Trial Outcomes & Findings for Comparative Study to Evaluate Efficacy and Safety When Metformin Hydrochloride 500 mg Once Daily is Added on to SYR-322 25 mg in Type 2 Diabetic Patients With Inadequate Glycemic Control Despite Treatment With SYR-322 25 mg in Addition to Diet and Exercise Therapy (NCT NCT02068443)
NCT ID: NCT02068443
Last Updated: 2023-09-28
Results Overview
The change in the value of HbA1c (NGSP) (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at End of Treatment Period relative to Baseline. A negative change from Baseline indicates improvement. An Analysis of Covariate (ANCOVA) model with change from Baseline as a dependent variable and Baseline and treatment as independent variables was used for main analyses.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
374 participants
Primary outcome timeframe
Baseline and End of Treatment (EOT) (Up to Week 24)
Results posted on
2023-09-28
Participant Flow
Participants took part in the study at 34 investigative sites in Japan from 06 February 2014 (first patient to sign the informed consent form) to 28 February 2015.
Participants with a diagnosis of Type 2 Diabetes Mellitus were enrolled equally in a 2:2:1 ratio to 1 of 3 treatment groups: alogliptin in combination with 500 mg total dose metformin hydrochloride administered either once a day (QD) or twice a day (BID) and alogliptin alone.
Participant milestones
| Measure |
Alogliptin Alone
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride QD
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride BID
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
71
|
152
|
151
|
|
Overall Study
COMPLETED
|
64
|
146
|
148
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
3
|
Reasons for withdrawal
| Measure |
Alogliptin Alone
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride QD
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride BID
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
|
|---|---|---|---|
|
Overall Study
Pretreatment Event/Adverse Event
|
0
|
5
|
2
|
|
Overall Study
Voluntary Withdrawal
|
4
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
0
|
|
Overall Study
Other Reason Not Specified
|
1
|
0
|
0
|
Baseline Characteristics
Comparative Study to Evaluate Efficacy and Safety When Metformin Hydrochloride 500 mg Once Daily is Added on to SYR-322 25 mg in Type 2 Diabetic Patients With Inadequate Glycemic Control Despite Treatment With SYR-322 25 mg in Addition to Diet and Exercise Therapy
Baseline characteristics by cohort
| Measure |
Alogliptin Alone
n=71 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride QD
n=152 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride BID
n=151 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
|
Total
n=374 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.2 years
STANDARD_DEVIATION 10.07 • n=5 Participants
|
56.9 years
STANDARD_DEVIATION 8.79 • n=7 Participants
|
57.6 years
STANDARD_DEVIATION 9.72 • n=5 Participants
|
57.2 years
STANDARD_DEVIATION 9.40 • n=4 Participants
|
|
Age, Customized
< 65 years
|
52 participants
n=5 Participants
|
119 participants
n=7 Participants
|
109 participants
n=5 Participants
|
280 participants
n=4 Participants
|
|
Age, Customized
≥ 65 years
|
19 participants
n=5 Participants
|
33 participants
n=7 Participants
|
42 participants
n=5 Participants
|
94 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
268 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
71 participants
n=5 Participants
|
152 participants
n=7 Participants
|
151 participants
n=5 Participants
|
374 participants
n=4 Participants
|
|
Height
|
165.3 cm
STANDARD_DEVIATION 8.89 • n=5 Participants
|
164.6 cm
STANDARD_DEVIATION 8.82 • n=7 Participants
|
164.6 cm
STANDARD_DEVIATION 9.12 • n=5 Participants
|
164.8 cm
STANDARD_DEVIATION 8.94 • n=4 Participants
|
|
Body Weight
|
68.00 kg
STANDARD_DEVIATION 13.702 • n=5 Participants
|
69.48 kg
STANDARD_DEVIATION 13.074 • n=7 Participants
|
69.55 kg
STANDARD_DEVIATION 14.927 • n=5 Participants
|
69.23 kg
STANDARD_DEVIATION 13.943 • n=4 Participants
|
|
Body Mass Index (BMI)
|
24.72 kg/m^2
STANDARD_DEVIATION 3.764 • n=5 Participants
|
25.61 kg/m^2
STANDARD_DEVIATION 4.231 • n=7 Participants
|
25.52 kg/m^2
STANDARD_DEVIATION 4.344 • n=5 Participants
|
25.41 kg/m^2
STANDARD_DEVIATION 4.196 • n=4 Participants
|
|
Duration of Type 2 Diabetes
|
7.73 years
STANDARD_DEVIATION 4.666 • n=5 Participants
|
7.02 years
STANDARD_DEVIATION 5.257 • n=7 Participants
|
7.04 years
STANDARD_DEVIATION 5.380 • n=5 Participants
|
7.16 years
STANDARD_DEVIATION 5.195 • n=4 Participants
|
|
Estimated Glomerular Filtration Rate (eGFR)
|
88.2 mL/min/1.73 m^2
STANDARD_DEVIATION 15.99 • n=5 Participants
|
91.0 mL/min/1.73 m^2
STANDARD_DEVIATION 16.82 • n=7 Participants
|
87.9 mL/min/1.73 m^2
STANDARD_DEVIATION 17.86 • n=5 Participants
|
89.2 mL/min/1.73 m^2
STANDARD_DEVIATION 17.11 • n=4 Participants
|
|
Hemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP)]
|
7.77 percent
STANDARD_DEVIATION 0.780 • n=5 Participants
|
7.82 percent
STANDARD_DEVIATION 0.820 • n=7 Participants
|
7.89 percent
STANDARD_DEVIATION 0.791 • n=5 Participants
|
7.84 percent
STANDARD_DEVIATION 0.800 • n=4 Participants
|
|
Fasting Blood Glucose
|
162.4 mg/dL
STANDARD_DEVIATION 31.03 • n=5 Participants
|
164.7 mg/dL
STANDARD_DEVIATION 31.02 • n=7 Participants
|
165.9 mg/dL
STANDARD_DEVIATION 30.92 • n=5 Participants
|
164.7 mg/dL
STANDARD_DEVIATION 30.92 • n=4 Participants
|
|
Fasting Insulin
|
9.918 μU/mL
STANDARD_DEVIATION 6.8797 • n=5 Participants
|
9.464 μU/mL
STANDARD_DEVIATION 6.7691 • n=7 Participants
|
9.342 μU/mL
STANDARD_DEVIATION 6.0645 • n=5 Participants
|
9.501 μU/mL
STANDARD_DEVIATION 6.4990 • n=4 Participants
|
|
Fasting Glucagon
|
91.7 pg/mL
STANDARD_DEVIATION 30.03 • n=5 Participants
|
86.8 pg/mL
STANDARD_DEVIATION 21.27 • n=7 Participants
|
89.3 pg/mL
STANDARD_DEVIATION 27.98 • n=5 Participants
|
88.8 pg/mL
STANDARD_DEVIATION 25.89 • n=4 Participants
|
|
Homeostasis Model Assessment of Insulin Resistance (HOMA-R)
|
4.05 unitless
STANDARD_DEVIATION 3.238 • n=5 Participants
|
3.87 unitless
STANDARD_DEVIATION 2.869 • n=7 Participants
|
3.92 unitless
STANDARD_DEVIATION 2.820 • n=5 Participants
|
3.93 unitless
STANDARD_DEVIATION 2.916 • n=4 Participants
|
|
Homeostasis Model Assessment Beta Cell Index (HOMA-β)
|
38.64 percent
STANDARD_DEVIATION 29.181 • n=5 Participants
|
36.05 percent
STANDARD_DEVIATION 27.848 • n=7 Participants
|
34.27 percent
STANDARD_DEVIATION 23.638 • n=5 Participants
|
35.82 percent
STANDARD_DEVIATION 26.464 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and End of Treatment (EOT) (Up to Week 24)Population: Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug.
The change in the value of HbA1c (NGSP) (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at End of Treatment Period relative to Baseline. A negative change from Baseline indicates improvement. An Analysis of Covariate (ANCOVA) model with change from Baseline as a dependent variable and Baseline and treatment as independent variables was used for main analyses.
Outcome measures
| Measure |
Alogliptin Alone
n=71 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride QD
n=152 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride BID
n=151 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) National Glycohemoglobin Standardization Program (NGSP) at the End of Treatment (EOT) Period
|
0.16 percent
Standard Error 0.072
|
-0.49 percent
Standard Error 0.049
|
-0.60 percent
Standard Error 0.049
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24)Population: FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.
The change in the value of HbA1c (NGSP) (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Weeks 2, 4, 8, 12, 16, 20, 24, and EOT relative to Baseline. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Alogliptin Alone
n=71 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride QD
n=152 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride BID
n=151 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in HbA1c (NGSP)
Week 2 (n=71, 152, 151)
|
0.01 percent
Standard Deviation 0.197
|
-0.14 percent
Standard Deviation 0.203
|
-0.19 percent
Standard Deviation 0.212
|
|
Change From Baseline in HbA1c (NGSP)
Week 4 (n=70, 150, 150)
|
0.01 percent
Standard Deviation 0.316
|
-0.28 percent
Standard Deviation 0.279
|
-0.35 percent
Standard Deviation 0.298
|
|
Change From Baseline in HbA1c (NGSP)
Week 8 (n=68, 149, 149)
|
-0.01 percent
Standard Deviation 0.402
|
-0.50 percent
Standard Deviation 0.408
|
-0.60 percent
Standard Deviation 0.454
|
|
Change From Baseline in HbA1c (NGSP)
Week 12 (n=67, 148, 148)
|
-0.02 percent
Standard Deviation 0.518
|
-0.61 percent
Standard Deviation 0.530
|
-0.75 percent
Standard Deviation 0.565
|
|
Change From Baseline in HbA1c (NGSP)
Week 16 (n=66, 148, 147)
|
0.01 percent
Standard Deviation 0.543
|
-0.64 percent
Standard Deviation 0.553
|
-0.81 percent
Standard Deviation 0.602
|
|
Change From Baseline in HbA1c (NGSP)
Week 20 (n=65, 146, 148)
|
0.11 percent
Standard Deviation 0.568
|
-0.58 percent
Standard Deviation 0.585
|
-0.71 percent
Standard Deviation 0.626
|
|
Change From Baseline in HbA1c (NGSP)
Week 24 (n=64, 146, 148)
|
0.17 percent
Standard Deviation 0.628
|
-0.49 percent
Standard Deviation 0.629
|
-0.62 percent
Standard Deviation 0.659
|
|
Change From Baseline in HbA1c (NGSP)
EOT (n=71, 152, 151)
|
0.17 percent
Standard Deviation 0.616
|
-0.49 percent
Standard Deviation 0.620
|
-0.62 percent
Standard Deviation 0.654
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24)Population: FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.
The value of HbA1c (NGSP) (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and EOT.
Outcome measures
| Measure |
Alogliptin Alone
n=71 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride QD
n=152 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride BID
n=151 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
|
|---|---|---|---|
|
HbA1c (NGSP)
Baseline (n=71, 152, 151)
|
7.77 percent
Standard Deviation 0.780
|
7.82 percent
Standard Deviation 0.820
|
7.89 percent
Standard Deviation 0.791
|
|
HbA1c (NGSP)
Week 2 (n=71, 152, 151)
|
7.78 percent
Standard Deviation 0.824
|
7.67 percent
Standard Deviation 0.796
|
7.70 percent
Standard Deviation 0.787
|
|
HbA1c (NGSP)
Week 4 (n=70, 150, 150)
|
7.78 percent
Standard Deviation 0.913
|
7.55 percent
Standard Deviation 0.773
|
7.54 percent
Standard Deviation 0.735
|
|
HbA1c (NGSP)
Week 8 (n=68, 149, 149)
|
7.72 percent
Standard Deviation 0.889
|
7.32 percent
Standard Deviation 0.725
|
7.28 percent
Standard Deviation 0.707
|
|
HbA1c (NGSP)
Week 12 (n=67, 148, 148)
|
7.70 percent
Standard Deviation 0.987
|
7.19 percent
Standard Deviation 0.721
|
7.13 percent
Standard Deviation 0.706
|
|
HbA1c (NGSP)
Week 16 (n=66, 148, 147)
|
7.70 percent
Standard Deviation 0.990
|
7.16 percent
Standard Deviation 0.725
|
7.08 percent
Standard Deviation 0.717
|
|
HbA1c (NGSP)
Week 20 (n=65, 146, 148)
|
7.81 percent
Standard Deviation 1.023
|
7.23 percent
Standard Deviation 0.749
|
7.18 percent
Standard Deviation 0.780
|
|
HbA1c (NGSP)
Week 24 (n=64, 146, 148)
|
7.86 percent
Standard Deviation 0.983
|
7.32 percent
Standard Deviation 0.798
|
7.27 percent
Standard Deviation 0.805
|
|
HbA1c (NGSP)
EOT (n=71, 152, 151)
|
7.95 percent
Standard Deviation 1.018
|
7.33 percent
Standard Deviation 0.819
|
7.28 percent
Standard Deviation 0.804
|
SECONDARY outcome
Timeframe: Baseline and EOT (Up to Week 24)Population: FAS included all randomized participants who received at least 1 dose of study drug.
HbA1c (NGSP) is the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound. The percentage of participants with HbA1c levels of ≥6.0, ≥7.0 and ≥8.0 at the end of Screening (Baseline) with change to target values \<6.0, \<7.0 and \<8.0 respectively at EOT.
Outcome measures
| Measure |
Alogliptin Alone
n=71 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride QD
n=152 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride BID
n=151 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving Target HbA1c (NGSP) Levels at the EOT Period
≥6.0 at Baseline to <6.0 at EOT (n=71, 152, 151)
|
0.0 percentage of participants
Interval 0.197 to
|
0.7 percentage of participants
Interval 0.203 to
|
1.3 percentage of participants
Interval 0.212 to
|
|
Percentage of Participants Achieving Target HbA1c (NGSP) Levels at the EOT Period
≥7.0 at Baseline to <7.0 at EOT ( n=63, 137, 140)
|
4.8 percentage of participants
Interval 0.316 to
|
35.0 percentage of participants
Interval 0.279 to
|
34.3 percentage of participants
Interval 0.298 to
|
|
Percentage of Participants Achieving Target HbA1c (NGSP) Levels at the EOT Period
≥8.0 at Baseline to <8.0 at EOT (n=26, 59, 64)
|
23.1 percentage of participants
Interval 0.402 to
|
47.5 percentage of participants
Interval 0.408 to
|
60.9 percentage of participants
Interval 0.454 to
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24)Population: FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.
The change in the value of the fasting plasma glucose collected at Weeks 2, 4, 8, 12, 16, 20 and 24 relative to Baseline. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Alogliptin Alone
n=71 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride QD
n=152 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride BID
n=151 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose
Week 2 (n=71, 152, 151)
|
0.4 mg/dL
Standard Deviation 16.62
|
-16.6 mg/dL
Standard Deviation 18.99
|
-23.7 mg/dL
Standard Deviation 20.50
|
|
Change From Baseline in Fasting Blood Glucose
Week 4 (n=70, 150, 150)
|
-0.9 mg/dL
Standard Deviation 26.32
|
-16.4 mg/dL
Standard Deviation 20.79
|
-25.2 mg/dL
Standard Deviation 20.73
|
|
Change From Baseline in Fasting Blood Glucose
Week 8 (n=68, 149, 149)
|
-2.1 mg/dL
Standard Deviation 23.30
|
-18.4 mg/dL
Standard Deviation 20.90
|
-23.4 mg/dL
Standard Deviation 24.13
|
|
Change From Baseline in Fasting Blood Glucose
Week 12 (n=67, 148, 148)
|
1.5 mg/dL
Standard Deviation 20.42
|
-15.2 mg/dL
Standard Deviation 23.83
|
-22.9 mg/dL
Standard Deviation 24.36
|
|
Change From Baseline in Fasting Blood Glucose
Week 16 (n=66, 148, 148)
|
0.4 mg/dL
Standard Deviation 22.63
|
-13.0 mg/dL
Standard Deviation 24.70
|
-22.6 mg/dL
Standard Deviation 25.50
|
|
Change From Baseline in Fasting Blood Glucose
Week 20 (n=65, 146, 148)
|
6.6 mg/dL
Standard Deviation 23.87
|
-11.3 mg/dL
Standard Deviation 23.34
|
-17.6 mg/dL
Standard Deviation 25.25
|
|
Change From Baseline in Fasting Blood Glucose
Week 24 (n=64, 146, 148)
|
8.0 mg/dL
Standard Deviation 21.85
|
-7.2 mg/dL
Standard Deviation 26.53
|
-18.2 mg/dL
Standard Deviation 25.28
|
|
Change From Baseline in Fasting Blood Glucose
EOT (n=71, 152, 151)
|
7.4 mg/dL
Standard Deviation 26.89
|
-7.6 mg/dL
Standard Deviation 26.41
|
-18.2 mg/dL
Standard Deviation 25.41
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24)Population: FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.
The value of the fasting plasma glucose collected at Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT.
Outcome measures
| Measure |
Alogliptin Alone
n=71 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride QD
n=152 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride BID
n=151 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
|
|---|---|---|---|
|
Fasting Blood Glucose
Baseline (n=71, 152, 151)
|
162.4 mg/dL
Standard Deviation 31.03
|
164.7 mg/dL
Standard Deviation 31.02
|
165.9 mg/dL
Standard Deviation 30.92
|
|
Fasting Blood Glucose
Week 2 (n=71, 152, 151)
|
162.8 mg/dL
Standard Deviation 33.42
|
148.1 mg/dL
Standard Deviation 26.70
|
142.3 mg/dL
Standard Deviation 25.24
|
|
Fasting Blood Glucose
Week 4 (n=70, 150, 150)
|
161.4 mg/dL
Standard Deviation 37.17
|
148.7 mg/dL
Standard Deviation 27.56
|
140.7 mg/dL
Standard Deviation 23.74
|
|
Fasting Blood Glucose
Week 8 (n=68, 149, 149)
|
158.9 mg/dL
Standard Deviation 33.15
|
146.5 mg/dL
Standard Deviation 25.21
|
142.0 mg/dL
Standard Deviation 25.35
|
|
Fasting Blood Glucose
Week 12 (n=67, 148, 148)
|
161.1 mg/dL
Standard Deviation 33.43
|
149.2 mg/dL
Standard Deviation 30.70
|
142.5 mg/dL
Standard Deviation 27.85
|
|
Fasting Blood Glucose
Week 16 (n=66, 148, 148)
|
158.5 mg/dL
Standard Deviation 29.71
|
151.4 mg/dL
Standard Deviation 32.52
|
142.9 mg/dL
Standard Deviation 26.16
|
|
Fasting Blood Glucose
Week 20 (n=65, 146, 148)
|
164.6 mg/dL
Standard Deviation 31.64
|
153.2 mg/dL
Standard Deviation 30.92
|
147.8 mg/dL
Standard Deviation 28.21
|
|
Fasting Blood Glucose
Week 24 (n=64, 146, 148)
|
165.9 mg/dL
Standard Deviation 31.19
|
157.4 mg/dL
Standard Deviation 33.21
|
147.3 mg/dL
Standard Deviation 26.85
|
|
Fasting Blood Glucose
EOT (n=71, 152, 151)
|
169.8 mg/dL
Standard Deviation 36.03
|
157.1 mg/dL
Standard Deviation 32.82
|
147.7 mg/dL
Standard Deviation 27.20
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Safety Analysis Set included all participants who received at least 1 dose of study drug.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Alogliptin Alone
n=71 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride QD
n=152 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride BID
n=151 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAE)
|
57.7 percentage of participants
|
50.7 percentage of participants
|
52.3 percentage of participants
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Safety Analysis Set included all participants who received at least 1 dose of study drug.
The percentage of participants with any clinically relevant safety laboratory changes (chemistry, hematology and urinalysis) collected throughout study and recorded as AEs.
Outcome measures
| Measure |
Alogliptin Alone
n=71 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride QD
n=152 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride BID
n=151 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis
Blood Creatine Phosphokinase increased
|
0 percentage of participants
|
2.0 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis
Blood Lactic Acid increased
|
0 percentage of participants
|
1.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis
Amylase increased
|
0 percentage of participants
|
0 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis
Lipase increased
|
0 percentage of participants
|
0 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis
Blood Albumin decreased
|
0 percentage of participants
|
0 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis
Gamma-glutamyltransferase increased
|
0 percentage of participants
|
0 percentage of participants
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Safety Analysis Set included all participants who received at least 1 dose of study drug.
Vital signs included sitting systolic and diastolic blood pressures (mmHg) (measured after resting for ≥ 5 minutes) and pulse rate (beats per minute \[bpm\]).
Outcome measures
| Measure |
Alogliptin Alone
n=71 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride QD
n=152 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride BID
n=151 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants With TEAEs Related to Vital Signs
Hypertension
|
1.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With TEAEs Related to Vital Signs
Blood Pressure increased
|
0 percentage of participants
|
0 percentage of participants
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 24Population: Safety Analysis Set, all participants who received at least 1 dose of study drug, with ECG values "normal" or "abnormal not clinically significant" at Baseline.
Number of participants who had ECG findings changed from "normal" or "abnormal but not clinically relevant" at Baseline to "abnormal and clinically relevant".
Outcome measures
| Measure |
Alogliptin Alone
n=71 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride QD
n=151 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride BID
n=151 Participants
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
|
|---|---|---|---|
|
Number of Participants Who Had Clinically Relevant Changes in 12-Lead Electrocardiogram (ECG) Findings
Week 24
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants Who Had Clinically Relevant Changes in 12-Lead Electrocardiogram (ECG) Findings
Week 12
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Alogliptin Alone
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Alogliptin + Metformin Hydrochloride QD
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Alogliptin + Metformin Hydrochloride BID
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alogliptin Alone
n=71 participants at risk
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride QD
n=152 participants at risk
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride BID
n=151 participants at risk
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
|
|---|---|---|---|
|
Infections and infestations
Diverticulitis
|
1.4%
1/71 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/152 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/151 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/71 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.66%
1/152 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/151 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/71 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.66%
1/152 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/151 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/71 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.66%
1/152 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/151 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/71 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.66%
1/152 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/151 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.00%
0/71 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.66%
1/152 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/151 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.00%
0/71 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.66%
1/152 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/151 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/71 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.66%
1/152 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/151 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/71 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.66%
1/152 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/151 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/71 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.66%
1/152 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/151 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/71 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.66%
1/152 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/151 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Splenic injury
|
0.00%
0/71 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.66%
1/152 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/151 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/71 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.66%
1/152 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/151 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/71 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.66%
1/152 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/151 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Alogliptin Alone
n=71 participants at risk
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride QD
n=152 participants at risk
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
|
Alogliptin + Metformin Hydrochloride BID
n=151 participants at risk
Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
11.3%
8/71 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.5%
22/152 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.6%
19/151 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pharyngitis
|
4.2%
3/71 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.0%
3/152 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.0%
9/151 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
5.6%
4/71 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.66%
1/152 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/151 • 24 Weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Study Director
Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)
Phone: +1-877-825-3327
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER