Trial Outcomes & Findings for Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI" (NCT NCT01945216)
NCT ID: NCT01945216
Last Updated: 2019-11-19
Results Overview
Recruitment status
COMPLETED
Target enrollment
3317 participants
Primary outcome timeframe
Up to Month 36
Results posted on
2019-11-19
Participant Flow
Participants took part in the study at 608 investigative sites in Japan, from 8-July-2010 to 31-October-2015. Data reports overall population, since data not collected separately per arm as specified in protocol.
Participants with type 2 diabetes mellitus who failed to respond adequately to diet and/or exercise therapy and α-glucosidase inhibitor were enrolled to receive Alogliptin as routine medical care. Treatments were not allocated at the start of the study. Thus, the Participant Flow cannot be presented "per Arm".
Participant milestones
| Measure |
Overall Population
Alogliptin 25 milligram (mg), tablets, orally, once daily, up to 36 months along with an alpha-glucosidase inhibitor (α-GI), without an α-GI, or the other diabetic drugs from the start of administration of alogliptin and during the treatment period of alogliptin in routine medical care.
|
|---|---|
|
Overall Study
STARTED
|
3317
|
|
Overall Study
COMPLETED
|
3218
|
|
Overall Study
NOT COMPLETED
|
99
|
Reasons for withdrawal
| Measure |
Overall Population
Alogliptin 25 milligram (mg), tablets, orally, once daily, up to 36 months along with an alpha-glucosidase inhibitor (α-GI), without an α-GI, or the other diabetic drugs from the start of administration of alogliptin and during the treatment period of alogliptin in routine medical care.
|
|---|---|
|
Overall Study
Case report forms (CRF) uncollected
|
52
|
|
Overall Study
Protocol Violation
|
42
|
|
Overall Study
CRF not assured by investigators
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Alogliptin
n=1560 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 36 months in routine medical care. Participants in this group received no diabetic drugs within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
|
Alogliptin + αGI
n=669 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 36 months in routine medical care. Participants in this group received an α-GI within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
|
Alogliptin + Other
n=989 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in routine medical care. Participants in this group did not receive an α-GI within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
|
Total
n=3218 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Complications
Had No Complications
|
314 Participants
n=1560 Participants
|
61 Participants
n=669 Participants
|
103 Participants
n=989 Participants
|
478 Participants
n=3218 Participants
|
|
Age, Continuous
|
65.0 years
STANDARD_DEVIATION 12.28 • n=1560 Participants
|
67.1 years
STANDARD_DEVIATION 12.13 • n=669 Participants
|
64.0 years
STANDARD_DEVIATION 12.57 • n=989 Participants
|
65.1 years
STANDARD_DEVIATION 12.39 • n=3218 Participants
|
|
Sex: Female, Male
Female
|
640 Participants
n=1560 Participants
|
286 Participants
n=669 Participants
|
438 Participants
n=989 Participants
|
1364 Participants
n=3218 Participants
|
|
Sex: Female, Male
Male
|
920 Participants
n=1560 Participants
|
383 Participants
n=669 Participants
|
551 Participants
n=989 Participants
|
1854 Participants
n=3218 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Japan
|
1560 Participants
n=1560 Participants
|
669 Participants
n=669 Participants
|
989 Participants
n=989 Participants
|
3218 Participants
n=3218 Participants
|
|
Time From Diagnosis of Type 2 Diabetes
|
3.45 years
STANDARD_DEVIATION 4.923 • n=1161 Participants • The number analyzed is the number of participants with data available for analysis.
|
8.10 years
STANDARD_DEVIATION 7.018 • n=501 Participants • The number analyzed is the number of participants with data available for analysis.
|
5.03 years
STANDARD_DEVIATION 5.732 • n=722 Participants • The number analyzed is the number of participants with data available for analysis.
|
4.91 years
STANDARD_DEVIATION 5.937 • n=2384 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Height
|
160.22 cm
STANDARD_DEVIATION 9.686 • n=1439 Participants • The number analyzed is the number of participants with data available for analysis.
|
159.33 cm
STANDARD_DEVIATION 9.535 • n=621 Participants • The number analyzed is the number of participants with data available for analysis.
|
160.18 cm
STANDARD_DEVIATION 9.738 • n=894 Participants • The number analyzed is the number of participants with data available for analysis.
|
160.02 cm
STANDARD_DEVIATION 9.674 • n=2954 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Body Weight
|
64.49 kg
STANDARD_DEVIATION 13.699 • n=1538 Participants • The number analyzed is the number of participants with data available for analysis.
|
62.68 kg
STANDARD_DEVIATION 13.005 • n=664 Participants • The number analyzed is the number of participants with data available for analysis.
|
64.51 kg
STANDARD_DEVIATION 14.046 • n=976 Participants • The number analyzed is the number of participants with data available for analysis.
|
64.12 kg
STANDARD_DEVIATION 13.681 • n=3178 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
BMI
|
25.00 kg/m^2
STANDARD_DEVIATION 4.225 • n=1431 Participants • The number analyzed is the number of participants with data available for analysis.
|
24.52 kg/m^2
STANDARD_DEVIATION 4.277 • n=619 Participants • The number analyzed is the number of participants with data available for analysis.
|
25.04 kg/m^2
STANDARD_DEVIATION 4.190 • n=889 Participants • The number analyzed is the number of participants with data available for analysis.
|
24.91 kg/m^2
STANDARD_DEVIATION 4.229 • n=2939 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Waist Circumference (Male)
< 85cm
|
96 Participants
n=920 Participants • This baseline characteristic was analyzed only in male participants.
|
55 Participants
n=383 Participants • This baseline characteristic was analyzed only in male participants.
|
61 Participants
n=551 Participants • This baseline characteristic was analyzed only in male participants.
|
212 Participants
n=1854 Participants • This baseline characteristic was analyzed only in male participants.
|
|
Waist Circumference (Male)
≥ 85cm
|
211 Participants
n=920 Participants • This baseline characteristic was analyzed only in male participants.
|
80 Participants
n=383 Participants • This baseline characteristic was analyzed only in male participants.
|
120 Participants
n=551 Participants • This baseline characteristic was analyzed only in male participants.
|
411 Participants
n=1854 Participants • This baseline characteristic was analyzed only in male participants.
|
|
Waist Circumference (Male)
Unknown
|
613 Participants
n=920 Participants • This baseline characteristic was analyzed only in male participants.
|
248 Participants
n=383 Participants • This baseline characteristic was analyzed only in male participants.
|
370 Participants
n=551 Participants • This baseline characteristic was analyzed only in male participants.
|
1231 Participants
n=1854 Participants • This baseline characteristic was analyzed only in male participants.
|
|
Waist Circumference (Female)
< 90cm
|
152 Participants
n=640 Participants • This baseline characteristic was analyzed only in female participants.
|
65 Participants
n=286 Participants • This baseline characteristic was analyzed only in female participants.
|
85 Participants
n=438 Participants • This baseline characteristic was analyzed only in female participants.
|
302 Participants
n=1364 Participants • This baseline characteristic was analyzed only in female participants.
|
|
Waist Circumference (Female)
≥ 90cm
|
70 Participants
n=640 Participants • This baseline characteristic was analyzed only in female participants.
|
37 Participants
n=286 Participants • This baseline characteristic was analyzed only in female participants.
|
52 Participants
n=438 Participants • This baseline characteristic was analyzed only in female participants.
|
159 Participants
n=1364 Participants • This baseline characteristic was analyzed only in female participants.
|
|
Waist Circumference (Female)
Unknown
|
418 Participants
n=640 Participants • This baseline characteristic was analyzed only in female participants.
|
184 Participants
n=286 Participants • This baseline characteristic was analyzed only in female participants.
|
301 Participants
n=438 Participants • This baseline characteristic was analyzed only in female participants.
|
903 Participants
n=1364 Participants • This baseline characteristic was analyzed only in female participants.
|
|
Healthcare category
Out-patient
|
1524 Participants
n=1560 Participants
|
640 Participants
n=669 Participants
|
942 Participants
n=989 Participants
|
3106 Participants
n=3218 Participants
|
|
Healthcare category
In-patient
|
3 Participants
n=1560 Participants
|
8 Participants
n=669 Participants
|
11 Participants
n=989 Participants
|
22 Participants
n=3218 Participants
|
|
Healthcare category
In- to/from out-patient
|
33 Participants
n=1560 Participants
|
21 Participants
n=669 Participants
|
36 Participants
n=989 Participants
|
90 Participants
n=3218 Participants
|
|
Pregnancy Status
Not pregnant
|
640 Participants
n=640 Participants • This baseline characteristic was analyzed only in female participants.
|
286 Participants
n=286 Participants • This baseline characteristic was analyzed only in female participants.
|
438 Participants
n=438 Participants • This baseline characteristic was analyzed only in female participants.
|
1364 Participants
n=1364 Participants • This baseline characteristic was analyzed only in female participants.
|
|
Pregnancy Status
Pregnant
|
0 Participants
n=640 Participants • This baseline characteristic was analyzed only in female participants.
|
0 Participants
n=286 Participants • This baseline characteristic was analyzed only in female participants.
|
0 Participants
n=438 Participants • This baseline characteristic was analyzed only in female participants.
|
0 Participants
n=1364 Participants • This baseline characteristic was analyzed only in female participants.
|
|
History of Allergy
Had no history of Allergy
|
1377 Participants
n=1560 Participants
|
583 Participants
n=669 Participants
|
856 Participants
n=989 Participants
|
2816 Participants
n=3218 Participants
|
|
History of Allergy
Had history of Allergy
|
127 Participants
n=1560 Participants
|
57 Participants
n=669 Participants
|
104 Participants
n=989 Participants
|
288 Participants
n=3218 Participants
|
|
History of Allergy
Unknown
|
56 Participants
n=1560 Participants
|
29 Participants
n=669 Participants
|
29 Participants
n=989 Participants
|
114 Participants
n=3218 Participants
|
|
Complications
Had Complications
|
1246 Participants
n=1560 Participants
|
608 Participants
n=669 Participants
|
886 Participants
n=989 Participants
|
2740 Participants
n=3218 Participants
|
|
Diabetic Complications
Had No Diabetic Complications
|
1402 Participants
n=1560 Participants
|
506 Participants
n=669 Participants
|
831 Participants
n=989 Participants
|
2739 Participants
n=3218 Participants
|
|
Diabetic Complications
Had Diabetic Complications
|
158 Participants
n=1560 Participants
|
163 Participants
n=669 Participants
|
158 Participants
n=989 Participants
|
479 Participants
n=3218 Participants
|
|
Hypertension Complications
Had No Hypertension Complications
|
676 Participants
n=1560 Participants
|
249 Participants
n=669 Participants
|
383 Participants
n=989 Participants
|
1308 Participants
n=3218 Participants
|
|
Hypertension Complications
Had Hypertension Complications
|
884 Participants
n=1560 Participants
|
420 Participants
n=669 Participants
|
606 Participants
n=989 Participants
|
1910 Participants
n=3218 Participants
|
|
Hyperlipidemia Complications
Had No Hyperlipidemia Complications
|
715 Participants
n=1560 Participants
|
246 Participants
n=669 Participants
|
375 Participants
n=989 Participants
|
1336 Participants
n=3218 Participants
|
|
Hyperlipidemia Complications
Had Hyperlipidemia Complications
|
845 Participants
n=1560 Participants
|
423 Participants
n=669 Participants
|
614 Participants
n=989 Participants
|
1882 Participants
n=3218 Participants
|
|
Hyperuricemia Complications
Had No Hyperuricemia Complications
|
1411 Participants
n=1560 Participants
|
611 Participants
n=669 Participants
|
891 Participants
n=989 Participants
|
2913 Participants
n=3218 Participants
|
|
Hyperuricemia Complications
Had Hyperuricemia Complications
|
149 Participants
n=1560 Participants
|
58 Participants
n=669 Participants
|
98 Participants
n=989 Participants
|
305 Participants
n=3218 Participants
|
|
Hepatic Dysfunction Complications
Had No Hepatic Dysfunction Complications
|
1322 Participants
n=1560 Participants
|
553 Participants
n=669 Participants
|
799 Participants
n=989 Participants
|
2674 Participants
n=3218 Participants
|
|
Hepatic Dysfunction Complications
Had Hepatic Dysfunction Complications
|
238 Participants
n=1560 Participants
|
116 Participants
n=669 Participants
|
190 Participants
n=989 Participants
|
544 Participants
n=3218 Participants
|
|
Degree of Hepatic Dysfunction
Normal
|
986 Participants
n=1560 Participants
|
443 Participants
n=669 Participants
|
596 Participants
n=989 Participants
|
2025 Participants
n=3218 Participants
|
|
Degree of Hepatic Dysfunction
Grade 1
|
122 Participants
n=1560 Participants
|
36 Participants
n=669 Participants
|
87 Participants
n=989 Participants
|
245 Participants
n=3218 Participants
|
|
Degree of Hepatic Dysfunction
Grade 2
|
22 Participants
n=1560 Participants
|
10 Participants
n=669 Participants
|
19 Participants
n=989 Participants
|
51 Participants
n=3218 Participants
|
|
Degree of Hepatic Dysfunction
Grade 3
|
0 Participants
n=1560 Participants
|
0 Participants
n=669 Participants
|
0 Participants
n=989 Participants
|
0 Participants
n=3218 Participants
|
|
Degree of Hepatic Dysfunction
Unknown
|
430 Participants
n=1560 Participants
|
180 Participants
n=669 Participants
|
287 Participants
n=989 Participants
|
897 Participants
n=3218 Participants
|
|
Renal Dysfunction Complications
Had No Renal Dysfunction Complications
|
1427 Participants
n=1560 Participants
|
563 Participants
n=669 Participants
|
861 Participants
n=989 Participants
|
2851 Participants
n=3218 Participants
|
|
Renal Dysfunction Complications
Had Renal Dysfunction Complications
|
133 Participants
n=1560 Participants
|
106 Participants
n=669 Participants
|
128 Participants
n=989 Participants
|
367 Participants
n=3218 Participants
|
|
Degree of Renal Dysfunction (eGFR)
Normal
|
249 Participants
n=1560 Participants
|
108 Participants
n=669 Participants
|
189 Participants
n=989 Participants
|
546 Participants
n=3218 Participants
|
|
Degree of Renal Dysfunction (eGFR)
Mild
|
667 Participants
n=1560 Participants
|
254 Participants
n=669 Participants
|
361 Participants
n=989 Participants
|
1282 Participants
n=3218 Participants
|
|
Degree of Renal Dysfunction (eGFR)
Moderate
|
190 Participants
n=1560 Participants
|
108 Participants
n=669 Participants
|
121 Participants
n=989 Participants
|
419 Participants
n=3218 Participants
|
|
Degree of Renal Dysfunction (eGFR)
Severe
|
28 Participants
n=1560 Participants
|
22 Participants
n=669 Participants
|
25 Participants
n=989 Participants
|
75 Participants
n=3218 Participants
|
|
Degree of Renal Dysfunction (eGFR)
Unknown
|
426 Participants
n=1560 Participants
|
177 Participants
n=669 Participants
|
293 Participants
n=989 Participants
|
896 Participants
n=3218 Participants
|
|
Degree of Renal Dysfunction (Cr)
Normal or Mild
|
1089 Participants
n=1560 Participants
|
466 Participants
n=669 Participants
|
664 Participants
n=989 Participants
|
2219 Participants
n=3218 Participants
|
|
Degree of Renal Dysfunction (Cr)
Moderate
|
24 Participants
n=1560 Participants
|
7 Participants
n=669 Participants
|
17 Participants
n=989 Participants
|
48 Participants
n=3218 Participants
|
|
Degree of Renal Dysfunction (Cr)
Severe
|
21 Participants
n=1560 Participants
|
19 Participants
n=669 Participants
|
15 Participants
n=989 Participants
|
55 Participants
n=3218 Participants
|
|
Degree of Renal Dysfunction (Cr)
Unknown
|
426 Participants
n=1560 Participants
|
177 Participants
n=669 Participants
|
293 Participants
n=989 Participants
|
896 Participants
n=3218 Participants
|
|
Cardiac Disease Complications
Had No Cardiac Disease Complications
|
1417 Participants
n=1560 Participants
|
578 Participants
n=669 Participants
|
870 Participants
n=989 Participants
|
2865 Participants
n=3218 Participants
|
|
Cardiac Disease Complications
Had Cardiac Disease Complications
|
143 Participants
n=1560 Participants
|
91 Participants
n=669 Participants
|
119 Participants
n=989 Participants
|
353 Participants
n=3218 Participants
|
|
Heart Failure Complications
Had No Heart Failure Complications
|
1517 Participants
n=1560 Participants
|
649 Participants
n=669 Participants
|
970 Participants
n=989 Participants
|
3136 Participants
n=3218 Participants
|
|
Heart Failure Complications
Had Heart Failure Complications
|
43 Participants
n=1560 Participants
|
20 Participants
n=669 Participants
|
19 Participants
n=989 Participants
|
82 Participants
n=3218 Participants
|
|
New York Heart Association (NYHA) Heart Failure Classification
NYHA Class I
|
26 Participants
n=43 Participants • This baseline characteristic was analyzed only for Participants who had complications of heart failure.
|
13 Participants
n=20 Participants • This baseline characteristic was analyzed only for Participants who had complications of heart failure.
|
11 Participants
n=19 Participants • This baseline characteristic was analyzed only for Participants who had complications of heart failure.
|
50 Participants
n=82 Participants • This baseline characteristic was analyzed only for Participants who had complications of heart failure.
|
|
New York Heart Association (NYHA) Heart Failure Classification
NYHA Class II
|
16 Participants
n=43 Participants • This baseline characteristic was analyzed only for Participants who had complications of heart failure.
|
5 Participants
n=20 Participants • This baseline characteristic was analyzed only for Participants who had complications of heart failure.
|
5 Participants
n=19 Participants • This baseline characteristic was analyzed only for Participants who had complications of heart failure.
|
26 Participants
n=82 Participants • This baseline characteristic was analyzed only for Participants who had complications of heart failure.
|
|
New York Heart Association (NYHA) Heart Failure Classification
NYHA Class III
|
1 Participants
n=43 Participants • This baseline characteristic was analyzed only for Participants who had complications of heart failure.
|
1 Participants
n=20 Participants • This baseline characteristic was analyzed only for Participants who had complications of heart failure.
|
1 Participants
n=19 Participants • This baseline characteristic was analyzed only for Participants who had complications of heart failure.
|
3 Participants
n=82 Participants • This baseline characteristic was analyzed only for Participants who had complications of heart failure.
|
|
New York Heart Association (NYHA) Heart Failure Classification
NYHA Class IV
|
0 Participants
n=43 Participants • This baseline characteristic was analyzed only for Participants who had complications of heart failure.
|
0 Participants
n=20 Participants • This baseline characteristic was analyzed only for Participants who had complications of heart failure.
|
0 Participants
n=19 Participants • This baseline characteristic was analyzed only for Participants who had complications of heart failure.
|
0 Participants
n=82 Participants • This baseline characteristic was analyzed only for Participants who had complications of heart failure.
|
|
New York Heart Association (NYHA) Heart Failure Classification
Unknown
|
0 Participants
n=43 Participants • This baseline characteristic was analyzed only for Participants who had complications of heart failure.
|
1 Participants
n=20 Participants • This baseline characteristic was analyzed only for Participants who had complications of heart failure.
|
2 Participants
n=19 Participants • This baseline characteristic was analyzed only for Participants who had complications of heart failure.
|
3 Participants
n=82 Participants • This baseline characteristic was analyzed only for Participants who had complications of heart failure.
|
|
Stroke-Related Disorder Complications
Had No Stroke-Related Disorder Complications
|
1505 Participants
n=1560 Participants
|
613 Participants
n=669 Participants
|
922 Participants
n=989 Participants
|
3040 Participants
n=3218 Participants
|
|
Stroke-Related Disorder Complications
Had Stroke-Related Disorder Complications
|
55 Participants
n=1560 Participants
|
56 Participants
n=669 Participants
|
67 Participants
n=989 Participants
|
178 Participants
n=3218 Participants
|
|
Allergic Disease Complications
Had No Allergic Disease Complications
|
1466 Participants
n=1560 Participants
|
627 Participants
n=669 Participants
|
914 Participants
n=989 Participants
|
3007 Participants
n=3218 Participants
|
|
Allergic Disease Complications
Had Allergic Disease Complications
|
94 Participants
n=1560 Participants
|
42 Participants
n=669 Participants
|
75 Participants
n=989 Participants
|
211 Participants
n=3218 Participants
|
|
Malignancy Complications
Had No Malignancy Complications
|
1543 Participants
n=1560 Participants
|
661 Participants
n=669 Participants
|
960 Participants
n=989 Participants
|
3164 Participants
n=3218 Participants
|
|
Malignancy Complications
Had Malignancy Complications
|
17 Participants
n=1560 Participants
|
8 Participants
n=669 Participants
|
29 Participants
n=989 Participants
|
54 Participants
n=3218 Participants
|
|
Medical history
Had No Medical History
|
1255 Participants
n=1560 Participants
|
501 Participants
n=669 Participants
|
768 Participants
n=989 Participants
|
2524 Participants
n=3218 Participants
|
|
Medical history
Had Medical History
|
225 Participants
n=1560 Participants
|
126 Participants
n=669 Participants
|
166 Participants
n=989 Participants
|
517 Participants
n=3218 Participants
|
|
Medical history
Unknown
|
80 Participants
n=1560 Participants
|
42 Participants
n=669 Participants
|
55 Participants
n=989 Participants
|
177 Participants
n=3218 Participants
|
|
Alcohol Consumption Classification
Drinking Almost Everyday
|
412 Participants
n=1560 Participants
|
158 Participants
n=669 Participants
|
276 Participants
n=989 Participants
|
846 Participants
n=3218 Participants
|
|
Alcohol Consumption Classification
Not Drinking Almost Everyday
|
891 Participants
n=1560 Participants
|
383 Participants
n=669 Participants
|
526 Participants
n=989 Participants
|
1800 Participants
n=3218 Participants
|
|
Alcohol Consumption Classification
Unknown
|
257 Participants
n=1560 Participants
|
128 Participants
n=669 Participants
|
187 Participants
n=989 Participants
|
572 Participants
n=3218 Participants
|
|
Smoking Classification
Never Smoked
|
737 Participants
n=1560 Participants
|
292 Participants
n=669 Participants
|
414 Participants
n=989 Participants
|
1443 Participants
n=3218 Participants
|
|
Smoking Classification
Current Smoker
|
227 Participants
n=1560 Participants
|
77 Participants
n=669 Participants
|
155 Participants
n=989 Participants
|
459 Participants
n=3218 Participants
|
|
Smoking Classification
Ex-Smoker
|
249 Participants
n=1560 Participants
|
153 Participants
n=669 Participants
|
160 Participants
n=989 Participants
|
562 Participants
n=3218 Participants
|
|
Smoking Classification
Unknown
|
347 Participants
n=1560 Participants
|
147 Participants
n=669 Participants
|
260 Participants
n=989 Participants
|
754 Participants
n=3218 Participants
|
|
Glycosylated Hemoglobin A1c (HbA1c)
HbA1c <6.0 percent
|
28 Participants
n=1560 Participants
|
24 Participants
n=669 Participants
|
33 Participants
n=989 Participants
|
85 Participants
n=3218 Participants
|
|
Glycosylated Hemoglobin A1c (HbA1c)
HbA1c >=6.0 to <7.0 percent
|
475 Participants
n=1560 Participants
|
134 Participants
n=669 Participants
|
195 Participants
n=989 Participants
|
804 Participants
n=3218 Participants
|
|
Glycosylated Hemoglobin A1c (HbA1c)
HbA1c >=7.0 to <8.0 percent
|
576 Participants
n=1560 Participants
|
270 Participants
n=669 Participants
|
320 Participants
n=989 Participants
|
1166 Participants
n=3218 Participants
|
|
Glycosylated Hemoglobin A1c (HbA1c)
HbA1c >=8.0 percent
|
351 Participants
n=1560 Participants
|
195 Participants
n=669 Participants
|
345 Participants
n=989 Participants
|
891 Participants
n=3218 Participants
|
|
Glycosylated Hemoglobin A1c (HbA1c)
Unknown
|
130 Participants
n=1560 Participants
|
46 Participants
n=669 Participants
|
96 Participants
n=989 Participants
|
272 Participants
n=3218 Participants
|
PRIMARY outcome
Timeframe: Up to Month 36Population: Safety Analysis Set was defined as all participants who were enrolled and completed the study.
Outcome measures
| Measure |
Alogliptin
n=1560 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 36 months in routine medical care. Participants in this group received no diabetic drugs within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
|
Alogliptin + α-GI
n=669 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 36 months in routine medical care. Participants in this group received an α-GI within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
|
Alogliptin + Other
n=989 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in routine medical care. Participants in this group did not receive an α-GI within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
|
|---|---|---|---|
|
Number of Participants Who Experience at Least One Adverse Events
|
151 Participants
|
98 Participants
|
139 Participants
|
PRIMARY outcome
Timeframe: Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36)Population: The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. Reported group were Alogliptin and Alogliptin + α-GI and data for Alogliptin + Other were not collected as specified in protocol.
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 month 36 relative to baseline.
Outcome measures
| Measure |
Alogliptin
n=1341 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 36 months in routine medical care. Participants in this group received no diabetic drugs within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
|
Alogliptin + α-GI
n=612 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 36 months in routine medical care. Participants in this group received an α-GI within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
|
Alogliptin + Other
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in routine medical care. Participants in this group did not receive an α-GI within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change at Month 1
|
-0.45 Percent
Standard Deviation 0.581
|
-0.33 Percent
Standard Deviation 0.708
|
—
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change at Month 3
|
-0.79 Percent
Standard Deviation 1.007
|
-0.54 Percent
Standard Deviation 1.074
|
—
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change at Month 6
|
-0.84 Percent
Standard Deviation 1.045
|
-0.70 Percent
Standard Deviation 1.128
|
—
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change at Month 12
|
-0.83 Percent
Standard Deviation 1.102
|
-0.75 Percent
Standard Deviation 1.054
|
—
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change at Month 18
|
-0.81 Percent
Standard Deviation 1.077
|
-0.62 Percent
Standard Deviation 1.190
|
—
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change at Month 24
|
-0.82 Percent
Standard Deviation 1.095
|
-0.66 Percent
Standard Deviation 1.214
|
—
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change at Month 30
|
-0.83 Percent
Standard Deviation 1.114
|
-0.73 Percent
Standard Deviation 1.271
|
—
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change at Month 36
|
-0.84 Percent
Standard Deviation 1.131
|
-0.72 Percent
Standard Deviation 1.318
|
—
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change at Final Assessment
|
-0.81 Percent
Standard Deviation 1.140
|
-0.63 Percent
Standard Deviation 1.381
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36)Population: The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. Reported group were Alogliptin and Alogliptin + α-GI and data for Alogliptin + Other were not collected as specified in protocol.
The change in the value of fasting blood glucose collected at month 36 relative to baseline.
Outcome measures
| Measure |
Alogliptin
n=510 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 36 months in routine medical care. Participants in this group received no diabetic drugs within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
|
Alogliptin + α-GI
n=229 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 36 months in routine medical care. Participants in this group received an α-GI within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
|
Alogliptin + Other
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in routine medical care. Participants in this group did not receive an α-GI within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
|
|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose
Change at Month 1
|
-22.9 mg/dL
Standard Deviation 45.05
|
-4.9 mg/dL
Standard Deviation 41.17
|
—
|
|
Change From Baseline in Fasting Blood Glucose
Change at Month 3
|
-21.7 mg/dL
Standard Deviation 39.40
|
-8.3 mg/dL
Standard Deviation 36.58
|
—
|
|
Change From Baseline in Fasting Blood Glucose
Change at Month 6
|
-19.1 mg/dL
Standard Deviation 36.46
|
-14.5 mg/dL
Standard Deviation 49.90
|
—
|
|
Change From Baseline in Fasting Blood Glucose
Change at Month 12
|
-23.1 mg/dL
Standard Deviation 43.60
|
-18.4 mg/dL
Standard Deviation 41.37
|
—
|
|
Change From Baseline in Fasting Blood Glucose
Change at Month 18
|
-21.1 mg/dL
Standard Deviation 41.54
|
-16.0 mg/dL
Standard Deviation 46.75
|
—
|
|
Change From Baseline in Fasting Blood Glucose
Change at Month 24
|
-19.9 mg/dL
Standard Deviation 42.56
|
-14.0 mg/dL
Standard Deviation 42.09
|
—
|
|
Change From Baseline in Fasting Blood Glucose
Change at Month 30
|
-24.4 mg/dL
Standard Deviation 39.14
|
-11.7 mg/dL
Standard Deviation 52.27
|
—
|
|
Change From Baseline in Fasting Blood Glucose
Change at Month 36
|
-23.0 mg/dL
Standard Deviation 45.19
|
-18.6 mg/dL
Standard Deviation 48.80
|
—
|
|
Change From Baseline in Fasting Blood Glucose
Change at Final Assessment
|
-24.5 mg/dL
Standard Deviation 48.45
|
-12.2 mg/dL
Standard Deviation 51.25
|
—
|
Adverse Events
Alogliptin
Serious events: 2 serious events
Other events: 26 other events
Deaths: 1 deaths
Alogliptin + αGI
Serious events: 2 serious events
Other events: 19 other events
Deaths: 1 deaths
Alogliptin + Other
Serious events: 8 serious events
Other events: 23 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Alogliptin
n=1560 participants at risk
Alogliptin 25 mg, tablets, orally, once daily for up to 36 months in routine medical care. Participants in this group received no diabetic drugs within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
|
Alogliptin + αGI
n=669 participants at risk
Alogliptin 25 mg, tablets, orally, once daily for up to 36 months in routine medical care. Participants in this group received an α-GI within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
|
Alogliptin + Other
n=989 participants at risk
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in routine medical care. Participants in this group did not receive an α-GI within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/1560 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.00%
0/669 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.10%
1/989 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/1560 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.00%
0/669 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.10%
1/989 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/1560 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.00%
0/669 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.10%
1/989 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/1560 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.00%
0/669 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.10%
1/989 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/1560 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.00%
0/669 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.10%
1/989 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/1560 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.00%
0/669 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.10%
1/989 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/1560 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.15%
1/669 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.10%
1/989 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/1560 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.15%
1/669 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.00%
0/989 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/1560 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.00%
0/669 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.10%
1/989 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
|
General disorders
Sudden death
|
0.06%
1/1560 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.00%
0/669 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.00%
0/989 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
|
Injury, poisoning and procedural complications
Fall
|
0.06%
1/1560 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.00%
0/669 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.00%
0/989 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/1560 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.00%
0/669 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.10%
1/989 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.06%
1/1560 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.00%
0/669 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.00%
0/989 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
|
General disorders
Death
|
0.00%
0/1560 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.00%
0/669 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.10%
1/989 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
Other adverse events
| Measure |
Alogliptin
n=1560 participants at risk
Alogliptin 25 mg, tablets, orally, once daily for up to 36 months in routine medical care. Participants in this group received no diabetic drugs within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
|
Alogliptin + αGI
n=669 participants at risk
Alogliptin 25 mg, tablets, orally, once daily for up to 36 months in routine medical care. Participants in this group received an α-GI within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
|
Alogliptin + Other
n=989 participants at risk
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in routine medical care. Participants in this group did not receive an α-GI within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
|
|---|---|---|---|
|
Vascular disorders
Hypertension
|
1.3%
20/1560 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
1.9%
13/669 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
1.7%
17/989 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.38%
6/1560 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.90%
6/669 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
0.61%
6/989 • Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. Participants may be represented in more than 1 category.
|
Additional Information
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