Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus - Type 2, Diabetes Mellitus, Drug Therapy
Brief summary
The purpose of this study was to evaluate the long-term safety and efficacy of SYR-322, once daily (QD), to an α-glucosidase inhibitor, three times daily (TID), administered for 40 consecutive weeks in participants who completed a phase 2 dose-ranging study.
Detailed description
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, this extension study was administered for 40 consecutive weeks (52 weeks from the start of treatment in the phase 2 dose-ranging study) to participants who had completed the phase 2 dose-ranging study SYR-322/CCT-001 (NCT01263470).
Interventions
DRUGVoglibose
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
DRUGAlogliptin
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
29 Years to 87 Years
Healthy volunteers
No
Inclusion criteria
* Had completed the phase 2 dose-ranging study (i.e., the subject had completed the study visit at Week 12).
Exclusion criteria
* Had clinical manifestations of hepatic impairment (e.g., an aspartate aminotransferase or alanine aminotransferase value 2.5 times or more of the upper reference limit at Week 8 of treatment in the phase 2 dose-ranging study). * Had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of treatment in the phase 2 dose-ranging study).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events. | 52 Weeks. | A treatment-emergent adverse event (TEAE) is defined as an adverse event 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, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date \>30) will be listed, but not included in the summary tables below. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (Week 16). | Baseline and 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. |
| Change From Baseline in Glycosylated Hemoglobin (Week 20). | Baseline and 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. |
| Change From Baseline in Glycosylated Hemoglobin (Week 24). | Baseline and 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. |
| Change From Baseline in Glycosylated Hemoglobin (Week 28). | Baseline and 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. |
| Change From Baseline in Glycosylated Hemoglobin (Week 32). | Baseline and 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. |
| Change From Baseline in Glycosylated Hemoglobin (Week 36). | Baseline and 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. |
| Change From Baseline in Glycosylated Hemoglobin (Week 40). | Baseline and 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. |
| Change From Baseline in Glycosylated Hemoglobin (Week 44). | Baseline and 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. |
| Change From Baseline in Glycosylated Hemoglobin (Week 48). | Baseline and 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. |
| Change From Baseline in Glycosylated Hemoglobin (Week 52). | Baseline and 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. |
| Change From Baseline in Glycosylated Hemoglobin (Final Visit). | Baseline and Final Visit (up to 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 or final visit and glycosylated hemoglobin collected at baseline. |
| Change From Baseline in Fasting Plasma Glucose (Week 12). | Baseline and Week 12 | The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline. |
| Change From Baseline in Fasting Plasma Glucose (Week 16). | Baseline and Week 16. | The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline. |
| Change From Baseline in Fasting Plasma Glucose (Week 20). | Baseline and Week 20. | The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline. |
| Change From Baseline in Fasting Plasma Glucose (Week 24). | Baseline and Week 24. | The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline. |
| Change From Baseline in Fasting Plasma Glucose (Week 28). | Baseline and Week 28. | The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline. |
| Change From Baseline in Fasting Plasma Glucose (Week 32). | Baseline and Week 32. | The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline. |
| Change From Baseline in Fasting Plasma Glucose (Week 36). | Baseline and Week 36. | The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline. |
| Change From Baseline in Fasting Plasma Glucose (Week 40). | Baseline and Week 40. | The change between the value of fasting plasma glucose collected at week 40 and fasting plasma glucose collected at baseline. |
| Change From Baseline in Fasting Plasma Glucose (Week 44). | Baseline and Week 44. | The change between the value of fasting plasma glucose collected at week 44 and fasting plasma glucose collected at baseline. |
| Change From Baseline in Fasting Plasma Glucose (Week 48). | Baseline and Week 48. | The change between the value of fasting plasma glucose collected at week 48 and fasting plasma glucose collected at baseline. |
| Change From Baseline in Fasting Plasma Glucose (Week 52). | Baseline and Week 52. | The change between the value of fasting plasma glucose collected at week 52 and fasting plasma glucose collected at baseline. |
| Change From Baseline in Fasting Plasma Glucose (Final Visit). | Baseline and Final Visit (up to Week 52). | The change between the value of fasting plasma glucose collected at week 52 or final visit and fasting plasma glucose collected at baseline. |
| Change From Baseline in Fasting C-peptide (Week 12). | Baseline and Week 12. | The change between the value of fasting C-peptide collected at week 12 and fasting C-peptide collected at baseline. |
| Change From Baseline in Fasting C-peptide (Week 16). | Baseline and Week 16. | The change between the value of fasting C-peptide collected at week 16 and fasting C-peptide collected at baseline. |
| Change From Baseline in Fasting C-peptide (Week 20). | Baseline and Week 20. | The change between the value of fasting C-peptide collected at week 20 and fasting C-peptide collected at baseline. |
| Change From Baseline in Fasting C-peptide (Week 24). | Baseline and Week 24. | The change between the value of fasting C-peptide collected at week 24 and fasting C-peptide collected at baseline. |
| Change From Baseline in Fasting C-peptide (Week 28). | Baseline and Week 28. | The change between the value of fasting C-peptide collected at week 28 and fasting C-peptide collected at baseline. |
| Change From Baseline in Fasting C-peptide (Week 32). | Baseline and Week 32. | The change between the value of fasting C-peptide collected at week 32 and fasting C-peptide collected at baseline. |
| Change From Baseline in Fasting C-peptide (Week 36). | Baseline and Week 36. | The change between the value of fasting C-peptide collected at week 36 and fasting C-peptide collected at baseline. |
| Change From Baseline in Fasting C-peptide (Week 40). | Baseline and Week 40. | The change between the value of fasting C-peptide collected at week 40 and fasting C-peptide collected at baseline. |
| Change From Baseline in Fasting C-peptide (Week 44). | Baseline and Week 44. | The change between the value of fasting C-peptide collected at week 44 and fasting C-peptide collected at baseline. |
| Change From Baseline in Fasting C-peptide (Week 48). | Baseline and Week 48. | The change between the value of fasting C-peptide collected at week 48 and fasting C-peptide collected at baseline. |
| Change From Baseline in Fasting C-peptide (Week 52). | Baseline and Week 52. | The change between the value of fasting C-peptide collected at week 52 and fasting C-peptide collected at baseline. |
| Change From Baseline in Fasting C-peptide (Final Visit). | Baseline and Final Visit (up to Week 52). | The change between the value of fasting C-peptide collected at week 52 or final visit and fasting C-peptide collected at baseline. |
| Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12). | Baseline and Week 12. | The change between the value of blood glucose collected at week 12 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 2 hours after the start of the meal. |
| Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24). | Baseline and Week 24. | The change between the value of blood glucose collected at week 24 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 2 hours after the start of the meal. |
| Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52). | Baseline and Week 52. | The change between the value of blood glucose collected at week 52 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 2 hours after the start of the meal. |
| Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit). | Baseline and Final Visit (up to Week 52). | The change between the value of blood glucose collected at week 52 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 2 hours after the start of the meal. |
| Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12). | Baseline and Week 12. | The change between the value of blood glucose collected at week 12 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 2 hours after the start of the meal. |
| Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24). | Baseline and Week 24. | The change between the value of blood glucose collected at week 24 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 2 hours after the start of the meal. |
| Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52). | Baseline and Week 52. | The change between the value of blood glucose collected at week 52 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 2 hours after the start of the meal. |
| Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit). | Baseline and Final Visit (up to Week 52). | The change between the value of blood glucose collected at week 52 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 2 hours after the start of the meal. |
| Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12). | Baseline and Week 12. | The change between the value of C-peptide collected at week 12 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. |
| Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24). | Baseline and Week 24. | The change between the value of C-peptide collected at week 24 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. |
| Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52). | Baseline and Week 52. | The change between the value of C-peptide collected at week 52 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. |
| Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit). | Baseline and Final Visit (up to Week 52). | The change between the value of C-peptide collected at week 52 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. |
| Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12). | Baseline and Week 12 | The change between the value of insulin collected at week 12 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. |
| Change From Baseline in Glycosylated Hemoglobin (Week 12). | Baseline and 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. |
| Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52). | Baseline and Week 52. | The change between the value of insulin collected at week 52 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. |
| Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit). | Baseline and Final Visit (up to Week 52). | The change between the value of insulin collected at week 52 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. |
| Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12). | Baseline and Week 12 | The change between the value of glucagons collected at week 12 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. |
| Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24). | Baseline and Week 24. | The change between the value of glucagons collected at week 24 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. |
| Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52). | Baseline and Week 52. | The change between the value of glucagons collected at week 52 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. |
| Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit). | Baseline and Final Visit (up to Week 52). | The change between the value of glucagons collected at week 52 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. |
| Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24). | Baseline and Week 24. | The change between the value of insulin collected at week 24 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. |
Participant flow
Recruitment details
Participants enrolled at 53 investigative sites in Japan from 10 May 2007 to 27 September 2008.
Pre-assignment details
Participants with a historical diagnosis of type 2 diabetes mellitus with uncontrolled blood glucose despite diet and exercise therapies were enrolled in one of 5, once-daily (QD) or three-times daily (TID) treatment groups. Analyses were performed by treatment dose group or by treatment dose in this study.
Participants by arm
| Arm | Count |
|---|---|
| Alogliptin 6.25 mg QD Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. | 96 |
| Alogliptin 12.5 mg QD Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. | 101 |
| Alogliptin 25 mg QD Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. | 97 |
| Alogliptin 50 mg QD Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. | 97 |
| Voglibose 0.2 mg TID Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. | 83 |
| Total | 474 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Enrolled - Long-Term Extension Study | Adverse Event | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 |
| Enrolled - Long-Term Extension Study | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Entered - Long-Term Extension Study | Adverse Event | 0 | 5 | 6 | 3 | 1 | 0 | 0 | 0 | 1 |
| Entered - Long-Term Extension Study | Lack of Efficacy | 8 | 4 | 4 | 1 | 5 | 0 | 0 | 0 | 1 |
| Entered - Long-Term Extension Study | Lost to Follow-up | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Entered - Long-Term Extension Study | Participant Unavailability | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Entered - Long-Term Extension Study | Withdrawal by Subject | 1 | 2 | 0 | 2 | 4 | 1 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Alogliptin 6.25 mg QD | Alogliptin 12.5 mg QD | Alogliptin 25 mg QD | Alogliptin 50 mg QD | Voglibose 0.2 mg TID | Total |
|---|---|---|---|---|---|---|
| Age, Customized ≤ 64 years | 69 participants | 67 participants | 64 participants | 65 participants | 51 participants | 316 participants |
| Age, Customized ≥ 65 years | 27 participants | 34 participants | 33 participants | 32 participants | 32 participants | 158 participants |
| Sex: Female, Male Female | 26 Participants | 29 Participants | 22 Participants | 29 Participants | 27 Participants | 133 Participants |
| Sex: Female, Male Male | 70 Participants | 72 Participants | 75 Participants | 68 Participants | 56 Participants | 341 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 78 / 96 | 81 / 101 | 81 / 97 | 88 / 97 | 74 / 83 |
| serious Total, serious adverse events | 2 / 96 | 8 / 101 | 8 / 97 | 5 / 97 | 4 / 83 |
Outcome results
Primary
Number of Participants With Adverse Events.
A treatment-emergent adverse event (TEAE) is defined as an adverse event 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, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date \>30) will be listed, but not included in the summary tables below.
Time frame: 52 Weeks.
Population: Adverse Event Profile in the Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Number of Participants With Adverse Events. | Serious Adverse Event | 1 participants |
| Alogliptin 6.25 mg QD | Number of Participants With Adverse Events. | Other Adverse Events (Incidence ≥3%) | 78 participants |
| Alogliptin 6.25 mg QD | Number of Participants With Adverse Events. | Serious Adverse Event Related to Study Drug | 1 participants |
| Alogliptin 12.5 mg QD | Number of Participants With Adverse Events. | Serious Adverse Event Related to Study Drug | 2 participants |
| Alogliptin 12.5 mg QD | Number of Participants With Adverse Events. | Serious Adverse Event | 5 participants |
| Alogliptin 12.5 mg QD | Number of Participants With Adverse Events. | Other Adverse Events (Incidence ≥3%) | 81 participants |
| Alogliptin 25 mg QD | Number of Participants With Adverse Events. | Serious Adverse Event Related to Study Drug | 2 participants |
| Alogliptin 25 mg QD | Number of Participants With Adverse Events. | Serious Adverse Event | 8 participants |
| Alogliptin 25 mg QD | Number of Participants With Adverse Events. | Other Adverse Events (Incidence ≥3%) | 81 participants |
| Alogliptin 50 mg QD | Number of Participants With Adverse Events. | Serious Adverse Event | 5 participants |
| Alogliptin 50 mg QD | Number of Participants With Adverse Events. | Other Adverse Events (Incidence ≥3%) | 88 participants |
| Alogliptin 50 mg QD | Number of Participants With Adverse Events. | Serious Adverse Event Related to Study Drug | 2 participants |
| Voglibose 0.2 mg TID | Number of Participants With Adverse Events. | Serious Adverse Event Related to Study Drug | 0 participants |
| Voglibose 0.2 mg TID | Number of Participants With Adverse Events. | Serious Adverse Event | 4 participants |
| Voglibose 0.2 mg TID | Number of Participants With Adverse Events. | Other Adverse Events (Incidence ≥3%) | 74 participants |
Secondary
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit).
The change between the value of blood glucose collected at week 52 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 2 hours after the start of the meal.
Time frame: Baseline and Final Visit (up to Week 52).
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit). | 65.0 mg/dL | Standard Deviation 37.48 |
| Alogliptin 12.5 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit). | 63.8 mg/dL | Standard Deviation 32.46 |
| Alogliptin 25 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit). | 60.4 mg/dL | Standard Deviation 35.09 |
| Alogliptin 50 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit). | 52.6 mg/dL | Standard Deviation 37.07 |
| Voglibose 0.2 mg TID | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit). | 52.6 mg/dL | Standard Deviation 32.38 |
95% CI: [-11.44, 9.84]
95% CI: [-11.74, 7.66]
95% CI: [-15.62, 4.75]
95% CI: [-23.83, -2.74]
Secondary
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12).
The change between the value of blood glucose collected at week 12 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 2 hours after the start of the meal.
Time frame: Baseline and Week 12.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12). | 62.9 mg/dL | Standard Deviation 33.75 |
| Alogliptin 12.5 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12). | 61.8 mg/dL | Standard Deviation 31.41 |
| Alogliptin 25 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12). | 56.4 mg/dL | Standard Deviation 36.7 |
| Alogliptin 50 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12). | 55.8 mg/dL | Standard Deviation 30.83 |
| Voglibose 0.2 mg TID | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12). | 64.8 mg/dL | Standard Deviation 31.62 |
95% CI: [-11.82, 7.99]
95% CI: [-12.45, 6.4]
95% CI: [-18.77, 1.96]
95% CI: [-18.35, 0.44]
Secondary
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24).
The change between the value of blood glucose collected at week 24 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 2 hours after the start of the meal.
Time frame: Baseline and Week 24.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24). | 64.3 mg/dL | Standard Deviation 37.8 |
| Alogliptin 12.5 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24). | 55.5 mg/dL | Standard Deviation 30.63 |
| Alogliptin 25 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24). | 55.5 mg/dL | Standard Deviation 39.78 |
| Alogliptin 50 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24). | 55.9 mg/dL | Standard Deviation 33.6 |
| Voglibose 0.2 mg TID | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24). | 56.6 mg/dL | Standard Deviation 30.02 |
95% CI: [-3.88, 19.19]
95% CI: [-11.41, 9.24]
95% CI: [-12.91, 10.75]
95% CI: [-11.32, 9.99]
Secondary
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52).
The change between the value of blood glucose collected at week 52 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 2 hours after the start of the meal.
Time frame: Baseline and Week 52.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52). | 65.7 mg/dL | Standard Deviation 38.39 |
| Alogliptin 12.5 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52). | 62.6 mg/dL | Standard Deviation 30.18 |
| Alogliptin 25 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52). | 58.3 mg/dL | Standard Deviation 32.62 |
| Alogliptin 50 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52). | 51.8 mg/dL | Standard Deviation 36.73 |
| Voglibose 0.2 mg TID | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52). | 61.0 mg/dL | Standard Deviation 30.16 |
95% CI: [-7.09, 16.49]
95% CI: [-8.63, 11.89]
95% CI: [-13.36, 7.98]
95% CI: [-20.58, 2.17]
Secondary
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).
The change between the value of blood glucose collected at week 52 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 2 hours after the start of the meal.
Time frame: Baseline and Final Visit (up to Week 52).
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit). | -53.5 mg·hr/dL | Standard Deviation 70.32 |
| Alogliptin 12.5 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit). | -55.1 mg·hr/dL | Standard Deviation 76.72 |
| Alogliptin 25 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit). | -67.6 mg·hr/dL | Standard Deviation 69.49 |
| Alogliptin 50 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit). | -91.3 mg·hr/dL | Standard Deviation 71.93 |
| Voglibose 0.2 mg TID | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit). | -56.4 mg·hr/dL | Standard Deviation 73.88 |
95% CI: [-18.77, 24.71]
95% CI: [-21.21, 23.94]
95% CI: [-32.69, 10.3]
95% CI: [-56.85, -12.96]
Secondary
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).
The change between the value of blood glucose collected at week 12 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 2 hours after the start of the meal.
Time frame: Baseline and Week 12.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12). | -57.0 mg·hr/dL | Standard Deviation 75.68 |
| Alogliptin 12.5 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12). | -55.4 mg·hr/dL | Standard Deviation 61.17 |
| Alogliptin 25 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12). | -67.8 mg·hr/dL | Standard Deviation 55.52 |
| Alogliptin 50 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12). | -80.5 mg·hr/dL | Standard Deviation 51.95 |
| Voglibose 0.2 mg TID | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12). | -50.0 mg·hr/dL | Standard Deviation 62.49 |
95% CI: [-28.15, 14.1]
95% CI: [-23.93, 13.02]
95% CI: [-35.46, -0.13]
95% CI: [-47.75, -13.41]
Secondary
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).
The change between the value of blood glucose collected at week 24 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 2 hours after the start of the meal.
Time frame: Baseline and Week 24.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24). | -43.9 mg·hr/dL | Standard Deviation 76.23 |
| Alogliptin 12.5 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24). | -52.5 mg·hr/dL | Standard Deviation 74.32 |
| Alogliptin 25 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24). | -69.8 mg·hr/dL | Standard Deviation 73.23 |
| Alogliptin 50 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24). | -75.1 mg·hr/dL | Standard Deviation 68.57 |
| Voglibose 0.2 mg TID | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24). | -62.4 mg·hr/dL | Standard Deviation 62.68 |
95% CI: [-5.18, 42.09]
95% CI: [-13.56, 33.28]
95% CI: [-30.25, 15.37]
95% CI: [-34.75, 9.15]
Secondary
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).
The change between the value of blood glucose collected at week 52 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 2 hours after the start of the meal.
Time frame: Baseline and Week 52.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52). | -59.5 mg·hr/dL | Standard Deviation 50.66 |
| Alogliptin 12.5 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52). | -62.0 mg·hr/dL | Standard Deviation 59.52 |
| Alogliptin 25 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52). | -69.0 mg·hr/dL | Standard Deviation 64.88 |
| Alogliptin 50 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52). | -88.7 mg·hr/dL | Standard Deviation 73.36 |
| Voglibose 0.2 mg TID | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52). | -65.4 mg·hr/dL | Standard Deviation 67.93 |
95% CI: [-13.9, 25.58]
95% CI: [-18.2, 24.9]
95% CI: [-26.03, 18.74]
95% CI: [-47.08, 0.34]
Secondary
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).
The change between the value of C-peptide collected at week 52 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.
Time frame: Baseline and Final Visit (up to Week 52).
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit). | 0.99 ng·hr/mL | Standard Deviation 2.087 |
| Alogliptin 12.5 mg QD | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit). | 1.45 ng·hr/mL | Standard Deviation 2.257 |
| Alogliptin 25 mg QD | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit). | 1.14 ng·hr/mL | Standard Deviation 2.054 |
| Alogliptin 50 mg QD | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit). | 1.41 ng·hr/mL | Standard Deviation 2.028 |
| Voglibose 0.2 mg TID | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit). | 0.15 ng·hr/mL | Standard Deviation 1.866 |
95% CI: [0.239, 1.443]
95% CI: [0.679, 1.93]
95% CI: [0.4, 1.585]
95% CI: [0.674, 1.853]
Secondary
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).
The change between the value of C-peptide collected at week 12 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.
Time frame: Baseline and Week 12.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12). | 0.56 ng·hr/mL | Standard Deviation 1.765 |
| Alogliptin 12.5 mg QD | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12). | 0.97 ng·hr/mL | Standard Deviation 1.975 |
| Alogliptin 25 mg QD | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12). | 0.96 ng·hr/mL | Standard Deviation 2.073 |
| Alogliptin 50 mg QD | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12). | 0.99 ng·hr/mL | Standard Deviation 1.742 |
| Voglibose 0.2 mg TID | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12). | -0.39 ng·hr/mL | Standard Deviation 2.091 |
95% CI: [0.375, 1.535]
95% CI: [0.752, 1.965]
95% CI: [0.724, 1.975]
95% CI: [0.804, 1.955]
Secondary
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).
The change between the value of C-peptide collected at week 24 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.
Time frame: Baseline and Week 24.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24). | 0.93 ng·hr/mL | Standard Deviation 2.068 |
| Alogliptin 12.5 mg QD | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24). | 1.35 ng·hr/mL | Standard Deviation 1.928 |
| Alogliptin 25 mg QD | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24). | 1.14 ng·hr/mL | Standard Deviation 1.743 |
| Alogliptin 50 mg QD | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24). | 1.38 ng·hr/mL | Standard Deviation 1.934 |
| Voglibose 0.2 mg TID | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24). | -0.10 ng·hr/mL | Standard Deviation 1.994 |
95% CI: [0.344, 1.723]
95% CI: [0.78, 2.115]
95% CI: [0.616, 1.87]
95% CI: [0.827, 2.136]
Secondary
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).
The change between the value of C-peptide collected at week 52 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.
Time frame: Baseline and Week 52.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52). | 1.91 ng·hr/mL | Standard Deviation 2.922 |
| Alogliptin 12.5 mg QD | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52). | 3.44 ng·hr/mL | Standard Deviation 3.32 |
| Alogliptin 25 mg QD | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52). | 2.37 ng·hr/mL | Standard Deviation 5.399 |
| Alogliptin 50 mg QD | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52). | 3.14 ng·hr/mL | Standard Deviation 2.368 |
| Voglibose 0.2 mg TID | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52). | 1.86 ng·hr/mL | Standard Deviation 0.293 |
95% CI: [-4.088, 4.188]
95% CI: [-3.476, 6.647]
95% CI: [-8.151, 9.184]
95% CI: [-2.191, 4.744]
Secondary
Change From Baseline in Fasting C-peptide (Final Visit).
The change between the value of fasting C-peptide collected at week 52 or final visit and fasting C-peptide collected at baseline.
Time frame: Baseline and Final Visit (up to Week 52).
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting C-peptide (Final Visit). | 0.34 ng/mL | Standard Deviation 1.046 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting C-peptide (Final Visit). | 0.44 ng/mL | Standard Deviation 0.82 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting C-peptide (Final Visit). | 0.32 ng/mL | Standard Deviation 0.805 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting C-peptide (Final Visit). | 0.48 ng/mL | Standard Deviation 0.765 |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting C-peptide (Final Visit). | 0.18 ng/mL | Standard Deviation 0.97 |
95% CI: [-0.14, 0.458]
95% CI: [-0.001, 0.52]
95% CI: [-0.126, 0.398]
95% CI: [0.042, 0.553]
Secondary
Change From Baseline in Fasting C-peptide (Week 12).
The change between the value of fasting C-peptide collected at week 12 and fasting C-peptide collected at baseline.
Time frame: Baseline and Week 12.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting C-peptide (Week 12). | -0.02 ng/mL | Standard Deviation 0.667 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting C-peptide (Week 12). | 0.19 ng/mL | Standard Deviation 0.604 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting C-peptide (Week 12). | 0.19 ng/mL | Standard Deviation 0.567 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting C-peptide (Week 12). | 0.25 ng/mL | Standard Deviation 0.706 |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting C-peptide (Week 12). | -0.04 ng/mL | Standard Deviation 0.9 |
95% CI: [-0.219, 0.254]
95% CI: [0.002, 0.451]
95% CI: [0.008, 0.453]
95% CI: [0.041, 0.524]
Secondary
Change From Baseline in Fasting C-peptide (Week 16).
The change between the value of fasting C-peptide collected at week 16 and fasting C-peptide collected at baseline.
Time frame: Baseline and Week 16.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting C-peptide (Week 16). | 0.08 ng/mL | Standard Deviation 0.79 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting C-peptide (Week 16). | 0.22 ng/mL | Standard Deviation 0.64 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting C-peptide (Week 16). | 0.33 ng/mL | Standard Deviation 0.679 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting C-peptide (Week 16). | 0.46 ng/mL | Standard Deviation 0.924 |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting C-peptide (Week 16). | -0.01 ng/mL | Standard Deviation 0.886 |
95% CI: [-0.173, 0.353]
95% CI: [-0.01, 0.467]
95% CI: [0.095, 0.584]
95% CI: [0.184, 0.752]
Secondary
Change From Baseline in Fasting C-peptide (Week 20).
The change between the value of fasting C-peptide collected at week 20 and fasting C-peptide collected at baseline.
Time frame: Baseline and Week 20.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting C-peptide (Week 20). | 0.15 ng/mL | Standard Deviation 0.634 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting C-peptide (Week 20). | 0.35 ng/mL | Standard Deviation 0.781 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting C-peptide (Week 20). | 0.28 ng/mL | Standard Deviation 0.608 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting C-peptide (Week 20). | 0.56 ng/mL | Standard Deviation 0.971 |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting C-peptide (Week 20). | -0.16 ng/mL | Standard Deviation 0.953 |
95% CI: [0.064, 0.57]
95% CI: [0.236, 0.786]
95% CI: [0.19, 0.685]
95% CI: [0.413, 1.022]
Secondary
Change From Baseline in Fasting C-peptide (Week 24).
The change between the value of fasting C-peptide collected at week 24 and fasting C-peptide collected at baseline.
Time frame: Baseline and Week 24.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting C-peptide (Week 24). | 0.12 ng/mL | Standard Deviation 0.742 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting C-peptide (Week 24). | 0.26 ng/mL | Standard Deviation 0.722 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting C-peptide (Week 24). | 0.20 ng/mL | Standard Deviation 0.603 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting C-peptide (Week 24). | 0.23 ng/mL | Standard Deviation 0.62 |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting C-peptide (Week 24). | -0.10 ng/mL | Standard Deviation 0.831 |
95% CI: [-0.029, 0.481]
95% CI: [0.104, 0.612]
95% CI: [0.076, 0.54]
95% CI: [0.098, 0.565]
Secondary
Change From Baseline in Fasting C-peptide (Week 28).
The change between the value of fasting C-peptide collected at week 28 and fasting C-peptide collected at baseline.
Time frame: Baseline and Week 28.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting C-peptide (Week 28). | 0.11 ng/mL | Standard Deviation 0.692 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting C-peptide (Week 28). | 0.21 ng/mL | Standard Deviation 0.642 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting C-peptide (Week 28). | 0.26 ng/mL | Standard Deviation 0.591 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting C-peptide (Week 28). | 0.29 ng/mL | Standard Deviation 0.857 |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting C-peptide (Week 28). | -0.04 ng/mL | Standard Deviation 0.951 |
95% CI: [-0.13, 0.41]
95% CI: [-0.026, 0.516]
95% CI: [0.035, 0.552]
95% CI: [0.032, 0.626]
Secondary
Change From Baseline in Fasting C-peptide (Week 32).
The change between the value of fasting C-peptide collected at week 32 and fasting C-peptide collected at baseline.
Time frame: Baseline and Week 32.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting C-peptide (Week 32). | 0.03 ng/mL | Standard Deviation 0.778 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting C-peptide (Week 32). | 0.41 ng/mL | Standard Deviation 0.652 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting C-peptide (Week 32). | 0.45 ng/mL | Standard Deviation 0.718 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting C-peptide (Week 32). | 0.37 ng/mL | Standard Deviation 0.816 |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting C-peptide (Week 32). | -0.01 ng/mL | Standard Deviation 0.95 |
95% CI: [-0.252, 0.349]
95% CI: [0.138, 0.703]
95% CI: [0.178, 0.742]
95% CI: [0.085, 0.683]
Secondary
Change From Baseline in Fasting C-peptide (Week 36).
The change between the value of fasting C-peptide collected at week 36 and fasting C-peptide collected at baseline.
Time frame: Baseline and Week 36.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting C-peptide (Week 36). | 0.12 ng/mL | Standard Deviation 0.714 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting C-peptide (Week 36). | 0.33 ng/mL | Standard Deviation 0.639 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting C-peptide (Week 36). | 0.20 ng/mL | Standard Deviation 0.75 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting C-peptide (Week 36). | 0.42 ng/mL | Standard Deviation 0.856 |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting C-peptide (Week 36). | 0.09 ng/mL | Standard Deviation 0.777 |
95% CI: [-0.257, 0.326]
95% CI: [-0.043, 0.542]
95% CI: [-0.196, 0.417]
95% CI: [0.01, 0.656]
Secondary
Change From Baseline in Fasting C-peptide (Week 40).
The change between the value of fasting C-peptide collected at week 40 and fasting C-peptide collected at baseline.
Time frame: Baseline and Week 40.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting C-peptide (Week 40). | -0.14 ng/mL | Standard Deviation 0.998 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting C-peptide (Week 40). | 0.48 ng/mL | Standard Deviation 0.836 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting C-peptide (Week 40). | 0.27 ng/mL | Standard Deviation 0.735 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting C-peptide (Week 40). | 0.44 ng/mL | Standard Deviation 0.567 |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting C-peptide (Week 40). | 0.13 ng/mL | Standard Deviation 1.066 |
95% CI: [-0.769, 0.233]
95% CI: [-0.156, 0.855]
95% CI: [-0.297, 0.577]
95% CI: [-0.075, 0.69]
Secondary
Change From Baseline in Fasting C-peptide (Week 44).
The change between the value of fasting C-peptide collected at week 44 and fasting C-peptide collected at baseline.
Time frame: Baseline and Week 44.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting C-peptide (Week 44). | 0.22 ng/mL | Standard Deviation 0.963 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting C-peptide (Week 44). | 0.52 ng/mL | Standard Deviation 0.887 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting C-peptide (Week 44). | 0.59 ng/mL | Standard Deviation 0.881 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting C-peptide (Week 44). | 0.20 ng/mL | Standard Deviation 0.651 |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting C-peptide (Week 44). | -0.06 ng/mL | Standard Deviation 0.991 |
95% CI: [-0.367, 0.928]
95% CI: [-0.035, 1.194]
95% CI: [0.054, 1.241]
95% CI: [-0.28, 0.785]
Secondary
Change From Baseline in Fasting C-peptide (Week 48).
The change between the value of fasting C-peptide collected at week 48 and fasting C-peptide collected at baseline.
Time frame: Baseline and Week 48.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting C-peptide (Week 48). | -0.40 ng/mL | Standard Deviation 0.632 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting C-peptide (Week 48). | 0.54 ng/mL | Standard Deviation 0.796 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting C-peptide (Week 48). | 0.04 ng/mL | Standard Deviation 0.485 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting C-peptide (Week 48). | 0.15 ng/mL | Standard Deviation 0.558 |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting C-peptide (Week 48). | -0.10 ng/mL | Standard Deviation 0.934 |
95% CI: [-1.246, 0.646]
95% CI: [-0.305, 1.591]
95% CI: [-0.599, 0.888]
95% CI: [-0.673, 1.173]
Secondary
Change From Baseline in Fasting C-peptide (Week 52).
The change between the value of fasting C-peptide collected at week 52 and fasting C-peptide collected at baseline.
Time frame: Baseline and Week 52.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting C-peptide (Week 52). | -0.25 ng/mL | Standard Deviation 0.212 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting C-peptide (Week 52). | 0.73 ng/mL | Standard Deviation 0.874 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting C-peptide (Week 52). | 0.10 ng/mL | Standard Deviation 0.781 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting C-peptide (Week 52). | 0.30 ng/mL | Standard Deviation 1.095 |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting C-peptide (Week 52). | 0.70 ng/mL | Standard Deviation 1.473 |
95% CI: [-4.462, 2.562]
95% CI: [-2.712, 2.779]
95% CI: [-3.273, 2.073]
95% CI: [-2.874, 2.074]
Secondary
Change From Baseline in Fasting Plasma Glucose (Final Visit).
The change between the value of fasting plasma glucose collected at week 52 or final visit and fasting plasma glucose collected at baseline.
Time frame: Baseline and Final Visit (up to Week 52).
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting Plasma Glucose (Final Visit). | -10.4 mg/dL | Standard Deviation 27.13 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Final Visit). | -15.5 mg/dL | Standard Deviation 31.02 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose (Final Visit). | -17.1 mg/dL | Standard Deviation 26.5 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting Plasma Glucose (Final Visit). | -27.6 mg/dL | Standard Deviation 28.13 |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting Plasma Glucose (Final Visit). | -8.8 mg/dL | Standard Deviation 30.14 |
95% CI: [-10.09, 6.8]
95% CI: [-15.66, 2.25]
95% CI: [-16.64, 0.07]
95% CI: [-27.39, -10.24]
Secondary
Change From Baseline in Fasting Plasma Glucose (Week 12).
The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 12
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 12). | -12.1 mg/dL | Standard Deviation 32.26 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 12). | -15.3 mg/dL | Standard Deviation 23.57 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 12). | -17.0 mg/dL | Standard Deviation 21.42 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 12). | -23.0 mg/dL | Standard Deviation 23.35 |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting Plasma Glucose (Week 12). | -3.6 mg/dL | Standard Deviation 26.98 |
95% CI: [-17.56, 0.54]
95% CI: [-19.23, -4.18]
95% CI: [-20.68, -6.15]
95% CI: [-26.93, -11.83]
Secondary
Change From Baseline in Fasting Plasma Glucose (Week 16).
The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 16.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 16). | -10.8 mg/dL | Standard Deviation 24.52 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 16). | -15.8 mg/dL | Standard Deviation 23.76 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 16). | -17.0 mg/dL | Standard Deviation 23.34 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 16). | -18.8 mg/dL | Standard Deviation 29.74 |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting Plasma Glucose (Week 16). | -6.4 mg/dL | Standard Deviation 28.02 |
95% CI: [-12.67, 3.8]
95% CI: [-17.48, -1.3]
95% CI: [-18.58, -2.54]
95% CI: [-21.44, -3.31]
Secondary
Change From Baseline in Fasting Plasma Glucose (Week 20).
The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 20.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 20). | -11.5 mg/dL | Standard Deviation 27.5 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 20). | -15.3 mg/dL | Standard Deviation 24.49 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 20). | -13.8 mg/dL | Standard Deviation 23.1 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 20). | -20.1 mg/dL | Standard Deviation 27.94 |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting Plasma Glucose (Week 20). | -4.6 mg/dL | Standard Deviation 27.53 |
95% CI: [-15.66, 1.86]
95% CI: [-18.97, -2.49]
95% CI: [-17.2, -1.23]
95% CI: [-24.27, -6.72]
Secondary
Change From Baseline in Fasting Plasma Glucose (Week 24).
The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 24.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 24). | -10.6 mg/dL | Standard Deviation 29.15 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 24). | -11.7 mg/dL | Standard Deviation 28.19 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 24). | -13.8 mg/dL | Standard Deviation 23.7 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 24). | -20.2 mg/dL | Standard Deviation 28.9 |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting Plasma Glucose (Week 24). | -8.3 mg/dL | Standard Deviation 25.58 |
95% CI: [-11.22, 6.67]
95% CI: [-12.16, 5.44]
95% CI: [-13.3, 2.44]
95% CI: [-20.74, -3.06]
Secondary
Change From Baseline in Fasting Plasma Glucose (Week 28).
The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 28.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 28). | -9.6 mg/dL | Standard Deviation 30.07 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 28). | -13.4 mg/dL | Standard Deviation 30.06 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 28). | -14.1 mg/dL | Standard Deviation 23.86 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 28). | -19.9 mg/dL | Standard Deviation 32.36 |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting Plasma Glucose (Week 28). | -7.2 mg/dL | Standard Deviation 28.13 |
95% CI: [-11.97, 7.08]
95% CI: [-15.84, 3.35]
95% CI: [-15.28, 1.41]
95% CI: [-22.67, -2.78]
Secondary
Change From Baseline in Fasting Plasma Glucose (Week 32).
The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 32.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 32). | -14.5 mg/dL | Standard Deviation 21.13 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 32). | -12.9 mg/dL | Standard Deviation 31.64 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 32). | -14.9 mg/dL | Standard Deviation 25.86 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 32). | -20.3 mg/dL | Standard Deviation 30.72 |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting Plasma Glucose (Week 32). | -9.1 mg/dL | Standard Deviation 26.59 |
95% CI: [-13.19, 2.31]
95% CI: [-13.53, 5.99]
95% CI: [-14.36, 2.67]
95% CI: [-20.72, -1.73]
Secondary
Change From Baseline in Fasting Plasma Glucose (Week 36).
The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 36.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 36). | -10.7 mg/dL | Standard Deviation 24.25 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 36). | -14.3 mg/dL | Standard Deviation 32.31 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 36). | -16.9 mg/dL | Standard Deviation 23.66 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 36). | -20.9 mg/dL | Standard Deviation 32.48 |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting Plasma Glucose (Week 36). | -8.4 mg/dL | Standard Deviation 25.36 |
95% CI: [-10.42, 5.9]
95% CI: [-15.64, 3.84]
95% CI: [-16.52, -0.42]
95% CI: [-22.18, -2.76]
Secondary
Change From Baseline in Fasting Plasma Glucose (Week 40).
The change between the value of fasting plasma glucose collected at week 40 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 40.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 40). | -13.5 mg/dL | Standard Deviation 19.32 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 40). | -14.8 mg/dL | Standard Deviation 28.76 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 40). | -15.7 mg/dL | Standard Deviation 21.38 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 40). | -23.2 mg/dL | Standard Deviation 29.4 |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting Plasma Glucose (Week 40). | -13.8 mg/dL | Standard Deviation 25.82 |
95% CI: [-7.1, 7.77]
95% CI: [-10.16, 8.21]
95% CI: [-9.71, 5.95]
95% CI: [-18.59, -0.18]
Secondary
Change From Baseline in Fasting Plasma Glucose (Week 44).
The change between the value of fasting plasma glucose collected at week 44 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 44.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 44). | -16.7 mg/dL | Standard Deviation 22.28 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 44). | -18.7 mg/dL | Standard Deviation 26.79 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 44). | -19.0 mg/dL | Standard Deviation 24.77 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 44). | -24.7 mg/dL | Standard Deviation 29.69 |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting Plasma Glucose (Week 44). | -15.0 mg/dL | Standard Deviation 26.09 |
95% CI: [-10.2, 6.75]
95% CI: [-13.1, 5.7]
95% CI: [-12.94, 5]
95% CI: [-19.4, -0.08]
Secondary
Change From Baseline in Fasting Plasma Glucose (Week 48).
The change between the value of fasting plasma glucose collected at week 48 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 48.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 48). | -16.0 mg/dL | Standard Deviation 21.54 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 48). | -20.8 mg/dL | Standard Deviation 24.97 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 48). | -22.8 mg/dL | Standard Deviation 21.89 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 48). | -25.4 mg/dL | Standard Deviation 30.5 |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting Plasma Glucose (Week 48). | -13.5 mg/dL | Standard Deviation 26.3 |
95% CI: [-11, 6.15]
95% CI: [-16.53, 1.94]
95% CI: [-17.93, -0.67]
95% CI: [-21.83, -1.93]
Secondary
Change From Baseline in Fasting Plasma Glucose (Week 52).
The change between the value of fasting plasma glucose collected at week 52 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 52.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 52). | -13.7 mg/dL | Standard Deviation 21.54 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 52). | -19.5 mg/dL | Standard Deviation 25.63 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 52). | -21.4 mg/dL | Standard Deviation 22.35 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 52). | -26.0 mg/dL | Standard Deviation 29.05 |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting Plasma Glucose (Week 52). | -12.5 mg/dL | Standard Deviation 25.77 |
95% CI: [-9.68, 7.27]
95% CI: [-16.34, 2.24]
95% CI: [-17.47, -0.26]
95% CI: [-23.12, -3.89]
Secondary
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).
The change between the value of glucagons collected at week 52 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.
Time frame: Baseline and Final Visit (up to Week 52).
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit). | -9.8 pg·hr/mL | Standard Deviation 45.93 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit). | -9.0 pg·hr/mL | Standard Deviation 48.99 |
| Alogliptin 25 mg QD | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit). | -10.3 pg·hr/mL | Standard Deviation 61.18 |
| Alogliptin 50 mg QD | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit). | -14.6 pg·hr/mL | Standard Deviation 51.22 |
| Voglibose 0.2 mg TID | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit). | -13.9 pg·hr/mL | Standard Deviation 58.84 |
95% CI: [-11.7, 19.86]
95% CI: [-11.14, 21.03]
95% CI: [-14.42, 21.73]
95% CI: [-17.24, 15.89]
Secondary
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).
The change between the value of glucagons collected at week 12 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.
Time frame: Baseline and Week 12
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12). | -9.5 pg·hr/mL | Standard Deviation 38.86 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12). | -4.4 pg·hr/mL | Standard Deviation 36.89 |
| Alogliptin 25 mg QD | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12). | -6.6 pg·hr/mL | Standard Deviation 46.85 |
| Alogliptin 50 mg QD | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12). | -15.5 pg·hr/mL | Standard Deviation 41.23 |
| Voglibose 0.2 mg TID | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12). | -16.3 pg·hr/mL | Standard Deviation 52.26 |
95% CI: [-7.03, 20.55]
95% CI: [-1.49, 25.19]
95% CI: [-5.12, 24.56]
95% CI: [-13.26, 14.9]
Secondary
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).
The change between the value of glucagons collected at week 24 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.
Time frame: Baseline and Week 24.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24). | -1.7 pg·hr/mL | Standard Deviation 37.9 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24). | 3.0 pg·hr/mL | Standard Deviation 41.66 |
| Alogliptin 25 mg QD | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24). | 0.9 pg·hr/mL | Standard Deviation 50.56 |
| Alogliptin 50 mg QD | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24). | -0.8 pg·hr/mL | Standard Deviation 43.71 |
| Voglibose 0.2 mg TID | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24). | -7.6 pg·hr/mL | Standard Deviation 60.64 |
95% CI: [-11.11, 22.91]
95% CI: [-7.21, 28.35]
95% CI: [-10.08, 26.98]
95% CI: [-10.67, 24.3]
Secondary
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).
The change between the value of glucagons collected at week 52 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.
Time frame: Baseline and Week 52.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52). | -10.7 pg·hr/mL | Standard Deviation 47.21 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52). | -11.3 pg·hr/mL | Standard Deviation 45.41 |
| Alogliptin 25 mg QD | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52). | -14.5 pg·hr/mL | Standard Deviation 59.39 |
| Alogliptin 50 mg QD | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52). | -12.5 pg·hr/mL | Standard Deviation 52.1 |
| Voglibose 0.2 mg TID | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52). | -13.8 pg·hr/mL | Standard Deviation 61.15 |
95% CI: [-14.95, 21.13]
95% CI: [-15.61, 20.57]
95% CI: [-21, 19.68]
95% CI: [-17.47, 20.05]
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.
Time frame: Baseline and Final Visit (up to Week 52).
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Final Visit). | -0.40 percentage of Glycosylated Hemoglobin | Standard Deviation 0.713 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glycosylated Hemoglobin (Final Visit). | -0.47 percentage of Glycosylated Hemoglobin | Standard Deviation 0.817 |
| Alogliptin 25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Final Visit). | -0.63 percentage of Glycosylated Hemoglobin | Standard Deviation 0.788 |
| Alogliptin 50 mg QD | Change From Baseline in Glycosylated Hemoglobin (Final Visit). | -0.86 percentage of Glycosylated Hemoglobin | Standard Deviation 0.723 |
| Voglibose 0.2 mg TID | Change From Baseline in Glycosylated Hemoglobin (Final Visit). | -0.22 percentage of Glycosylated Hemoglobin | Standard Deviation 0.882 |
95% CI: [-0.416, 0.055]
95% CI: [-0.492, 0.003]
95% CI: [-0.654, -0.161]
95% CI: [-0.874, -0.402]
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.
Time frame: Baseline and Week 12.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 12). | -0.55 percentage of Glycosylated Hemoglobin | Standard Deviation 0.703 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 12). | -0.70 percentage of Glycosylated Hemoglobin | Standard Deviation 0.545 |
| Alogliptin 25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 12). | -0.74 percentage of Glycosylated Hemoglobin | Standard Deviation 0.52 |
| Alogliptin 50 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 12). | -0.86 percentage of Glycosylated Hemoglobin | Standard Deviation 0.499 |
| Voglibose 0.2 mg TID | Change From Baseline in Glycosylated Hemoglobin (Week 12). | -0.15 percentage of Glycosylated Hemoglobin | Standard Deviation 0.735 |
95% CI: [-0.618, -0.184]
95% CI: [-0.739, -0.358]
95% CI: [-0.779, -0.401]
95% CI: [-0.894, -0.522]
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.
Time frame: Baseline and Week 16.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 16). | -0.57 percentage of Glycosylated Hemoglobin | Standard Deviation 0.758 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 16). | -0.75 percentage of Glycosylated Hemoglobin | Standard Deviation 0.586 |
| Alogliptin 25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 16). | -0.77 percentage of Glycosylated Hemoglobin | Standard Deviation 0.616 |
| Alogliptin 50 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 16). | -0.90 percentage of Glycosylated Hemoglobin | Standard Deviation 0.565 |
| Voglibose 0.2 mg TID | Change From Baseline in Glycosylated Hemoglobin (Week 16). | -0.25 percentage of Glycosylated Hemoglobin | Standard Deviation 0.633 |
95% CI: [-0.538, -0.093]
95% CI: [-0.684, -0.302]
95% CI: [-0.706, -0.314]
95% CI: [-0.834, -0.461]
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.
Time frame: Baseline and Week 20.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 20). | -0.56 percentage of Glycosylated Hemoglobin | Standard Deviation 0.699 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 20). | -0.69 percentage of Glycosylated Hemoglobin | Standard Deviation 0.628 |
| Alogliptin 25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 20). | -0.70 percentage of Glycosylated Hemoglobin | Standard Deviation 0.672 |
| Alogliptin 50 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 20). | -0.88 percentage of Glycosylated Hemoglobin | Standard Deviation 0.602 |
| Voglibose 0.2 mg TID | Change From Baseline in Glycosylated Hemoglobin (Week 20). | -0.30 percentage of Glycosylated Hemoglobin | Standard Deviation 0.65 |
95% CI: [-0.479, -0.047]
95% CI: [-0.598, -0.192]
95% CI: [-0.616, -0.195]
95% CI: [-0.78, -0.386]
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.
Time frame: Baseline and Week 24.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 24). | -0.47 percentage of Glycosylated Hemoglobin | Standard Deviation 0.736 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 24). | -0.61 percentage of Glycosylated Hemoglobin | Standard Deviation 0.697 |
| Alogliptin 25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 24). | -0.66 percentage of Glycosylated Hemoglobin | Standard Deviation 0.714 |
| Alogliptin 50 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 24). | -0.83 percentage of Glycosylated Hemoglobin | Standard Deviation 0.647 |
| Voglibose 0.2 mg TID | Change From Baseline in Glycosylated Hemoglobin (Week 24). | -0.29 percentage of Glycosylated Hemoglobin | Standard Deviation 0.73 |
95% CI: [-0.41, 0.065]
95% CI: [-0.55, -0.088]
95% CI: [-0.601, -0.139]
95% CI: [-0.752, -0.314]
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.
Time frame: Baseline and Week 28.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 28). | -0.39 percentage of Glycosylated Hemoglobin | Standard Deviation 0.804 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 28). | -0.56 percentage of Glycosylated Hemoglobin | Standard Deviation 0.721 |
| Alogliptin 25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 28). | -0.67 percentage of Glycosylated Hemoglobin | Standard Deviation 0.749 |
| Alogliptin 50 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 28). | -0.78 percentage of Glycosylated Hemoglobin | Standard Deviation 0.705 |
| Voglibose 0.2 mg TID | Change From Baseline in Glycosylated Hemoglobin (Week 28). | -0.32 percentage of Glycosylated Hemoglobin | Standard Deviation 0.676 |
95% CI: [-0.323, 0.166]
95% CI: [-0.471, -0.011]
95% CI: [-0.59, -0.124]
95% CI: [-0.692, -0.242]
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.
Time frame: Baseline and Week 32.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 32). | -0.35 percentage of Glycosylated Hemoglobin | Standard Deviation 0.787 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 32). | -0.56 percentage of Glycosylated Hemoglobin | Standard Deviation 0.811 |
| Alogliptin 25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 32). | -0.61 percentage of Glycosylated Hemoglobin | Standard Deviation 0.777 |
| Alogliptin 50 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 32). | -0.76 percentage of Glycosylated Hemoglobin | Standard Deviation 0.757 |
| Voglibose 0.2 mg TID | Change From Baseline in Glycosylated Hemoglobin (Week 32). | -0.27 percentage of Glycosylated Hemoglobin | Standard Deviation 0.662 |
95% CI: [-0.321, 0.162]
95% CI: [-0.542, -0.046]
95% CI: [-0.579, -0.103]
95% CI: [-0.722, -0.252]
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.
Time frame: Baseline and Week 36.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 36). | -0.33 percentage of Glycosylated Hemoglobin | Standard Deviation 0.724 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 36). | -0.52 percentage of Glycosylated Hemoglobin | Standard Deviation 0.857 |
| Alogliptin 25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 36). | -0.66 percentage of Glycosylated Hemoglobin | Standard Deviation 0.722 |
| Alogliptin 50 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 36). | -0.77 percentage of Glycosylated Hemoglobin | Standard Deviation 0.759 |
| Voglibose 0.2 mg TID | Change From Baseline in Glycosylated Hemoglobin (Week 36). | -0.28 percentage of Glycosylated Hemoglobin | Standard Deviation 0.664 |
95% CI: [-0.279, 0.182]
95% CI: [-0.491, 0.023]
95% CI: [-0.605, -0.145]
95% CI: [-0.724, -0.252]
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.
Time frame: Baseline and Week 40.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 40). | -0.33 percentage of Glycosylated Hemoglobin | Standard Deviation 0.686 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 40). | -0.48 percentage of Glycosylated Hemoglobin | Standard Deviation 0.882 |
| Alogliptin 25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 40). | -0.66 percentage of Glycosylated Hemoglobin | Standard Deviation 0.694 |
| Alogliptin 50 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 40). | -0.77 percentage of Glycosylated Hemoglobin | Standard Deviation 0.765 |
| Voglibose 0.2 mg TID | Change From Baseline in Glycosylated Hemoglobin (Week 40). | -0.28 percentage of Glycosylated Hemoglobin | Standard Deviation 0.627 |
95% CI: [-0.27, 0.169]
95% CI: [-0.453, 0.067]
95% CI: [-0.596, -0.152]
95% CI: [-0.723, -0.256]
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.
Time frame: Baseline and Week 44.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 44). | -0.29 percentage of Glycosylated Hemoglobin | Standard Deviation 0.649 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 44). | -0.59 percentage of Glycosylated Hemoglobin | Standard Deviation 0.722 |
| Alogliptin 25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 44). | -0.71 percentage of Glycosylated Hemoglobin | Standard Deviation 0.767 |
| Alogliptin 50 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 44). | -0.79 percentage of Glycosylated Hemoglobin | Standard Deviation 0.77 |
| Voglibose 0.2 mg TID | Change From Baseline in Glycosylated Hemoglobin (Week 44). | -0.35 percentage of Glycosylated Hemoglobin | Standard Deviation 0.632 |
95% CI: [-0.16, 0.289]
95% CI: [-0.477, 0.005]
95% CI: [-0.608, -0.113]
95% CI: [-0.679, -0.191]
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.
Time frame: Baseline and Week 48.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 48). | -0.43 percentage of Glycosylated Hemoglobin | Standard Deviation 0.59 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 48). | -0.66 percentage of Glycosylated Hemoglobin | Standard Deviation 0.716 |
| Alogliptin 25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 48). | -0.76 percentage of Glycosylated Hemoglobin | Standard Deviation 0.736 |
| Alogliptin 50 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 48). | -0.83 percentage of Glycosylated Hemoglobin | Standard Deviation 0.779 |
| Voglibose 0.2 mg TID | Change From Baseline in Glycosylated Hemoglobin (Week 48). | -0.40 percentage of Glycosylated Hemoglobin | Standard Deviation 0.695 |
95% CI: [-0.262, 0.196]
95% CI: [-0.516, -0.008]
95% CI: [-0.614, -0.103]
95% CI: [-0.69, -0.174]
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.
Time frame: Baseline and Week 52.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 52). | -0.49 percentage of Glycosylated Hemoglobin | Standard Deviation 0.544 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 52). | -0.65 percentage of Glycosylated Hemoglobin | Standard Deviation 0.726 |
| Alogliptin 25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 52). | -0.74 percentage of Glycosylated Hemoglobin | Standard Deviation 0.754 |
| Alogliptin 50 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 52). | -0.85 percentage of Glycosylated Hemoglobin | Standard Deviation 0.785 |
| Voglibose 0.2 mg TID | Change From Baseline in Glycosylated Hemoglobin (Week 52). | -0.37 percentage of Glycosylated Hemoglobin | Standard Deviation 0.723 |
95% CI: [-0.346, 0.11]
95% CI: [-0.539, -0.015]
95% CI: [-0.637, -0.109]
95% CI: [-0.741, -0.213]
Secondary
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).
The change between the value of insulin collected at week 52 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.
Time frame: Baseline and Final Visit (up to Week 52).
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit). | -6.93 μU·hr/mL | Standard Deviation 18.945 |
| Alogliptin 12.5 mg QD | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit). | -1.67 μU·hr/mL | Standard Deviation 15.508 |
| Alogliptin 25 mg QD | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit). | 0.43 μU·hr/mL | Standard Deviation 14.532 |
| Alogliptin 50 mg QD | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit). | -1.56 μU·hr/mL | Standard Deviation 21.843 |
| Voglibose 0.2 mg TID | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit). | -14.65 μU·hr/mL | Standard Deviation 19.322 |
95% CI: [1.657, 13.782]
95% CI: [7.556, 18.399]
95% CI: [9.808, 20.345]
95% CI: [6.561, 19.614]
Secondary
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).
The change between the value of insulin collected at week 12 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.
Time frame: Baseline and Week 12
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12). | 0.49 μU·hr/mL | Standard Deviation 18.988 |
| Alogliptin 12.5 mg QD | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12). | 2.63 μU·hr/mL | Standard Deviation 15.416 |
| Alogliptin 25 mg QD | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12). | 4.44 μU·hr/mL | Standard Deviation 13.637 |
| Alogliptin 50 mg QD | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12). | -0.03 μU·hr/mL | Standard Deviation 21.572 |
| Voglibose 0.2 mg TID | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12). | -15.40 μU·hr/mL | Standard Deviation 20.416 |
95% CI: [9.597, 22.184]
95% CI: [12.466, 23.585]
95% CI: [14.379, 25.297]
95% CI: [8.677, 22.06]
Secondary
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).
The change between the value of insulin collected at week 24 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.
Time frame: Baseline and Week 24.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24). | -1.89 μU·hr/mL | Standard Deviation 21.943 |
| Alogliptin 12.5 mg QD | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24). | 4.50 μU·hr/mL | Standard Deviation 12.876 |
| Alogliptin 25 mg QD | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24). | 2.85 μU·hr/mL | Standard Deviation 12.309 |
| Alogliptin 50 mg QD | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24). | -0.98 μU·hr/mL | Standard Deviation 27.457 |
| Voglibose 0.2 mg TID | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24). | -16.21 μU·hr/mL | Standard Deviation 20.927 |
95% CI: [6.567, 22.079]
95% CI: [14.563, 26.864]
95% CI: [13.125, 25.002]
95% CI: [6.618, 23.847]
Secondary
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).
The change between the value of insulin collected at week 52 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.
Time frame: Baseline and Week 52.
Population: Values are Summary Statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52). | -7.62 μU·hr/mL | Standard Deviation 19.526 |
| Alogliptin 12.5 mg QD | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52). | -1.71 μU·hr/mL | Standard Deviation 15.032 |
| Alogliptin 25 mg QD | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52). | -0.44 μU·hr/mL | Standard Deviation 14.871 |
| Alogliptin 50 mg QD | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52). | -2.30 μU·hr/mL | Standard Deviation 22.985 |
| Voglibose 0.2 mg TID | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52). | -15.66 μU·hr/mL | Standard Deviation 20.026 |
95% CI: [1.169, 14.924]
95% CI: [7.767, 20.133]
95% CI: [9.191, 21.251]
95% CI: [5.847, 20.885]