Trial Outcomes & Findings for Effects of Single Doses of Liraglutide and Dapagliflozin on Ketogenesis in Type 1 Diabetes (NCT NCT02777073)

NCT ID: NCT02777073

Last Updated: 2024-02-29

Results Overview

To compare levels of ketone bodies beta-hydroxybutyrate in plasma following a single dose treatment of either liraglutide 1.8mg,dapagliflozin 10mg or placebo in insulinopenic state.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 43 participants
• Primary outcome timeframe: 8 hours
• Results posted on: 2024-02-29

Participant Flow

Participant milestones

Measure	Liraglutide 1.8 mg single dose of Victoza ( liraglutide) 1.8 mg Victoza: Single dose of Liraglutide	Dapagliflozin 10 single dose of Farxiga ( dapagliflozin) 10 mg Farxiga: Single dose of dapagliflozin	Placebo Single dose of placebo Placebo: Single dose of generic placebo
Overall Study STARTED	13	17	13
Overall Study COMPLETED	13	17	13
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Single Doses of Liraglutide and Dapagliflozin on Ketogenesis in Type 1 Diabetes

Baseline characteristics by cohort

Measure	Liraglutide 1.8 mg n=13 Participants single dose of Victoza ( liraglutide) 1.8 mg Victoza: Single dose of Liraglutide	Dapagliflozin 10 n=17 Participants single dose of Farxiga ( dapagliflozin) 10 mg Farxiga: Single dose of dapagliflozin	Placebo n=13 Participants Single dose of placebo Placebo: Single dose of generic placebo	Total n=43 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	13 Participants n=5 Participants	17 Participants n=7 Participants	13 Participants n=5 Participants	43 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	10 Participants n=7 Participants	7 Participants n=5 Participants	24 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	19 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	17 Participants n=7 Participants	13 Participants n=5 Participants	43 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 8 hours

To compare levels of ketone bodies beta-hydroxybutyrate in plasma following a single dose treatment of either liraglutide 1.8mg,dapagliflozin 10mg or placebo in insulinopenic state.

Outcome measures

Measure	Liraglutide 1.8 mg n=13 Participants single dose of Victoza ( liraglutide) 1.8 mg Victoza: Single dose of Liraglutide	Placebo n=13 Participants Single dose of placebo Placebo: Single dose of generic placebo	Dapagliflozin n=17 Participants Single dose of dapagliflozin 10 mg
Difference in Ketone Bodies Formation After Single Dose of Liraglutide and Dapagliflozin	0.08 mM Standard Error 0.05	0.25 mM Standard Error 0.05	0.21 mM Standard Error 0.05

SECONDARY outcome

Timeframe: 8 hours

This secondary endpoint compares change in glucagon concentrations (in pg/ml) from baseline at 8 hours following liraglutide and dapagliflozin compared to placebo

Outcome measures

Measure	Liraglutide 1.8 mg n=13 Participants single dose of Victoza ( liraglutide) 1.8 mg Victoza: Single dose of Liraglutide	Placebo n=13 Participants Single dose of placebo Placebo: Single dose of generic placebo	Dapagliflozin n=17 Participants Single dose of dapagliflozin 10 mg
Change in Glucagon Levels.	-19 pg/mL Standard Error 14	1 pg/mL Standard Error 6	-15 pg/mL Standard Error 5

SECONDARY outcome

Timeframe: 8 hours

This secondary endpoint compares the change in FFA concentrations (mM) from baseline at 8 hours following liraglutide and dapagliflozin compared to placebo

Outcome measures

Measure	Liraglutide 1.8 mg n=13 Participants single dose of Victoza ( liraglutide) 1.8 mg Victoza: Single dose of Liraglutide	Placebo n=13 Participants Single dose of placebo Placebo: Single dose of generic placebo	Dapagliflozin n=17 Participants Single dose of dapagliflozin 10 mg
Change in Free Fatty Acid (FFA) Concentrations	0.1 mM Standard Error 0.06	0.17 mM Standard Error 0.06	0.11 mM Standard Error .06

SECONDARY outcome

Timeframe: 8 Hours

This secondary endpoint compares the change in ghrelin concentrations (pg/ml) from baseline at 8 hours following liraglutide and dapagliflozin compared to placebo

Outcome measures

Measure	Liraglutide 1.8 mg n=13 Participants single dose of Victoza ( liraglutide) 1.8 mg Victoza: Single dose of Liraglutide	Placebo n=13 Participants Single dose of placebo Placebo: Single dose of generic placebo	Dapagliflozin n=17 Participants Single dose of dapagliflozin 10 mg
Change in Ghrelin Concentrations	-32 pg/mL Standard Error 28	66 pg/mL Standard Error 29	32 pg/mL Standard Error 26

Adverse Events

Liraglutide 1.8 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dapagliflozin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paresh Dandona

State University of NY at Buffalo

Phone: 7165351850

Email: dandona@buffalo.edu

Results disclosure agreements

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