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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1118-3955 | Registry Identifier | WHO | |
| JapicCTI-080589 | Registry Identifier | JapicCTI |
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The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily (QD) combined with an α-glucosidase inhibitor taken three times daily (TID) in type 2 diabetic patients with uncontrolled blood glucose.
Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.
Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.
In Japan, α-glucosidase inhibitors are widely used as a first-line treatment for type 2 diabetes mellitus. Because alogliptin has a different mechanism of action compared to α-glucosidase inhibitors, the study evaluated the efficacy and safety of alogliptin combined with an α-glucosidase inhibitor in type 2 diabetic patients with uncontrolled blood glucose while taking a α-glucosidase inhibitor and receiving diet and/or exercise therapies.
To evaluate the long-term safety and efficacy of the concomitant use of alogliptin and an α-glucosidase inhibitor, subjects who participated in the present study could enter a long-term extension study SYR-322/OCT-003 (NCT01263509) that was planned separately.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Voglibose 0.2 mg TID | Active Comparator |
| |
| Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID | Experimental |
| |
| Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alogliptin and voglibose | Drug | Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (Week 12). | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline. | Baseline and Week 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (Week 2). | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline. | Baseline and Week 2. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Professor, Department of Medicine | Kawasaki Medical School | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22106975 | Derived | Seino Y, Fujita T, Hiroi S, Hirayama M, Kaku K. Alogliptin plus voglibose in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension. Curr Med Res Opin. 2011 Nov;27 Suppl 3:21-9. doi: 10.1185/03007995.2011.614936. |
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Participants with a historical diagnosis of type 2 diabetes mellitus with uncontrolled blood glucose despite diet and exercise therapies were enrolled in one of 3, once-daily (QD) or three-times daily (TID) treatment groups.
Participants enrolled at investigative sites in Japan from to .
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| ID | Title | Description |
|---|---|---|
| FG000 | Voglibose 0.2 mg TID | Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. |
| FG001 | Alogliptin 12.5 mg QD | Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID |
| FG002 | Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Voglibose 0.2 mg TID | Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. |
| BG001 | Alogliptin 12.5 mg QD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 Glycosylated Hemoglobin (Week 12). | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline. | Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 12. |
|
Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to 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 | Voglibose 0.2 mg TID | Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteomyelitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| General Manager | Japan Development Center, Pharmaceutical Development Division | +81-6-6204-5257 | clinicaltrialregistry@tpna.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C520853 | alogliptin |
| C102817 | voglibose |
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|
| Alogliptin and voglibose | Drug | Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. |
|
|
| Voglibose | Drug | Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. |
|
|
| Change From Baseline in Glycosylated Hemoglobin (Week 4). |
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline. |
| Baseline and Week 4. |
| Change From Baseline in Glycosylated Hemoglobin (Week 8). | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline. | Baseline and Week 8. |
| Change From Baseline in Fasting Plasma Glucose (Week 2). | The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline. | Baseline and Week 2 |
| Change From Baseline in Fasting Plasma Glucose (Week 4). | The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline. | Baseline and Week 4. |
| Change From Baseline in Fasting Plasma Glucose (Week 8). | The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline. | Baseline and Week 8. |
| Change From Baseline in Fasting Plasma Glucose (Week 12). | The change between the value of fasting plasma glucose collected at week 12 or final visit and fasting plasma glucose collected at baseline. | Baseline and Week 12. |
| Change From Baseline in Fasting C-peptide (Week 2). | The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline. | Baseline and Week 2. |
| Change From Baseline in Fasting C-peptide (Week 4). | The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline. | Baseline and Week 4. |
| Change From Baseline in Fasting C-peptide (Week 8). | The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline. | Baseline and Week 8. |
| Change From Baseline in Fasting C-peptide (Week 12). | The change between the value of fasting C-peptide collected at week 12 or final visit and fasting C-peptide collected at baseline. | Baseline and Week 12. |
| Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value). | The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal. | Baseline and Week 12. |
| Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)). | The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal. | Baseline and Week 12. |
| Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2). | The change between the value of insulin collected at week 12 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal. | Baseline and Week 12 |
| Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2). | The change between the value of C-peptide collected at week 12 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal. | Baseline and Week 12. |
| Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)). | The change between the value of glucagons collected at week 12 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal. | Baseline and Week 12 |
| Lack of Efficacy |
|
| Protocol Violation |
|
| Participant Unavailability |
|
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
| BG002 | Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Alogliptin 12.5 mg QD |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID |
| OG002 | Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. |
|
|
|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 2). | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline. | Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 2. |
|
|
|
|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 4). | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline. | Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 4. |
|
|
|
|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 8). | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline. | Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 8. |
|
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 2). | The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline. | Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 2 |
|
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 4). | The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline. | Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 4. |
|
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 8). | The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline. | Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 8. |
|
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 12). | The change between the value of fasting plasma glucose collected at week 12 or final visit and fasting plasma glucose collected at baseline. | Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 12. |
|
|
|
|
| Secondary | Change From Baseline in Fasting C-peptide (Week 2). | The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline. | Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | ng/mL | Baseline and Week 2. |
|
|
|
|
| Secondary | Change From Baseline in Fasting C-peptide (Week 4). | The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline. | Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | ng/mL | Baseline and Week 4. |
|
|
|
|
| Secondary | Change From Baseline in Fasting C-peptide (Week 8). | The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline. | Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | ng/mL | Baseline and Week 8. |
|
|
|
|
| Secondary | Change From Baseline in Fasting C-peptide (Week 12). | The change between the value of fasting C-peptide collected at week 12 or final visit and fasting C-peptide collected at baseline. | Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | ng/mL | Baseline and Week 12. |
|
|
|
|
| Secondary | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value). | The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 12. |
|
|
|
|
| Secondary | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)). | The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | mg·hr/dL | Baseline and Week 12. |
|
|
|
|
| Secondary | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2). | The change between the value of insulin collected at week 12 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | μU·hr/mL | Baseline and Week 12 |
|
|
|
|
| Secondary | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2). | The change between the value of C-peptide collected at week 12 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | ng·hr/mL | Baseline and Week 12. |
|
|
|
|
| Secondary | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)). | The change between the value of glucagons collected at week 12 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | pg·hr/mL | Baseline and Week 12 |
|
|
|
|
| 9 |
| 75 |
| 7 |
| 75 |
| EG001 | Alogliptin 12.5 mg QD | Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID | 0 | 76 | 18 | 76 |
| EG002 | Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. | 1 | 79 | 13 | 79 |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardiac failure acute | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Intracardiac thrombus | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
The clinical trial contract states that information should never be disclosed without prior consent of the sponsor, although it does not specify the number of days during which disclosure of information is limited.
| Mean Difference (Final Values) |
| -0.190 |
| 2-Sided |
| 95 |
| -0.247 |
| -0.133 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) |
| -0.414 |
| 2-Sided |
| 95 |
| -0.504 |
| -0.324 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) |
| -0.749 |
| 2-Sided |
| 95 |
| -0.875 |
| -0.623 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) |
| -15.33 |
| 2-Sided |
| 95 |
| -21.93 |
| -8.73 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) |
| -22.03 |
| 2-Sided |
| 95 |
| -29.68 |
| -14.38 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) |
| -19.34 |
| 2-Sided |
| 95 |
| -27.34 |
| -11.34 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) |
| -12.97 |
| 2-Sided |
| 95 |
| -21.53 |
| -4.41 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) |
| -0.036 |
| 2-Sided |
| 95 |
| -0.239 |
| 0.167 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) |
| -0.034 |
| 2-Sided |
| 95 |
| -0.264 |
| 0.196 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) |
| -0.073 |
| 2-Sided |
| 95 |
| -0.261 |
| 0.115 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) |
| 0.082 |
| 2-Sided |
| 95 |
| -0.124 |
| 0.288 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) |
| -33.73 |
| 2-Sided |
| 95 |
| -44.88 |
| -22.57 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) |
| -72.49 |
| 2-Sided |
| 95 |
| -93.10 |
| -51.88 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) |
| 3.967 |
| 2-Sided |
| 95 |
| -0.521 |
| 8.455 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) |
| 0.428 |
| 2-Sided |
| 95 |
| -0.233 |
| 1.090 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) |
| -20.04 |
| 2-Sided |
| 95 |
| -37.82 |
| -2.27 |
| No |
| Superiority or Other |