Effect of Different Fixed Pramlintide:Insulin Dose Ratios on Postprandial Glucose in T1DM

What Was Tested

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

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 32 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: Is 18 to 70 years old. Is male, or is female and meets all the following criteria:. Negative pregnancy test result and, if of childbearing potential, must practice and be willing to continue to practice appropriate birth control. Has a body mass index (BMI) \<30 kg/m2.

The full record lists 8 inclusion and 22 exclusion criteria; among the exclusions: has experienced recurrent severe hypoglycemia requiring assistance within 6 months before visit 1 screening; has a history of hypoglycemia unawareness; has a confirmed diagnosis of gastroparesis.

How the Study Was Run

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

Because people in this Amylin (Islet Amyloid Polypeptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Amylin (Islet Amyloid Polypeptide) and the comparison in turn, acting as their own control.

Only one side, usually the participants, was kept unaware of whether Amylin (Islet Amyloid Polypeptide) was given.

Those kept unaware of assignments: participant.

It started in 2012-11 with completion listed for 2013-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Incremental area under the concentration-time curve (AUC(0-3 h)) of plasma glucose concentrations for each treatment (time frame: AUC 0-3 hrs compared to Placebo).

It also tracked 4 secondary outcomes, for example Incremental AUC (0-3 h) of plasma glucagon, Absolute AUC (0-3 h), peak plasma concentration (Cmax), Cave, and Tmax of glucagon of plasma glucose, PK of pramlintide and Safety.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Amylin (Islet Amyloid Polypeptide) in 32 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Amylin (Islet Amyloid Polypeptide) compound page, all human trials.