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 efficacy and safety of alogliptin, once daily (QD) combined with an α-glucosidase inhibitor taken three times daily (TID) in type 2 diabetic patients with uncontrolled blood glucose.
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. In Japan, α-glucosidase inhibitors are widely used as a first-line treatment for type 2 diabetes mellitus. Because alogliptin has a different mechanism of action compared to α-glucosidase inhibitors, the study evaluated the efficacy and safety of alogliptin combined with an α-glucosidase inhibitor in type 2 diabetic patients with uncontrolled blood glucose while taking a α-glucosidase inhibitor and receiving diet and/or exercise therapies. To evaluate the long-term safety and efficacy of the concomitant use of alogliptin and an α-glucosidase inhibitor, subjects who participated in the present study could enter a long-term extension study SYR-322/OCT-003 (NCT01263509) that was planned separately.
Interventions
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
DRUGVoglibose
Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
33 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Had been receiving a stable dose and regimen of an α-glucosidase inhibitor for the last 4 weeks or longer before the start of the screening phase (Week -8) and during the screening phase. * Had a glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of the screening phase (Week -4). * Had HbA1c differences within 10.0% at the start of the screening phase (Week -8) and 4 weeks after the start of the screening phase (Week -4) from the HbA1c value at the start of the screening phase. * Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of the screening phase (Week -8).
Exclusion criteria
* Had received any antidiabetic drug other than α-glucosidase inhibitors within the last 4 weeks before the start of the screening phase (Week -8) or during the screening phase.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 or final visit and glycosylated hemoglobin collected at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (Week 2). | Baseline and Week 2. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline. |
| Change From Baseline in Glycosylated Hemoglobin (Week 8). | Baseline and Week 8. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline. |
| Change From Baseline in Fasting Plasma Glucose (Week 2). | Baseline and Week 2 | The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline. |
| Change From Baseline in Fasting Plasma Glucose (Week 4). | Baseline and Week 4. | The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline. |
| Change From Baseline in Fasting Plasma Glucose (Week 8). | Baseline and Week 8. | The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose 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 or final visit and fasting plasma glucose collected at baseline. |
| Change From Baseline in Fasting C-peptide (Week 2). | Baseline and Week 2. | The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline. |
| Change From Baseline in Glycosylated Hemoglobin (Week 4). | Baseline and Week 4. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline. |
| Change From Baseline in Fasting C-peptide (Week 8). | Baseline and Week 8. | The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide 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 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). | Baseline and Week 12. | The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal. |
| Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)). | Baseline and Week 12. | The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal. |
| Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2). | Baseline and Week 12 | The change between the value of insulin collected at week 12 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal. |
| Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2). | Baseline and Week 12. | The change between the value of C-peptide collected at week 12 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal. |
| Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)). | Baseline and Week 12 | The change between the value of glucagons collected at week 12 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal. |
| Change From Baseline in Fasting C-peptide (Week 4). | Baseline and Week 4. | The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline. |
Participant flow
Recruitment details
Participants enrolled at investigative sites in Japan from to .
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 3, once-daily (QD) or three-times daily (TID) treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Voglibose 0.2 mg TID Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. | 75 |
| Alogliptin 12.5 mg QD Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID | 76 |
| Alogliptin 25 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. | 79 |
| Total | 230 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 4 | 0 | 3 |
| Overall Study | Lack of Efficacy | 2 | 0 | 0 |
| Overall Study | Participant Unavailability | 0 | 1 | 1 |
| Overall Study | Protocol Violation | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Voglibose 0.2 mg TID | Alogliptin 12.5 mg QD | Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Total |
|---|---|---|---|---|
| Age, Customized ≤ 64 years | 39 participants | 52 participants | 39 participants | 130 participants |
| Age, Customized ≥ 65 years | 36 participants | 24 participants | 40 participants | 100 participants |
| Sex: Female, Male Female | 27 Participants | 32 Participants | 29 Participants | 88 Participants |
| Sex: Female, Male Male | 48 Participants | 44 Participants | 50 Participants | 142 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 75 | 18 / 76 | 13 / 79 |
| serious Total, serious adverse events | 9 / 75 | 0 / 76 | 1 / 79 |
Outcome results
Primary
Change From Baseline in Glycosylated Hemoglobin (Week 12).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.
Time frame: Baseline and Week 12.
Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voglibose 0.2 mg TID | Change From Baseline in Glycosylated Hemoglobin (Week 12). | 0.04 percentage of Glycosylated Hemoglobin | Standard Deviation 0.457 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 12). | -0.96 percentage of Glycosylated Hemoglobin | Standard Deviation 0.553 |
| Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Change From Baseline in Glycosylated Hemoglobin (Week 12). | -0.91 percentage of Glycosylated Hemoglobin | Standard Deviation 0.485 |
95% CI: [-1.166, -0.838]
95% CI: [-1.097, -0.796]
Secondary
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value).
The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.
Time frame: Baseline and Week 12.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voglibose 0.2 mg TID | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value). | 72.4 mg/dL | Standard Deviation 34.89 |
| Alogliptin 12.5 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value). | 40.9 mg/dL | Standard Deviation 23.23 |
| Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value). | 38.7 mg/dL | Standard Deviation 32.33 |
95% CI: [-41.28, -21.8]
95% CI: [-44.88, -22.57]
Secondary
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)).
The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.
Time frame: Baseline and Week 12.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voglibose 0.2 mg TID | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)). | -4.3 mg·hr/dL | Standard Deviation 60.23 |
| Alogliptin 12.5 mg QD | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)). | -74.7 mg·hr/dL | Standard Deviation 61.76 |
| Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)). | -76.8 mg·hr/dL | Standard Deviation 63.19 |
95% CI: [-90.67, -50.09]
95% CI: [-93.1, -51.88]
Secondary
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2).
The change between the value of C-peptide collected at week 12 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.
Time frame: Baseline and Week 12.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voglibose 0.2 mg TID | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2). | 0.14 ng·hr/mL | Standard Deviation 1.67 |
| Alogliptin 12.5 mg QD | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2). | 0.69 ng·hr/mL | Standard Deviation 1.901 |
| Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2). | 0.57 ng·hr/mL | Standard Deviation 2.247 |
95% CI: [-0.045, 1.144]
95% CI: [-0.233, 1.09]
Secondary
Change From Baseline in Fasting C-peptide (Week 12).
The change between the value of fasting C-peptide collected at week 12 or final visit and fasting C-peptide collected at baseline.
Time frame: Baseline and Week 12.
Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voglibose 0.2 mg TID | Change From Baseline in Fasting C-peptide (Week 12). | 0.02 ng/mL | Standard Deviation 0.664 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting C-peptide (Week 12). | 0.06 ng/mL | Standard Deviation 0.68 |
| Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Change From Baseline in Fasting C-peptide (Week 12). | 0.10 ng/mL | Standard Deviation 0.62 |
95% CI: [-0.183, 0.252]
95% CI: [-0.124, 0.288]
Secondary
Change From Baseline in Fasting C-peptide (Week 2).
The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline.
Time frame: Baseline and Week 2.
Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voglibose 0.2 mg TID | Change From Baseline in Fasting C-peptide (Week 2). | 0.03 ng/mL | Standard Deviation 0.668 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting C-peptide (Week 2). | -0.07 ng/mL | Standard Deviation 0.593 |
| Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Change From Baseline in Fasting C-peptide (Week 2). | -0.01 ng/mL | Standard Deviation 0.599 |
95% CI: [-0.304, 0.104]
95% CI: [-0.239, 0.167]
Secondary
Change From Baseline in Fasting C-peptide (Week 4).
The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline.
Time frame: Baseline and Week 4.
Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voglibose 0.2 mg TID | Change From Baseline in Fasting C-peptide (Week 4). | 0.05 ng/mL | Standard Deviation 0.753 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting C-peptide (Week 4). | 0.06 ng/mL | Standard Deviation 0.955 |
| Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Change From Baseline in Fasting C-peptide (Week 4). | 0.01 ng/mL | Standard Deviation 0.682 |
95% CI: [-0.267, 0.292]
95% CI: [-0.264, 0.196]
Secondary
Change From Baseline in Fasting C-peptide (Week 8).
The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.
Time frame: Baseline and Week 8.
Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voglibose 0.2 mg TID | Change From Baseline in Fasting C-peptide (Week 8). | 0.07 ng/mL | Standard Deviation 0.691 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting C-peptide (Week 8). | 0.03 ng/mL | Standard Deviation 0.725 |
| Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Change From Baseline in Fasting C-peptide (Week 8). | -0.01 ng/mL | Standard Deviation 0.468 |
95% CI: [-0.268, 0.191]
95% CI: [-0.261, 0.115]
Secondary
Change From Baseline in Fasting Plasma Glucose (Week 12).
The change between the value of fasting plasma glucose collected at week 12 or final visit and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 12.
Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voglibose 0.2 mg TID | Change From Baseline in Fasting Plasma Glucose (Week 12). | -5.6 mg/dL | Standard Deviation 27.87 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 12). | -19.1 mg/dL | Standard Deviation 20.7 |
| Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Change From Baseline in Fasting Plasma Glucose (Week 12). | -18.5 mg/dL | Standard Deviation 25.53 |
95% CI: [-21.46, -5.6]
95% CI: [-21.53, -4.41]
Secondary
Change From Baseline in Fasting Plasma Glucose (Week 2).
The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 2
Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voglibose 0.2 mg TID | Change From Baseline in Fasting Plasma Glucose (Week 2). | -3.5 mg/dL | Standard Deviation 21.28 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 2). | -15.5 mg/dL | Standard Deviation 18.77 |
| Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Change From Baseline in Fasting Plasma Glucose (Week 2). | -18.8 mg/dL | Standard Deviation 19.89 |
95% CI: [-18.5, -5.52]
95% CI: [-21.93, -8.73]
Secondary
Change From Baseline in Fasting Plasma Glucose (Week 4).
The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 4.
Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voglibose 0.2 mg TID | Change From Baseline in Fasting Plasma Glucose (Week 4). | -0.6 mg/dL | Standard Deviation 23.71 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 4). | -16.2 mg/dL | Standard Deviation 21.84 |
| Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Change From Baseline in Fasting Plasma Glucose (Week 4). | -22.6 mg/dL | Standard Deviation 23.96 |
95% CI: [-23.02, -8.27]
95% CI: [-29.68, -14.38]
Secondary
Change From Baseline in Fasting Plasma Glucose (Week 8).
The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 8.
Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voglibose 0.2 mg TID | Change From Baseline in Fasting Plasma Glucose (Week 8). | -2.5 mg/dL | Standard Deviation 25.94 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 8). | -20.8 mg/dL | Standard Deviation 22.1 |
| Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Change From Baseline in Fasting Plasma Glucose (Week 8). | -21.9 mg/dL | Standard Deviation 23.96 |
95% CI: [-26.09, -10.5]
95% CI: [-27.34, -11.34]
Secondary
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)).
The change between the value of glucagons collected at week 12 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.
Time frame: Baseline and Week 12
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voglibose 0.2 mg TID | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)). | -0.4 pg·hr/mL | Standard Deviation 64.18 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)). | -19.2 pg·hr/mL | Standard Deviation 42.72 |
| Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)). | -20.5 pg·hr/mL | Standard Deviation 41.97 |
95% CI: [-36.65, -0.9]
95% CI: [-37.82, -2.27]
Secondary
Change From Baseline in Glycosylated Hemoglobin (Week 2).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.
Time frame: Baseline and Week 2.
Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voglibose 0.2 mg TID | Change From Baseline in Glycosylated Hemoglobin (Week 2). | -0.01 percentage of Glycosylated Hemoglobin | Standard Deviation 0.18 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 2). | -0.19 percentage of Glycosylated Hemoglobin | Standard Deviation 0.149 |
| Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Change From Baseline in Glycosylated Hemoglobin (Week 2). | -0.21 percentage of Glycosylated Hemoglobin | Standard Deviation 0.175 |
95% CI: [-0.229, -0.123]
95% CI: [-0.247, -0.133]
Secondary
Change From Baseline in Glycosylated Hemoglobin (Week 4).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.
Time frame: Baseline and Week 4.
Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voglibose 0.2 mg TID | Change From Baseline in Glycosylated Hemoglobin (Week 4). | -0.02 percentage of Glycosylated Hemoglobin | Standard Deviation 0.301 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 4). | -0.44 percentage of Glycosylated Hemoglobin | Standard Deviation 0.234 |
| Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Change From Baseline in Glycosylated Hemoglobin (Week 4). | -0.43 percentage of Glycosylated Hemoglobin | Standard Deviation 0.263 |
95% CI: [-0.507, -0.334]
95% CI: [-0.504, -0.324]
Secondary
Change From Baseline in Glycosylated Hemoglobin (Week 8).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.
Time frame: Baseline and Week 8.
Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voglibose 0.2 mg TID | Change From Baseline in Glycosylated Hemoglobin (Week 8). | -0.01 percentage of Glycosylated Hemoglobin | Standard Deviation 0.398 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 8). | -0.74 percentage of Glycosylated Hemoglobin | Standard Deviation 0.427 |
| Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Change From Baseline in Glycosylated Hemoglobin (Week 8). | -0.75 percentage of Glycosylated Hemoglobin | Standard Deviation 0.392 |
95% CI: [-0.871, -0.605]
95% CI: [-0.875, -0.623]
Secondary
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2).
The change between the value of insulin collected at week 12 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.
Time frame: Baseline and Week 12
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voglibose 0.2 mg TID | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2). | -2.47 μU·hr/mL | Standard Deviation 10.817 |
| Alogliptin 12.5 mg QD | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2). | 4.62 μU·hr/mL | Standard Deviation 16.599 |
| Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2). | 1.50 μU·hr/mL | Standard Deviation 14.845 |
95% CI: [2.229, 11.958]
95% CI: [-0.521, 8.455]