Trial Outcomes & Findings for Sitagliptin and Glucagon Counterregulation (NCT NCT02256189)

NCT ID: NCT02256189

Last Updated: 2019-02-20

Results Overview

Change in plasma glucagon to insulin-induced hypoglycemia after four weeks of treatment with sitagliptin and placebo

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 28 participants
• Primary outcome timeframe: Four weeks treatment
• Results posted on: 2019-02-20

Participant Flow

Participant milestones

Measure	Sitagliptin First, Then Placebo Sitagliptin first for four weeks, then washout for four weeks, then placebo for four weeks	Placebo First, Then Sitagliptin Placebo first for four weeks, then washout for four weeks, then placebo for four weeks
Overall Study STARTED	15	13
Overall Study COMPLETED	15	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sitagliptin and Glucagon Counterregulation

Baseline characteristics by cohort

Measure	Sitagliptin First, Then Placebo n=15 Participants Hypoglycemia clamp with sitagliptin Sitagliptin: Treatment with sitagliptin 100mg QD for four weeks followed by hyperinsulinemic hypoglycemic clamp	Placebo First, Then Stagliptin n=13 Participants Hypoglycemia clamp with placebo Placebo: Treatment with placebo QD for four weeks followed by hyperinsulinemic hypoglycemic clamp	Total n=28 Participants Total of all reporting groups
Age, Customized	75.0 years STANDARD_DEVIATION 5.9 • n=5 Participants	71.9 years STANDARD_DEVIATION 5.7 • n=7 Participants	73.6 years STANDARD_DEVIATION 5.9 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Sweden	15 participants n=5 Participants	13 participants n=7 Participants	28 participants n=5 Participants
Fasting glucagon	29.5 pmol/l STANDARD_DEVIATION 9.7 • n=5 Participants	30.0 pmol/l STANDARD_DEVIATION 12.2 • n=7 Participants	29.8 pmol/l STANDARD_DEVIATION 10.9 • n=5 Participants

PRIMARY outcome

Timeframe: Four weeks treatment

Change in plasma glucagon to insulin-induced hypoglycemia after four weeks of treatment with sitagliptin and placebo

Outcome measures

Measure	Sitagliptin n=28 Participants Hypoglycemia clamp with sitagliptin Sitagliptin: Treatment with sitagliptin 100mg QD for four weeks followed by hyperinsulinemic hypoglycemic clamp	Placebo n=28 Participants Hypoglycemia clamp with placebo Placebo: Treatment with placebo QD for four weeks followed by hyperinsulinemic hypoglycemic clamp
Glucagon Counterregulation to Hypoglycemia	16.0 pmol/l Standard Error 2.9	16.5 pmol/l Standard Error 2.8

Adverse Events

Sitagliptin First, Then Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo First, Then Stagliptin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sitagliptin

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

Professor 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