Single Dose Pharmacodynamic and Pharmacokinetic Study of DG3173

What Was Tested

The trial (phase 1) is built around Octreotide.

The main purpose of the study was to investigate the effects of each treatment on the control of plasma glucose as well as the secretion of insulin and glucagon following a standard meal.

It had three arms (groups): DG3173 (experimental), Saline (placebo comparator) and Octreotide (active comparator).

The registry classes the interventions as drug.

Who Took Part

8 actual participants took part.

It was open to men only aged from 18 years up to 45 years.

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

Examples of who could join: Ethnic origin: Caucasian. Body Mass Index (BMI): 19-27 kg/m2 inclusive. Medical history without clinically relevant pathologies. Physical examination parameters without signs of clinically relevant pathologies. Electrocardiogram recording without signs of clinically relevant pathology, in particular QTc (Bazett) \<450 ms.

The full record lists 8 inclusion and 23 exclusion criteria; among the exclusions: evidence of clinically relevant pathology or disease; any history of moderate or severe hypertension, hypotension or orthostatic hypotension; mental handicap.

How the Study Was Run

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

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

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

Only one side, usually the participants, was kept unaware of whether Octreotide was given.

Those kept unaware of assignments: participant.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Concentration of glucose, insulin and glucagon in plasma.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Octreotide in 8 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 Octreotide compound page, all human trials.