Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1118-3752 | Registry Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study was to evaluate the dose-response relationships of alogliptin, once daily (QD) to an α-glucosidase inhibitor, three times daily (TID), to determine the optimal clinical dose for type 2 diabetic patients.
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.
To evaluate the long-term safety and efficacy of alogliptin, participants in the present study could enter a long-term extension study SYR-322/OCT-001 (NCT01263496) that was planned separately.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Alogliptin 6.25 mg QD | Experimental |
| |
| Alogliptin 12.5 mg QD | Experimental |
| |
| Alogliptin 25 mg QD | Experimental |
| |
| Alogliptin 50 mg QD | Experimental |
| |
| Voglibose 0.2 mg TID | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alogliptin | Drug | Alogliptin 6.25 mg, tablets, orally, once 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Professor, Department of Medicine | Kawasaki Medical School | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Okayama | 701-0192 | Japan |
Participants with a historical diagnosis of type 2 diabetes mellitus with uncontrolled blood glucose despite diet and exercise therapies were enrolled in one of 6, once-daily (QD) or three-times daily (TID) treatment groups.
Participants enrolled at 54 investigative sites in Japan from 17 January 2007 to 22 December 2007.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo-matching tablets, orally, once or three times daily for up to 12 weeks. |
| FG001 | Alogliptin 6.25 mg QD | Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks. |
| FG002 | Alogliptin 12.5 mg QD | Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. |
| FG003 | Alogliptin 25 mg QD | Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. |
| FG004 | Alogliptin 50 mg QD | Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. |
| FG005 | Voglibose 0.2 mg TID | Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo-matching tablets, orally, once or three times daily for up to 12 weeks. |
| BG001 | Alogliptin 6.25 mg QD | Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks. |
| 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.
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 | Placebo-matching tablets, orally, once or three times daily for up to 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's disease | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flatulence | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| General Manager | Japan Development Center, Pharmaceutical Development Division | +81-6-6204-5257 | clinicaltrialregistry@tpna.com |
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C520853 | alogliptin |
| C102817 | voglibose |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Alogliptin | Drug | Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. |
|
|
| Alogliptin | Drug | Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. |
|
|
| Alogliptin | Drug | Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks |
|
|
| Voglibose | Drug | Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. |
|
|
| Placebo | Drug | Placebo-matching tablets, orally, once or 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 - Area Under the Curve at 2 Hours (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 - Area Under the Curve at 2 Hours (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 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 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 2 hours after the start of the meal. | Baseline and Week 12 |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| Participant Unavailability |
|
| Study Drug Non-compliance |
|
| BG002 | Alogliptin 12.5 mg QD | Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. |
| BG003 | Alogliptin 25 mg QD | Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. |
| BG004 | Alogliptin 50 mg QD | Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. |
| BG005 | Voglibose 0.2 mg TID | Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. |
| BG006 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Alogliptin 6.25 mg QD |
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks. |
| OG002 | Alogliptin 12.5 mg QD | Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. |
| OG003 | Alogliptin 25 mg QD | Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. |
| OG004 | Alogliptin 50 mg QD | Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. |
| OG005 | Voglibose 0.2 mg TID | 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. | 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 Blood Glucose Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (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. | 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·hr/dL | Baseline and Week 12. |
|
|
|
|
| Secondary | Change From Baseline in Insulin Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (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 2 hours after the start of the meal. | 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 | 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 2 hours after the start of the meal. | 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·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 2 hours after the start of the meal. | 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 | pg·hr/mL | Baseline and Week 12 |
|
|
|
|
| 1 |
| 75 |
| 20 |
| 75 |
| EG001 | Alogliptin 6.25 mg QD | Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks. | 2 | 79 | 17 | 79 |
| EG002 | Alogliptin 12.5 mg QD | Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. | 2 | 84 | 23 | 84 |
| EG003 | Alogliptin 25 mg QD | Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. | 1 | 80 | 27 | 80 |
| EG004 | Alogliptin 50 mg QD | Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. | 2 | 79 | 23 | 79 |
| EG005 | Voglibose 0.2 mg TID | Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. | 2 | 83 | 38 | 83 |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 10.1 | 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) |
| -0.174 |
| 2-Sided |
| 95 |
| -0.234 |
| -0.114 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) | -0.160 | 2-Sided | 95 | -0.219 | -0.100 | No | Superiority or Other |
| Mean Difference (Final Values) | -0.153 | 2-Sided | 95 | -0.212 | -0.095 | No | Superiority or Other |
| Mean Difference (Final Values) | -0.059 | 2-Sided | 95 | -0.116 | -0.003 | No | Superiority or Other |
| Mean Difference (Final Values) | -0.075 | 2-Sided | 95 | -0.136 | -0.014 | No | Superiority or Other |
| Mean Difference (Final Values) | -0.061 | 2-Sided | 95 | -0.121 | 0.000 | No | Superiority or Other |
| Mean Difference (Final Values) | -0.054 | 2-Sided | 95 | -0.114 | 0.006 | No | Superiority or Other |
| Mean Difference (Final Values) |
| -0.369 |
| 2-Sided |
| 95 |
| -0.470 |
| -0.268 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) | -0.340 | 2-Sided | 95 | -0.438 | -0.241 | No | Superiority or Other |
| Mean Difference (Final Values) | -0.387 | 2-Sided | 95 | -0.485 | -0.288 | No | Superiority or Other |
| Mean Difference (Final Values) | -0.178 | 2-Sided | 95 | -0.280 | -0.076 | No | Superiority or Other |
| Mean Difference (Final Values) | -0.221 | 2-Sided | 95 | -0.329 | -0.112 | No | Superiority or Other |
| Mean Difference (Final Values) | -0.192 | 2-Sided | 95 | -0.299 | -0.085 | No | Superiority or Other |
| Mean Difference (Final Values) | -0.239 | 2-Sided | 95 | -0.346 | -0.131 | No | Superiority or Other |
| Mean Difference (Final Values) |
| -0.614 |
| 2-Sided |
| 95 |
| -0.763 |
| -0.464 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) | -0.660 | 2-Sided | 95 | -0.804 | -0.516 | No | Superiority or Other |
| Mean Difference (Final Values) | -0.695 | 2-Sided | 95 | -0.832 | -0.559 | No | Superiority or Other |
| Mean Difference (Final Values) | -0.325 | 2-Sided | 95 | -0.494 | -0.156 | No | Superiority or Other |
| Mean Difference (Final Values) | -0.438 | 2-Sided | 95 | -0.610 | -0.267 | No | Superiority or Other |
| Mean Difference (Final Values) | -0.485 | 2-Sided | 95 | -0.654 | -0.315 | No | Superiority or Other |
| Mean Difference (Final Values) | -0.520 | 2-Sided | 95 | -0.683 | -0.357 | No | Superiority or Other |
| Mean Difference (Final Values) |
| -17.69 |
| 2-Sided |
| 95 |
| -25.34 |
| -10.05 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) | -16.08 | 2-Sided | 95 | -24.14 | -8.02 | No | Superiority or Other |
| Mean Difference (Final Values) | -23.47 | 2-Sided | 95 | -32.06 | -14.89 | No | Superiority or Other |
| Mean Difference (Final Values) | -5.82 | 2-Sided | 95 | -12.66 | 1.02 | No | Superiority or Other |
| Mean Difference (Final Values) | -7.92 | 2-Sided | 95 | -14.76 | -1.08 | No | Superiority or Other |
| Mean Difference (Final Values) | -6.30 | 2-Sided | 95 | -13.53 | 0.93 | No | Superiority or Other |
| Mean Difference (Final Values) | -13.69 | 2-Sided | 95 | -21.45 | -5.94 | No | Superiority or Other |
| Mean Difference (Final Values) |
| -17.69 |
| 2-Sided |
| 95 |
| -25.34 |
| -10.05 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) | -16.08 | 2-Sided | 95 | -24.14 | -8.02 | No | Superiority or Other |
| Mean Difference (Final Values) | -23.47 | 2-Sided | 95 | -32.06 | -14.89 | No | Superiority or Other |
| Mean Difference (Final Values) | -5.82 | 2-Sided | 95 | -12.66 | 1.02 | No | Superiority or Other |
| Mean Difference (Final Values) | -7.92 | 2-Sided | 95 | -14.76 | -1.08 | No | Superiority or Other |
| Mean Difference (Final Values) | -6.30 | 2-Sided | 95 | -13.53 | 0.93 | No | Superiority or Other |
| Mean Difference (Final Values) | -13.69 | 2-Sided | 95 | -21.45 | -5.94 | No | Superiority or Other |
| Mean Difference (Final Values) |
| -24.22 |
| 2-Sided |
| 95 |
| -32.07 |
| -16.37 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) | -24.34 | 2-Sided | 95 | -32.03 | -16.65 | No | Superiority or Other |
| Mean Difference (Final Values) | -28.28 | 2-Sided | 95 | -37.04 | -19.52 | No | Superiority or Other |
| Mean Difference (Final Values) | -8.55 | 2-Sided | 95 | -17.28 | 0.18 | No | Superiority or Other |
| Mean Difference (Final Values) | -15.04 | 2-Sided | 95 | -22.90 | -7.18 | No | Superiority or Other |
| Mean Difference (Final Values) | -15.16 | 2-Sided | 95 | -22.90 | -7.42 | No | Superiority or Other |
| Mean Difference (Final Values) | -19.10 | 2-Sided | 95 | -27.80 | -10.40 | No | Superiority or Other |
| Mean Difference (Final Values) |
| -20.17 |
| 2-Sided |
| 95 |
| -27.86 |
| -12.48 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) | -23.07 | 2-Sided | 95 | -30.41 | -15.73 | No | Superiority or Other |
| Mean Difference (Final Values) | -28.17 | 2-Sided | 95 | -36.05 | -20.29 | No | Superiority or Other |
| Mean Difference (Final Values) | -6.27 | 2-Sided | 95 | -15.60 | 3.06 | No | Superiority or Other |
| Mean Difference (Final Values) | -11.52 | 2-Sided | 95 | -19.41 | -3.64 | No | Superiority or Other |
| Mean Difference (Final Values) | -14.42 | 2-Sided | 95 | -22.04 | -6.80 | No | Superiority or Other |
| Mean Difference (Final Values) | -19.52 | 2-Sided | 95 | -27.61 | -11.43 | No | Superiority or Other |
| Mean Difference (Final Values) |
| 0.134 |
| 2-Sided |
| 95 |
| -0.106 |
| 0.374 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) | 0.144 | 2-Sided | 95 | -0.103 | 0.390 | No | Superiority or Other |
| Mean Difference (Final Values) | 0.004 | 2-Sided | 95 | -0.218 | 0.227 | No | Superiority or Other |
| Mean Difference (Final Values) | 0.002 | 2-Sided | 95 | -0.241 | 0.245 | No | Superiority or Other |
| Mean Difference (Final Values) | 0.281 | 2-Sided | 95 | 0.038 | 0.524 | No | Superiority or Other |
| Mean Difference (Final Values) | 0.291 | 2-Sided | 95 | 0.041 | 0.540 | No | Superiority or Other |
| Mean Difference (Final Values) | 0.151 | 2-Sided | 95 | -0.077 | 0.380 | No | Superiority or Other |
| Mean Difference (Final Values) |
| 0.012 |
| 2-Sided |
| 95 |
| -0.185 |
| 0.210 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) | 0.158 | 2-Sided | 95 | -0.053 | 0.369 | No | Superiority or Other |
| Mean Difference (Final Values) | 0.048 | 2-Sided | 95 | -0.140 | 0.235 | No | Superiority or Other |
| Mean Difference (Final Values) | 0.122 | 2-Sided | 95 | -0.097 | 0.341 | No | Superiority or Other |
| Mean Difference (Final Values) | 0.179 | 2-Sided | 95 | -0.036 | 0.395 | No | Superiority or Other |
| Mean Difference (Final Values) | 0.325 | 2-Sided | 95 | 0.097 | 0.553 | No | Superiority or Other |
| Mean Difference (Final Values) | 0.215 | 2-Sided | 95 | 0.006 | 0.423 | No | Superiority or Other |
| Mean Difference (Final Values) |
| -0.100 |
| 2-Sided |
| 95 |
| -0.362 |
| 0.162 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) | 0.079 | 2-Sided | 95 | -0.166 | 0.324 | No | Superiority or Other |
| Mean Difference (Final Values) | -0.117 | 2-Sided | 95 | -0.355 | 0.121 | No | Superiority or Other |
| Mean Difference (Final Values) | 0.102 | 2-Sided | 95 | -0.203 | 0.408 | No | Superiority or Other |
| Mean Difference (Final Values) | 0.120 | 2-Sided | 95 | -0.124 | 0.364 | No | Superiority or Other |
| Mean Difference (Final Values) | 0.299 | 2-Sided | 95 | 0.071 | 0.526 | No | Superiority or Other |
| Mean Difference (Final Values) | 0.102 | 2-Sided | 95 | -0.118 | 0.322 | No | Superiority or Other |
| Mean Difference (Final Values) |
| 0.175 |
| 2-Sided |
| 95 |
| -0.029 |
| 0.379 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) | 0.248 | 2-Sided | 95 | 0.044 | 0.453 | No | Superiority or Other |
| Mean Difference (Final Values) | 0.186 | 2-Sided | 95 | -0.035 | 0.407 | No | Superiority or Other |
| Mean Difference (Final Values) | 0.052 | 2-Sided | 95 | -0.236 | 0.340 | No | Superiority or Other |
| Mean Difference (Final Values) | 0.188 | 2-Sided | 95 | -0.044 | 0.421 | No | Superiority or Other |
| Mean Difference (Final Values) | 0.261 | 2-Sided | 95 | 0.026 | 0.496 | No | Superiority or Other |
| Mean Difference (Final Values) | 0.199 | 2-Sided | 95 | -0.049 | 0.448 | No | Superiority or Other |
| Mean Difference (Final Values) |
| -23.38 |
| 2-Sided |
| 95 |
| -37.14 |
| -9.61 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) | -40.60 | 2-Sided | 95 | -53.18 | -28.02 | No | Superiority or Other |
| Mean Difference (Final Values) | -42.75 | 2-Sided | 95 | -54.93 | -30.58 | No | Superiority or Other |
| Mean Difference (Final Values) | -5.36 | 2-Sided | 95 | -19.70 | 8.98 | No | Superiority or Other |
| Mean Difference (Final Values) | -4.89 | 2-Sided | 95 | -18.13 | 8.35 | No | Superiority or Other |
| Mean Difference (Final Values) | -22.11 | 2-Sided | 95 | -34.22 | -10.01 | No | Superiority or Other |
| Mean Difference (Final Values) | -24.27 | 2-Sided | 95 | -35.98 | -12.55 | No | Superiority or Other |
| Mean Difference (Final Values) |
| -60.66 |
| 2-Sided |
| 95 |
| -80.84 |
| -40.47 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) | -78.72 | 2-Sided | 95 | -97.03 | -60.40 | No | Superiority or Other |
| Mean Difference (Final Values) | -87.43 | 2-Sided | 95 | -106.26 | -68.60 | No | Superiority or Other |
| Mean Difference (Final Values) | -2.73 | 2-Sided | 95 | -24.69 | 19.23 | No | Superiority or Other |
| Mean Difference (Final Values) | -5.07 | 2-Sided | 95 | -24.85 | 14.70 | No | Superiority or Other |
| Mean Difference (Final Values) | -23.13 | 2-Sided | 95 | -41.16 | -5.11 | No | Superiority or Other |
| Mean Difference (Final Values) | -31.84 | 2-Sided | 95 | -50.36 | -13.33 | No | Superiority or Other |
| Mean Difference (Final Values) |
| 5.456 |
| 2-Sided |
| 95 |
| 0.748 |
| 10.165 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) | 7.715 | 2-Sided | 95 | 3.181 | 12.248 | No | Superiority or Other |
| Mean Difference (Final Values) | 2.557 | 2-Sided | 95 | -3.763 | 8.877 | No | Superiority or Other |
| Mean Difference (Final Values) | 14.660 | 2-Sided | 95 | 7.924 | 21.396 | No | Superiority or Other |
| Mean Difference (Final Values) | 17.257 | 2-Sided | 95 | 11.353 | 23.160 | No | Superiority or Other |
| Mean Difference (Final Values) | 19.515 | 2-Sided | 95 | 13.629 | 25.401 | No | Superiority or Other |
| Mean Difference (Final Values) | 14.357 | 2-Sided | 95 | 7.013 | 21.701 | No | Superiority or Other |
| Mean Difference (Final Values) |
| 0.764 |
| 2-Sided |
| 95 |
| 0.214 |
| 1.315 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) | 0.999 | 2-Sided | 95 | 0.418 | 1.580 | No | Superiority or Other |
| Mean Difference (Final Values) | 0.959 | 2-Sided | 95 | 0.430 | 1.489 | No | Superiority or Other |
| Mean Difference (Final Values) | 0.934 | 2-Sided | 95 | 0.315 | 1.552 | No | Superiority or Other |
| Mean Difference (Final Values) | 1.163 | 2-Sided | 95 | 0.551 | 1.774 | No | Superiority or Other |
| Mean Difference (Final Values) | 1.398 | 2-Sided | 95 | 0.759 | 2.036 | No | Superiority or Other |
| Mean Difference (Final Values) | 1.358 | 2-Sided | 95 | 0.760 | 1.956 | No | Superiority or Other |
| Mean Difference (Final Values) |
| 11.26 |
| 2-Sided |
| 95 |
| -0.90 |
| 23.42 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) | 3.19 | 2-Sided | 95 | -10.56 | 16.95 | No | Superiority or Other |
| Mean Difference (Final Values) | -3.66 | 2-Sided | 95 | -16.27 | 8.94 | No | Superiority or Other |
| Mean Difference (Final Values) | 4.75 | 2-Sided | 95 | -9.79 | 19.29 | No | Superiority or Other |
| Mean Difference (Final Values) | 11.76 | 2-Sided | 95 | -2.67 | 26.19 | No | Superiority or Other |
| Mean Difference (Final Values) | 3.69 | 2-Sided | 95 | -12.02 | 19.40 | No | Superiority or Other |
| Mean Difference (Final Values) | -3.17 | 2-Sided | 95 | -18.04 | 11.71 | No | Superiority or Other |