Trial Outcomes & Findings for A Study of Effects of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Participants With Type 1 Diabetes Mellitus (T1DM) (NCT NCT02139943)
NCT ID: NCT02139943
Last Updated: 2016-07-18
Results Overview
Clinical response at Weeks 18 was assessed by the percentage of participants with Hemoglobin A1c (HbA1c) reduction greater than or equal to 0.4 % and had no increase in body weight.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
352 participants
Primary outcome timeframe
Week 18
Results posted on
2016-07-18
Participant Flow
A total of 614 participants were screened and 352 subjects (57.3%) were randomized to study drug. One subject randomized to placebo did not take any study drug and withdrew consent on the day of randomization.
Participant milestones
| Measure |
Placebo
Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
|
Canagliflozin 100 Milligram (mg)
Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
|
Canagliflozin 300 mg
Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
117
|
117
|
117
|
|
Overall Study
COMPLETED
|
107
|
111
|
110
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
|
Canagliflozin 100 Milligram (mg)
Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
|
Canagliflozin 300 mg
Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
0
|
|
Overall Study
Other
|
0
|
0
|
1
|
|
Overall Study
Participant wishes to discontinue
|
2
|
0
|
0
|
|
Overall Study
Participant in Poor Compliance
|
1
|
0
|
1
|
|
Overall Study
eGFR Withdrawal Criteria
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Effects of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Participants With Type 1 Diabetes Mellitus (T1DM)
Baseline characteristics by cohort
| Measure |
Placebo
n=117 Participants
Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
|
Canagliflozin 100 Milligram (mg)
n=117 Participants
Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
|
Canagliflozin 300 mg
n=117 Participants
Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
|
Total
n=351 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
117 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
347 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
42 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
42.8 years
STANDARD_DEVIATION 10.96 • n=5 Participants
|
42.3 years
STANDARD_DEVIATION 11.47 • n=4 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
154 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
197 Participants
n=4 Participants
|
|
Region Enroll
Canada
|
24 participants
n=5 Participants
|
19 participants
n=7 Participants
|
20 participants
n=5 Participants
|
63 participants
n=4 Participants
|
|
Region Enroll
United Stats
|
93 participants
n=5 Participants
|
98 participants
n=7 Participants
|
97 participants
n=5 Participants
|
288 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 18Population: Modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of double-blind study drug. 'N (Number of Participants Analyzed)' signifies participants who were evaluable for this outcome measure.
Clinical response at Weeks 18 was assessed by the percentage of participants with Hemoglobin A1c (HbA1c) reduction greater than or equal to 0.4 % and had no increase in body weight.
Outcome measures
| Measure |
Placebo
n=110 Participants
Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
|
Canagliflozin 100 Milligram (mg)
n=111 Participants
Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
|
Canagliflozin 300 mg
n=111 Participants
Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Hemoglobin A1c (HbA1c) Reduction Greater Than or Equal to (>=) 0.4 Percent (%) and no Increase in Body Weight
Yes
|
14.5 percentage of participants
|
36.9 percentage of participants
|
41.4 percentage of participants
|
|
Percentage of Participants With Hemoglobin A1c (HbA1c) Reduction Greater Than or Equal to (>=) 0.4 Percent (%) and no Increase in Body Weight
No
|
85.5 percentage of participants
|
63.1 percentage of participants
|
58.6 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 22 WeeksPopulation: Safety Analysis Set included all randomized participants who took at least 1 dose of double-blind study drug.
Outcome measures
| Measure |
Placebo
n=117 Participants
Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
|
Canagliflozin 100 Milligram (mg)
n=117 Participants
Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
|
Canagliflozin 300 mg
n=117 Participants
Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events
|
54.7 percentage of participants
|
55.6 percentage of participants
|
67.5 percentage of participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Canagliflozin 100 Milligram (mg)
Serious events: 9 serious events
Other events: 36 other events
Deaths: 0 deaths
Canagliflozin 300 mg
Serious events: 8 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=117 participants at risk
Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
|
Canagliflozin 100 Milligram (mg)
n=117 participants at risk
Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
|
Canagliflozin 300 mg
n=117 participants at risk
Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
|
|---|---|---|---|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/117 • Up to 22 Weeks
|
0.85%
1/117 • Up to 22 Weeks
|
0.00%
0/117 • Up to 22 Weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/117 • Up to 22 Weeks
|
0.85%
1/117 • Up to 22 Weeks
|
0.00%
0/117 • Up to 22 Weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/117 • Up to 22 Weeks
|
0.85%
1/117 • Up to 22 Weeks
|
0.00%
0/117 • Up to 22 Weeks
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/117 • Up to 22 Weeks
|
4.3%
5/117 • Up to 22 Weeks
|
6.0%
7/117 • Up to 22 Weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/117 • Up to 22 Weeks
|
0.00%
0/117 • Up to 22 Weeks
|
0.85%
1/117 • Up to 22 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/117 • Up to 22 Weeks
|
0.85%
1/117 • Up to 22 Weeks
|
0.00%
0/117 • Up to 22 Weeks
|
Other adverse events
| Measure |
Placebo
n=117 participants at risk
Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
|
Canagliflozin 100 Milligram (mg)
n=117 participants at risk
Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
|
Canagliflozin 300 mg
n=117 participants at risk
Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.6%
3/117 • Up to 22 Weeks
|
3.4%
4/117 • Up to 22 Weeks
|
5.1%
6/117 • Up to 22 Weeks
|
|
Infections and infestations
Nasopharyngitis
|
8.5%
10/117 • Up to 22 Weeks
|
7.7%
9/117 • Up to 22 Weeks
|
5.1%
6/117 • Up to 22 Weeks
|
|
Infections and infestations
Sinusitis
|
5.1%
6/117 • Up to 22 Weeks
|
1.7%
2/117 • Up to 22 Weeks
|
2.6%
3/117 • Up to 22 Weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
9.4%
11/117 • Up to 22 Weeks
|
8.5%
10/117 • Up to 22 Weeks
|
8.5%
10/117 • Up to 22 Weeks
|
|
Infections and infestations
Urinary tract infection
|
1.7%
2/117 • Up to 22 Weeks
|
4.3%
5/117 • Up to 22 Weeks
|
5.1%
6/117 • Up to 22 Weeks
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.85%
1/117 • Up to 22 Weeks
|
1.7%
2/117 • Up to 22 Weeks
|
6.8%
8/117 • Up to 22 Weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.6%
3/117 • Up to 22 Weeks
|
0.85%
1/117 • Up to 22 Weeks
|
6.0%
7/117 • Up to 22 Weeks
|
|
Renal and urinary disorders
Pollakiuria
|
2.6%
3/117 • Up to 22 Weeks
|
4.3%
5/117 • Up to 22 Weeks
|
6.8%
8/117 • Up to 22 Weeks
|
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