Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of the Addition of Canagliflozin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin (NCT NCT02025907)
NCT ID: NCT02025907
Last Updated: 2016-10-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
218 participants
Primary outcome timeframe
Baseline and Week 26
Results posted on
2016-10-31
Participant Flow
One participant was randomized at 2 different sites (once to placebo and once to canagliflozin) and was therefore counted twice in the total number of randomized participants. The participant was withdrawn from the study and not included in any efficacy or safety analyses.
Participant milestones
| Measure |
Placebo
Participants administered with placebo (inactive medication) once daily for 26 weeks.
|
Canagliflozin
Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
108
|
|
Overall Study
COMPLETED
|
81
|
96
|
|
Overall Study
NOT COMPLETED
|
27
|
12
|
Reasons for withdrawal
| Measure |
Placebo
Participants administered with placebo (inactive medication) once daily for 26 weeks.
|
Canagliflozin
Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
15
|
8
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Potential misconduct,GCPcompliance issue
|
2
|
1
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of the Addition of Canagliflozin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin
Baseline characteristics by cohort
| Measure |
Placebo
n=106 Participants
Participants administered with placebo (inactive medication) once daily for 26 weeks.
|
Canagliflozin
n=107 Participants
Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
|
Total
n=213 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 10.14 • n=93 Participants
|
57.4 years
STANDARD_DEVIATION 9.28 • n=4 Participants
|
57.4 years
STANDARD_DEVIATION 9.69 • n=27 Participants
|
|
Gender
Female
|
51 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
92 Participants
n=27 Participants
|
|
Gender
Male
|
55 Participants
n=93 Participants
|
66 Participants
n=4 Participants
|
121 Participants
n=27 Participants
|
|
Region of Enrollment
Australia
|
13 participants
n=93 Participants
|
22 participants
n=4 Participants
|
35 participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
16 participants
n=93 Participants
|
23 participants
n=4 Participants
|
39 participants
n=27 Participants
|
|
Region of Enrollment
France
|
10 participants
n=93 Participants
|
6 participants
n=4 Participants
|
16 participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
16 participants
n=93 Participants
|
13 participants
n=4 Participants
|
29 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=93 Participants
|
43 participants
n=4 Participants
|
94 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 26Population: mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Placebo
n=94 Participants
Participants administered with placebo (inactive medication) once daily for 26 weeks.
|
Canagliflozin
n=99 Participants
Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
|
-0.01 percentage of glycosylated hemoglobin
Standard Error 0.119
|
-0.91 percentage of glycosylated hemoglobin
Standard Error 0.113
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants administered with placebo (inactive medication) once daily for 26 weeks.
|
Canagliflozin
n=103 Participants
Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
|
-0.14 millimoles per liter
Standard Error 0.281
|
-1.65 millimoles per liter
Standard Error 0.264
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants administered with placebo (inactive medication) once daily for 26 weeks.
|
Canagliflozin
n=103 Participants
Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Body Weight at Week 26
|
-1.60 percent change
Standard Error 0.337
|
-3.35 percent change
Standard Error 0.324
|
SECONDARY outcome
Timeframe: Week 26Population: mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants administered with placebo (inactive medication) once daily for 26 weeks.
|
Canagliflozin
n=96 Participants
Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
|
|---|---|---|
|
Percentage of Participants With HbA1c Less Than (<) 7.0 Percent at Week 26
|
12.2 percentage of participants
|
32.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants administered with placebo (inactive medication) once daily for 26 weeks.
|
Canagliflozin
n=103 Participants
Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Week 26
|
0.09 millimeter of mercury (mmHg)
Standard Error 1.123
|
-5.76 millimeter of mercury (mmHg)
Standard Error 1.078
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Canagliflozin
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=108 participants at risk
Participants administered with placebo (inactive medication) once daily for 26 weeks.
|
Canagliflozin
n=108 participants at risk
Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
|
|---|---|---|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/108 • From Baseline, up to end of treatment (Approximately 31 weeks)
Safety population included all randomized participants who received at least 1 dose of double-blind study drug and 3 participants who were excluded from the mITT population due to potential misconduct and GCP compliance issues.
|
0.93%
1/108 • From Baseline, up to end of treatment (Approximately 31 weeks)
Safety population included all randomized participants who received at least 1 dose of double-blind study drug and 3 participants who were excluded from the mITT population due to potential misconduct and GCP compliance issues.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/108 • From Baseline, up to end of treatment (Approximately 31 weeks)
Safety population included all randomized participants who received at least 1 dose of double-blind study drug and 3 participants who were excluded from the mITT population due to potential misconduct and GCP compliance issues.
|
0.93%
1/108 • From Baseline, up to end of treatment (Approximately 31 weeks)
Safety population included all randomized participants who received at least 1 dose of double-blind study drug and 3 participants who were excluded from the mITT population due to potential misconduct and GCP compliance issues.
|
|
Nervous system disorders
Cerebral Infarction
|
0.93%
1/108 • From Baseline, up to end of treatment (Approximately 31 weeks)
Safety population included all randomized participants who received at least 1 dose of double-blind study drug and 3 participants who were excluded from the mITT population due to potential misconduct and GCP compliance issues.
|
0.00%
0/108 • From Baseline, up to end of treatment (Approximately 31 weeks)
Safety population included all randomized participants who received at least 1 dose of double-blind study drug and 3 participants who were excluded from the mITT population due to potential misconduct and GCP compliance issues.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.93%
1/108 • From Baseline, up to end of treatment (Approximately 31 weeks)
Safety population included all randomized participants who received at least 1 dose of double-blind study drug and 3 participants who were excluded from the mITT population due to potential misconduct and GCP compliance issues.
|
0.00%
0/108 • From Baseline, up to end of treatment (Approximately 31 weeks)
Safety population included all randomized participants who received at least 1 dose of double-blind study drug and 3 participants who were excluded from the mITT population due to potential misconduct and GCP compliance issues.
|
Other adverse events
| Measure |
Placebo
n=108 participants at risk
Participants administered with placebo (inactive medication) once daily for 26 weeks.
|
Canagliflozin
n=108 participants at risk
Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.6%
6/108 • From Baseline, up to end of treatment (Approximately 31 weeks)
Safety population included all randomized participants who received at least 1 dose of double-blind study drug and 3 participants who were excluded from the mITT population due to potential misconduct and GCP compliance issues.
|
5.6%
6/108 • From Baseline, up to end of treatment (Approximately 31 weeks)
Safety population included all randomized participants who received at least 1 dose of double-blind study drug and 3 participants who were excluded from the mITT population due to potential misconduct and GCP compliance issues.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.8%
3/108 • From Baseline, up to end of treatment (Approximately 31 weeks)
Safety population included all randomized participants who received at least 1 dose of double-blind study drug and 3 participants who were excluded from the mITT population due to potential misconduct and GCP compliance issues.
|
1.9%
2/108 • From Baseline, up to end of treatment (Approximately 31 weeks)
Safety population included all randomized participants who received at least 1 dose of double-blind study drug and 3 participants who were excluded from the mITT population due to potential misconduct and GCP compliance issues.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.6%
5/108 • From Baseline, up to end of treatment (Approximately 31 weeks)
Safety population included all randomized participants who received at least 1 dose of double-blind study drug and 3 participants who were excluded from the mITT population due to potential misconduct and GCP compliance issues.
|
0.00%
0/108 • From Baseline, up to end of treatment (Approximately 31 weeks)
Safety population included all randomized participants who received at least 1 dose of double-blind study drug and 3 participants who were excluded from the mITT population due to potential misconduct and GCP compliance issues.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.93%
1/108 • From Baseline, up to end of treatment (Approximately 31 weeks)
Safety population included all randomized participants who received at least 1 dose of double-blind study drug and 3 participants who were excluded from the mITT population due to potential misconduct and GCP compliance issues.
|
2.8%
3/108 • From Baseline, up to end of treatment (Approximately 31 weeks)
Safety population included all randomized participants who received at least 1 dose of double-blind study drug and 3 participants who were excluded from the mITT population due to potential misconduct and GCP compliance issues.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.93%
1/108 • From Baseline, up to end of treatment (Approximately 31 weeks)
Safety population included all randomized participants who received at least 1 dose of double-blind study drug and 3 participants who were excluded from the mITT population due to potential misconduct and GCP compliance issues.
|
2.8%
3/108 • From Baseline, up to end of treatment (Approximately 31 weeks)
Safety population included all randomized participants who received at least 1 dose of double-blind study drug and 3 participants who were excluded from the mITT population due to potential misconduct and GCP compliance issues.
|
|
Psychiatric disorders
Depression
|
0.00%
0/108 • From Baseline, up to end of treatment (Approximately 31 weeks)
Safety population included all randomized participants who received at least 1 dose of double-blind study drug and 3 participants who were excluded from the mITT population due to potential misconduct and GCP compliance issues.
|
2.8%
3/108 • From Baseline, up to end of treatment (Approximately 31 weeks)
Safety population included all randomized participants who received at least 1 dose of double-blind study drug and 3 participants who were excluded from the mITT population due to potential misconduct and GCP compliance issues.
|
|
Renal and urinary disorders
Polyuria
|
2.8%
3/108 • From Baseline, up to end of treatment (Approximately 31 weeks)
Safety population included all randomized participants who received at least 1 dose of double-blind study drug and 3 participants who were excluded from the mITT population due to potential misconduct and GCP compliance issues.
|
2.8%
3/108 • From Baseline, up to end of treatment (Approximately 31 weeks)
Safety population included all randomized participants who received at least 1 dose of double-blind study drug and 3 participants who were excluded from the mITT population due to potential misconduct and GCP compliance issues.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER