Trial Outcomes & Findings for Randomized Trial Comparing Sitagliptin to Placebo in Closed Loop (NCT NCT02328040)

NCT ID: NCT02328040

Last Updated: 2018-08-07

Results Overview

Better targeted blood glucose levels in the CL setting in the treatment arm, Sitagliptin, compared to placebo (insulin monotherapy)

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 17 participants
• Primary outcome timeframe: 18 Months
• Results posted on: 2018-08-07

Participant Flow

22 participants were screened. However, only 17 participants were enrolled and of these 15 participants completed both study visits. Patients were recruited from diabetes clinics, via fliers, and online postings on clinical trial sites.

Participant milestones

Measure	Placebo/Insulin First, Then Sitagliptin/Insulin Participants first received Placebo/Insulin, placebo orally and Insulin subcutaneously for 2 days. Then they received Sitagliptin/Insulin, 100 mg of Sitagliptin orally and insulin subcutaneously for the next 2 days. Each visit is 3-4 weeks apart.	Sitagliptin/Insulin First, Then Placebo/Insulin Participants first received Sitagliptin/Insulin, 100 mg of Sitagliptin orally and insulin subcutaneously for the next 2 days. Then they received Placebo/Insulin, placebo orally and Insulin subcutaneously for the next 2 days. Each visit is 3-4 weeks apart.
First Intervention (2 Days) STARTED	8	9
First Intervention (2 Days) COMPLETED	7	8
First Intervention (2 Days) NOT COMPLETED	1	1
Second Intervention (2 Days) STARTED	7	8
Second Intervention (2 Days) COMPLETED	7	8
Second Intervention (2 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Placebo/Insulin First, Then Sitagliptin/Insulin Participants first received Placebo/Insulin, placebo orally and Insulin subcutaneously for 2 days. Then they received Sitagliptin/Insulin, 100 mg of Sitagliptin orally and insulin subcutaneously for the next 2 days. Each visit is 3-4 weeks apart.	Sitagliptin/Insulin First, Then Placebo/Insulin Participants first received Sitagliptin/Insulin, 100 mg of Sitagliptin orally and insulin subcutaneously for the next 2 days. Then they received Placebo/Insulin, placebo orally and Insulin subcutaneously for the next 2 days. Each visit is 3-4 weeks apart.
First Intervention (2 Days) Withdrawal by Subject	1	1

Baseline Characteristics

Randomized Trial Comparing Sitagliptin to Placebo in Closed Loop

Baseline characteristics by cohort

Measure	All Study Participants n=17 Participants Participants who were randomized to receive either Placebo/Insulin Participants, placebo orally and Insulin subcutaneously or Sitagliptin/Insulin, 100 mg of Sitagliptin orally and insulin subcutaneously.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	24.1 years STANDARD_DEVIATION 4.7 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: 18 Months

Better targeted blood glucose levels in the CL setting in the treatment arm, Sitagliptin, compared to placebo (insulin monotherapy)

Outcome measures

Measure	Placebo/Insulin n=15 Participants Participants who received Placebo/Insulin, placebo orally and Insulin subcutaneously for 2 days.	Sitagliptin/Insulin n=15 Participants Participants who received Sitagliptin/Insulin, 100 mg of Sitagliptin orally and insulin subcutaneously for 2 days.
Blood Glucose Measures in Subjects Treated With Sitagliptin, Compared to the Placebo	149.7 mg/dl Standard Deviation 37.8	155.9 mg/dl Standard Deviation 48.6

SECONDARY outcome

Timeframe: 18 months

Serum glucagon concentrations were measured in the CL setting in the treatment arm, sitagliptin, compared to the placebo (Insulin monotherapy)

Outcome measures

Measure	Placebo/Insulin n=15 Participants Participants who received Placebo/Insulin, placebo orally and Insulin subcutaneously for 2 days.	Sitagliptin/Insulin n=15 Participants Participants who received Sitagliptin/Insulin, 100 mg of Sitagliptin orally and insulin subcutaneously for 2 days.
Measure of Glucagon Concentration in Subjects Treated With Sitagliptin, Compared to Placebo	6.04 Pmol/L Standard Deviation 1.5	5.66 Pmol/L Standard Deviation 1.6

Adverse Events

Placebo/Insulin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Siatagliptin/Insulin

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

Dr. Rubina Heptulla

Children's Hospital at Montefiore

Phone: 718-920-7004

Email: rheptull@montefiore.org

Results disclosure agreements

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