximum concentration of the analyte in plasma after first dose (Day 1), denoted by tmax; and at steady state (Day 28), denoted by tmax,ss. |
| 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28 |
| t1/2 of Empagliflozin | terminal half-life of the analyte in plasma after first dose (Day 1), denoted by t1/2; and at steady state (Day 28), denoted by t1/2,ss. | 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28 |
| AUC0-∞ of Empagliflozin | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) and over a uniform dosing interval τ at steady state (AUCτ,ss) | 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 |
| CL/F of Empaglifozin | apparent clearance of the analyte in plasma after first dose (CL/F) and at steady state (CL/F,ss) | 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28 |
| fe0-24 of Empagliflozin | Fraction of analyte eliminated in urine from time point 0 to 24h after first dose (fe0-24) and at steady state (fe0-24,ss) | 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28 |
| LI (Linearity Index). | The linearity index is defined as AUC0-τ divided by AUC0-∞ both at steady state. | 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 after drug administration on day 1 and 28 |
| Ae0-24 of Glucose | Amount of glucose eliminated in urine over the time interval 0 to 24h on day -2, -1, 1, 27 and 28. (Urinary Glucose Excretion) | Day -2 and 27: -2 to 0, 0 to 5, 5 to 12 and 12 to 24h; Day -1 and 1: 0 to 5, 5 to 12 and 12 to 24; Day 28: 0 to 5, 5 to 12, 12 to 24, 24 to 36, 36 to 48 and 48 to 72h |
| Fasting Plasma Glucose (FPG) | fasting plasma glucose on day -1 (baseline) and change from baseline to day 28 | in the morning of days -1 and 28 |
| Mean Daily Glucose (MDG) Measured in Blood | change from baseline in MDG on the days 1, 7, 14, 21 and 27. Baseline is defined as day -2. | 0:00, 2:30, 5:00, 7:00, 10:00, 12:00, 13:30, 24:00 h after drug administration on day -2. 0:05 h before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00, 13:30, 24:00 h after drug administration on day 1, 7, 14, 21 and 27 |
| Insulin AUEC0-5 | change in AUEC0-5 from baseline on day 28. Baseline is defined as day -1. | 0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28. |
| Insulin Emax (Maximum Measured Effect) | change in Emax from baseline on day 28. Baseline is defined as day -1 | 0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28. |
| Fasting Insulin | Change from baseline to the days 1, 7, 14, 21 and 28. Baseline is defined as day -1. | in the morning of days -1( baseline), 1, 7, 14, 21 and 28 |
| Glucagon Emax (Maximum Measured Effect) | Change from baseline (day -1) in Emax on day 28. | 0:00, 2:30, 5:00, 7:00, 10:00, 12:00, 24:00 h after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28. |
| Glucagon AUEC0-5 | Change from baseline (day -1) in AUEC0-5 on day 28. | 0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28. |
| Fructosamine | change from baseline to days 14 and 18. Baseline is defined as day -1. | day -1 (baseline), 14 and 28 |
| HbA1c | change from baseline on day 28. Baseline is defined as day -1. | in the morning of days -1 and 28 |
| Mainz |
| Germany |
| 1245.4.49001 Boehringer Ingelheim Investigational Site | Neuss | Germany |
| Riggs MM, Staab A, Seman L, MacGregor TR, Bergsma TT, Gastonguay MR, Macha S. Population pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in patients with type 2 diabetes. J Clin Pharmacol. 2013 Oct;53(10):1028-38. doi: 10.1002/jcph.147. Epub 2013 Aug 13. |
| BG002 | 25mg Empagliflozin | oral administration in the fasted state once daily. |
| BG003 | 100mg Empagliflozin | oral administration in the fasted state once daily. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
oral administration in the fasted state once daily. |
| OG003 | 100mg Empagliflozin | oral administration in the fasted state once daily. |
|
|
| Primary | Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG | Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. | treated set | Posted | Number | participants | from drug administration up to 6 weeks |
|
|
|
| Secondary | Cmax of Empagliflozin | maximum concentration of the analyte in plasma after first dose (Cmax, Day 1 ) and at steady state over a uniform dosing interval (Cmax,ss, Day 28). | Pharmacokinetic (PK) analysis set: comprised all 62 patients who received Empagliflozin and had evaluable PK parameter data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 hours(h) after drug administration on day 1 and 28 |
|
|
|
| Secondary | Tmax of Empagliflozin | time from last dosing to maximum concentration of the analyte in plasma after first dose (Day 1), denoted by tmax; and at steady state (Day 28), denoted by tmax,ss. | PK analysis set | Posted | Median | Full Range | hours | 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28 |
|
|
|
| Secondary | t1/2 of Empagliflozin | terminal half-life of the analyte in plasma after first dose (Day 1), denoted by t1/2; and at steady state (Day 28), denoted by t1/2,ss. | PK analysis set | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28 |
|
|
|
| Secondary | AUC0-∞ of Empagliflozin | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) and over a uniform dosing interval τ at steady state (AUCτ,ss) | PK analysis set | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 |
|
|
|
| Secondary | CL/F of Empaglifozin | apparent clearance of the analyte in plasma after first dose (CL/F) and at steady state (CL/F,ss) | PK analysis set | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/min | 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28 |
|
|
|
| Secondary | fe0-24 of Empagliflozin | Fraction of analyte eliminated in urine from time point 0 to 24h after first dose (fe0-24) and at steady state (fe0-24,ss) | PK analysis set for patients who have fe data at day 1 and day 28 | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage of Empagliflozin | 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28 |
|
|
|
| Secondary | LI (Linearity Index). | The linearity index is defined as AUC0-τ divided by AUC0-∞ both at steady state. | PK analysis set | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 after drug administration on day 1 and 28 |
|
|
|
| Secondary | Ae0-24 of Glucose | Amount of glucose eliminated in urine over the time interval 0 to 24h on day -2, -1, 1, 27 and 28. (Urinary Glucose Excretion) | PD analysis set | Posted | Geometric Mean | Geometric Coefficient of Variation | mg | Day -2 and 27: -2 to 0, 0 to 5, 5 to 12 and 12 to 24h; Day -1 and 1: 0 to 5, 5 to 12 and 12 to 24; Day 28: 0 to 5, 5 to 12, 12 to 24, 24 to 36, 36 to 48 and 48 to 72h |
|
|
|
| Secondary | Fasting Plasma Glucose (FPG) | fasting plasma glucose on day -1 (baseline) and change from baseline to day 28 | PD analysis set | Posted | Mean | Standard Deviation | mg/dL | in the morning of days -1 and 28 |
|
|
|
| Secondary | Mean Daily Glucose (MDG) Measured in Blood | change from baseline in MDG on the days 1, 7, 14, 21 and 27. Baseline is defined as day -2. | PD analysis set | Posted | Mean | Standard Deviation | mg/dL | 0:00, 2:30, 5:00, 7:00, 10:00, 12:00, 13:30, 24:00 h after drug administration on day -2. 0:05 h before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00, 13:30, 24:00 h after drug administration on day 1, 7, 14, 21 and 27 |
|
|
|
| Secondary | Insulin AUEC0-5 | change in AUEC0-5 from baseline on day 28. Baseline is defined as day -1. | PD analysis set | Posted | Mean | Standard Deviation | µU*h/mL | 0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28. |
|
|
|
| Secondary | Insulin Emax (Maximum Measured Effect) | change in Emax from baseline on day 28. Baseline is defined as day -1 | PD analysis set | Posted | Mean | Standard Deviation | µU/mL | 0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28. |
|
|
|
| Secondary | Fasting Insulin | Change from baseline to the days 1, 7, 14, 21 and 28. Baseline is defined as day -1. | PD analysis set | Posted | Mean | Standard Deviation | µU/mL | in the morning of days -1( baseline), 1, 7, 14, 21 and 28 |
|
|
|
| Secondary | Glucagon Emax (Maximum Measured Effect) | Change from baseline (day -1) in Emax on day 28. | PD analysis set | Posted | Mean | Standard Deviation | ng/L | 0:00, 2:30, 5:00, 7:00, 10:00, 12:00, 24:00 h after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28. |
|
|
|
| Secondary | Glucagon AUEC0-5 | Change from baseline (day -1) in AUEC0-5 on day 28. | Pharmacodynamic (PD) analysis set: All patients who receive at least one dose of study medication (active drug or placebo) and had some PD data were included in the pharmacodynamic analysis. | Posted | Mean | Standard Deviation | ng*h/L | 0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28. |
|
|
|
| Secondary | Fructosamine | change from baseline to days 14 and 18. Baseline is defined as day -1. | PD analysis set | Posted | Mean | Standard Deviation | µmol/L | day -1 (baseline), 14 and 28 |
|
|
|
| Secondary | HbA1c | change from baseline on day 28. Baseline is defined as day -1. | PD analysis set | Posted | Mean | Standard Deviation | percentage of hemoglobin | in the morning of days -1 and 28 |
|
|
|
| 0 |
| 16 |
| 10 |
| 16 |
| EG001 | 10mg Empagliflozin | oral administration in the fasted state once daily | 0 | 16 | 8 | 16 |
| EG002 | 25mg Empagliflozin | oral administration in the fasted state once daily | 0 | 16 | 9 | 16 |
| EG003 | 100mg Empagliflozin | oral administration in the fasted state once daily | 0 | 30 | 18 | 30 |
| Vertigo | Ear and labyrinth disorders | MEDDRA 11.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
|
| Fatigue | General disorders | MEDDRA 11.1 | Systematic Assessment |
|
| Pain | General disorders | MEDDRA 11.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MEDDRA 11.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MEDDRA 11.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MEDDRA 11.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MEDDRA 11.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MEDDRA 11.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 11.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MEDDRA 11.1 | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MEDDRA 11.1 | Systematic Assessment |
|
| Balanitis | Reproductive system and breast disorders | MEDDRA 11.1 | Systematic Assessment |
|
| Pruritus genital | Reproductive system and breast disorders | MEDDRA 11.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.1 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MEDDRA 11.1 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MEDDRA 11.1 | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MEDDRA 11.1 | Systematic Assessment |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| D004700 | Endocrine System Diseases |
| Blood triglycerides increased |
|
| Blood creatine phosphokinase increased |
|
| Ventricular extrasystoles |
|
|
| tmax,ss |
|
|
|
|
|
| Ae0-24 on day -1 (N=13,15,16,25) |
|
| Ae0-24 on day 1 (N=15,15,16,29) |
|
| Ae0-24 on day 27 (N=14,13,14,27) |
|
| Ae0-24 on day 28 (N=13,13,11,23) |
|
| change from baseline to day 28 (N=15, 15, 16, 28) |
|
| change from baseline to day 1 |
|
| change from baseline to day 7 |
|
| change from baseline to day 14 |
|
| change from baseline to day 21 |
|
| change from baseline to day 27 |
|
| change from baseline to day 28 (N=16, 16, 16, 29) |
|
| change from baseline to day 28 (N=16, 16, 16, 29) |
|
| change from baseline to day 1 (N=11,12,14,22) |
|
| change from baseline to day 7 (N=9,10,9,18) |
|
| change from baseline to day 14 (N=12,11,14,22) |
|
| change from baseline to day 21 (N=10,11,14,21) |
|
| change from baseline to day 28 (N=11,11,12,20) |
|
| change from baseline to day 28 (N=14, 14, 16, 28) |
|
| change from baseline to day 28 (N=14, 14, 16, 28) |
|
| change from baseline to day 14 (N=14, 16, 15, 29) |
|
| change from baseline to day 28 (N=14, 15, 16, 28) |
|
| change from baseline to day 28 (N=13, 13, 15, 28) |
|