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

NCT03984370 | Completed Phase 2 DMC

• 2 other identifiers: CKN-DASI-RYGB2019-001915-22
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperinsulinemic Hypoglycemia; Postprandial Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Nadir plasma glucose concentration within two hundred forty minutes after MMT

  Nadir plasma glucose concentration within two hundred forty minutes after MMT

  Two hundred forty minutes

Secondary Outcomes (8)

• Time from dasiglucagon administration to recovery (first plasma glucose value above the fasting plasma glucose level

  Two hundred forty minutes

• Time in hypoglycaemia (plasma glucose concentration <3.9 mmol/l) from study drug administration until 240 minutes

  Two hundred forty minutes

• Time below fasting plasma glucose level from study drug administration until two hundred forty minutes

  Two hundred forty minutes

• Area 1: the area above the glucose curve and below the fasting level from the time of study drug administration until glucose values reach the fasting level.

  Two hundred forty minutes

• Area 2: the area below the glucose curve and above the fasting level from the time glucose values reach the fasting level until 240 minutes.

  Two hundred forty minutes

Study Arms (3)

80 ug of sc dasiglucagon

EXPERIMENTAL

80 ug of dasiglucagon in a 0.4 mL fluid (saline) is injected abdominal subcutaneous postprandial prior to hypoglycemia.

Drug: ZP4207

200 ug of sc dasiglucagon

EXPERIMENTAL

200 ug of dasiglucagon in a 0.4 mL fluid (saline) is injected abdominal subcutaneous postprandial prior to hypoglycemia.

Drug: ZP4207

0.4 mL of sc saline (placebo)

PLACEBO COMPARATOR

0.4 mL fluid (saline/placebo) is injected abdominal subcutaneous postprandial prior to hypoglycemia.

Other: Placebo (saline)

Interventions

ZP4207 DRUG

Abdominal SC administration

Also known as: Dasiglucagon

200 ug of sc dasiglucagon; 80 ug of sc dasiglucagon

Placebo (saline) OTHER

Abdominal SC administration

0.4 mL of sc saline (placebo)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented postprandial hypoglycaemia (\<3.9 mmol/l) by 6-day CGM or during a MMT
• Documented plasma glucose concentration excursions \>5.0 mmol/l by 6-day CGM or a MMT
• Haemoglobin levels for women \>7.3 mmol/l and for men \>8.3 mmol/l
• Ferritin \>10 μg/l
• Cobalamin \>150 pmol/l
• Fasting plasma glucose concentration within the range of 4.0-6.0 mmol/l CKN-DASI-RYGB protocol version 1.0 6
• Normal electrocardiogram (ECG)
• Negative urine human chorionic gonadotropin (hCG) (for fertile women)

You may not qualify if:

• Treatment with medication(s) affecting insulin secretion or any antidiabetic drugs
• Treatment with antipsychotics
• Current participation in another clinical trial with administration of investigational drug.
• Previous exposure to dasiglucagon (otherwise known as ZP4207)
• History of liver disease that is expected to interfere with the anti-hypoglycaemic action of glucagon (e.g. liver failure or cirrhosis).
• Pregnancy
• Breastfeeding
• Any factors that, in the opinion of the site principal investigator or clinical protocol chair, would interfere with the safe completion of the study, including medical conditions that may require hospitalization during the trial or allergy to the ingredients in the study drug.

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Center for Clinical Metabolic Research, Herlev-Gentofte Hospital

Hellerup, 2900, Denmark

Location

Related Publications (1)

• Nielsen CK, Ohrstrom CC, Kielgast UL, Hansen DL, Hartmann B, Holst JJ, Lund A, Vilsboll T, Knop FK. Dasiglucagon Effectively Mitigates Postbariatric Postprandial Hypoglycemia: A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial. Diabetes Care. 2022 Jun 2;45(6):1476-1481. doi: 10.2337/dc21-2252.

  PMID: 35320361 DERIVED

MeSH Terms

Conditions

Congenital Hyperinsulinism; Hypoglycemia

Interventions

dasiglucagon; Sodium Chloride

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Filip M. Knop, Prof., MD

  Herlev-Gentofte Hospital, Center for Clinical Metabolic Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, professor

Model Details: Double-blinded, randomised, 3-period, 3-treatment, crossover study comprising 3 separate treatment days

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 13, 2019
• Study Start: September 18, 2019
• Primary Completion: February 26, 2020
• Study Completion: February 26, 2020
• Last Updated: March 31, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)