Trial Outcomes & Findings for Alogliptin Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Sulfonylurea (NCT NCT01964950)
NCT ID: NCT01964950
Last Updated: 2017-04-13
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. The safety analysis was planned to be assessed in alogliptin + SU and alogliptin + other arm separately.
Recruitment status
COMPLETED
Target enrollment
1101 participants
Primary outcome timeframe
Baseline up to 12 months
Results posted on
2017-04-13
Participant Flow
Participants took part in the study at 221 investigative sites in Japan from 1-Jul-11 to 31-Dec-14.
Participants with type 2 diabetes mellitus started treatment with alogliptin as per routine clinical practice were observed. As per protocol, participants we enrolled in 1 observational group at the start and were divided into 2 groups based on Sulfonylurea (SU) use for analysis of safety endpoints. Participant data was collected for overall arm.
Participant milestones
| Measure |
All Population (Alogliptin)
All participants who received alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months along with an SU or without an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
|---|---|
|
Overall Study
STARTED
|
1101
|
|
Overall Study
COMPLETED
|
1076
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
All Population (Alogliptin)
All participants who received alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months along with an SU or without an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
|---|---|
|
Overall Study
Protocol Violation
|
25
|
Baseline Characteristics
Alogliptin Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Sulfonylurea
Baseline characteristics by cohort
| Measure |
Alogliptin + SU
n=916 Participants
Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
Alogliptin + Other
n=160 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
Total
n=1076 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Less Than (<) 65 Years
|
380 participants
11.67 • n=5 Participants
|
69 participants
12.19 • n=7 Participants
|
449 participants
n=5 Participants
|
|
Age, Customized
Greater Than or Equal to (>=) 65 Years
|
536 participants
n=5 Participants
|
91 participants
n=7 Participants
|
627 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
378 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
430 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
538 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
646 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
916 participants
n=5 Participants
|
160 participants
n=7 Participants
|
1076 participants
n=5 Participants
|
|
Time From Diagnosis of Type 2 Diabetes
Less than (<)2 years
|
102 participants
n=5 Participants
|
21 participants
n=7 Participants
|
123 participants
n=5 Participants
|
|
Time From Diagnosis of Type 2 Diabetes
Greater than or equal to (>=)2 to <5 years
|
138 participants
n=5 Participants
|
22 participants
n=7 Participants
|
160 participants
n=5 Participants
|
|
Time From Diagnosis of Type 2 Diabetes
>=5 to <10 years
|
216 participants
n=5 Participants
|
25 participants
n=7 Participants
|
241 participants
n=5 Participants
|
|
Time From Diagnosis of Type 2 Diabetes
>=10 years
|
232 participants
n=5 Participants
|
55 participants
n=7 Participants
|
287 participants
n=5 Participants
|
|
Time From Diagnosis of Type 2 Diabetes
Unknown
|
228 participants
n=5 Participants
|
37 participants
n=7 Participants
|
265 participants
n=5 Participants
|
|
Body Mass Index (BMI)
<25 kilogram per square meter (kg/m^2)
|
326 participants
n=5 Participants
|
63 participants
n=7 Participants
|
389 participants
n=5 Participants
|
|
Body Mass Index (BMI)
>=25 kg/m^2
|
318 participants
n=5 Participants
|
60 participants
n=7 Participants
|
378 participants
n=5 Participants
|
|
Body Mass Index (BMI)
Unknown
|
272 participants
n=5 Participants
|
37 participants
n=7 Participants
|
309 participants
n=5 Participants
|
|
Waist circumference
<85 centimeter (cm) (Male)
|
52 participants
n=5 Participants
|
7 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Waist circumference
>=85 cm (Male)
|
102 participants
n=5 Participants
|
22 participants
n=7 Participants
|
124 participants
n=5 Participants
|
|
Waist circumference
Unknown (Male)
|
384 participants
n=5 Participants
|
79 participants
n=7 Participants
|
463 participants
n=5 Participants
|
|
Waist circumference
<90 cm (Female)
|
52 participants
n=5 Participants
|
7 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Waist circumference
>=90 cm (Female)
|
39 participants
n=5 Participants
|
4 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Waist circumference
Unknown (Female)
|
287 participants
n=5 Participants
|
41 participants
n=7 Participants
|
328 participants
n=5 Participants
|
|
Pregnancy Status
Not pregnant
|
378 participants
n=5 Participants
|
52 participants
n=7 Participants
|
430 participants
n=5 Participants
|
|
Pregnancy Status
Pregnant
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Healthcare Category
Outpatient
|
891 participants
n=5 Participants
|
156 participants
n=7 Participants
|
1047 participants
n=5 Participants
|
|
Healthcare Category
Inpatient
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Healthcare Category
Outpatient and Inpatient
|
22 participants
n=5 Participants
|
3 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Degree of Renal Dysfunction
Normal
|
151 participants
n=5 Participants
|
25 participants
n=7 Participants
|
176 participants
n=5 Participants
|
|
Degree of Renal Dysfunction
Mild
|
351 participants
n=5 Participants
|
61 participants
n=7 Participants
|
412 participants
n=5 Participants
|
|
Degree of Renal Dysfunction
Moderate
|
146 participants
n=5 Participants
|
25 participants
n=7 Participants
|
171 participants
n=5 Participants
|
|
Degree of Renal Dysfunction
Severe
|
12 participants
n=5 Participants
|
0 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Degree of Renal Dysfunction
Unknown
|
256 participants
n=5 Participants
|
49 participants
n=7 Participants
|
305 participants
n=5 Participants
|
|
History of Allergy
Did not have allergy
|
742 participants
n=5 Participants
|
131 participants
n=7 Participants
|
873 participants
n=5 Participants
|
|
History of Allergy
Had allergy
|
78 participants
n=5 Participants
|
8 participants
n=7 Participants
|
86 participants
n=5 Participants
|
|
History of Allergy
Unknown
|
96 participants
n=5 Participants
|
21 participants
n=7 Participants
|
117 participants
n=5 Participants
|
|
Health-related Complications
Had complications
|
837 participants
n=5 Participants
|
145 participants
n=7 Participants
|
982 participants
n=5 Participants
|
|
Health-related Complications
Had no complications
|
79 participants
n=5 Participants
|
15 participants
n=7 Participants
|
94 participants
n=5 Participants
|
|
Diabetic Complications
Had complications
|
187 participants
n=5 Participants
|
43 participants
n=7 Participants
|
230 participants
n=5 Participants
|
|
Diabetic Complications
Had no complications
|
729 participants
n=5 Participants
|
117 participants
n=7 Participants
|
846 participants
n=5 Participants
|
|
Breakdown of Diabetic Complications
Diabetic nephropathy
|
114 participants
n=5 Participants
|
23 participants
n=7 Participants
|
137 participants
n=5 Participants
|
|
Breakdown of Diabetic Complications
Diabetic retinopathy
|
76 participants
n=5 Participants
|
21 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Breakdown of Diabetic Complications
Diabetic neuropathy
|
61 participants
n=5 Participants
|
20 participants
n=7 Participants
|
81 participants
n=5 Participants
|
|
Complications of Hypertension
Had complications
|
593 participants
n=5 Participants
|
97 participants
n=7 Participants
|
690 participants
n=5 Participants
|
|
Complications of Hypertension
Had no complications
|
323 participants
n=5 Participants
|
63 participants
n=7 Participants
|
386 participants
n=5 Participants
|
|
Complications of Dyslipidemia
Had complications
|
582 participants
n=5 Participants
|
99 participants
n=7 Participants
|
681 participants
n=5 Participants
|
|
Complications of Dyslipidemia
Had no complications
|
334 participants
n=5 Participants
|
61 participants
n=7 Participants
|
395 participants
n=5 Participants
|
|
Complications of Hyperuricemia
Had complications
|
74 participants
n=5 Participants
|
8 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Complications of Hyperuricemia
Had no complications
|
842 participants
n=5 Participants
|
152 participants
n=7 Participants
|
994 participants
n=5 Participants
|
|
Complications of Liver Damage
Had complications
|
181 participants
n=5 Participants
|
35 participants
n=7 Participants
|
216 participants
n=5 Participants
|
|
Complications of Liver Damage
Had no complications
|
735 participants
n=5 Participants
|
125 participants
n=7 Participants
|
860 participants
n=5 Participants
|
|
Breakdown of Complications of Liver Damage
Hepatic steatosis
|
122 participants
n=5 Participants
|
24 participants
n=7 Participants
|
146 participants
n=5 Participants
|
|
Breakdown of Complications of Liver Damage
Hepatitis alcoholic
|
30 participants
n=5 Participants
|
9 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Breakdown of Complications of Liver Damage
Chronic hepatitis
|
31 participants
n=5 Participants
|
5 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Breakdown of Complications of Liver Damage
Hepatic cirrhosis
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Breakdown of Complications of Liver Damage
Other
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Degree of Hepatic Dysfunction
Normal
|
599 participants
n=5 Participants
|
111 participants
n=7 Participants
|
710 participants
n=5 Participants
|
|
Degree of Hepatic Dysfunction
Grade 1
|
75 participants
n=5 Participants
|
11 participants
n=7 Participants
|
86 participants
n=5 Participants
|
|
Degree of Hepatic Dysfunction
Grade 2
|
10 participants
n=5 Participants
|
2 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Degree of Hepatic Dysfunction
Unknown
|
232 participants
n=5 Participants
|
36 participants
n=7 Participants
|
268 participants
n=5 Participants
|
|
Complications of Renal Damage
Had complications
|
126 participants
n=5 Participants
|
27 participants
n=7 Participants
|
153 participants
n=5 Participants
|
|
Complications of Renal Damage
Had no complications
|
790 participants
n=5 Participants
|
133 participants
n=7 Participants
|
923 participants
n=5 Participants
|
|
Breakdown of Complications of Renal Damage
Nephrotic syndrome
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Breakdown of Complications of Renal Damage
Glomerulonephritis
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Breakdown of Complications of Renal Damage
Renal failure chronic
|
9 participants
n=5 Participants
|
0 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Breakdown of Complications of Renal Damage
Other
|
113 participants
n=5 Participants
|
25 participants
n=7 Participants
|
138 participants
n=5 Participants
|
|
Complications of Heart Disease
Had complications
|
129 participants
n=5 Participants
|
18 participants
n=7 Participants
|
147 participants
n=5 Participants
|
|
Complications of Heart Disease
Had no complications
|
787 participants
n=5 Participants
|
142 participants
n=7 Participants
|
929 participants
n=5 Participants
|
|
Breakdown of Complications of Heart Disease
Cardiac failure
|
25 participants
n=5 Participants
|
3 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Breakdown of Complications of Heart Disease
Myocardial infarction
|
26 participants
n=5 Participants
|
4 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Breakdown of Complications of Heart Disease
Angina pectoris
|
70 participants
n=5 Participants
|
7 participants
n=7 Participants
|
77 participants
n=5 Participants
|
|
Breakdown of Complications of Heart Disease
Other
|
26 participants
n=5 Participants
|
4 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Complications of Heart Failure
Had complications
|
25 participants
n=5 Participants
|
3 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Complications of Heart Failure
Had no complications
|
891 participants
n=5 Participants
|
157 participants
n=7 Participants
|
1048 participants
n=5 Participants
|
|
New York Heart Association (NYHA) Heart Failure Classification
NYHA Class I
|
16 participants
n=5 Participants
|
2 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
New York Heart Association (NYHA) Heart Failure Classification
NYHA Class II
|
5 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
New York Heart Association (NYHA) Heart Failure Classification
NYHA Class III
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
New York Heart Association (NYHA) Heart Failure Classification
NYHA Class IV
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
New York Heart Association (NYHA) Heart Failure Classification
Unknown
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Complications of Stroke-related Disease
Had complications
|
65 participants
n=5 Participants
|
7 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Complications of Stroke-related Disease
Had no complications
|
851 participants
n=5 Participants
|
153 participants
n=7 Participants
|
1004 participants
n=5 Participants
|
|
Breakdown of Complications of Stroke-related Disease
Cerebral infarction
|
64 participants
n=5 Participants
|
7 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Breakdown of Complications of Stroke-related Disease
Cerebral haemorrhage
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Complications of Allergic Disease
Had complications
|
51 participants
n=5 Participants
|
7 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Complications of Allergic Disease
Had no complications
|
865 participants
n=5 Participants
|
153 participants
n=7 Participants
|
1018 participants
n=5 Participants
|
|
Complications of Malignant Tumor
Had complications
|
19 participants
n=5 Participants
|
3 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Complications of Malignant Tumor
Had no complications
|
897 participants
n=5 Participants
|
157 participants
n=7 Participants
|
1054 participants
n=5 Participants
|
|
Presence of Medical History
Had medical history
|
165 participants
n=5 Participants
|
31 participants
n=7 Participants
|
196 participants
n=5 Participants
|
|
Presence of Medical History
Did not have medical history
|
652 participants
n=5 Participants
|
113 participants
n=7 Participants
|
765 participants
n=5 Participants
|
|
Presence of Medical History
Unknown
|
99 participants
n=5 Participants
|
16 participants
n=7 Participants
|
115 participants
n=5 Participants
|
|
History of Alcohol Consumption
Yes
|
228 participants
n=5 Participants
|
44 participants
n=7 Participants
|
272 participants
n=5 Participants
|
|
History of Alcohol Consumption
No
|
527 participants
n=5 Participants
|
84 participants
n=7 Participants
|
611 participants
n=5 Participants
|
|
History of Alcohol Consumption
Unknown
|
161 participants
n=5 Participants
|
32 participants
n=7 Participants
|
193 participants
n=5 Participants
|
|
Smoking Classification
Never smoked
|
372 participants
n=5 Participants
|
51 participants
n=7 Participants
|
423 participants
n=5 Participants
|
|
Smoking Classification
Current smoker
|
145 participants
n=5 Participants
|
30 participants
n=7 Participants
|
175 participants
n=5 Participants
|
|
Smoking Classification
Ex-smoker
|
189 participants
n=5 Participants
|
39 participants
n=7 Participants
|
228 participants
n=5 Participants
|
|
Smoking Classification
Unknown
|
210 participants
n=5 Participants
|
40 participants
n=7 Participants
|
250 participants
n=5 Participants
|
|
Glycosylated Hemoglobin (HbA1c) Level
HbA1c <6.0 percent (%)
|
14 participants
n=5 Participants
|
4 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Glycosylated Hemoglobin (HbA1c) Level
HbA1c >=6.0% to <7.0%
|
149 participants
n=5 Participants
|
25 participants
n=7 Participants
|
174 participants
n=5 Participants
|
|
Glycosylated Hemoglobin (HbA1c) Level
HbA1c >=7.0% to <8.0%
|
312 participants
n=5 Participants
|
61 participants
n=7 Participants
|
373 participants
n=5 Participants
|
|
Glycosylated Hemoglobin (HbA1c) Level
HbA1c >=8.0%
|
374 participants
n=5 Participants
|
61 participants
n=7 Participants
|
435 participants
n=5 Participants
|
|
Glycosylated Hemoglobin (HbA1c) Level
Unknown
|
67 participants
n=5 Participants
|
9 participants
n=7 Participants
|
76 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 12 monthsPopulation: The safety analysis set was defined as all participants who completed the study and had safety data available.
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. The safety analysis was planned to be assessed in alogliptin + SU and alogliptin + other arm separately.
Outcome measures
| Measure |
Alogliptin + SU
n=916 Participants
Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
Alogliptin + Other
n=160 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
|---|---|---|
|
Number of Participants Reporting One or More Adverse Drug Reactions
|
19 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Baseline up to 12 monthsPopulation: The safety analysis set was defined as all participants who completed the study and had safety data available.
Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + SU and alogliptin + other arm separately.
Outcome measures
| Measure |
Alogliptin + SU
n=916 Participants
Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
Alogliptin + Other
n=160 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
|---|---|---|
|
Number of Participants Reporting One or More Serious Adverse Drug Reaction
|
5 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
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 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of SU treatment.
Outcome measures
| Measure |
Alogliptin + SU
n=830 Participants
Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
Alogliptin + Other
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Baseline (n=830)
|
8.03 percentage of glycosylated hemoglobin
Standard Deviation 1.348
|
—
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change at Month 1 (n = 655)
|
-0.40 percentage of glycosylated hemoglobin
Standard Deviation 0.708
|
—
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change at Month 3 (n = 710)
|
-0.66 percentage of glycosylated hemoglobin
Standard Deviation 1.117
|
—
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change at Month 6 (n = 725)
|
-0.72 percentage of glycosylated hemoglobin
Standard Deviation 1.117
|
—
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change at Month 12 (n = 670)
|
-0.64 percentage of glycosylated hemoglobin
Standard Deviation 1.106
|
—
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change at Final Assessment (n = 830)
|
-0.65 percentage of glycosylated hemoglobin
Standard Deviation 1.145
|
—
|
SECONDARY outcome
Timeframe: Baseline and final assessment (up to Month 12)Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
The rate of achieving objective glycemic control in HbA1c level was calculated at baseline and final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as \<8.0%, \<7.0%, and \<6.0% of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of SU treatment.
Outcome measures
| Measure |
Alogliptin + SU
n=830 Participants
Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
Alogliptin + Other
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
|---|---|---|
|
Percentage of Participants Achieving Objective Glycemic Control
<8.0 percent: Baseline
|
56.3 percentage of participants
|
—
|
|
Percentage of Participants Achieving Objective Glycemic Control
<8.0%: Final Assessment
|
75.4 percentage of participants
|
—
|
|
Percentage of Participants Achieving Objective Glycemic Control
<7.0%: Baseline
|
19.3 percentage of participants
|
—
|
|
Percentage of Participants Achieving Objective Glycemic Control
<7.0%: Final Assessment
|
43.0 percentage of participants
|
—
|
|
Percentage of Participants Achieving Objective Glycemic Control
<6.0%: Final Assessment
|
4.6 percentage of participants
|
—
|
|
Percentage of Participants Achieving Objective Glycemic Control
<6.0%: Baseline
|
1.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)Population: The efficacy assessment population was defined as participants who completed the study and had fasting blood glucose data at baseline and post-baseline time points available.
The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the SU treatment.
Outcome measures
| Measure |
Alogliptin + SU
n=250 Participants
Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
Alogliptin + Other
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
|---|---|---|
|
Change From Baseline in Fasting Blood Glucose
Baseline (n = 250)
|
151.1 milligram per deciliter (mg/dL)
Standard Deviation 43.07
|
—
|
|
Change From Baseline in Fasting Blood Glucose
Change at Month 1 (n = 159)
|
-14.6 milligram per deciliter (mg/dL)
Standard Deviation 42.91
|
—
|
|
Change From Baseline in Fasting Blood Glucose
Change at Month 3 (n = 175)
|
-13.8 milligram per deciliter (mg/dL)
Standard Deviation 40.08
|
—
|
|
Change From Baseline in Fasting Blood Glucose
Change at Month 6 (n = 185)
|
-13.1 milligram per deciliter (mg/dL)
Standard Deviation 47.37
|
—
|
|
Change From Baseline in Fasting Blood Glucose
Change at Month 12 (n = 168)
|
-16.4 milligram per deciliter (mg/dL)
Standard Deviation 43.97
|
—
|
|
Change From Baseline in Fasting Blood Glucose
Change at Final Assessment (n = 250)
|
-13.7 milligram per deciliter (mg/dL)
Standard Deviation 49.10
|
—
|
SECONDARY outcome
Timeframe: Months 1, 3, 6, 12, and final assessment (up to Month 12)Population: The efficacy assessment population was defined as participants who completed the study and had fasting insulin data at baseline and post-baseline time points available.
The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of SU treatment.
Outcome measures
| Measure |
Alogliptin + SU
n=33 Participants
Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
Alogliptin + Other
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
|---|---|---|
|
Change From Baseline in Fasting Insulin Level
Baseline (n = 33)
|
7.88 micro units per milliliter (mcU/mL)
Standard Deviation 5.674
|
—
|
|
Change From Baseline in Fasting Insulin Level
Change at Month 1 (n = 15)
|
1.27 micro units per milliliter (mcU/mL)
Standard Deviation 12.138
|
—
|
|
Change From Baseline in Fasting Insulin Level
Change at Month 3 (n = 17)
|
0.21 micro units per milliliter (mcU/mL)
Standard Deviation 3.474
|
—
|
|
Change From Baseline in Fasting Insulin Level
Change at Month 6 (n = 20)
|
0.69 micro units per milliliter (mcU/mL)
Standard Deviation 5.629
|
—
|
|
Change From Baseline in Fasting Insulin Level
Change at Month 12 (n = 22)
|
1.17 micro units per milliliter (mcU/mL)
Standard Deviation 3.521
|
—
|
|
Change From Baseline in Fasting Insulin Level
Change at Final Assessment (n = 33)
|
1.86 micro units per milliliter (mcU/mL)
Standard Deviation 5.455
|
—
|
Adverse Events
Alogliptin + SU
Serious events: 5 serious events
Other events: 19 other events
Deaths: 0 deaths
Alogliptin + Other
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alogliptin + SU
n=916 participants at risk
Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
Alogliptin + Other
n=160 participants at risk
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
|---|---|---|
|
Infections and infestations
Pneumonia pneumococcal
|
0.11%
1/916 • Baseline up to 12 months
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 were collected in the safety population.
|
0.00%
0/160 • Baseline up to 12 months
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 were collected in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.11%
1/916 • Baseline up to 12 months
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 were collected in the safety population.
|
0.00%
0/160 • Baseline up to 12 months
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 were collected in the safety population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.11%
1/916 • Baseline up to 12 months
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 were collected in the safety population.
|
0.00%
0/160 • Baseline up to 12 months
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 were collected in the safety population.
|
|
Nervous system disorders
Cerebral infarction
|
0.11%
1/916 • Baseline up to 12 months
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 were collected in the safety population.
|
0.00%
0/160 • Baseline up to 12 months
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 were collected in the safety population.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.11%
1/916 • Baseline up to 12 months
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 were collected in the safety population.
|
0.00%
0/160 • Baseline up to 12 months
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 were collected in the safety population.
|
Other adverse events
| Measure |
Alogliptin + SU
n=916 participants at risk
Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
Alogliptin + Other
n=160 participants at risk
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
|---|---|---|
|
Infections and infestations
Influenza
|
0.11%
1/916 • Baseline up to 12 months
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 were collected in the safety population.
|
0.00%
0/160 • Baseline up to 12 months
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 were collected in the safety population.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.11%
1/916 • Baseline up to 12 months
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 were collected in the safety population.
|
0.00%
0/160 • Baseline up to 12 months
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 were collected in the safety population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.22%
2/916 • Baseline up to 12 months
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 were collected in the safety population.
|
0.00%
0/160 • Baseline up to 12 months
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 were collected in the safety population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.11%
1/916 • Baseline up to 12 months
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 were collected in the safety population.
|
0.00%
0/160 • Baseline up to 12 months
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 were collected in the safety population.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.11%
1/916 • Baseline up to 12 months
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 were collected in the safety population.
|
0.00%
0/160 • Baseline up to 12 months
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 were collected in the safety population.
|
|
Vascular disorders
Hypertension
|
0.11%
1/916 • Baseline up to 12 months
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 were collected in the safety population.
|
0.00%
0/160 • Baseline up to 12 months
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 were collected in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.11%
1/916 • Baseline up to 12 months
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 were collected in the safety population.
|
0.00%
0/160 • Baseline up to 12 months
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 were collected in the safety population.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.11%
1/916 • Baseline up to 12 months
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 were collected in the safety population.
|
0.00%
0/160 • Baseline up to 12 months
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 were collected in the safety population.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.11%
1/916 • Baseline up to 12 months
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 were collected in the safety population.
|
0.00%
0/160 • Baseline up to 12 months
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 were collected in the safety population.
|
|
Gastrointestinal disorders
Nausea
|
0.11%
1/916 • Baseline up to 12 months
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 were collected in the safety population.
|
0.00%
0/160 • Baseline up to 12 months
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 were collected in the safety population.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.11%
1/916 • Baseline up to 12 months
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 were collected in the safety population.
|
0.00%
0/160 • Baseline up to 12 months
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 were collected in the safety population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.11%
1/916 • Baseline up to 12 months
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 were collected in the safety population.
|
0.00%
0/160 • Baseline up to 12 months
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 were collected in the safety population.
|
|
General disorders
Feeling abnormal
|
0.22%
2/916 • Baseline up to 12 months
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 were collected in the safety population.
|
0.00%
0/160 • Baseline up to 12 months
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 were collected in the safety population.
|
|
General disorders
Malaise
|
0.11%
1/916 • Baseline up to 12 months
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 were collected in the safety population.
|
0.62%
1/160 • Baseline up to 12 months
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 were collected in the safety population.
|
|
General disorders
Pyrexia
|
0.11%
1/916 • Baseline up to 12 months
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 were collected in the safety population.
|
0.00%
0/160 • Baseline up to 12 months
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 were collected in the safety population.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.11%
1/916 • Baseline up to 12 months
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 were collected in the safety population.
|
0.00%
0/160 • Baseline up to 12 months
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 were collected in the safety population.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.11%
1/916 • Baseline up to 12 months
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 were collected in the safety population.
|
0.00%
0/160 • Baseline up to 12 months
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 were collected in the safety population.
|
Additional Information
Medical Director
Takeda Pharmaceutical Company Limited
Phone: +1-877-825-3327
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER