Randomized Trial Comparing Sitagliptin to Placebo in Closed Loop

What Was Tested

In this phase 1 trial, researchers set out to test Insulin Aspart.

There are many recent advances in insulin treatment of type 1 Diabetes Mellitus (T1DM), however after a meal sugars are always a concern.

There is a drug sitagliptin (Januvia) which is FDA approved to treat people with type 2 diabetes which helps correct their glucose (sugars) after meals.

It had two arms (groups): Part A (placebo comparator) and Part B (active comparator).

Placebo and Insulin monotherapy via CL.

Sitagliptin and insulin/novolog via CL.

The registry classes the interventions as drug.

More on the Plan

The safety data after the meeting will be submitted to the Institutional Review Board (IRB).

A randomized double-blinded 2-period cross over study trial will be used for the subjects to participate in the study .

All the study subject's (18-30 yrs old) and the study staff (except one person) will be blinded to the study parts and they will do all the study Parts A and B in random order.

The participants will be admitted to the Clinical Research Center (CRC) on two occasions for the Parts A and B following the screening visit.

Who Took Part

Enrollment: 17 actual participants took part.

It was open to people of any sex aged from 14 years up to 30 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age of 14 to 30 years. Subjects must be otherwise healthy except for T1DM, and treated for hypothyroidism if present. Menstruating women must have negative pregnancy test.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: having any other chronic condition except hypothyroidism stable on medications; on chronic medications that may affect glucose excursions; positive pregnancy test (based on urine).

How the Study Was Run

The set-up was randomized, single-group and triple-blind.

The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.

As a double-blind Insulin Aspart study, the assignments were hidden from both participants and investigators until the end.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2014-09 with completion listed for 2016-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Blood Glucose Measures in Subjects Treated With Sitagliptin, Compared to the Placebo (time frame: 18 Months).

It also tracked 1 secondary outcome, for example Measure of Glucagon Concentration in Subjects Treated With Sitagliptin, Compared to Placebo.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 17 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Aspart compound page, all human trials.