Effects of Canagliflozin on C-peptide Clearance in Healthy Volunteers

What Was Tested

In this phase 1 trial, researchers set out to test C-Peptide and Somatostatin.

It had two arms (groups): Treatment Sequence Group AB (experimental) and Treatment Sequence Group BA (experimental).

The registry classes the interventions as drug.

More on the Plan

Somatostatin will suppress the normal secretion of C-peptide, a protein that is released from the pancreas during insulin secretion, so that the human C-peptide administered to volunteers can be accurately measured.

The total study duration for each volunteer will be approximately 44 days.

During the study, blood and urine samples will be drawn (collected) for clinical laboratory evaluations.

Who Took Part

Enrollment: 10 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: known hypersensitivity of synthetic human c-peptide, somatostatin preparation, or other structurally related peptides.

How the Study Was Run

Design: randomized, crossover and triple-blind.

Random assignment meant chance, not the researchers, decided who got C-Peptide and who got the comparison, which limits bias.

Each person switched between C-Peptide and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on C-Peptide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2012-09 with completion listed for 2012-10.

It ran at 1 site in Germany.

What Was Measured

The main thing measured (primary outcome): Change from baseline in C-peptide kinetic parameters (time frame: Before and after study drug administration on Day 1 of Treatment Periods 1 and 2).

It also tracked 1 secondary outcome, for example The number of volunteers who report adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of C-Peptide and Somatostatin in 10 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 C-Peptide compound page and the Somatostatin compound page, all human trials.