A Phase 2/3 interventional study of Alogliptin and glimepiride and Alogliptin and glimepiride in Type 2 Diabetes Mellitus, sponsored by Takeda. Completed. Open to participants aged 20 Years to 64 Years. Per ClinicalTrials.gov, last updated 2012-08-16.
Sponsored by Takeda · Phase 2/3, Interventional, and Treatment
To evaluate the efficacy and safety of alogliptin administered as an add-on to sulfonylurea (glimepiride) or metformin, once daily (QD), twice daily (BID) or three times daily (TID).
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.
This was a phase 2/3, multicenter, open-label study, in participants who had completed the core phase 2/3 sulfonylurea add-on study (SYR-322/CCT-005; NCT01318083) or the core phase 2/3 metformin add-on study (SYR-322/CCT-006; NCT01318109) to evaluate the safety and efficacy of alogliptin administered as an add-on to a sulfonylurea (glimepiride) or metformin continuously for 40 weeks (52 weeks from the start of study treatment with alogliptin in the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 576 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:
Exclusion Criteria:
Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:
Criteria that applied only to participants completing the core phase 2/3 metformin add-on study:
Drug: Alogliptin and glimepiride
Drug: Alogliptin and glimepiride
Drug: Alogliptin and metformin
Drug: Alogliptin and metformin
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
Also known as: SYR-322, Amaryl
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
Also known as: SYR-322, Amaryl
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Also known as: SYR-322, Glycoran
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Also known as: SYR-322, Glycoran
Number of Participants With Adverse Events.
Treatment-emergent adverse events (TEAE) are defined as 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 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment 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.
Time frame: 52 Weeks.
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.
Time frame: Baseline and Week 8.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 final visit and glycosylated hemoglobin collected at baseline.
Time frame: Baseline and Final Visit (up to 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 52.
Change From Baseline in Fasting Blood Glucose (Final Visit).
The change between the value of fasting blood glucose collected at final visit and baseline.
Time frame: 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.
Time frame: 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.
Time frame: 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 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.
Time frame: 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 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.
Time frame: Baseline and Final Visit (up to Week 52).
Participants enrolled at 58 investigative sites in Japan from 06 January 2009 to 23 January 2010.
| Milestone | CCT/005 - 12.5 mg Dose Group* → 12.5 mg Combination Group | CCT/005 - 25 mg Dose Group* → 25 mg Combination Dose Group | Glimepiride Monotherapy Group* → 12.5 mg Combination Group | Glimepiride Monotherapy Group* → 25 mg Combination Group | CCT/006 - 12.5 mg Dose Group* → 12.5 mg Combination Group | CCT/006 - 25 mg Dose Group* → 25 mg Combination Group | Metformin Monotherapy Group* → 12.5 mg Combination Group | Metformin Monotherapy Group* → 25 mg Combination Group |
|---|---|---|---|---|---|---|---|---|
| Started | 99 | 102 | 46 | 49 | 91 | 90 | 50 | 49 |
| Completed | 97 | 102 | 46 | 49 | 91 | 90 | 50 | 49 |
| Not completed | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Treatment complications | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | CCT/005 - 12.5 mg Dose Group* → 12.5 mg Combination Group | CCT/005 - 25 mg Dose Group* → 25 mg Combination Dose Group | Glimepiride Monotherapy Group* → 12.5 mg Combination Group | Glimepiride Monotherapy Group* → 25 mg Combination Group | CCT/006 - 12.5 mg Dose Group* → 12.5 mg Combination Group | CCT/006 - 25 mg Dose Group* → 25 mg Combination Group | Metformin Monotherapy Group* → 12.5 mg Combination Group | Metformin Monotherapy Group* → 25 mg Combination Group |
|---|---|---|---|---|---|---|---|---|
| Started | 97 | 102 | 46 | 49 | 90 | 87 | 50 | 49 |
| Completed | 80 | 89 | 38 | 42 | 81 | 83 | 49 | 46 |
| Not completed | 17 | 13 | 8 | 7 | 9 | 4 | 1 | 3 |
| Withdrew: Adverse event | 9 | 3 | 4 | 3 | 4 | 2 | 0 | 0 |
| Withdrew: Protocol violation | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 2 | 2 | 1 | 2 | 0 | 0 | 1 |
| Withdrew: Lack of efficacy | 5 | 7 | 2 | 3 | 2 | 2 | 1 | 1 |
| Withdrew: Use of excluded medications | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Treatment-emergent adverse events (TEAE) are defined as 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 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment 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.
| participants | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Serious Adverse Event | 16 | 3 | 7 | 5 |
| Other Adverse Event (≥3% Frequency Threshold) | 116 | 134 | 108 | 113 |
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.
| percentage of Glycosylated Hemoglobin | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (Week 8). | -0.53 ± 0.506 | -0.65 ± 0.515 | -0.53 ± 0.486 | -0.59 ± 0.394 |
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.
| percentage of Glycosylated Hemoglobin | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (Week 12). | -0.63 ± 0.626 | -0.72 ± 0.589 | -0.61 ± 0.576 | -0.71 ± 0.489 |
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.
| percentage of Glycosylated Hemoglobin | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (Week 16). | -0.66 ± 0.685 | -0.76 ± 0.660 | -0.69 ± 0.614 | -0.78 ± 0.495 |
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.
| percentage of Glycosylated Hemoglobin | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (Week 20). | -0.63 ± 0.754 | -0.70 ± 0.689 | -0.67 ± 0.648 | -0.78 ± 0.553 |
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.
| percentage of Glycosylated Hemoglobin | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (Week 24). | -0.59 ± 0.823 | -0.70 ± 0.740 | -0.68 ± 0.668 | -0.78 ± 0.623 |
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.
| percentage of Glycosylated Hemoglobin | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (Week 28). | -0.62 ± 0.841 | -0.76 ± 0.721 | -0.70 ± 0.659 | -0.84 ± 0.596 |
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.
| percentage of Glycosylated Hemoglobin | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (Week 32). | -0.63 ± 0.868 | -0.77 ± 0.736 | -0.67 ± 0.644 | -0.81 ± 0.634 |
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.
| percentage of Glycosylated Hemoglobin | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (Week 36). | -0.64 ± 0.881 | -0.77 ± 0.745 | -0.67 ± 0.659 | -0.79 ± 0.653 |
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.
| percentage of Glycosylated Hemoglobin | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (Week 40). | -0.66 ± 0.799 | -0.74 ± 0.779 | -0.63 ± 0.676 | -0.74 ± 0.698 |
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.
| percentage of Glycosylated Hemoglobin | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (Week 44). | -0.48 ± 0.726 | -0.71 ± 0.666 | -0.47 ± 0.787 | -0.70 ± 0.688 |
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.
| percentage of Glycosylated Hemoglobin | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (Week 48). | -0.40 ± 0.706 | -0.61 ± 0.660 | -0.36 ± 0.762 | -0.62 ± 0.707 |
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.
| percentage of Glycosylated Hemoglobin | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (Week 52). | -0.33 ± 0.652 | -0.53 ± 0.643 | -0.29 ± 0.744 | -0.53 ± 0.790 |
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 final visit and glycosylated hemoglobin collected at baseline.
| percentage of Glycosylated Hemoglobin | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (Final Visit). | -0.42 ± 0.838 | -0.58 ± 0.791 | -0.44 ± 0.720 | -0.58 ± 0.781 |
The change between the value of fasting blood glucose collected at week 8 and baseline.
| mg/dL | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Fasting Blood Glucose (Week 8). | -20.7 ± 26.50 | -19.6 ± 30.53 | -22.0 ± 22.76 | -23.4 ± 26.75 |
The change between the value of fasting blood glucose collected at week 12 and baseline.
| mg/dL | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Fasting Blood Glucose (Week 12). | -22.0 ± 32.19 | -18.1 ± 29.05 | -22.9 ± 24.04 | -24.2 ± 27.30 |
The change between the value of fasting blood glucose collected at week 6 and baseline.
| mg/dL | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Fasting Blood Glucose (Week 16). | -22.3 ± 34.37 | -17.8 ± 32.22 | -21.8 ± 26.86 | -26.1 ± 26.93 |
The change between the value of fasting blood glucose collected at week 20 and baseline.
| mg/dL | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Fasting Blood Glucose (Week 20). | -22.4 ± 31.75 | -22.3 ± 30.93 | -23.4 ± 27.88 | -26.1 ± 26.19 |
The change between the value of fasting blood glucose collected at week 24 and baseline.
| mg/dL | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Fasting Blood Glucose (Week 24). | -24.0 ± 31.69 | -25.0 ± 32.68 | -25.6 ± 24.22 | -26.3 ± 28.09 |
The change between the value of fasting blood glucose collected at week 28 and baseline.
| mg/dL | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Fasting Blood Glucose (Week 28). | -19.9 ± 36.87 | -25.9 ± 33.67 | -25.8 ± 26.16 | -28.2 ± 29.49 |
The change between the value of fasting blood glucose collected at week 32 and baseline.
| mg/dL | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Fasting Blood Glucose (Week 32). | -22.4 ± 37.47 | -26.1 ± 30.69 | -23.2 ± 25.71 | -28.2 ± 29.31 |
The change between the value of fasting blood glucose collected at week 36 and baseline.
| mg/dL | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Fasting Blood Glucose (Week 36). | -25.5 ± 34.16 | -26.7 ± 33.12 | -23.4 ± 24.00 | -26.0 ± 31.26 |
The change between the value of fasting blood glucose collected at week 40 and baseline.
| mg/dL | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Fasting Blood Glucose (Week 40). | -21.3 ± 33.44 | -22.7 ± 30.19 | -19.8 ± 24.81 | -23.2 ± 31.13 |
The change between the value of fasting blood glucose collected at week 44 and baseline.
| mg/dL | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Fasting Blood Glucose (Week 44). | -15.4 ± 31.69 | -21.9 ± 29.33 | -16.3 ± 26.22 | -24.0 ± 31.49 |
The change between the value of fasting blood glucose collected at week 48 and baseline.
| mg/dL | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Fasting Blood Glucose (Week 48). | -13.6 ± 28.29 | -16.6 ± 30.68 | -14.3 ± 24.22 | -23.3 ± 29.73 |
The change between the value of fasting blood glucose collected at week 52 and baseline.
| mg/dL | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Fasting Blood Glucose (Week 52). | -13.3 ± 31.74 | -11.9 ± 30.11 | -14.0 ± 26.92 | -16.1 ± 29.60 |
The change between the value of fasting blood glucose collected at final visit and baseline.
| mg/dL | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Fasting Blood Glucose (Final Visit). | -16.0 ± 33.73 | -13.0 ± 34.68 | -16.4 ± 25.81 | -17.7 ± 29.54 |
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.
| mg/dL | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12). | 80.2 ± 43.24 | 80.1 ± 47.77 | 61.6 ± 38.72 | 64.0 ± 34.39 |
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.
| mg/dL | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24). | 87.4 ± 38.74 | 77.9 ± 42.68 | 60.7 ± 34.96 | 62.4 ± 32.23 |
The change between the value of blood glucose measured by the meal tolerance test collected at week 52 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.
| mg/dL | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52). | 83.8 ± 46.24 | 83.2 ± 43.61 | 62.5 ± 42.91 | 62.7 ± 32.81 |
The change between the value of blood glucose measured by the meal tolerance test collected at 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.
| mg/dL | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit). | 84.8 ± 45.47 | 84.9 ± 44.35 | 63.5 ± 43.06 | 63.7 ± 32.32 |
Collected over 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 30 days after receiving the last dose of study drug.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | — | 16/150 (10.7%) | 116/150 (77.3%) |
| Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | — | 3/152 (2%) | 134/152 (88.2%) |
| Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | — | 7/142 (4.9%) | 108/142 (76.1%) |
| Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID | — | 5/145 (3.4%) | 113/145 (77.9%) |
| Event | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| Acute myocardial infarctionCardiac disorders | 1/150 | 0/152 | 2/142 | 0/145 |
| Gastric cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/150 | 0/152 | 0/142 | 0/145 |
| Road traffic accidentInjury, poisoning and procedural complications | 2/150 | 1/152 | 1/142 | 0/145 |
| Enteritis infectiousInfections and infestations | 0/150 | 0/152 | 1/142 | 0/145 |
| FallInjury, poisoning and procedural complications | 1/150 | 0/152 | 1/142 | 0/145 |
| Pancreatic carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/150 | 0/1 | 1/142 | 0/145 |
| Pneumonia legionellaInfections and infestations | 0/150 | 0/152 | 1/142 | 0/145 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/150 | — | 0/142 | 1/145 |
| Cardiac failureCardiac disorders | 0/150 | 0/152 | 0/142 | 1/145 |
| Cerebral circulatory failureNervous system disorders | 0/150 | 0/152 | 0/142 | 1/145 |
| Event | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID |
|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 46/150 | 57/152 | 44/142 | 53/145 |
| Upper respiratory tract inflammationRespiratory, thoracic and mediastinal disorders | 10/150 | 16/152 | 6/142 | 6/145 |
| FallInjury, poisoning and procedural complications | 7/150 | 12/152 | 0/142 | 0/145 |
| Back painMusculoskeletal and connective tissue disorders | 8/150 | 11/152 | 9/142 | 6/145 |
| Diabetic retinopathyEye disorders | 4/150 | 8/152 | 6/142 | 10/145 |
| HeadacheNervous system disorders | 0/150 | 0/152 | 9/142 | 3/145 |
| ConstipationGastrointestinal disorders | 7/150 | 7/152 | 7/142 | 8/145 |
| GastritisGastrointestinal disorders | 4/150 | 8/152 | 0/142 | 0/145 |
| HypoglycaemiaMetabolism and nutrition disorders | 4/150 | 8/152 | 0/142 | 0/145 |
| EczemaSkin and subcutaneous tissue disorders | 0/150 | 0/152 | 7/142 | 6/145 |
| Age, Customized(participants) | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID | Total |
|---|---|---|---|---|---|
| ≤ 64 years | 93 ± 9.50 | 105 ± 8.92 | 142 ± 8.12 | 145 ± 8.41 | 485 |
| ≥ 65 years | 57 | 47 | 0 | 0 | 104 |
| Sex: Female, Male(Participants) | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID | Total |
|---|---|---|---|---|---|
| Female | 53 | 52 | 46 | 44 | 195 |
| Male | 97 | 100 | 96 | 101 | 394 |
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