Effect of a Fixed Pramlintide: Insulin Dose Ratio on Postprandial Glucose in Type 1 Diabetes Mellitus

What Was Tested

This registered phase 1 trial tested Insulin Lispro and Amylin (Islet Amyloid Polypeptide).

It had two arms (groups): Pramlintide acetate & regular insulin (experimental) and Placebo and regular insulin (placebo comparator).

Placebo is similar sterile solution without pramlintide.

The registry classes the interventions as drug.

More on the Plan

Visit 1 is approximately 3-6 weeks prior to randomization.

Given some variability in HbA1c and C-peptide assays, re-testing for HbA1c and C-peptide can be performed within 18 days from the initial visit.

Visit 2 is approximately 2-5 weeks prior to randomization.

Subjects are on lispro insulin throughout study except during Visit 4 and Visit 5, the domicile 24 hr treatment period, when they are switched to regular insulin U-100.

Who Took Part

The registry lists 34 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Provision of informed consent prior to any study-specific procedures. Female and/or male aged between 18 and 70 years. Must have a prior diagnosis of T1DM. Body mass index (BMI) \<30 kg/m2. Subjects are not on current treatment with pramlintide (Symlin) and have not received pramlintide during the 6-month period prior to enrollment.

The full record lists 9 inclusion and 20 exclusion criteria; among the exclusions: recurrent severe hypoglycemia requiring assistance within 6 months before screening; A history of hypoglycemia unawareness; A confirmed diagnosis of gastroparesis.

How the Study Was Run

It was run as a randomized, crossover and single-blind study.

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

In the crossover set-up each of the participants took both Insulin Lispro and the comparison in turn, acting as their own control.

In this single-blind Insulin Lispro study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2015-08-17 with completion listed for 2016-08-05.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 14 secondary outcomes, for example Fasting Plasma Glucose Concentration.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro and Amylin (Islet Amyloid Polypeptide) in 34 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 Lispro compound page and the Amylin (Islet Amyloid Polypeptide) compound page, all human trials.