Trial Outcomes & Findings for Alogliptin Tablets Specified Drug-use Survey "Type 2 Diabetic Patients Receiving Combination Therapy With a Hypoglycemic Agent (e.g., Insulin Preparations or Rapid-acting Insulin Secretagogues)" (NCT NCT02221284)
NCT ID: NCT02221284
Last Updated: 2019-11-06
Results Overview
Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
Recruitment status
COMPLETED
Target enrollment
964 participants
Primary outcome timeframe
Up to Month 12
Results posted on
2019-11-06
Participant Flow
Participants took part in the study at 196 investigative sites in Japan, from 30 June 2014 to 30 June 2017. Data reports overall population, since data not collected separately per arm as specified in protocol.
Enrolled participants had a diagnosis of type 2 diabetic mellitus and an inadequate response to hypoglycemic agents in addition to dietary/exercise therapy. Participants received interventions as part of routine medical care. Data reports overall population, since data not collected separately per arm as specified in protocol.
Participant milestones
| Measure |
Overall Population
Alogliptin 25 milligram (mg), tablets, orally, once daily, up to 12 months, along with an insulin preparations, with a rapid-acting insulin secretagogue (Glinide), with a SGLT-2 inhibitor, or the other diabetic drugs within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period in routine medical care.
|
|---|---|
|
Overall Study
STARTED
|
964
|
|
Overall Study
COMPLETED
|
903
|
|
Overall Study
NOT COMPLETED
|
61
|
Reasons for withdrawal
| Measure |
Overall Population
Alogliptin 25 milligram (mg), tablets, orally, once daily, up to 12 months, along with an insulin preparations, with a rapid-acting insulin secretagogue (Glinide), with a SGLT-2 inhibitor, or the other diabetic drugs within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period in routine medical care.
|
|---|---|
|
Overall Study
Case Report Forms Uncollected
|
56
|
|
Overall Study
Protocol Deviation
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Alogliptin + Insulin
n=573 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with insulin preparation within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + Glinide
n=166 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with rapid-acting insulin secretagogue (Glinide) within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + SGLT-2 Inhibitor
n=102 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + Other
n=62 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along without insulin preparations, glinide, or SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Total
n=903 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.6 Years
STANDARD_DEVIATION 12.27 • n=573 Participants
|
67.9 Years
STANDARD_DEVIATION 11.71 • n=166 Participants
|
61.0 Years
STANDARD_DEVIATION 13.72 • n=102 Participants
|
61.2 Years
STANDARD_DEVIATION 14.31 • n=62 Participants
|
65.2 Years
STANDARD_DEVIATION 12.65 • n=903 Participants
|
|
Sex: Female, Male
Female
|
257 Participants
n=573 Participants
|
67 Participants
n=166 Participants
|
35 Participants
n=102 Participants
|
26 Participants
n=62 Participants
|
385 Participants
n=903 Participants
|
|
Sex: Female, Male
Male
|
316 Participants
n=573 Participants
|
99 Participants
n=166 Participants
|
67 Participants
n=102 Participants
|
36 Participants
n=62 Participants
|
518 Participants
n=903 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Japan
|
573 Participants
n=573 Participants
|
166 Participants
n=166 Participants
|
102 Participants
n=102 Participants
|
62 Participants
n=62 Participants
|
903 Participants
n=903 Participants
|
|
Duration of Diagnosis of Type-2 Diabetes Mellitus (Years)
|
14.24 Years
STANDARD_DEVIATION 10.858 • n=417 Participants • The number analyzed is the number of participants with data available for analysis.
|
9.03 Years
STANDARD_DEVIATION 9.058 • n=120 Participants • The number analyzed is the number of participants with data available for analysis.
|
6.57 Years
STANDARD_DEVIATION 6.911 • n=34 Participants • The number analyzed is the number of participants with data available for analysis.
|
7.45 Years
STANDARD_DEVIATION 6.831 • n=50 Participants • The number analyzed is the number of participants with data available for analysis.
|
12.26 Years
STANDARD_DEVIATION 10.458 • n=621 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Height
|
160.0 Centimeters (cm)
STANDARD_DEVIATION 9.70 • n=523 Participants • The number analyzed is the number of participants with data available for analysis.
|
160.2 Centimeters (cm)
STANDARD_DEVIATION 10.12 • n=155 Participants • The number analyzed is the number of participants with data available for analysis.
|
164.3 Centimeters (cm)
STANDARD_DEVIATION 9.38 • n=75 Participants • The number analyzed is the number of participants with data available for analysis.
|
162.4 Centimeters (cm)
STANDARD_DEVIATION 9.02 • n=50 Participants • The number analyzed is the number of participants with data available for analysis.
|
160.6 Centimeters (cm)
STANDARD_DEVIATION 9.78 • n=803 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Weight
|
62.57 Kilograms (kg)
STANDARD_DEVIATION 12.910 • n=516 Participants • The number analyzed is the number of participants with data available for analysis.
|
62.45 Kilograms (kg)
STANDARD_DEVIATION 13.141 • n=146 Participants • The number analyzed is the number of participants with data available for analysis.
|
72.37 Kilograms (kg)
STANDARD_DEVIATION 14.654 • n=101 Participants • The number analyzed is the number of participants with data available for analysis.
|
68.32 Kilograms (kg)
STANDARD_DEVIATION 14.248 • n=49 Participants • The number analyzed is the number of participants with data available for analysis.
|
64.11 Kilograms (kg)
STANDARD_DEVIATION 13.667 • n=812 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
BMI
|
24.40 kg/meter (m)^2
STANDARD_DEVIATION 4.037 • n=488 Participants • The number analyzed is the number of participants with data available for analysis.
|
24.22 kg/meter (m)^2
STANDARD_DEVIATION 3.515 • n=140 Participants • The number analyzed is the number of participants with data available for analysis.
|
26.71 kg/meter (m)^2
STANDARD_DEVIATION 4.380 • n=75 Participants • The number analyzed is the number of participants with data available for analysis.
|
25.90 kg/meter (m)^2
STANDARD_DEVIATION 4.312 • n=46 Participants • The number analyzed is the number of participants with data available for analysis.
|
24.69 kg/meter (m)^2
STANDARD_DEVIATION 4.065 • n=749 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Waist Circumference (Male)
< 85 cm
|
15 Participants
n=316 Participants • This baseline characteristic was analyzed only in male participants.
|
12 Participants
n=99 Participants • This baseline characteristic was analyzed only in male participants.
|
2 Participants
n=67 Participants • This baseline characteristic was analyzed only in male participants.
|
1 Participants
n=36 Participants • This baseline characteristic was analyzed only in male participants.
|
30 Participants
n=518 Participants • This baseline characteristic was analyzed only in male participants.
|
|
Waist Circumference (Male)
>= 85 cm
|
22 Participants
n=316 Participants • This baseline characteristic was analyzed only in male participants.
|
17 Participants
n=99 Participants • This baseline characteristic was analyzed only in male participants.
|
9 Participants
n=67 Participants • This baseline characteristic was analyzed only in male participants.
|
5 Participants
n=36 Participants • This baseline characteristic was analyzed only in male participants.
|
53 Participants
n=518 Participants • This baseline characteristic was analyzed only in male participants.
|
|
Waist Circumference (Male)
Unknown
|
279 Participants
n=316 Participants • This baseline characteristic was analyzed only in male participants.
|
70 Participants
n=99 Participants • This baseline characteristic was analyzed only in male participants.
|
56 Participants
n=67 Participants • This baseline characteristic was analyzed only in male participants.
|
30 Participants
n=36 Participants • This baseline characteristic was analyzed only in male participants.
|
435 Participants
n=518 Participants • This baseline characteristic was analyzed only in male participants.
|
|
Waist Circumference (Female)
< 90 cm
|
25 Participants
n=257 Participants • This baseline characteristic was analyzed only in female participants.
|
13 Participants
n=67 Participants • This baseline characteristic was analyzed only in female participants.
|
2 Participants
n=35 Participants • This baseline characteristic was analyzed only in female participants.
|
1 Participants
n=26 Participants • This baseline characteristic was analyzed only in female participants.
|
41 Participants
n=385 Participants • This baseline characteristic was analyzed only in female participants.
|
|
Waist Circumference (Female)
>= 90 cm
|
15 Participants
n=257 Participants • This baseline characteristic was analyzed only in female participants.
|
3 Participants
n=67 Participants • This baseline characteristic was analyzed only in female participants.
|
2 Participants
n=35 Participants • This baseline characteristic was analyzed only in female participants.
|
1 Participants
n=26 Participants • This baseline characteristic was analyzed only in female participants.
|
21 Participants
n=385 Participants • This baseline characteristic was analyzed only in female participants.
|
|
Waist Circumference (Female)
Unknown
|
217 Participants
n=257 Participants • This baseline characteristic was analyzed only in female participants.
|
51 Participants
n=67 Participants • This baseline characteristic was analyzed only in female participants.
|
31 Participants
n=35 Participants • This baseline characteristic was analyzed only in female participants.
|
24 Participants
n=26 Participants • This baseline characteristic was analyzed only in female participants.
|
323 Participants
n=385 Participants • This baseline characteristic was analyzed only in female participants.
|
|
Healthcare Category
Outpatient
|
539 Participants
n=573 Participants
|
161 Participants
n=166 Participants
|
101 Participants
n=102 Participants
|
57 Participants
n=62 Participants
|
858 Participants
n=903 Participants
|
|
Healthcare Category
Inpatient
|
34 Participants
n=573 Participants
|
5 Participants
n=166 Participants
|
1 Participants
n=102 Participants
|
5 Participants
n=62 Participants
|
45 Participants
n=903 Participants
|
|
Medical Complications
Had No Medical Complications
|
69 Participants
n=573 Participants
|
18 Participants
n=166 Participants
|
21 Participants
n=102 Participants
|
14 Participants
n=62 Participants
|
122 Participants
n=903 Participants
|
|
Medical Complications
Had Medical Complications
|
504 Participants
n=573 Participants
|
148 Participants
n=166 Participants
|
81 Participants
n=102 Participants
|
48 Participants
n=62 Participants
|
781 Participants
n=903 Participants
|
|
Concomitant Diabetes Mellitus
Had No Concomitant Diabetes Mellitus
|
324 Participants
n=573 Participants
|
123 Participants
n=166 Participants
|
65 Participants
n=102 Participants
|
44 Participants
n=62 Participants
|
556 Participants
n=903 Participants
|
|
Concomitant Diabetes Mellitus
Had Concomitant Diabetes Mellitus
|
249 Participants
n=573 Participants
|
43 Participants
n=166 Participants
|
37 Participants
n=102 Participants
|
18 Participants
n=62 Participants
|
347 Participants
n=903 Participants
|
|
Concomitant Hypertension
Had No Concomitant Hypertension
|
247 Participants
n=573 Participants
|
63 Participants
n=166 Participants
|
41 Participants
n=102 Participants
|
26 Participants
n=62 Participants
|
377 Participants
n=903 Participants
|
|
Concomitant Hypertension
Had Concomitant Hypertension
|
326 Participants
n=573 Participants
|
103 Participants
n=166 Participants
|
61 Participants
n=102 Participants
|
36 Participants
n=62 Participants
|
526 Participants
n=903 Participants
|
|
Concomitant Hyperlipidemia
Had No Concomitant Hyperlipidemia
|
261 Participants
n=573 Participants
|
68 Participants
n=166 Participants
|
38 Participants
n=102 Participants
|
29 Participants
n=62 Participants
|
396 Participants
n=903 Participants
|
|
Concomitant Hyperlipidemia
Had Concomitant Hyperlipidemia
|
312 Participants
n=573 Participants
|
98 Participants
n=166 Participants
|
64 Participants
n=102 Participants
|
33 Participants
n=62 Participants
|
507 Participants
n=903 Participants
|
|
Concomitant Hyperuricaemia
Had No Concomitant Hyperuricaemia
|
522 Participants
n=573 Participants
|
145 Participants
n=166 Participants
|
93 Participants
n=102 Participants
|
60 Participants
n=62 Participants
|
820 Participants
n=903 Participants
|
|
Concomitant Hyperuricaemia
Had Concomitant Hyperuricaemia
|
51 Participants
n=573 Participants
|
21 Participants
n=166 Participants
|
9 Participants
n=102 Participants
|
2 Participants
n=62 Participants
|
83 Participants
n=903 Participants
|
|
Concomitant Hepatic Disorder
Had No Concomitant Hepatic Disorder
|
467 Participants
n=573 Participants
|
147 Participants
n=166 Participants
|
84 Participants
n=102 Participants
|
51 Participants
n=62 Participants
|
749 Participants
n=903 Participants
|
|
Concomitant Hepatic Disorder
Had Concomitant Hepatic Disorder
|
106 Participants
n=573 Participants
|
19 Participants
n=166 Participants
|
18 Participants
n=102 Participants
|
11 Participants
n=62 Participants
|
154 Participants
n=903 Participants
|
|
Degree of Hepatic Dysfunction
Normal
|
404 Participants
n=573 Participants
|
94 Participants
n=166 Participants
|
63 Participants
n=102 Participants
|
36 Participants
n=62 Participants
|
597 Participants
n=903 Participants
|
|
Degree of Hepatic Dysfunction
Grade 1
|
25 Participants
n=573 Participants
|
7 Participants
n=166 Participants
|
5 Participants
n=102 Participants
|
4 Participants
n=62 Participants
|
41 Participants
n=903 Participants
|
|
Degree of Hepatic Dysfunction
Grade 2
|
4 Participants
n=573 Participants
|
3 Participants
n=166 Participants
|
5 Participants
n=102 Participants
|
1 Participants
n=62 Participants
|
13 Participants
n=903 Participants
|
|
Degree of Hepatic Dysfunction
Unknown
|
140 Participants
n=573 Participants
|
62 Participants
n=166 Participants
|
29 Participants
n=102 Participants
|
21 Participants
n=62 Participants
|
252 Participants
n=903 Participants
|
|
Concomitant Renal Disorder
Had No Concomitant Renal Disorder
|
412 Participants
n=573 Participants
|
139 Participants
n=166 Participants
|
73 Participants
n=102 Participants
|
49 Participants
n=62 Participants
|
673 Participants
n=903 Participants
|
|
Concomitant Renal Disorder
Had Concomitant Renal Disorder
|
161 Participants
n=573 Participants
|
27 Participants
n=166 Participants
|
29 Participants
n=102 Participants
|
13 Participants
n=62 Participants
|
230 Participants
n=903 Participants
|
|
Degree of Renal Dysfunction (eGFR)
Normal
|
85 Participants
n=573 Participants
|
30 Participants
n=166 Participants
|
23 Participants
n=102 Participants
|
16 Participants
n=62 Participants
|
154 Participants
n=903 Participants
|
|
Degree of Renal Dysfunction (eGFR)
Mild
|
235 Participants
n=573 Participants
|
38 Participants
n=166 Participants
|
38 Participants
n=102 Participants
|
22 Participants
n=62 Participants
|
333 Participants
n=903 Participants
|
|
Degree of Renal Dysfunction (eGFR)
Moderate
|
118 Participants
n=573 Participants
|
28 Participants
n=166 Participants
|
18 Participants
n=102 Participants
|
4 Participants
n=62 Participants
|
168 Participants
n=903 Participants
|
|
Degree of Renal Dysfunction (eGFR)
Severe
|
12 Participants
n=573 Participants
|
1 Participants
n=166 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=62 Participants
|
13 Participants
n=903 Participants
|
|
Degree of Renal Dysfunction (eGFR)
Normal or Mild
|
320 Participants
n=573 Participants
|
68 Participants
n=166 Participants
|
61 Participants
n=102 Participants
|
38 Participants
n=62 Participants
|
487 Participants
n=903 Participants
|
|
Degree of Renal Dysfunction (eGFR)
Moderate or Severe
|
130 Participants
n=573 Participants
|
29 Participants
n=166 Participants
|
18 Participants
n=102 Participants
|
4 Participants
n=62 Participants
|
181 Participants
n=903 Participants
|
|
Degree of Renal Dysfunction (eGFR)
Unknown
|
123 Participants
n=573 Participants
|
69 Participants
n=166 Participants
|
23 Participants
n=102 Participants
|
20 Participants
n=62 Participants
|
235 Participants
n=903 Participants
|
|
Degree of Renal Dysfunction (Cr)
Normal or Mild
|
431 Participants
n=573 Participants
|
94 Participants
n=166 Participants
|
78 Participants
n=102 Participants
|
42 Participants
n=62 Participants
|
645 Participants
n=903 Participants
|
|
Degree of Renal Dysfunction (Cr)
Moderate
|
17 Participants
n=573 Participants
|
3 Participants
n=166 Participants
|
1 Participants
n=102 Participants
|
0 Participants
n=62 Participants
|
21 Participants
n=903 Participants
|
|
Degree of Renal Dysfunction (Cr)
Severe
|
2 Participants
n=573 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=903 Participants
|
|
Degree of Renal Dysfunction (Cr)
Moderate or Severe
|
19 Participants
n=573 Participants
|
3 Participants
n=166 Participants
|
1 Participants
n=102 Participants
|
0 Participants
n=62 Participants
|
23 Participants
n=903 Participants
|
|
Degree of Renal Dysfunction (Cr)
Unknown
|
123 Participants
n=573 Participants
|
69 Participants
n=166 Participants
|
23 Participants
n=102 Participants
|
20 Participants
n=62 Participants
|
235 Participants
n=903 Participants
|
|
Concomitant Cardiac Disease
Had No Concomitant Cardiac Disease
|
467 Participants
n=573 Participants
|
154 Participants
n=166 Participants
|
96 Participants
n=102 Participants
|
54 Participants
n=62 Participants
|
771 Participants
n=903 Participants
|
|
Concomitant Cardiac Disease
Had Concomitant Cardiac Disease
|
106 Participants
n=573 Participants
|
12 Participants
n=166 Participants
|
6 Participants
n=102 Participants
|
8 Participants
n=62 Participants
|
132 Participants
n=903 Participants
|
|
Concomitant Heart Failure
Had No Concomitant Heart Failure
|
546 Participants
n=573 Participants
|
166 Participants
n=166 Participants
|
101 Participants
n=102 Participants
|
61 Participants
n=62 Participants
|
874 Participants
n=903 Participants
|
|
Concomitant Heart Failure
Had Concomitant Heart Failure
|
27 Participants
n=573 Participants
|
0 Participants
n=166 Participants
|
1 Participants
n=102 Participants
|
1 Participants
n=62 Participants
|
29 Participants
n=903 Participants
|
|
New York Heart Association (NYHA) Heart Failure Classification
Class I
|
15 Participants
n=27 Participants • This baseline characteristic was analyzed only for participants who had complications of heart failure.
|
0 Participants
This baseline characteristic was analyzed only for participants who had complications of heart failure.
|
0 Participants
n=1 Participants • This baseline characteristic was analyzed only for participants who had complications of heart failure.
|
1 Participants
n=1 Participants • This baseline characteristic was analyzed only for participants who had complications of heart failure.
|
16 Participants
n=29 Participants • This baseline characteristic was analyzed only for participants who had complications of heart failure.
|
|
New York Heart Association (NYHA) Heart Failure Classification
Class II
|
9 Participants
n=27 Participants • This baseline characteristic was analyzed only for participants who had complications of heart failure.
|
0 Participants
This baseline characteristic was analyzed only for participants who had complications of heart failure.
|
1 Participants
n=1 Participants • This baseline characteristic was analyzed only for participants who had complications of heart failure.
|
0 Participants
n=1 Participants • This baseline characteristic was analyzed only for participants who had complications of heart failure.
|
10 Participants
n=29 Participants • This baseline characteristic was analyzed only for participants who had complications of heart failure.
|
|
New York Heart Association (NYHA) Heart Failure Classification
Unknown
|
3 Participants
n=27 Participants • This baseline characteristic was analyzed only for participants who had complications of heart failure.
|
0 Participants
This baseline characteristic was analyzed only for participants who had complications of heart failure.
|
0 Participants
n=1 Participants • This baseline characteristic was analyzed only for participants who had complications of heart failure.
|
0 Participants
n=1 Participants • This baseline characteristic was analyzed only for participants who had complications of heart failure.
|
3 Participants
n=29 Participants • This baseline characteristic was analyzed only for participants who had complications of heart failure.
|
|
Concomitant Stroke-Related Disease
Had No Concomitant Stroke-Related Disease
|
520 Participants
n=573 Participants
|
157 Participants
n=166 Participants
|
99 Participants
n=102 Participants
|
61 Participants
n=62 Participants
|
837 Participants
n=903 Participants
|
|
Concomitant Stroke-Related Disease
Had Concomitant Stroke-Related Disease
|
53 Participants
n=573 Participants
|
9 Participants
n=166 Participants
|
3 Participants
n=102 Participants
|
1 Participants
n=62 Participants
|
66 Participants
n=903 Participants
|
|
Concomitant Allergic Condition
Had No Concomitant Allergic Condition
|
553 Participants
n=573 Participants
|
161 Participants
n=166 Participants
|
99 Participants
n=102 Participants
|
59 Participants
n=62 Participants
|
872 Participants
n=903 Participants
|
|
Concomitant Allergic Condition
Had Concomitant Allergic Condition
|
20 Participants
n=573 Participants
|
5 Participants
n=166 Participants
|
3 Participants
n=102 Participants
|
3 Participants
n=62 Participants
|
31 Participants
n=903 Participants
|
|
Concomitant Malignant Tumor
Had No Concomitant Malignant Tumor
|
548 Participants
n=573 Participants
|
160 Participants
n=166 Participants
|
102 Participants
n=102 Participants
|
59 Participants
n=62 Participants
|
869 Participants
n=903 Participants
|
|
Concomitant Malignant Tumor
Had Concomitant Malignant Tumor
|
25 Participants
n=573 Participants
|
6 Participants
n=166 Participants
|
0 Participants
n=102 Participants
|
3 Participants
n=62 Participants
|
34 Participants
n=903 Participants
|
|
Medical History
Had No Medical History
|
411 Participants
n=573 Participants
|
123 Participants
n=166 Participants
|
95 Participants
n=102 Participants
|
47 Participants
n=62 Participants
|
676 Participants
n=903 Participants
|
|
Medical History
Had Medical History
|
125 Participants
n=573 Participants
|
28 Participants
n=166 Participants
|
5 Participants
n=102 Participants
|
12 Participants
n=62 Participants
|
170 Participants
n=903 Participants
|
|
Medical History
Unknown
|
37 Participants
n=573 Participants
|
15 Participants
n=166 Participants
|
2 Participants
n=102 Participants
|
3 Participants
n=62 Participants
|
57 Participants
n=903 Participants
|
|
Predisposition to Hypersensitivity
Had No Predisposition to Hypersensitivity
|
508 Participants
n=573 Participants
|
141 Participants
n=166 Participants
|
98 Participants
n=102 Participants
|
56 Participants
n=62 Participants
|
803 Participants
n=903 Participants
|
|
Predisposition to Hypersensitivity
Had Predisposition to Hypersensitivity
|
33 Participants
n=573 Participants
|
11 Participants
n=166 Participants
|
3 Participants
n=102 Participants
|
4 Participants
n=62 Participants
|
51 Participants
n=903 Participants
|
|
Predisposition to Hypersensitivity
Unknown
|
32 Participants
n=573 Participants
|
14 Participants
n=166 Participants
|
1 Participants
n=102 Participants
|
2 Participants
n=62 Participants
|
49 Participants
n=903 Participants
|
|
Drinking Habits
Yes
|
110 Participants
n=573 Participants
|
49 Participants
n=166 Participants
|
23 Participants
n=102 Participants
|
14 Participants
n=62 Participants
|
196 Participants
n=903 Participants
|
|
Drinking Habits
No
|
377 Participants
n=573 Participants
|
92 Participants
n=166 Participants
|
57 Participants
n=102 Participants
|
39 Participants
n=62 Participants
|
565 Participants
n=903 Participants
|
|
Drinking Habits
Unknown
|
86 Participants
n=573 Participants
|
25 Participants
n=166 Participants
|
22 Participants
n=102 Participants
|
9 Participants
n=62 Participants
|
142 Participants
n=903 Participants
|
|
Smoking Classification
Never Smoked
|
289 Participants
n=573 Participants
|
65 Participants
n=166 Participants
|
43 Participants
n=102 Participants
|
25 Participants
n=62 Participants
|
422 Participants
n=903 Participants
|
|
Smoking Classification
Current Smoker
|
64 Participants
n=573 Participants
|
31 Participants
n=166 Participants
|
15 Participants
n=102 Participants
|
16 Participants
n=62 Participants
|
126 Participants
n=903 Participants
|
|
Smoking Classification
Ex-Smoker
|
103 Participants
n=573 Participants
|
45 Participants
n=166 Participants
|
19 Participants
n=102 Participants
|
10 Participants
n=62 Participants
|
177 Participants
n=903 Participants
|
|
Smoking Classification
Unknown
|
117 Participants
n=573 Participants
|
25 Participants
n=166 Participants
|
25 Participants
n=102 Participants
|
11 Participants
n=62 Participants
|
178 Participants
n=903 Participants
|
|
Hemoglobin A1c (HbA1c)
|
8.44 Percent
STANDARD_DEVIATION 1.662 • n=559 Participants • The number analyzed is the number of participants with data available for analysis.
|
7.60 Percent
STANDARD_DEVIATION 1.051 • n=160 Participants • The number analyzed is the number of participants with data available for analysis.
|
7.66 Percent
STANDARD_DEVIATION 1.379 • n=96 Participants • The number analyzed is the number of participants with data available for analysis.
|
8.78 Percent
STANDARD_DEVIATION 2.053 • n=61 Participants • The number analyzed is the number of participants with data available for analysis.
|
8.21 Percent
STANDARD_DEVIATION 1.612 • n=876 Participants • The number analyzed is the number of participants with data available for analysis.
|
PRIMARY outcome
Timeframe: Up to Month 12Population: Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.
Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
Outcome measures
| Measure |
Alogliptin + Insulin
n=573 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with insulin preparation within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + Glinide
n=166 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with rapid-acting insulin secretagogue (Glinide) within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + SGLT-2 Inhibitor
n=102 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + Other
n=62 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along without insulin preparations, glinide, or SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
|---|---|---|---|---|
|
Percentage of Participants Who Had One or More Adverse Reactions
|
5.41 Percentage of Participants
|
1.20 Percentage of Participants
|
0.98 Percentage of Participants
|
0.00 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, and final assessment point (up to Month 12)Population: Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups 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 final assessment point (up to Month 12) relative to baseline.
Outcome measures
| Measure |
Alogliptin + Insulin
n=546 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with insulin preparation within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + Glinide
n=158 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with rapid-acting insulin secretagogue (Glinide) within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + SGLT-2 Inhibitor
n=96 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + Other
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along without insulin preparations, glinide, or SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
|
-0.66 Percent
Standard Deviation 1.622
|
-0.49 Percent
Standard Deviation 0.940
|
-0.60 Percent
Standard Deviation 1.102
|
—
|
SECONDARY outcome
Timeframe: Baseline, and final assessment point (up to Month 12)Population: Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol.
The reported data were number of participants who achieved specified HbA1c Level (\< 7.0% and \<6.0%) during this study.
Outcome measures
| Measure |
Alogliptin + Insulin
n=557 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with insulin preparation within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + Glinide
n=162 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with rapid-acting insulin secretagogue (Glinide) within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + SGLT-2 Inhibitor
n=101 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + Other
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along without insulin preparations, glinide, or SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
|---|---|---|---|---|
|
Number of Participants Achieving Specified HbA1c Level (< 7.0% and <6.0%)
HbA1c Level < 7.0%
|
161 Participants
|
87 Participants
|
55 Participants
|
—
|
|
Number of Participants Achieving Specified HbA1c Level (< 7.0% and <6.0%)
HbA1c Level < 6.0%
|
22 Participants
|
10 Participants
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, and final assessment point (up to Month 12)Population: Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol.
The reported data were change from baseline in fasting blood glucose level.
Outcome measures
| Measure |
Alogliptin + Insulin
n=87 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with insulin preparation within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + Glinide
n=33 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with rapid-acting insulin secretagogue (Glinide) within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + SGLT-2 Inhibitor
n=21 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + Other
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along without insulin preparations, glinide, or SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
|---|---|---|---|---|
|
Change From Baseline in Laboratory Test Values (Fasting Blood Glucose Level)
|
-16.4 Milligram (mg)/deciliter (dL)
Standard Deviation 65.96
|
-32.0 Milligram (mg)/deciliter (dL)
Standard Deviation 42.00
|
-18.7 Milligram (mg)/deciliter (dL)
Standard Deviation 35.86
|
—
|
SECONDARY outcome
Timeframe: Baseline, and final assessment point (up to Month 12)Population: Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol.
The reported data were change from baseline in fasting insulin level.
Outcome measures
| Measure |
Alogliptin + Insulin
n=5 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with insulin preparation within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + Glinide
n=10 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with rapid-acting insulin secretagogue (Glinide) within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + SGLT-2 Inhibitor
n=1 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + Other
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along without insulin preparations, glinide, or SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
|---|---|---|---|---|
|
Change From Baseline in Laboratory Test Values (Fasting Insulin Level)
|
-3.08 Micro Units per Milliliter (μU/mL)
Standard Deviation 3.414
|
2.26 Micro Units per Milliliter (μU/mL)
Standard Deviation 4.948
|
0.40 Micro Units per Milliliter (μU/mL)
Standard Deviation NA
Standard Deviation was not calculated as only one participant was analyzed.
|
—
|
SECONDARY outcome
Timeframe: Baseline, and final assessment point (up to Month 12)Population: Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol.
The reported data were change from baseline in HOMA-R. HOMA-R measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance.
Outcome measures
| Measure |
Alogliptin + Insulin
n=5 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with insulin preparation within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + Glinide
n=10 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with rapid-acting insulin secretagogue (Glinide) within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + SGLT-2 Inhibitor
n=1 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + Other
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along without insulin preparations, glinide, or SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
|---|---|---|---|---|
|
Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment Ratio [HOMA-R])
|
-2.58 HOMA-R Score
Standard Deviation 2.170
|
-0.25 HOMA-R Score
Standard Deviation 2.094
|
0.00 HOMA-R Score
Standard Deviation NA
Standard Deviation was not calculated as only one participant was analyzed.
|
—
|
SECONDARY outcome
Timeframe: Baseline, and final assessment point (up to Month 12)Population: Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol.
The reported data were change from baseline in HOMA-β. HOMA-β measures as following; HOMA-β = fasting insulin (μU/mL) ×360/{fasting glucose (mg/dL) - 63}.
Outcome measures
| Measure |
Alogliptin + Insulin
n=5 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with insulin preparation within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + Glinide
n=10 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with rapid-acting insulin secretagogue (Glinide) within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + SGLT-2 Inhibitor
n=1 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + Other
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along without insulin preparations, glinide, or SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
|---|---|---|---|---|
|
Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment of Beta-cell Function [HOMA-β])
|
12.32 Percentage of beta cell function
Standard Deviation 17.286
|
33.38 Percentage of beta cell function
Standard Deviation 19.851
|
15.40 Percentage of beta cell function
Standard Deviation NA
Standard Deviation was not calculated as only one participant was analyzed.
|
—
|
Adverse Events
Alogliptin + Insulin
Serious events: 3 serious events
Other events: 10 other events
Deaths: 3 deaths
Alogliptin + Glinide
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Alogliptin + SGLT-2 Inhibit
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Alogliptin + Other
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alogliptin + Insulin
n=573 participants at risk
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with insulin preparation within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + Glinide
n=166 participants at risk
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with rapid-acting insulin secretagogue (Glinide) within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + SGLT-2 Inhibit
n=102 participants at risk
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + Other
n=62 participants at risk
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along without insulin preparations, glinide, or SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure acut
|
0.17%
1/573 • Up to Month 12
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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment.
|
0.00%
0/166 • Up to Month 12
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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment.
|
0.00%
0/102 • Up to Month 12
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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment.
|
0.00%
0/62 • Up to Month 12
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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.17%
1/573 • Up to Month 12
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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment.
|
0.00%
0/166 • Up to Month 12
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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment.
|
0.00%
0/102 • Up to Month 12
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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment.
|
0.00%
0/62 • Up to Month 12
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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment.
|
|
General disorders
Death
|
0.17%
1/573 • Up to Month 12
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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment.
|
0.00%
0/166 • Up to Month 12
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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment.
|
0.00%
0/102 • Up to Month 12
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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment.
|
0.00%
0/62 • Up to Month 12
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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment.
|
Other adverse events
| Measure |
Alogliptin + Insulin
n=573 participants at risk
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with insulin preparation within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + Glinide
n=166 participants at risk
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with rapid-acting insulin secretagogue (Glinide) within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + SGLT-2 Inhibit
n=102 participants at risk
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
Alogliptin + Other
n=62 participants at risk
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along without insulin preparations, glinide, or SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.2%
7/573 • Up to Month 12
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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment.
|
0.00%
0/166 • Up to Month 12
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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment.
|
0.00%
0/102 • Up to Month 12
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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment.
|
0.00%
0/62 • Up to Month 12
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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.52%
3/573 • Up to Month 12
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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment.
|
1.2%
2/166 • Up to Month 12
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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment.
|
0.00%
0/102 • Up to Month 12
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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment.
|
0.00%
0/62 • Up to Month 12
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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment.
|
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