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

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ClinicalTrials.gov Identifier: NCT03984370
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Filip Krag Knop, University Hospital, Gentofte, Copenhagen

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.

Condition or disease Intervention/treatment Phase
Hyperinsulinemic Hypoglycemia Postprandial Hypoglycemia Drug: ZP4207 Other: Placebo (saline) Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Double-blinded, randomised, 3-period, 3-treatment, crossover study comprising 3 separate treatment days
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass
Estimated Study Start Date : August 26, 2019
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arm Intervention/treatment
Experimental: 80 ug of sc dasiglucagon
80 ug of dasiglucagon in a 0.4 mL fluid (saline) is injected abdominal subcutaneous postprandial prior to hypoglycemia.
Drug: ZP4207
Abdominal SC administration
Other Name: Dasiglucagon

Experimental: 200 ug of sc dasiglucagon
200 ug of dasiglucagon in a 0.4 mL fluid (saline) is injected abdominal subcutaneous postprandial prior to hypoglycemia.
Drug: ZP4207
Abdominal SC administration
Other Name: Dasiglucagon

Placebo Comparator: 0.4 mL of sc saline (placebo)
0.4 mL fluid (saline/placebo) is injected abdominal subcutaneous postprandial prior to hypoglycemia.
Other: Placebo (saline)
Abdominal SC administration




Primary Outcome Measures :
  1. Nadir plasma glucose concentration within two hundred forty minutes after MMT [ Time Frame: Two hundred forty minutes ]
    Nadir plasma glucose concentration within two hundred forty minutes after MMT


Secondary Outcome Measures :
  1. Time from dasiglucagon administration to recovery (first plasma glucose value above the fasting plasma glucose level [ Time Frame: Two hundred forty minutes ]
    Time from dasiglucagon administration to recovery (first plasma glucose value above the fasting plasma glucose level

  2. Time in hypoglycaemia (plasma glucose concentration <3.9 mmol/l) from study drug administration until 240 minutes [ Time Frame: Two hundred forty minutes ]
    Time in hypoglycaemia

  3. Time below fasting plasma glucose level from study drug administration until two hundred forty minutes [ Time Frame: Two hundred forty minutes ]
    Time below fasting plasma glucose level

  4. 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. [ Time Frame: Two hundred forty minutes ]
    Area 1

  5. 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. [ Time Frame: Two hundred forty minutes ]
    Area 2

  6. Edinburgh Hypoglycaemia Symptom Scale (EHSS) responses of the Edinburgh Hypoglycaemia Symptom Scale (EHSS) and early dumping symptoms based on [ Time Frame: t=zero to t=Two hundred forty minutes ]
    likert scale one (absent) to seven (severe)

  7. The Dumping Severity Score (DSS). [ Time Frame: t=zero to t=Two hundred forty minutes ]
    likert scale, zero (absent) to three (severe)

  8. Frequency and severity of adverse events and serious adverse events recorded during the meal test [ Time Frame: from t= minus thirty to t=Two hundred forty minutes ]
    Frequency



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984370


Contacts
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Contact: Casper K. Nielsen, MSc 60117434 casper.kjaersgaard.nielsen@regionh.dk
Contact: Filip K Knop, Prof., MD 38674266 filip.krag.knop.01@regionh.dk

Locations
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Denmark
Center for Clinical Metabolic Research, Herlev-Gentofte Hospital Not yet recruiting
Hellerup, Denmark, 2900
Contact: Casper Nielsen, MSc    +45 60 11 74 34    casper.kjaersgaard.nielsen@regionh.dk   
Contact: Filip Knop, MD, prof.    38674266    filip.krag.knop.01@regionh.dk   
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
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Principal Investigator: Filip M. Knop, Prof., MD Herlev-Gentofte Hospital, Center for Clinical Metabolic Research

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Responsible Party: Filip Krag Knop, MD, professor, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT03984370     History of Changes
Other Study ID Numbers: CKN-DASI-RYGB
2019-001915-22 ( EudraCT Number )
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hypoglycemia
Congenital Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pancreatic Diseases
Digestive System Diseases
Infant, Newborn, Diseases
Hyperinsulinism