Trial Outcomes & Findings for Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Combination Therapy With Thiazolidinediones" (NCT NCT01945242)
NCT ID: NCT01945242
Last Updated: 2016-09-27
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 + thiazolidinedione and alogliptin + other arm separately.
Recruitment status
COMPLETED
Target enrollment
1374 participants
Primary outcome timeframe
Baseline up to 12 months
Results posted on
2016-09-27
Participant Flow
Participants took part in the study at 252 investigative site in Japan from 25 March 2011 to 30 June 2014.
Participants with a historical diagnosis of type 2 diabetes mellitus who failed to respond adequately to treatment receiving thiazolidinediones were enrolled in 1 of 2 treatment groups as follows: alogliptin + thiazolidinediones; alogliptin + other.
Participant milestones
| Measure |
Alogliptin + Thiazolidinedione
Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
|
Alogliptin + Other
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
|
|---|---|---|
|
Overall Study
STARTED
|
1251
|
123
|
|
Overall Study
COMPLETED
|
1248
|
120
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Alogliptin + Thiazolidinedione
Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
|
Alogliptin + Other
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
|
|---|---|---|
|
Overall Study
Physician Decision
|
3
|
3
|
Baseline Characteristics
Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Combination Therapy With Thiazolidinediones"
Baseline characteristics by cohort
| Measure |
Alogliptin + Thiazolidinedione
n=1248 Participants
Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
|
Alogliptin + Other
n=120 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
|
Total
n=1368 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Less than (<) 20 years
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Age, Customized
20-29 years
|
5 participants
n=99 Participants
|
0 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Age, Customized
30-39 years
|
29 participants
n=99 Participants
|
4 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
Age, Customized
40-49 years
|
120 participants
n=99 Participants
|
12 participants
n=107 Participants
|
132 participants
n=206 Participants
|
|
Age, Customized
50-59 years
|
214 participants
n=99 Participants
|
22 participants
n=107 Participants
|
236 participants
n=206 Participants
|
|
Age, Customized
60-69 years
|
412 participants
n=99 Participants
|
35 participants
n=107 Participants
|
447 participants
n=206 Participants
|
|
Age, Customized
70-79 years
|
337 participants
n=99 Participants
|
39 participants
n=107 Participants
|
376 participants
n=206 Participants
|
|
Age, Customized
Greater than equal to (>=) 80 years
|
130 participants
n=99 Participants
|
8 participants
n=107 Participants
|
138 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
462 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
503 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
786 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
865 Participants
n=206 Participants
|
|
Body Mass Index
<18.5 kilogram/square meter (kg/m^2)
|
16 participants
n=99 Participants
|
0 participants
n=107 Participants
|
16 participants
n=206 Participants
|
|
Body Mass Index
>=18.5 to <25 kg/m^2
|
318 participants
n=99 Participants
|
26 participants
n=107 Participants
|
344 participants
n=206 Participants
|
|
Body Mass Index
>=25 to <30 kg/m^2
|
353 participants
n=99 Participants
|
31 participants
n=107 Participants
|
384 participants
n=206 Participants
|
|
Body Mass Index
>=30 kg/m^2
|
134 participants
n=99 Participants
|
16 participants
n=107 Participants
|
150 participants
n=206 Participants
|
|
Body Mass Index
Unknown
|
427 participants
n=99 Participants
|
47 participants
n=107 Participants
|
474 participants
n=206 Participants
|
|
Waist Circumference
<85 centimeter (cm) (Male)
|
60 participants
n=99 Participants
|
7 participants
n=107 Participants
|
67 participants
n=206 Participants
|
|
Waist Circumference
>=85 cm (Male)
|
184 participants
n=99 Participants
|
17 participants
n=107 Participants
|
201 participants
n=206 Participants
|
|
Waist Circumference
Unknown (Male)
|
542 participants
n=99 Participants
|
55 participants
n=107 Participants
|
597 participants
n=206 Participants
|
|
Waist Circumference
<90 cm (Female)
|
92 participants
n=99 Participants
|
4 participants
n=107 Participants
|
96 participants
n=206 Participants
|
|
Waist Circumference
>=90 cm (Female)
|
49 participants
n=99 Participants
|
4 participants
n=107 Participants
|
53 participants
n=206 Participants
|
|
Waist Circumference
Unknown (Female)
|
321 participants
n=99 Participants
|
33 participants
n=107 Participants
|
354 participants
n=206 Participants
|
|
Pregnancy Status
Not pregnant
|
462 participants
n=99 Participants
|
41 participants
n=107 Participants
|
503 participants
n=206 Participants
|
|
Pregnancy Status
Pregnant
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Healthcare category
Outpatient
|
1209 participants
n=99 Participants
|
120 participants
n=107 Participants
|
1329 participants
n=206 Participants
|
|
Healthcare category
Inpatient
|
11 participants
n=99 Participants
|
0 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Healthcare category
Outpatient and Inpatient
|
28 participants
n=99 Participants
|
0 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Health-related Complications
Had Complications
|
1064 participants
n=99 Participants
|
96 participants
n=107 Participants
|
1160 participants
n=206 Participants
|
|
Health-related Complications
Had No Complications
|
184 participants
n=99 Participants
|
24 participants
n=107 Participants
|
208 participants
n=206 Participants
|
|
Diabetic complications
Had Diabetic Complications
|
203 participants
n=99 Participants
|
15 participants
n=107 Participants
|
218 participants
n=206 Participants
|
|
Diabetic complications
Had No Diabetic Complications
|
1045 participants
n=99 Participants
|
105 participants
n=107 Participants
|
1150 participants
n=206 Participants
|
|
Breakdown of diabetic complications
Diabetic nephropathy
|
128 participants
n=99 Participants
|
5 participants
n=107 Participants
|
133 participants
n=206 Participants
|
|
Breakdown of diabetic complications
Diabetic retinopathy
|
65 participants
n=99 Participants
|
9 participants
n=107 Participants
|
74 participants
n=206 Participants
|
|
Breakdown of diabetic complications
Diabetic neuropathy
|
71 participants
n=99 Participants
|
6 participants
n=107 Participants
|
77 participants
n=206 Participants
|
|
Complications of Hypertension
Had Hypertension Complications
|
760 participants
n=99 Participants
|
69 participants
n=107 Participants
|
829 participants
n=206 Participants
|
|
Complications of Hypertension
Had No Hypertension Complications
|
488 participants
n=99 Participants
|
51 participants
n=107 Participants
|
539 participants
n=206 Participants
|
|
Complications of Dyslipidemia
Had Dyslipidemia Complications
|
766 participants
n=99 Participants
|
63 participants
n=107 Participants
|
829 participants
n=206 Participants
|
|
Complications of Dyslipidemia
Had No Dyslipidemia Complications
|
482 participants
n=99 Participants
|
57 participants
n=107 Participants
|
539 participants
n=206 Participants
|
|
Complications of Hyperuricemia
Had Hyperuricemia Complications
|
106 participants
n=99 Participants
|
10 participants
n=107 Participants
|
116 participants
n=206 Participants
|
|
Complications of Hyperuricemia
Had No Hyperuricemia Complications
|
1142 participants
n=99 Participants
|
110 participants
n=107 Participants
|
1252 participants
n=206 Participants
|
|
Complications of Liver Damage
Had Liver Damage Complications
|
200 participants
n=99 Participants
|
18 participants
n=107 Participants
|
218 participants
n=206 Participants
|
|
Complications of Liver Damage
Had No Liver Damage Complications
|
1048 participants
n=99 Participants
|
102 participants
n=107 Participants
|
1150 participants
n=206 Participants
|
|
Breakdown of Complications of Liver Damage
Hepatic steatosis
|
158 participants
n=99 Participants
|
14 participants
n=107 Participants
|
172 participants
n=206 Participants
|
|
Breakdown of Complications of Liver Damage
Hepatitis alcoholic
|
18 participants
n=99 Participants
|
1 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Breakdown of Complications of Liver Damage
Chronic hepatitis
|
17 participants
n=99 Participants
|
2 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Breakdown of Complications of Liver Damage
Hepatic cirrhosis
|
5 participants
n=99 Participants
|
0 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Breakdown of Complications of Liver Damage
Other
|
8 participants
n=99 Participants
|
2 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Degree of Hepatic Dysfunction
Normal
|
769 participants
n=99 Participants
|
74 participants
n=107 Participants
|
843 participants
n=206 Participants
|
|
Degree of Hepatic Dysfunction
Grade 1
|
89 participants
n=99 Participants
|
10 participants
n=107 Participants
|
99 participants
n=206 Participants
|
|
Degree of Hepatic Dysfunction
Grade 2
|
11 participants
n=99 Participants
|
0 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Degree of Hepatic Dysfunction
Grade 3
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Degree of Hepatic Dysfunction
Unknown
|
379 participants
n=99 Participants
|
36 participants
n=107 Participants
|
415 participants
n=206 Participants
|
|
Complications of Renal Damage
Had Renal Damage Complications
|
138 participants
n=99 Participants
|
5 participants
n=107 Participants
|
143 participants
n=206 Participants
|
|
Complications of Renal Damage
Had No Renal Damage Complications
|
1110 participants
n=99 Participants
|
115 participants
n=107 Participants
|
1225 participants
n=206 Participants
|
|
Breakdown of Complications of Renal Damage
Nephrotic syndrome
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Breakdown of Complications of Renal Damage
Glomerulonephritis
|
3 participants
n=99 Participants
|
0 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Breakdown of Complications of Renal Damage
Renal failure chronic
|
8 participants
n=99 Participants
|
0 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Breakdown of Complications of Renal Damage
Other
|
126 participants
n=99 Participants
|
5 participants
n=107 Participants
|
131 participants
n=206 Participants
|
|
Degree of Renal Dysfunction
Normal
|
198 participants
n=99 Participants
|
26 participants
n=107 Participants
|
224 participants
n=206 Participants
|
|
Degree of Renal Dysfunction
Mild
|
488 participants
n=99 Participants
|
46 participants
n=107 Participants
|
534 participants
n=206 Participants
|
|
Degree of Renal Dysfunction
Moderate
|
174 participants
n=99 Participants
|
15 participants
n=107 Participants
|
189 participants
n=206 Participants
|
|
Degree of Renal Dysfunction
Severe
|
10 participants
n=99 Participants
|
0 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Degree of Renal Dysfunction
Unknown
|
378 participants
n=99 Participants
|
33 participants
n=107 Participants
|
411 participants
n=206 Participants
|
|
Complications of Heart Disease
Had Heart Disease Complications
|
142 participants
n=99 Participants
|
9 participants
n=107 Participants
|
151 participants
n=206 Participants
|
|
Complications of Heart Disease
Had No Heart Disease Complications
|
1106 participants
n=99 Participants
|
111 participants
n=107 Participants
|
1217 participants
n=206 Participants
|
|
Breakdown of Complications of Heart Disease
Cardiac failure
|
16 participants
n=99 Participants
|
2 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Breakdown of Complications of Heart Disease
Myocardial infarction
|
27 participants
n=99 Participants
|
3 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
Breakdown of Complications of Heart Disease
Angina pectoris
|
71 participants
n=99 Participants
|
4 participants
n=107 Participants
|
75 participants
n=206 Participants
|
|
Breakdown of Complications of Heart Disease
Other
|
42 participants
n=99 Participants
|
3 participants
n=107 Participants
|
45 participants
n=206 Participants
|
|
Complications of Heart Failure
Had Heart Failure Complications
|
16 participants
n=99 Participants
|
2 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Complications of Heart Failure
Had No Heart Failure Complications
|
1232 participants
n=99 Participants
|
118 participants
n=107 Participants
|
1350 participants
n=206 Participants
|
|
New York Heart Association (NYHA) Heart Failure Classification
NYHA Class I
|
15 participants
n=99 Participants
|
1 participants
n=107 Participants
|
16 participants
n=206 Participants
|
|
New York Heart Association (NYHA) Heart Failure Classification
NYHA Class II
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
New York Heart Association (NYHA) Heart Failure Classification
NYHA Class III
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
New York Heart Association (NYHA) Heart Failure Classification
NYHA Class IV
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Complications of Stroke-related Disease
Had Stroke-related Disease Complication
|
81 participants
n=99 Participants
|
7 participants
n=107 Participants
|
88 participants
n=206 Participants
|
|
Complications of Stroke-related Disease
Had No Stroke-related Disease Complication
|
1167 participants
n=99 Participants
|
113 participants
n=107 Participants
|
1280 participants
n=206 Participants
|
|
Breakdown of complications of stroke-related disease
Cerebral infarction
|
80 participants
n=99 Participants
|
7 participants
n=107 Participants
|
87 participants
n=206 Participants
|
|
Breakdown of complications of stroke-related disease
Transient ischemic attack
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Complications of Allergic Disease
Had Allergic Disease Complication
|
58 participants
n=99 Participants
|
7 participants
n=107 Participants
|
65 participants
n=206 Participants
|
|
Complications of Allergic Disease
Had No Allergic Disease Complication
|
1190 participants
n=99 Participants
|
113 participants
n=107 Participants
|
1303 participants
n=206 Participants
|
|
Breakdown of Complications of Allergic Disease
Asthma bronchial
|
27 participants
n=99 Participants
|
3 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
Breakdown of Complications of Allergic Disease
Pollinosis
|
12 participants
n=99 Participants
|
0 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Breakdown of Complications of Allergic Disease
Rhinitis allergic
|
25 participants
n=99 Participants
|
4 participants
n=107 Participants
|
29 participants
n=206 Participants
|
|
Breakdown of Complications of Allergic Disease
Dermatitis allergic
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Complications of Malignant Tumor
Had Malignant Tumor Complications
|
13 participants
n=99 Participants
|
5 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Complications of Malignant Tumor
Had No Malignant Tumor Complications
|
1235 participants
n=99 Participants
|
115 participants
n=107 Participants
|
1350 participants
n=206 Participants
|
|
Complications of Malignant Tumor (narrow definition)
Had Malignant Tumor Complications
|
11 participants
n=99 Participants
|
2 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Complications of Malignant Tumor (narrow definition)
Had No Malignant Tumor Complications
|
1237 participants
n=99 Participants
|
118 participants
n=107 Participants
|
1355 participants
n=206 Participants
|
|
Other Complications
Had Other Complications
|
376 participants
n=99 Participants
|
34 participants
n=107 Participants
|
410 participants
n=206 Participants
|
|
Other Complications
Had No Other Complications
|
872 participants
n=99 Participants
|
86 participants
n=107 Participants
|
958 participants
n=206 Participants
|
|
Presence of Medical History
Had Presence of Medical History
|
162 participants
n=99 Participants
|
19 participants
n=107 Participants
|
181 participants
n=206 Participants
|
|
Presence of Medical History
Had No Presence of Medical History
|
960 participants
n=99 Participants
|
88 participants
n=107 Participants
|
1048 participants
n=206 Participants
|
|
Presence of Medical History
Unknown
|
126 participants
n=99 Participants
|
13 participants
n=107 Participants
|
139 participants
n=206 Participants
|
|
History of Allergies
Had History of Allergies
|
78 participants
n=99 Participants
|
7 participants
n=107 Participants
|
85 participants
n=206 Participants
|
|
History of Allergies
Had No History of Allergies
|
1066 participants
n=99 Participants
|
95 participants
n=107 Participants
|
1161 participants
n=206 Participants
|
|
History of Allergies
Unknown
|
104 participants
n=99 Participants
|
18 participants
n=107 Participants
|
122 participants
n=206 Participants
|
|
History of Alcohol Consumption
Had Alcohol Consumption
|
333 participants
n=99 Participants
|
34 participants
n=107 Participants
|
367 participants
n=206 Participants
|
|
History of Alcohol Consumption
Had No Alcohol Consumption
|
690 participants
n=99 Participants
|
60 participants
n=107 Participants
|
750 participants
n=206 Participants
|
|
History of Alcohol Consumption
Unknown
|
225 participants
n=99 Participants
|
26 participants
n=107 Participants
|
251 participants
n=206 Participants
|
|
Smoking Classification
Never Smoked
|
525 participants
n=99 Participants
|
45 participants
n=107 Participants
|
570 participants
n=206 Participants
|
|
Smoking Classification
Current Smoker
|
204 participants
n=99 Participants
|
25 participants
n=107 Participants
|
229 participants
n=206 Participants
|
|
Smoking Classification
Ex-smoker
|
233 participants
n=99 Participants
|
24 participants
n=107 Participants
|
257 participants
n=206 Participants
|
|
Smoking Classification
Unknown
|
286 participants
n=99 Participants
|
26 participants
n=107 Participants
|
312 participants
n=206 Participants
|
|
Time from Diagnosis of Type 2 Diabetes
<2 years
|
158 participants
n=99 Participants
|
35 participants
n=107 Participants
|
193 participants
n=206 Participants
|
|
Time from Diagnosis of Type 2 Diabetes
>=2 to <5 years
|
187 participants
n=99 Participants
|
17 participants
n=107 Participants
|
204 participants
n=206 Participants
|
|
Time from Diagnosis of Type 2 Diabetes
>=5 to <10 years
|
247 participants
n=99 Participants
|
21 participants
n=107 Participants
|
268 participants
n=206 Participants
|
|
Time from Diagnosis of Type 2 Diabetes
>=10 years
|
288 participants
n=99 Participants
|
22 participants
n=107 Participants
|
310 participants
n=206 Participants
|
|
Time from Diagnosis of Type 2 Diabetes
Unknown
|
368 participants
n=99 Participants
|
25 participants
n=107 Participants
|
393 participants
n=206 Participants
|
|
Glycosylated Hemoglobin A1c (HbA1c)
HbA1c <6.0 percent
|
30 participants
n=99 Participants
|
3 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
Glycosylated Hemoglobin A1c (HbA1c)
HbA1c >=6.0 to <7.0 percent
|
289 participants
n=99 Participants
|
27 participants
n=107 Participants
|
316 participants
n=206 Participants
|
|
Glycosylated Hemoglobin A1c (HbA1c)
HbA1c >=7.0 to <8.0 percent
|
461 participants
n=99 Participants
|
44 participants
n=107 Participants
|
505 participants
n=206 Participants
|
|
Glycosylated Hemoglobin A1c (HbA1c)
HbA1c >=8.0 percent
|
365 participants
n=99 Participants
|
36 participants
n=107 Participants
|
401 participants
n=206 Participants
|
|
Glycosylated Hemoglobin A1c (HbA1c)
Unknown
|
103 participants
n=99 Participants
|
10 participants
n=107 Participants
|
113 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 12 monthsPopulation: The safety analysis set was defined as all participants who were enrolled and 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. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately.
Outcome measures
| Measure |
Alogliptin + Thiazolidinedione
n=1248 Participants
Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
|
Alogliptin + Other
n=120 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
|
|---|---|---|
|
Number of Participants Reporting One or More Adverse Drug Reactions
Hyperglycaemia
|
1 participants
|
0 participants
|
|
Number of Participants Reporting One or More Adverse Drug Reactions
Hypoglycaemia
|
5 participants
|
1 participants
|
|
Number of Participants Reporting One or More Adverse Drug Reactions
Dyslipidaemia
|
1 participants
|
0 participants
|
|
Number of Participants Reporting One or More Adverse Drug Reactions
Dizziness
|
3 participants
|
0 participants
|
|
Number of Participants Reporting One or More Adverse Drug Reactions
Photopsia
|
1 participants
|
0 participants
|
|
Number of Participants Reporting One or More Adverse Drug Reactions
Hypertension
|
1 participants
|
0 participants
|
|
Number of Participants Reporting One or More Adverse Drug Reactions
Abdominal distension
|
1 participants
|
0 participants
|
|
Number of Participants Reporting One or More Adverse Drug Reactions
Diarrhoea
|
1 participants
|
0 participants
|
|
Number of Participants Reporting One or More Adverse Drug Reactions
Eczema
|
1 participants
|
0 participants
|
|
Number of Participants Reporting One or More Adverse Drug Reactions
Pruritus
|
1 participants
|
0 participants
|
|
Number of Participants Reporting One or More Adverse Drug Reactions
Arthralgia
|
1 participants
|
0 participants
|
|
Number of Participants Reporting One or More Adverse Drug Reactions
Joint swelling
|
1 participants
|
0 participants
|
|
Number of Participants Reporting One or More Adverse Drug Reactions
Local swelling
|
1 participants
|
0 participants
|
|
Number of Participants Reporting One or More Adverse Drug Reactions
Pyrexia
|
1 participants
|
0 participants
|
|
Number of Participants Reporting One or More Adverse Drug Reactions
Blood insulin decreased
|
1 participants
|
0 participants
|
|
Number of Participants Reporting One or More Adverse Drug Reactions
Blood insulin increased
|
1 participants
|
0 participants
|
|
Number of Participants Reporting One or More Adverse Drug Reactions
Hand fracture
|
1 participants
|
0 participants
|
|
Number of Participants Reporting One or More Adverse Drug Reactions
Rib fracture
|
1 participants
|
0 participants
|
|
Number of Participants Reporting One or More Adverse Drug Reactions
Hypothyroidism
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to 12 monthsPopulation: The safety analysis set was defined as all participants who were enrolled and completed the study.
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. An 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 + thiazolidinedione and alogliptin + other arm separately.
Outcome measures
| Measure |
Alogliptin + Thiazolidinedione
n=1248 Participants
Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
|
Alogliptin + Other
n=120 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
|
|---|---|---|
|
Number of Participants Reporting One or More Serious Adverse Drug Reactions
Hyperglycaemia
|
1 participants
|
0 participants
|
|
Number of Participants Reporting One or More Serious Adverse Drug Reactions
Hypoglycaemia
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)Population: The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.
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 the thiazolidinedione treatment.
Outcome measures
| Measure |
Alogliptin + Thiazolidinedione
n=1129 Participants
Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
|
Alogliptin + Other
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Baseline (n=1124)
|
7.67 percentage of glycosylated hemoglobin
Standard Deviation 1.179
|
—
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change at Month 1 (n=879)
|
-0.25 percentage of glycosylated hemoglobin
Standard Deviation 0.597
|
—
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change at Month 6 (n=988)
|
-0.53 percentage of glycosylated hemoglobin
Standard Deviation 1.098
|
—
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change at Month 12 (n=949)
|
-0.64 percentage of glycosylated hemoglobin
Standard Deviation 1.133
|
—
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change at Final assessment (n=1124)
|
-0.57 percentage of glycosylated hemoglobin
Standard Deviation 1.143
|
—
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change at Month 3 (n=1005)
|
-0.47 percentage of glycosylated hemoglobin
Standard Deviation 0.988
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)Population: The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.
The rate of achieving objective glycemic control in HbA1c level, was calculated at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as \<8.0 percent, \<7.0 percent, and \<6.0 percent of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.
Outcome measures
| Measure |
Alogliptin + Thiazolidinedione
n=1129 Participants
Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
|
Alogliptin + Other
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
|
|---|---|---|
|
Percentage of Participants of Achieving Objective Glycemic Control
<8.0 percent (Baseline) (n=1124)
|
68.0 percentage of participants
1.179
|
—
|
|
Percentage of Participants of Achieving Objective Glycemic Control
<8.0 percent (Month 1) (n=879)
|
75.8 percentage of participants
0.597
|
—
|
|
Percentage of Participants of Achieving Objective Glycemic Control
<7.0 percent (Month 3) (n=1005)
|
47.1 percentage of participants
|
—
|
|
Percentage of Participants of Achieving Objective Glycemic Control
<7.0 percent (Month 6) (n=988)
|
51.2 percentage of participants
|
—
|
|
Percentage of Participants of Achieving Objective Glycemic Control
<7.0 percent (Month 12) (n=949)
|
57.5 percentage of participants
|
—
|
|
Percentage of Participants of Achieving Objective Glycemic Control
<7.0 percent (Final assessment) (n=1124)
|
54.2 percentage of participants
|
—
|
|
Percentage of Participants of Achieving Objective Glycemic Control
<6.0 percent (Baseline) (n=1124)
|
2.7 percentage of participants
|
—
|
|
Percentage of Participants of Achieving Objective Glycemic Control
<6.0 percent (Month 1) (n=879)
|
3.2 percentage of participants
|
—
|
|
Percentage of Participants of Achieving Objective Glycemic Control
<6.0 percent (Month 6) (n=988)
|
6.8 percentage of participants
|
—
|
|
Percentage of Participants of Achieving Objective Glycemic Control
<6.0 percent (Month 12) (n=949)
|
8.2 percentage of participants
|
—
|
|
Percentage of Participants of Achieving Objective Glycemic Control
<8.0 percent (Month 3) (n=1005)
|
84.2 percentage of participants
0.988
|
—
|
|
Percentage of Participants of Achieving Objective Glycemic Control
<8.0 percent (Month 6) (n=988)
|
84.5 percentage of participants
1.098
|
—
|
|
Percentage of Participants of Achieving Objective Glycemic Control
<8.0 percent (Month 12) (n=949)
|
87.1 percentage of participants
1.133
|
—
|
|
Percentage of Participants of Achieving Objective Glycemic Control
<8.0 percent (Final assessment) (n=1124)
|
83.6 percentage of participants
1.143
|
—
|
|
Percentage of Participants of Achieving Objective Glycemic Control
<7.0 percent (Baseline) (n=1124)
|
27.6 percentage of participants
|
—
|
|
Percentage of Participants of Achieving Objective Glycemic Control
<7.0 percent (Month 1) (n=879)
|
34.3 percentage of participants
|
—
|
|
Percentage of Participants of Achieving Objective Glycemic Control
<6.0 percent (Month 3) (n=1005)
|
5.6 percentage of participants
|
—
|
|
Percentage of Participants of Achieving Objective Glycemic Control
<6.0 percent (Final assessment) (n=1124)
|
8.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)Population: The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.
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 thiazolidinedione treatment.
Outcome measures
| Measure |
Alogliptin + Thiazolidinedione
n=1129 Participants
Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
|
Alogliptin + Other
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
|
|---|---|---|
|
Change From Baseline in Fasting Blood Glucose
Baseline (n=389)
|
145.4 milligram per deciliter (mg/dL)
Standard Deviation 41.25
|
—
|
|
Change From Baseline in Fasting Blood Glucose
Change at Month 1 (n=283)
|
-9.8 milligram per deciliter (mg/dL)
Standard Deviation 35.39
|
—
|
|
Change From Baseline in Fasting Blood Glucose
Change at Month 3 (n=301)
|
-11.8 milligram per deciliter (mg/dL)
Standard Deviation 37.63
|
—
|
|
Change From Baseline in Fasting Blood Glucose
Change at Month 12 (n=293)
|
-16.2 milligram per deciliter (mg/dL)
Standard Deviation 35.46
|
—
|
|
Change From Baseline in Fasting Blood Glucose
Change at Final assessment (n=398)
|
-13.5 milligram per deciliter (mg/dL)
Standard Deviation 40.25
|
—
|
|
Change From Baseline in Fasting Blood Glucose
Change at Month 6 (n=297)
|
-13.9 milligram per deciliter (mg/dL)
Standard Deviation 41.75
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)Population: The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.
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 the thiazolidinedione treatment.
Outcome measures
| Measure |
Alogliptin + Thiazolidinedione
n=1129 Participants
Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
|
Alogliptin + Other
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
|
|---|---|---|
|
Change From Baseline in Fasting Insulin
Baseline (n=82)
|
6.32 mg/dL
Standard Deviation 3.121
|
—
|
|
Change From Baseline in Fasting Insulin
Change at Month 1 (n=54)
|
0.19 mg/dL
Standard Deviation 1.519
|
—
|
|
Change From Baseline in Fasting Insulin
Change at Month 3 (n=57)
|
-0.02 mg/dL
Standard Deviation 1.946
|
—
|
|
Change From Baseline in Fasting Insulin
Change at Month 6 (n=60)
|
0.29 mg/dL
Standard Deviation 3.505
|
—
|
|
Change From Baseline in Fasting Insulin
Change at Month 12 (n=68)
|
-0.32 mg/dL
Standard Deviation 1.980
|
—
|
|
Change From Baseline in Fasting Insulin
Change at Final assessment (n=82)
|
-0.25 mg/dL
Standard Deviation 1.951
|
—
|
Adverse Events
Alogliptin + Thiazolidinedione
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Alogliptin + Other
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alogliptin + Thiazolidinedione
n=1248 participants at risk
Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
|
Alogliptin + Other
n=120 participants at risk
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.08%
1/1248 • 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.
|
0.00%
0/120 • 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.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.16%
2/1248 • 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.
|
0.00%
0/120 • 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.
|
Other adverse events
| Measure |
Alogliptin + Thiazolidinedione
n=1248 participants at risk
Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
|
Alogliptin + Other
n=120 participants at risk
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
|
|---|---|---|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.88%
11/1248 • 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.
|
1.7%
2/120 • 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.
|
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