Trial Outcomes & Findings for Vildagliptin Versus Dapagliflozin on Glucagon (NCT NCT02475070)

NCT ID: NCT02475070

Last Updated: 2019-05-02

Results Overview

Area under the curve (AUC) of the 180 min glucagon levels after mixed meal ingestion (0, 5, 10, 15, 30, 45, 60, 75, 90, 120, 150,180 and 240 minutes post-dose)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 28 participants
• Primary outcome timeframe: 240 min
• Results posted on: 2019-05-02

Participant Flow

Participant milestones

Measure	Vildagliptin First First intervention vildagliptin 50mg twice daily (2 weeks), Washout (4 weeks), Second intervention dapagliflozin 10mg once daily (2 weeks)	Dapagliflozin First First intervention dapagliflozin 10mg once Daily (2 weeks), washout (4 weeks), second intervention with vildaglipitn 50mg twice Daily (2 weeks)
Overall Study STARTED	17	11
Overall Study COMPLETED	17	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vildagliptin Versus Dapagliflozin on Glucagon

Baseline characteristics by cohort

Measure	Vildagliptin First n=17 Participants Treatment with vildagliptin 50mg twice daily for two weeks followed by four weeks washout and then treatment with dapagliflozin 10mg once daily for two weeks Vildagliptin: Vildagliptin added at 50 mg twice daily for two weeks followed by four weeks washout and then dapagliflozin 10mg once daily for two weeks Dapagliflozin: Dapagliflozin added at 10 mg once daily for two weeks followed by four weeks washout and then vildagliptin 50 mg twice daily for two weeks	Dapagliflozin First n=11 Participants Treatment with dapagliflozin 10 mg once daily for two weeks followed by four weeks washout and then treatment with vildagliptin 50 mg twice daily for two weeks Vildagliptin: Vildagliptin added at 50 mg twice daily for two weeks followed by four weeks washout and then dapagliflozin 10mg once daily for two weeks Dapagliflozin: Dapagliflozin added at 10 mg once daily for two weeks followed by four weeks washout and then vildagliptin 50 mg twice daily for two weeks	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=93 Participants	11 Participants n=4 Participants	28 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	64 years STANDARD_DEVIATION 7.3 • n=93 Participants	61 years STANDARD_DEVIATION 6.7 • n=4 Participants	63 years STANDARD_DEVIATION 7.1 • n=27 Participants
Sex: Female, Male Female	13 Participants n=93 Participants	7 Participants n=4 Participants	20 Participants n=27 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	17 Participants n=93 Participants	11 Participants n=4 Participants	28 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment Sweden	17 participants n=93 Participants	11 participants n=4 Participants	28 participants n=27 Participants

PRIMARY outcome

Timeframe: 240 min

Area under the curve (AUC) of the 180 min glucagon levels after mixed meal ingestion (0, 5, 10, 15, 30, 45, 60, 75, 90, 120, 150,180 and 240 minutes post-dose)

Outcome measures

Measure	Vildagliptin Treatment n=28 Participants Vildagliptin 50mg twice daily for 2 weeks	Dapagliflozin Treatment n=28 Participants Dapagliflozin 10mg once Daily for 2 weeks
Glucagon Response to Meal	39.0 nmol/l min Standard Error 2.6	38.8 nmol/l min Standard Error 2.7

SECONDARY outcome

Timeframe: 240min

Area under the curve (AUC) of the 180 min glucagon like peptide-1 levels after mixed meal (0, 5, 10, 15, 30, 45, 60, 75, 90, 120, 150, 180 and 240 minutes post-dose)

Outcome measures

Measure	Vildagliptin Treatment n=28 Participants Vildagliptin 50mg twice daily for 2 weeks	Dapagliflozin Treatment n=28 Participants Dapagliflozin 10mg once Daily for 2 weeks
Incretin Hormones	3.8 nmol/l min Standard Error 0.5	3.7 nmol/l min Standard Error 0.5

Adverse Events

Vildagliptin

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Dapagliflozin

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Vildagliptin n=28 participants at risk Treatment with vildagliptin 50mg twice daily for two weeks	Dapagliflozin n=28 participants at risk Treatment with dapagliflozin 10 mg once daily for two weeks
Infections and infestations common cold	3.6% 1/28 • Number of events 1 • 2 weeks	3.6% 1/28 • Number of events 1 • 2 weeks
Musculoskeletal and connective tissue disorders Myalgia	7.1% 2/28 • Number of events 2 • 2 weeks	3.6% 1/28 • Number of events 1 • 2 weeks
Nervous system disorders Fatigue	3.6% 1/28 • Number of events 1 • 2 weeks	3.6% 1/28 • Number of events 1 • 2 weeks
Metabolism and nutrition disorders Thirst	3.6% 1/28 • Number of events 1 • 2 weeks	7.1% 2/28 • Number of events 2 • 2 weeks

Additional Information

Dr Bo Ahrén

Lund University

Phone: +46462220758

Email: Bo.Ahren@med.lu.se

Results disclosure agreements

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