Trial Outcomes & Findings for Dietary Impacts on Glucose-lowering Effects of Sitagliptin in Type 2 Diabetes (NCT NCT02312063)

NCT ID: NCT02312063

Last Updated: 2019-07-01

Results Overview

Pearson's correlation coefficient of HbA1c reduction with plasma levels of EPA and DHA at baseline

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 48 participants
• Primary outcome timeframe: 0-16 weeks
• Results posted on: 2019-07-01

Participant Flow

Participant milestones

Measure	Sitagliptin Sitagliptin 50 mg a day for 16 weeks Sitagliptin	Glimepiride Glimepiride 0.5 mg a day for 16 weeks Glimepiride
Overall Study STARTED	23	25
Overall Study COMPLETED	23	24
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Sitagliptin Sitagliptin 50 mg a day for 16 weeks Sitagliptin	Glimepiride Glimepiride 0.5 mg a day for 16 weeks Glimepiride
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Dietary Impacts on Glucose-lowering Effects of Sitagliptin in Type 2 Diabetes

Baseline characteristics by cohort

Measure	Sitagliptin n=23 Participants Sitagliptin 50 mg a day for 16 weeks	Glimepiride n=25 Participants Glimepiride 0.5 mg a day for 16 weeks	Total n=48 Participants Total of all reporting groups
Age, Continuous	58.4 years STANDARD_DEVIATION 8.5 • n=5 Participants	58.8 years STANDARD_DEVIATION 8.6 • n=7 Participants	58.6 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Region of Enrollment Japan	23 participants n=5 Participants	25 participants n=7 Participants	48 participants n=5 Participants
Duration of Type 2 diabetes	2.7 years STANDARD_DEVIATION 3.6 • n=5 Participants	1.0 years STANDARD_DEVIATION 2.3 • n=7 Participants	1.8 years STANDARD_DEVIATION 3.1 • n=5 Participants
HbA1c	7.1 % STANDARD_DEVIATION 0.5 • n=5 Participants	6.8 % STANDARD_DEVIATION 0.4 • n=7 Participants	6.9 % STANDARD_DEVIATION 0.5 • n=5 Participants
FPG	151.8 mg/dL STANDARD_DEVIATION 27.9 • n=5 Participants	134.2 mg/dL STANDARD_DEVIATION 18.3 • n=7 Participants	142.6 mg/dL STANDARD_DEVIATION 24.8 • n=5 Participants
BMI	24.6 kg/m2 STANDARD_DEVIATION 3.0 • n=5 Participants	24.5 kg/m2 STANDARD_DEVIATION 2.9 • n=7 Participants	24.5 kg/m2 STANDARD_DEVIATION 2.9 • n=5 Participants
EPA	82.1 microgram/mL STANDARD_DEVIATION 39.7 • n=5 Participants	75.0 microgram/mL STANDARD_DEVIATION 41.5 • n=7 Participants	78.4 microgram/mL STANDARD_DEVIATION 40.4 • n=5 Participants

PRIMARY outcome

Timeframe: 0-16 weeks

Pearson's correlation coefficient of HbA1c reduction with plasma levels of EPA and DHA at baseline

Outcome measures

Measure	Sitagliptin n=23 Participants The participants started sitagliptin and continued the 16-week intervention with all pre-defined data collected.	Glimepiride n=23 Participants The participants started glimepiride and continued the 16-week intervention with all pre-defined data collected.
Correlation of Plasma Levels of EPA and DHA With HbA1c Reduction r (EPA and delta HbA1c)	-0.414 pearson's correlation coefficient	0.067 pearson's correlation coefficient
Correlation of Plasma Levels of EPA and DHA With HbA1c Reduction r (DHA and delta HbA1c)	-0.319 pearson's correlation coefficient	0.093 pearson's correlation coefficient

SECONDARY outcome

Timeframe: 0-16 weeks

Pearson's correlation coefficient of HbA1c reduction with estimated seafood intake

Outcome measures

Measure	Sitagliptin n=23 Participants The participants started sitagliptin and continued the 16-week intervention with all pre-defined data collected.	Glimepiride n=23 Participants The participants started glimepiride and continued the 16-week intervention with all pre-defined data collected.
Correlation of Estimated Seafood Intake With HbA1c Reduction	-0.042 pearson's correlation coefficient	0.215 pearson's correlation coefficient

Adverse Events

Sitagliptin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Glimepiride

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	Sitagliptin n=23 participants at risk The participants started sitagliptin at week 0	Glimepiride n=25 participants at risk The participants started glimepiride at week 0
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/23 • 16 weeks	20.0% 5/25 • Number of events 5 • 16 weeks

Additional Information

Dr. Daisuke Yabe

Kansai Electric Power Medical Research Institute

Phone: +81-6-6458-5821

Email: ydaisuke-kyoto@umin.ac.jp

Results disclosure agreements

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