Delineation of the Diabetogenic Role of Extrapancreatic Glucagon in Totally Pancreatectomised Patients Using Glucagon Receptor Antagonism

What Was Tested

The trial (not phased) is built around Glucagon for pancreatitis (after the acute phase).

Patients with diabetes are characterised not only by compromised insulin secretion and action, but also by elevated plasma levels of the 29-amino acid peptide hormone glucagon, which hitherto has been considered a pancreas-derived hormone (produced in and secreted from alpha cells in the islets of Langerhans).

It had four arms (groups): Pancreatectomised + LY2409021 (active comparator), Pancreatectomised + placebo (placebo comparator), Healthy + LLY2409021 (active comparator) and Healthy + placebo (placebo comparator).

During the experimental day the patient will undergo a 75gr-OGTT. On the evening before the experimental day, the patient will ingest placebo tablets.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 20 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Caucasian above 18 years of age who have undergone total pancreatectomy. Normal fasting plasma glucose and normal HbA1C (according to the World Health Organization (WHO) criteria). Age above 18 years.

The full record lists 7 inclusion and 18 exclusion criteria; among the exclusions: inflammatory bowel disease; operation within the last 3 months; ongoing chemotherapy or chemotherapy within the last 3 months.

How the Study Was Run

Design: randomized, crossover and double-blind.

The pancreatitis (after the acute phase) participants were allocated by chance, so the Glucagon group and the comparison group should start out alike.

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

Blinding on both sides kept the pancreatitis (after the acute phase) participants and researchers unaware of who received Glucagon.

Those kept unaware of assignments: participant and investigator.

It started in 2016-04 with completion listed for 2019-11.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: PPG excursions measured as incremental area under curve (iAUC) (time frame: -120,-45,-30,-15,0,5,10,15,20,25,30,40,50,60,70,80,90,105,120,135,150,180 minutes).

It also tracked 10 secondary outcomes, for example differences in gastric emptying, measurement of s-paracetamol, food intake and appetite, resting energy expenditure (REE), p-glucose mmol/L, glucagon pmol/l and free fatty acids μmol/l.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glucagon in 20 people with pancreatitis (after the acute phase).

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glucagon compound page, Pancreatitis (after the acute phase) research.