Trial Outcomes & Findings for Effect of Canagliflozin in T1DM (Type 1 Diabetes Melitus) After Interruption of Continuous Subcutaneous Insulin Infusion (NCT NCT02673138)

NCT ID: NCT02673138

Last Updated: 2021-10-13

Results Overview

The primary outcome measure for this study will be differences in plasma glucose levels following the interruption of basal subcutaneous infusion of insulin under the two study conditions; i.e., control study during treatment with insulin alone vs. experimental study during treatment with insulin plus canagliflozin or other SGLT2 inhibitor.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: 20 hours
• Results posted on: 2021-10-13

Participant Flow

Participant milestones

Measure	Basal Interruption With or Without Canagliflozin Subjects will undergo basal interruption with or without canagliflozin during an overnight stay on the research unit canagliflozin: basal interruption with canagliflozin
Overall Study STARTED	10
Overall Study Started Day 1	10
Overall Study Ended Day 1	10
Overall Study Started Day 2	10
Overall Study Ended Day 2	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Canagliflozin in T1DM (Type 1 Diabetes Melitus) After Interruption of Continuous Subcutaneous Insulin Infusion

Baseline characteristics by cohort

Measure	Basal Interruption With or Without Canagliflozin n=10 Participants Subjects will undergo basal interruption with canagliflozin during an overnight stay on the research unit canagliflozin: basal interruption with canagliflozin
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 20 hours

The primary outcome measure for this study will be differences in plasma glucose levels following the interruption of basal subcutaneous infusion of insulin under the two study conditions; i.e., control study during treatment with insulin alone vs. experimental study during treatment with insulin plus canagliflozin or other SGLT2 inhibitor.

Outcome measures

Measure	Basal Interruption n=10 Participants Subjects will undergo basal interruption without canagliflozin during an overnight stay on the research unit basal interruption without canagliflozin: basal interruption	Basal Interruption With Canagliflozin n=10 Participants Subjects will undergo basal interruption with canagliflozin during an overnight stay on the research unit canagliflozin: basal interruption with canagliflozin
Differences in Plasma Glucose Levels Following the Interruption of Basal Subcutaneous Infusion of Insulin	197 mg/dL Standard Error 24	99 mg/dL Standard Error 13

PRIMARY outcome

Timeframe: 20 hours

Outcome measures

Measure	Basal Interruption n=10 Participants Subjects will undergo basal interruption without canagliflozin during an overnight stay on the research unit basal interruption without canagliflozin: basal interruption	Basal Interruption With Canagliflozin n=10 Participants Subjects will undergo basal interruption with canagliflozin during an overnight stay on the research unit canagliflozin: basal interruption with canagliflozin
Differences in BHB (Beta-hydroxybutyrate) Levels Following Interruption of Basal	1.2 mmol/L Standard Error 0.2	1.5 mmol/L Standard Error 0.2

SECONDARY outcome

Timeframe: 20 hours

Outcome measures

Measure	Basal Interruption n=10 Participants Subjects will undergo basal interruption without canagliflozin during an overnight stay on the research unit basal interruption without canagliflozin: basal interruption	Basal Interruption With Canagliflozin n=10 Participants Subjects will undergo basal interruption with canagliflozin during an overnight stay on the research unit canagliflozin: basal interruption with canagliflozin
Differences in Free Fatty Acid Levels Following Interruption of Basal Subcutaneous Insulin Infusion	0.8 mmol/L Standard Error 0.1	0.7 mmol/L Standard Error 0.1

SECONDARY outcome

Timeframe: 20 hours

Outcome measures

Measure	Basal Interruption n=10 Participants Subjects will undergo basal interruption without canagliflozin during an overnight stay on the research unit basal interruption without canagliflozin: basal interruption	Basal Interruption With Canagliflozin n=10 Participants Subjects will undergo basal interruption with canagliflozin during an overnight stay on the research unit canagliflozin: basal interruption with canagliflozin
Differences in Glucagon Levels Following the Interruption of the Basal Subcutaneous Insulin Infusion	14 pg/mL Standard Error 5	36 pg/mL Standard Error 15

Adverse Events

Basal Interruption

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Basal Interruption With Canagliflozin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Basal Interruption n=10 participants at risk Subjects will undergo basal interruption without canagliflozin during an overnight stay on the research unit basal interruption without canagliflozin: basal interruption	Basal Interruption With Canagliflozin n=10 participants at risk Subjects will undergo basal interruption with canagliflozin during an overnight stay on the research unit canagliflozin: basal interruption with canagliflozin
Infections and infestations Vaginal Candidiasis	0.00% 0/10	10.0% 1/10 • Number of events 1

Additional Information

Neha S. Patel, DO

Yale Pediatric Diabetes

Phone: 203-764-6747

Email: neha.patel@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place