Trial Outcomes & Findings for Efficacy and Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus (NCT NCT02220920)
NCT ID: NCT02220920
Last Updated: 2016-12-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
146 participants
Primary outcome timeframe
baseline and Week 16
Results posted on
2016-12-15
Participant Flow
Participant milestones
| Measure |
Canagliflozin (TA-7284) ＋Insulin
Canagliflozin, once daily for 16 weeks
|
Placebo＋Insulin
Placebo, once daily for 16 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
70
|
|
Overall Study
COMPLETED
|
73
|
67
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Canagliflozin (TA-7284) ＋Insulin
Canagliflozin, once daily for 16 weeks
|
Placebo＋Insulin
Placebo, once daily for 16 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Conflict with the stopping criteria
|
1
|
2
|
Baseline Characteristics
Efficacy and Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Canagliflozin (TA-7284) ＋Insulin
n=76 Participants
Canagliflozin, once daily for 16 weeks
|
Placebo＋Insulin
n=70 Participants
Placebo, once daily for 16 weeks
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Gender
Female
|
32 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Gender
Male
|
44 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and Week 16Population: Full analysis set, last observation carried forward
Outcome measures
| Measure |
Canagliflozin (TA-7284) ＋Insulin
n=76 Participants
Canagliflozin, once daily for 16 weeks
|
Placebo＋Insulin
n=70 Participants
Placebo, once daily for 16 weeks
|
|---|---|---|
|
Change in HbA1c From Baseline
|
-0.97 Percent
Standard Error 0.08
|
0.13 Percent
Standard Error 0.08
|
SECONDARY outcome
Timeframe: baseline and Week 16Population: Full analysis set, last observation carried forward. There was a lack of measurement of fasting plasma glucose at the end of treatment visit(Week 4) in one participant who was randomized to "Canagliflozin(TA-7284) + Insulin" group.
Outcome measures
| Measure |
Canagliflozin (TA-7284) ＋Insulin
n=75 Participants
Canagliflozin, once daily for 16 weeks
|
Placebo＋Insulin
n=70 Participants
Placebo, once daily for 16 weeks
|
|---|---|---|
|
Change in Fasting Plasma Glucose
|
-34.1 mg/dL
Standard Error 4.8
|
-1.4 mg/dL
Standard Error 5.0
|
SECONDARY outcome
Timeframe: baseline and Week 16Population: Full analysis set, last observation carried forward. There was a lack of measurement of body weight at the end of treatment visit(Week 4) in one participant who was randomized to "Canagliflozin(TA-7284) + Insulin" group.
Outcome measures
| Measure |
Canagliflozin (TA-7284) ＋Insulin
n=75 Participants
Canagliflozin, once daily for 16 weeks
|
Placebo＋Insulin
n=70 Participants
Placebo, once daily for 16 weeks
|
|---|---|---|
|
Percent Change in Body Weight
|
-2.13 percent change
Standard Error 0.25
|
0.24 percent change
Standard Error 0.26
|
SECONDARY outcome
Timeframe: baseline and Week 16Population: Full analysis set, last observation carried forward
Outcome measures
| Measure |
Canagliflozin (TA-7284) ＋Insulin
n=76 Participants
Canagliflozin, once daily for 16 weeks
|
Placebo＋Insulin
n=70 Participants
Placebo, once daily for 16 weeks
|
|---|---|---|
|
Change in Blood Pressure
Systolic blood pressure
|
-3.58 mmHg
Standard Error 1.14
|
-0.40 mmHg
Standard Error 1.19
|
|
Change in Blood Pressure
Diastolic blood pressure
|
-1.55 mmHg
Standard Error 0.71
|
-0.31 mmHg
Standard Error 0.74
|
SECONDARY outcome
Timeframe: Week 16Population: Safety analysis set. "Safety Population" reflects the "as treated" population, and one "Canagliflozin (TA-7284) + Insulin" participant actually received "Placebo + Insulin".
Outcome measures
| Measure |
Canagliflozin (TA-7284) ＋Insulin
n=75 Participants
Canagliflozin, once daily for 16 weeks
|
Placebo＋Insulin
n=71 Participants
Placebo, once daily for 16 weeks
|
|---|---|---|
|
Percentage of Participants With "Adverse Events" and "Hypoglycemia and Blood Glucose Decreased"
adverse events
|
68.0 percentage of participants
|
64.8 percentage of participants
|
|
Percentage of Participants With "Adverse Events" and "Hypoglycemia and Blood Glucose Decreased"
Hypoglycemia and Blood glucose decreased
|
40.0 percentage of participants
|
29.6 percentage of participants
|
Adverse Events
Canagliflozin (TA-7284) ＋Insulin
Serious events: 3 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo＋Insulin
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Canagliflozin (TA-7284) ＋Insulin
n=75 participants at risk
Canagliflozin, once daily for 16 weeks
|
Placebo＋Insulin
n=71 participants at risk
Placebo, once daily for 16 weeks
|
|---|---|---|
|
Eye disorders
Cataract
|
1.3%
1/75
"Safety Population" reflects the "as treated" population, and one "Canagliflozin(TA-7284) + Insulin" participant actually received "Placebo + Insulin".
|
1.4%
1/71
"Safety Population" reflects the "as treated" population, and one "Canagliflozin(TA-7284) + Insulin" participant actually received "Placebo + Insulin".
|
|
Eye disorders
Retinal detachment
|
1.3%
1/75
"Safety Population" reflects the "as treated" population, and one "Canagliflozin(TA-7284) + Insulin" participant actually received "Placebo + Insulin".
|
0.00%
0/71
"Safety Population" reflects the "as treated" population, and one "Canagliflozin(TA-7284) + Insulin" participant actually received "Placebo + Insulin".
|
|
Eye disorders
Vitreous haemorrhage
|
1.3%
1/75
"Safety Population" reflects the "as treated" population, and one "Canagliflozin(TA-7284) + Insulin" participant actually received "Placebo + Insulin".
|
0.00%
0/71
"Safety Population" reflects the "as treated" population, and one "Canagliflozin(TA-7284) + Insulin" participant actually received "Placebo + Insulin".
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
1.3%
1/75
"Safety Population" reflects the "as treated" population, and one "Canagliflozin(TA-7284) + Insulin" participant actually received "Placebo + Insulin".
|
0.00%
0/71
"Safety Population" reflects the "as treated" population, and one "Canagliflozin(TA-7284) + Insulin" participant actually received "Placebo + Insulin".
|
Other adverse events
| Measure |
Canagliflozin (TA-7284) ＋Insulin
n=75 participants at risk
Canagliflozin, once daily for 16 weeks
|
Placebo＋Insulin
n=71 participants at risk
Placebo, once daily for 16 weeks
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
16.0%
12/75
"Safety Population" reflects the "as treated" population, and one "Canagliflozin(TA-7284) + Insulin" participant actually received "Placebo + Insulin".
|
18.3%
13/71
"Safety Population" reflects the "as treated" population, and one "Canagliflozin(TA-7284) + Insulin" participant actually received "Placebo + Insulin".
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
25.3%
19/75
"Safety Population" reflects the "as treated" population, and one "Canagliflozin(TA-7284) + Insulin" participant actually received "Placebo + Insulin".
|
21.1%
15/71
"Safety Population" reflects the "as treated" population, and one "Canagliflozin(TA-7284) + Insulin" participant actually received "Placebo + Insulin".
|
|
Renal and urinary disorders
Pollakiuria
|
5.3%
4/75
"Safety Population" reflects the "as treated" population, and one "Canagliflozin(TA-7284) + Insulin" participant actually received "Placebo + Insulin".
|
1.4%
1/71
"Safety Population" reflects the "as treated" population, and one "Canagliflozin(TA-7284) + Insulin" participant actually received "Placebo + Insulin".
|
|
Investigations
Blood glucose decreased
|
26.7%
20/75
"Safety Population" reflects the "as treated" population, and one "Canagliflozin(TA-7284) + Insulin" participant actually received "Placebo + Insulin".
|
16.9%
12/71
"Safety Population" reflects the "as treated" population, and one "Canagliflozin(TA-7284) + Insulin" participant actually received "Placebo + Insulin".
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER