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Trial record 50 of 914 for:    tablet | Japan

Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01945216
Recruitment Status : Completed
First Posted : September 18, 2013
Results First Posted : November 8, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Type 2 Diabetes Mellitus Who Have Been Examined at a Medical Institution
Intervention Drug: Alogliptin
Enrollment 3317
Recruitment Details 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.
Pre-assignment Details 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".
Arm/Group Title Overall Population
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 3317
Completed 3223
Not Completed 94
Reason Not Completed
Case report forms uncollected             52
Protocol Violation             42
Arm/Group Title Alogliptin Alogliptin + αGI Alogliptin + Other Total
Hide Arm/Group Description 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 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 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 of all reporting groups
Overall Number of Baseline Participants 1564 670 989 3223
Hide Baseline Analysis Population Description
The safety analysis set was defined as all participants who were enrolled and completed the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
65.0  (12.28) 67.2  (12.12) 64.0  (12.57) 65.1  (12.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
Female
643
  41.1%
286
  42.7%
438
  44.3%
1367
  42.4%
Male
921
  58.9%
384
  57.3%
551
  55.7%
1856
  57.6%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
1564 670 989 3223
[1]
Measure Description: All participants were enrolled in Japan.
Time From Diagnosis of Type 2 Diabetes  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
3.45  (4.923) 8.10  (7.018) 5.03  (5.732) 4.91  (5.937)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
160.19  (9.725) 159.34  (9.528) 160.18  (9.738) 160.01  (9.691)
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
64.45  (13.723) 62.67  (13.000) 64.51  (14.046) 64.10  (13.691)
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
24.99  (4.223) 24.52  (4.277) 25.04  (4.190) 24.91  (4.228)
[1]
Measure Description: Body Mass Index = weight (kg)/[height (m)^2]
Waist Circumference (Male)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 921 participants 384 participants 551 participants 1856 participants
< 85cm
96
  10.4%
55
  14.3%
61
  11.1%
212
  11.4%
≥ 85cm
211
  22.9%
80
  20.8%
120
  21.8%
411
  22.1%
Unknown
614
  66.7%
249
  64.8%
370
  67.2%
1233
  66.4%
[1]
Measure Analysis Population Description: This baseline characteristic was analyzed only in male participants.
Waist Circumference (Female)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 643 participants 286 participants 438 participants 1367 participants
< 90cm
152
  23.6%
65
  22.7%
85
  19.4%
302
  22.1%
≥ 90cm
70
  10.9%
37
  12.9%
52
  11.9%
159
  11.6%
Unknown
421
  65.5%
184
  64.3%
301
  68.7%
906
  66.3%
[1]
Measure Analysis Population Description: This baseline characteristic was analyzed only in female participants.
Healthcare category   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Out-patient Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
1528
  97.7%
641
  95.7%
942
  95.2%
3111
  96.5%
In-patient Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
3
   0.2%
8
   1.2%
11
   1.1%
22
   0.7%
In- to/from out-patient Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
33
   2.1%
21
   3.1%
36
   3.6%
90
   2.8%
[1]
Measure Description: Participants were categorized as outpatient, inpatient, and In- to/from out-patient (participants who were both outpatient and inpatient at any time prior to enrollment).
Pregnancy Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 643 participants 286 participants 438 participants 1367 participants
Not pregnant
643
 100.0%
286
 100.0%
438
 100.0%
1367
 100.0%
Pregnant
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: This baseline characteristic was analyzed only in female participants.
History of Allergy  
Measure Type: Count of Participants
Unit of measure:  Participants
Had no history of Allergy Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
1381
  88.3%
584
  87.2%
856
  86.6%
2821
  87.5%
Had history of Allergy Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
127
   8.1%
57
   8.5%
104
  10.5%
288
   8.9%
Unknown Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
56
   3.6%
29
   4.3%
29
   2.9%
114
   3.5%
Complications   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Had No Complications Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
317
  20.3%
61
   9.1%
103
  10.4%
481
  14.9%
Had Complications Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
1247
  79.7%
609
  90.9%
886
  89.6%
2742
  85.1%
[1]
Measure Description: Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above.
Diabetic Complications  
Measure Type: Count of Participants
Unit of measure:  Participants
Had No Diabetic Complications Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
1406
  89.9%
507
  75.7%
831
  84.0%
2744
  85.1%
Had Diabetic Complications Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
158
  10.1%
163
  24.3%
158
  16.0%
479
  14.9%
Hypertension Complications  
Measure Type: Count of Participants
Unit of measure:  Participants
Had No Hypertension Complications Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
679
  43.4%
249
  37.2%
383
  38.7%
1311
  40.7%
Had Hypertension Complications Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
885
  56.6%
421
  62.8%
606
  61.3%
1912
  59.3%
Hyperlipidemia Complications  
Measure Type: Count of Participants
Unit of measure:  Participants
Had No Hyperlipidemia Complications Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
719
  46.0%
247
  36.9%
375
  37.9%
1341
  41.6%
Had Hyperlipidemia Complications Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
845
  54.0%
423
  63.1%
614
  62.1%
1882
  58.4%
Hyperuricemia Complications  
Measure Type: Count of Participants
Unit of measure:  Participants
Had No Hyperuricemia Complications Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
1415
  90.5%
612
  91.3%
891
  90.1%
2918
  90.5%
Had Hyperuricemia Complications Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
149
   9.5%
58
   8.7%
98
   9.9%
305
   9.5%
Hepatic Dysfunction Complications  
Measure Type: Count of Participants
Unit of measure:  Participants
Had No Hepatic Dysfunction Complications Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
1326
  84.8%
554
  82.7%
799
  80.8%
2679
  83.1%
Had Hepatic Dysfunction Complications Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
238
  15.2%
116
  17.3%
190
  19.2%
544
  16.9%
Degree of Hepatic Dysfunction   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Normal Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
986
  63.0%
443
  66.1%
596
  60.3%
2025
  62.8%
Grade 1 Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
122
   7.8%
36
   5.4%
87
   8.8%
245
   7.6%
Grade 2 Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
22
   1.4%
10
   1.5%
19
   1.9%
51
   1.6%
Grade 3 Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
434
  27.7%
181
  27.0%
287
  29.0%
902
  28.0%
[1]
Measure Description: Severity was determined using aspartate aminotransferase (AST) or alanine transaminase (ALT) values at the start of treatment with alogliptin. For the assessment of severity, the following categories were used and higher grades of serum AST or ALT were adopted. Normal: <50 international units per liter (IU/L) Grade 1: >=50 to <100 IU/L Grade 2: >=100 to <500 IU/L Grade 3: >=500 IU/L
Renal Dysfunction Complications  
Measure Type: Count of Participants
Unit of measure:  Participants
Had No Renal Dysfunction Complications Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
1431
  91.5%
564
  84.2%
861
  87.1%
2856
  88.6%
Had Renal Dysfunction Complications Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
133
   8.5%
106
  15.8%
128
  12.9%
367
  11.4%
Degree of Renal Dysfunction (eGFR)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Normal Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
249
  15.9%
108
  16.1%
189
  19.1%
546
  16.9%
Mild Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
667
  42.6%
254
  37.9%
361
  36.5%
1282
  39.8%
Moderate Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
190
  12.1%
108
  16.1%
121
  12.2%
419
  13.0%
Severe Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
28
   1.8%
22
   3.3%
25
   2.5%
75
   2.3%
Unknown Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
430
  27.5%
178
  26.6%
293
  29.6%
901
  28.0%
[1]
Measure Description: Estimated glomerular filtration rate (eGFR) was calculated using variables of gender, age at the start of treatment, and serum creatinine values, and severity was determined based on the following categories. If the serum creatinine value at the start of treatment was not listed, the severity was reported as “unknown.” Normal: >=90 milliliter per min (mL/min)/1.73^2, Mild: >=60 mL/min/1.73^2 to <90 mL/min/1.73^2, Moderate: >=30 mL/min/1.73^2 to <60 mL/min/1.73^2, Severe: <30 mL/min/1.73^2 eGFR = 194 * Cr^-1.094 * (age)^-0.287 (* 0.739 if female) where Cr is creatinine value.
Degree of Renal Dysfunction (Cr)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Normal or Mild Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
1089
  69.6%
466
  69.6%
664
  67.1%
2219
  68.8%
Moderate Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
24
   1.5%
7
   1.0%
17
   1.7%
48
   1.5%
Severe Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
21
   1.3%
19
   2.8%
15
   1.5%
55
   1.7%
Unknown Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
430
  27.5%
178
  26.6%
293
  29.6%
901
  28.0%
[1]
Measure Description: Normal or Mild: =< 1.4 mg/dL (for male) or =< 1.2 mg/dL (for female), Moderate: >1.4 mg/dL to =< 2.4 mg/dL (for male) or >1.2 mg/dL to =< 2.0 mg/dL (for female), Severe: > 2.4 mg/dL (for male), > 2.0 mg/dL (for female). If the serum creatinine value (Cr) at the start of treatment was not listed, the severity was reported as “unknown.”
Cardiac Disease Complications  
Measure Type: Count of Participants
Unit of measure:  Participants
Had No Cardiac Disease Complications Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
1421
  90.9%
579
  86.4%
870
  88.0%
2870
  89.0%
Had Cardiac Disease Complications Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
143
   9.1%
91
  13.6%
119
  12.0%
353
  11.0%
Heart Failure Complications  
Measure Type: Count of Participants
Unit of measure:  Participants
Had No Heart Failure Complications Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
1521
  97.3%
650
  97.0%
970
  98.1%
3141
  97.5%
Had Heart Failure Complications Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
43
   2.7%
20
   3.0%
19
   1.9%
82
   2.5%
New York Heart Association (NYHA) Heart Failure Classification   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 20 participants 19 participants 82 participants
NYHA Class I
26
  60.5%
13
  65.0%
11
  57.9%
50
  61.0%
NYHA Class II
16
  37.2%
5
  25.0%
5
  26.3%
26
  31.7%
NYHA Class III
1
   2.3%
1
   5.0%
1
   5.3%
3
   3.7%
NYHA Class IV
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown
0
   0.0%
1
   5.0%
2
  10.5%
3
   3.7%
[1]
Measure Description: NYHA functional classification ranges from Class I (Participants with cardiac disease but without resulting limitations of physical activity), Class II (Participants with cardiac disease resulting in slight limitation of physical activity), Class III (Participants with cardiac disease resulting in marked limitation of physical activity), Class IV (Participants with cardiac disease resulting in inability to carry on any physical activity without discomfort).
[2]
Measure Analysis Population Description: This baseline characteristic was analyzed only for Participants who had complications of heart failure.
Stroke-Related Disorder Complications  
Measure Type: Count of Participants
Unit of measure:  Participants
Had No Stroke-Related Disorder Complications Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
1509
  96.5%
614
  91.6%
922
  93.2%
3045
  94.5%
Had Stroke-Related Disorder Complications Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
55
   3.5%
56
   8.4%
67
   6.8%
178
   5.5%
Allergic Disease Complications  
Measure Type: Count of Participants
Unit of measure:  Participants
Had No Allergic Disease Complications Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
1470
  94.0%
628
  93.7%
914
  92.4%
3012
  93.5%
Had Allergic Disease Complications Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
94
   6.0%
42
   6.3%
75
   7.6%
211
   6.5%
Malignancy Complications  
Measure Type: Count of Participants
Unit of measure:  Participants
Had No Malignancy Complications Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
1547
  98.9%
662
  98.8%
960
  97.1%
3169
  98.3%
Had Malignancy Complications Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
17
   1.1%
8
   1.2%
29
   2.9%
54
   1.7%
Medical history   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Had No Medical History Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
1259
  80.5%
502
  74.9%
768
  77.7%
2529
  78.5%
Had Medical History Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
225
  14.4%
126
  18.8%
166
  16.8%
517
  16.0%
Unknown Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
80
   5.1%
42
   6.3%
55
   5.6%
177
   5.5%
[1]
Measure Description: Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above.
Alcohol Consumption Classification  
Measure Type: Count of Participants
Unit of measure:  Participants
Drinking Almost Everyday Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
412
  26.3%
158
  23.6%
276
  27.9%
846
  26.2%
Not Drinking Almost Everyday Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
895
  57.2%
384
  57.3%
526
  53.2%
1805
  56.0%
Unknown Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
257
  16.4%
128
  19.1%
187
  18.9%
572
  17.7%
Smoking Classification  
Measure Type: Count of Participants
Unit of measure:  Participants
Never Smoked Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
740
  47.3%
292
  43.6%
414
  41.9%
1446
  44.9%
Current Smoker Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
227
  14.5%
77
  11.5%
155
  15.7%
459
  14.2%
Ex-Smoker Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
249
  15.9%
153
  22.8%
160
  16.2%
562
  17.4%
Unknown Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
348
  22.3%
148
  22.1%
260
  26.3%
756
  23.5%
Glycosylated Hemoglobin A1c (HbA1c)  
Measure Type: Count of Participants
Unit of measure:  Participants
HbA1c <6.0 percent Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
28
   1.8%
24
   3.6%
33
   3.3%
85
   2.6%
HbA1c >=6.0 to <7.0 percent Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
475
  30.4%
134
  20.0%
195
  19.7%
804
  24.9%
HbA1c >=7.0 to <8.0 percent Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
576
  36.8%
270
  40.3%
320
  32.4%
1166
  36.2%
HbA1c >=8.0 percent Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
351
  22.4%
195
  29.1%
345
  34.9%
891
  27.6%
Unknown Number Analyzed 1564 participants 670 participants 989 participants 3223 participants
134
   8.6%
47
   7.0%
96
   9.7%
277
   8.6%
1.Primary Outcome
Title Number of Participants Who Experience at Least One Adverse Events
Hide Description [Not Specified]
Time Frame Up to Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set was defined as all participants who were enrolled and completed the study.
Arm/Group Title Alogliptin Alogliptin + α-GI Alogliptin + Other
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 1564 670 989
Measure Type: Count of Participants
Unit of Measure: Participants
151
   9.7%
98
  14.6%
139
  14.1%
2.Primary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Hide Description 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.
Time Frame Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Alogliptin Alogliptin + α-GI
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 1341 612
Mean (Standard Deviation)
Unit of Measure: Percent
Change at Month 1 Number Analyzed 1015 participants 504 participants
-0.45  (0.581) -0.33  (0.708)
Change at Month 3 Number Analyzed 1104 participants 535 participants
-0.79  (1.007) -0.54  (1.074)
Change at Month 6 Number Analyzed 1043 participants 526 participants
-0.84  (1.045) -0.70  (1.128)
Change at Month 12 Number Analyzed 1030 participants 498 participants
-0.83  (1.102) -0.75  (1.054)
Change at Month 18 Number Analyzed 805 participants 423 participants
-0.81  (1.077) -0.62  (1.190)
Change at Month 24 Number Analyzed 753 participants 394 participants
-0.82  (1.095) -0.66  (1.214)
Change at Month 30 Number Analyzed 664 participants 353 participants
-0.83  (1.114) -0.73  (1.271)
Change at Month 36 Number Analyzed 663 participants 331 participants
-0.84  (1.131) -0.72  (1.318)
Change at Final Assessment Number Analyzed 1341 participants 612 participants
-0.81  (1.140) -0.63  (1.381)
3.Secondary Outcome
Title Change From Baseline in Fasting Blood Glucose
Hide Description The change in the value of fasting blood glucose collected at month 36 relative to baseline.
Time Frame Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Alogliptin Alogliptin + α-GI
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 510 229
Mean (Standard Deviation)
Unit of Measure: mg/dL
Change at Month 1 Number Analyzed 311 participants 152 participants
-22.9  (45.05) -4.9  (41.17)
Change at Month 3 Number Analyzed 358 participants 175 participants
-21.7  (39.40) -8.3  (36.58)
Change at Month 6 Number Analyzed 322 participants 171 participants
-19.1  (36.46) -14.5  (49.90)
Change at Month 12 Number Analyzed 324 participants 163 participants
-23.1  (43.60) -18.4  (41.37)
Change at Month 18 Number Analyzed 234 participants 126 participants
-21.1  (41.54) -16.0  (46.75)
Change at Month 24 Number Analyzed 214 participants 119 participants
-19.9  (42.56) -14.0  (42.09)
Change at Month 30 Number Analyzed 183 participants 102 participants
-24.4  (39.14) -11.7  (52.27)
Change at Month 36 Number Analyzed 201 participants 99 participants
-23.0  (45.19) -18.6  (48.80)
Change at Final Assessment Number Analyzed 510 participants 229 participants
-24.5  (48.45) -12.2  (51.25)
Time Frame Up to Month 36
Adverse Event Reporting Description 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.
 
Arm/Group Title Alogliptin Alogliptin + αGI Alogliptin + Other
Hide Arm/Group Description 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 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 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.
All-Cause Mortality
Alogliptin Alogliptin + αGI Alogliptin + Other
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Alogliptin Alogliptin + αGI Alogliptin + Other
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/1564 (0.13%)   2/670 (0.30%)   8/989 (0.81%) 
Cardiac disorders       
Myocardial infarction  1  0/1564 (0.00%)  1/670 (0.15%)  1/989 (0.10%) 
Gastrointestinal disorders       
Intestinal obstruction  1  0/1564 (0.00%)  0/670 (0.00%)  1/989 (0.10%) 
General disorders       
Sudden death  1 [1]  1/1564 (0.06%)  0/670 (0.00%)  0/989 (0.00%) 
Death  1 [1]  0/1564 (0.00%)  0/670 (0.00%)  1/989 (0.10%) 
Injury, poisoning and procedural complications       
Fall  1  1/1564 (0.06%)  0/670 (0.00%)  0/989 (0.00%) 
Road traffic accident  1  0/1564 (0.00%)  0/670 (0.00%)  1/989 (0.10%) 
Tibia fracture  1  1/1564 (0.06%)  0/670 (0.00%)  0/989 (0.00%) 
Metabolism and nutrition disorders       
Hypoglycaemia  1  0/1564 (0.00%)  0/670 (0.00%)  1/989 (0.10%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bile duct cancer  1  0/1564 (0.00%)  0/670 (0.00%)  1/989 (0.10%) 
Hepatic neoplasm  1  0/1564 (0.00%)  0/670 (0.00%)  1/989 (0.10%) 
Metastases to lymph nodes  1  0/1564 (0.00%)  0/670 (0.00%)  1/989 (0.10%) 
Lung neoplasm  1  0/1564 (0.00%)  0/670 (0.00%)  1/989 (0.10%) 
Nervous system disorders       
Cerebral infarction  1  0/1564 (0.00%)  0/670 (0.00%)  1/989 (0.10%) 
Respiratory, thoracic and mediastinal disorders       
Interstitial lung disease  1  0/1564 (0.00%)  1/670 (0.15%)  0/989 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
[1]
The reasons of events are not determined because assessment findings were insufficient to specify the reason.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.4%
Alogliptin Alogliptin + αGI Alogliptin + Other
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   26/1564 (1.66%)   19/670 (2.84%)   23/989 (2.33%) 
Hepatobiliary disorders       
Hepatic function abnormal  1  6/1564 (0.38%)  6/670 (0.90%)  6/989 (0.61%) 
Vascular disorders       
Hypertension  1  20/1564 (1.28%)  13/670 (1.94%)  17/989 (1.72%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01945216     History of Changes
Other Study ID Numbers: 121-011
JapicCTI-132250 ( Registry Identifier: JapicCTI )
JapicCTI-R171018 ( Other Identifier: JapicCTI )
First Submitted: September 13, 2013
First Posted: September 18, 2013
Results First Submitted: August 2, 2017
Results First Posted: November 8, 2018
Last Update Posted: November 8, 2018