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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1119-6207 | Registry Identifier | WHO |
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The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and Thiazolidine administered once daily (QD) for 40 consecutive weeks in participants who completed a phase 2/3 Thiazolidine add on study.
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 were enrolled from a core phase 2/3 thiazolidine add on study (SYR-322/CCT-004; NCT01318070).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD | Active Comparator |
| |
| Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alogliptin and pioglitazone | Drug | Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events. | Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. | 52 Weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Professor, Department of Medicine | Department of Medicine, Kawasaki Medical School | Study Director |
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Participants who had completed the core phase 2/3 thiazolidine add on study (SYR-322/CCT-004; NCT01318070) were enrolled in one of 2, once-daily (QD) treatment groups.
Participants enrolled at 32 investigative sites in Japan from 10 May 2008 to 03 August 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | CCT/004 - 12.5 mg Dose Group* → 12.5 mg Combination Group | Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks. *for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study. |
| FG001 | CCT/004 - 25 mg Dose Group* → 25 mg Combination Dose Group | Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks. *for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study. |
| FG002 | Pioglitazone Monotherapy Group* → 12.5 mg Combination Group | Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks. *for participants from the pioglitazone 15 mg or 30 mg dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study. |
| FG003 | Pioglitazone Monotherapy Group* → 25 mg Combination Group | Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks. *for participants from the pioglitazone 15 mg or 30 mg dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrolled - Long-Term Extension Study |
|
| ||||||||||||||||||
| Entered - Long-Term Extension Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD | Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks. |
| BG001 | Alogliptin 25 mg QD and Pioglitazone 15 or 30 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 | Number of Participants With Adverse Events. | Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. | Full Analysis Set was defined as the population of participants randomized in the core phase 2/3 thiazolidine add on study (SYR-322/CCT-004 study; NCT01318070) and received at least 1 dose of the investigational products (SYR-322DB in combination with pioglitazone) for the treatment period. | Posted | Number | participants | 52 Weeks. |
|
Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through receiving the last dose of 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. 5 participants from alogliptin 12.5 & 25 mg group CCT-004 study did not enter this study.
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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 | Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD | Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epiglottitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
331 participants were randomized in the core phase 2/3 thiazolidine (CCT-004) study and included in the Full Analysis Set in this study. 5 participants from CCT-004 study did not enter this study.
| 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 |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
| Alogliptin and pioglitazone | Drug | Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks. |
|
|
| 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 and glycosylated hemoglobin collected at baseline. |
| Baseline and Week 12. |
| Change From Baseline in Glycosylated Hemoglobin (Week 16). | 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 16 and glycosylated hemoglobin collected at baseline. | Baseline and Week 16. |
| Change From Baseline in Glycosylated Hemoglobin (Week 20). | 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 20 and glycosylated hemoglobin collected at baseline. | Baseline and Week 20. |
| Change From Baseline in Glycosylated Hemoglobin (Week 24). | 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 24 and glycosylated hemoglobin collected at baseline. | Baseline and Week 24. |
| Change From Baseline in Glycosylated Hemoglobin (Week 28). | 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 28 and glycosylated hemoglobin collected at baseline. | Baseline and Week 28. |
| Change From Baseline in Glycosylated Hemoglobin (Week 32). | 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 32 and glycosylated hemoglobin collected at baseline. | Baseline and Week 32. |
| Change From Baseline in Glycosylated Hemoglobin (Week 36). | 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 36 and glycosylated hemoglobin collected at baseline. | Baseline and Week 36. |
| Change From Baseline in Glycosylated Hemoglobin (Week 40). | 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 40 and glycosylated hemoglobin collected at baseline. | Baseline and Week 40. |
| Change From Baseline in Glycosylated Hemoglobin (Week 44). | 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 44 and glycosylated hemoglobin collected at baseline. | Baseline and Week 44. |
| Change From Baseline in Glycosylated Hemoglobin (Week 48). | 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 48 and glycosylated hemoglobin collected at baseline. | Baseline and Week 48. |
| Change From Baseline in Glycosylated Hemoglobin (Week 52). | 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 52 and glycosylated hemoglobin collected at baseline. | Baseline and Week 52. |
| Change From Baseline in Glycosylated Hemoglobin (Final Visit). | 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 52 or final visit and glycosylated hemoglobin collected at baseline. | Baseline and Final Visit (up to Week 52). |
| Change From Baseline in Fasting Blood Glucose (Week 8). | The change between the value of fasting blood glucose collected at week 8 and baseline. | Baseline and Week 8. |
| Change From Baseline in Fasting Blood Glucose (Week 12). | The change between the value of fasting blood glucose collected at week 12 and baseline. | Baseline and Week 12. |
| Change From Baseline in Fasting Blood Glucose (Week 16). | The change between the value of fasting blood glucose collected at week 6 and baseline. | Baseline and Week 16. |
| Change From Baseline in Fasting Blood Glucose (Week 20). | The change between the value of fasting blood glucose collected at week 20 and baseline. | Baseline and Week 20. |
| Change From Baseline in Fasting Blood Glucose (Week 24). | The change between the value of fasting blood glucose collected at week 24 and baseline. | Baseline and Week 24. |
| Change From Baseline in Fasting Blood Glucose (Week 28). | The change between the value of fasting blood glucose collected at week 28 and baseline. | Baseline and Week 28. |
| Change From Baseline in Fasting Blood Glucose (Week 32). | The change between the value of fasting blood glucose collected at week 32 and baseline. | Baseline and Week 32. |
| Change From Baseline in Fasting Blood Glucose (Week 36). | The change between the value of fasting blood glucose collected at week 36 and baseline. | Baseline and Week 36. |
| Change From Baseline in Fasting Blood Glucose (Week 40). | The change between the value of fasting blood glucose collected at week 40 and baseline. | Baseline and Week 40. |
| Change From Baseline in Fasting Blood Glucose (Week 44). | The change between the value of fasting blood glucose collected at week 44 and baseline. | Baseline and Week 44. |
| Change From Baseline in Fasting Blood Glucose (Week 48). | The change between the value of fasting blood glucose collected at week 48 and baseline. | Baseline and Week 48. |
| Change From Baseline in Fasting Blood Glucose (Week 52). | The change between the value of fasting blood glucose collected at week 52 and baseline. | Baseline and Week 52. |
| Change From Baseline in Fasting Blood Glucose (Final Visit). | The change between the value of fasting blood glucose collected at week 52 or final visit and baseline. | Baseline and Final Visit (up to Week 52). |
| Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12). | The change between the value of blood glucose measured by the meal tolerance test collected at week 12 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose 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 the Meal Tolerance Test (Week 24). | The change between the value of blood glucose measured by the meal tolerance test collected at week 24 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal. | Baseline and Week 24. |
| Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52). | The change between the value of blood glucose measured by the meal tolerance test collected at week 52 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal. | Baseline and Week 52. |
| Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit). | The change between the value of blood glucose measured by the meal tolerance test collected at week 52 or end of study and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal. | Baseline and Final Visit (up to Week 52). |
| Other |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD | Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks. |
|
|
| 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. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 8. |
|
|
|
| Secondary | 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 and glycosylated hemoglobin collected at baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 12. |
|
|
|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 16). | 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 16 and glycosylated hemoglobin collected at baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 16. |
|
|
|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 20). | 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 20 and glycosylated hemoglobin collected at baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 20. |
|
|
|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 24). | 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 24 and glycosylated hemoglobin collected at baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 24. |
|
|
|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 28). | 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 28 and glycosylated hemoglobin collected at baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 28. |
|
|
|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 32). | 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 32 and glycosylated hemoglobin collected at baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 32. |
|
|
|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 36). | 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 36 and glycosylated hemoglobin collected at baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 36. |
|
|
|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 40). | 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 40 and glycosylated hemoglobin collected at baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 40. |
|
|
|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 44). | 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 44 and glycosylated hemoglobin collected at baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 44. |
|
|
|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 48). | 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 48 and glycosylated hemoglobin collected at baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 48. |
|
|
|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 52). | 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 52 and glycosylated hemoglobin collected at baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 52. |
|
|
|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Final Visit). | 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 52 or final visit and glycosylated hemoglobin collected at baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Final Visit (up to Week 52). |
|
|
|
| Secondary | Change From Baseline in Fasting Blood Glucose (Week 8). | The change between the value of fasting blood glucose collected at week 8 and baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 8. |
|
|
|
| Secondary | Change From Baseline in Fasting Blood Glucose (Week 12). | The change between the value of fasting blood glucose collected at week 12 and baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 12. |
|
|
|
| Secondary | Change From Baseline in Fasting Blood Glucose (Week 16). | The change between the value of fasting blood glucose collected at week 6 and baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 16. |
|
|
|
| Secondary | Change From Baseline in Fasting Blood Glucose (Week 20). | The change between the value of fasting blood glucose collected at week 20 and baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 20. |
|
|
|
| Secondary | Change From Baseline in Fasting Blood Glucose (Week 24). | The change between the value of fasting blood glucose collected at week 24 and baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 24. |
|
|
|
| Secondary | Change From Baseline in Fasting Blood Glucose (Week 28). | The change between the value of fasting blood glucose collected at week 28 and baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 28. |
|
|
|
| Secondary | Change From Baseline in Fasting Blood Glucose (Week 32). | The change between the value of fasting blood glucose collected at week 32 and baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 32. |
|
|
|
| Secondary | Change From Baseline in Fasting Blood Glucose (Week 36). | The change between the value of fasting blood glucose collected at week 36 and baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 36. |
|
|
|
| Secondary | Change From Baseline in Fasting Blood Glucose (Week 40). | The change between the value of fasting blood glucose collected at week 40 and baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 40. |
|
|
|
| Secondary | Change From Baseline in Fasting Blood Glucose (Week 44). | The change between the value of fasting blood glucose collected at week 44 and baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 44. |
|
|
|
| Secondary | Change From Baseline in Fasting Blood Glucose (Week 48). | The change between the value of fasting blood glucose collected at week 48 and baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 48. |
|
|
|
| Secondary | Change From Baseline in Fasting Blood Glucose (Week 52). | The change between the value of fasting blood glucose collected at week 52 and baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 52. |
|
|
|
| Secondary | Change From Baseline in Fasting Blood Glucose (Final Visit). | The change between the value of fasting blood glucose collected at week 52 or final visit and baseline. | Values are from the Full Analysis Set. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Final Visit (up to Week 52). |
|
|
|
| Secondary | Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12). | The change between the value of blood glucose measured by the meal tolerance test collected at week 12 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose 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 the Meal Tolerance Test (Week 24). | The change between the value of blood glucose measured by the meal tolerance test collected at week 24 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose 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 24. |
|
|
|
| Secondary | Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52). | The change between the value of blood glucose measured by the meal tolerance test collected at week 52 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose 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 52. |
|
|
|
| Secondary | Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit). | The change between the value of blood glucose measured by the meal tolerance test collected at week 52 or end of study and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose 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 Final Visit (up to Week 52). |
|
|
|
| 14 |
| 166 |
| 143 |
| 166 |
| EG001 | Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD | Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks. *for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study. | 11 | 165 | 146 | 165 |
| Nasopharyngitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
|
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (11.1) | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA (11.1) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (11.1) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Enterocele | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA (11.1) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
|
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA (11.1) | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Brain natriuretic peptide increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (11.1) | 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.
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |