NCT03984370

Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University Hospital, Gentofte, Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is investigating the effect of a novel glucagon analogue administration in gastric bypass operated individuals, who are reactive hypoglycemic.

Detailed description

The Roux-En-Y gastric bypass (RYGB) has major health-promoting effects - reversing type-2-diabetes, improving dyslipidemia and inducing robust weight loss. However, several RYGB-individuals, post surgery, suffers from dumping syndrome and postprandial hyperinsulinemic hypoglycemia (PHH) due to the anatomical rearrangement of the gastro-intestinal system. Dasiglugaon (also known as (ZP4207) has shown great pharmacokinetic- and dynamic effects, compared to other glucagon analogues on the market, when administrated to hypoglycemic type-1-diabetics. Therefore we aim to examine the effects of two different doses of dasiglucagon on the postprandial nadir plasma glucose concentration in RYGB-operated individuals suffering from PHH by use of a mixed meal test (MMT). The study is designed as a double-blinded, randomised, 3-period, 3-treatment, crossover study comprising 3 separate treatment days in which participants will undergo an MMT along with one of the following double-blinded interventions: 1. Subcutaneous (sc) placebo (saline) injection 2. Sc injection with 80 μg dasiglucagon 3. Sc injection with 200 μg dasiglucagon

Conditions

• Hyperinsulinemic Hypoglycemia
• Postprandial Hypoglycemia

Interventions

Type	Name	Description
DRUG	ZP4207	Abdominal SC administration
OTHER	Placebo (saline)	Abdominal SC administration

Timeline

• Start date: 2019-09-18
• Primary completion: 2020-02-26
• Completion: 2020-02-26
• First posted: 2019-06-13
• Last updated: 2020-03-31

Locations

1 site across 1 country: Denmark