Postprandial Hypoglycemia Clinical Trial
Official title:
Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass
Verified date | March 2020 |
Source | University Hospital, Gentofte, Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is investigating the effect of a novel glucagon analogue administration in gastric bypass operated individuals, who are reactive hypoglycemic.
Status | Completed |
Enrollment | 10 |
Est. completion date | February 26, 2020 |
Est. primary completion date | February 26, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Center for Clinical Metabolic Research, Herlev-Gentofte Hospital | Hellerup |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Gentofte, Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Time from dasiglucagon administration to recovery (first plasma glucose value above the fasting plasma glucose level | Time from dasiglucagon administration to recovery (first plasma glucose value above the fasting plasma glucose level | Two hundred forty minutes | |
Secondary | Time in hypoglycaemia (plasma glucose concentration <3.9 mmol/l) from study drug administration until 240 minutes | Time in hypoglycaemia | Two hundred forty minutes | |
Secondary | Time below fasting plasma glucose level from study drug administration until two hundred forty minutes | Time below fasting plasma glucose level | Two hundred forty minutes | |
Secondary | 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. | Area 1 | Two hundred forty minutes | |
Secondary | 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. | Area 2 | Two hundred forty minutes | |
Secondary | Edinburgh Hypoglycaemia Symptom Scale (EHSS) responses of the Edinburgh Hypoglycaemia Symptom Scale (EHSS) and early dumping symptoms based on | likert scale one (absent) to seven (severe) | t=zero to t=Two hundred forty minutes | |
Secondary | The Dumping Severity Score (DSS). | likert scale, zero (absent) to three (severe) | t=zero to t=Two hundred forty minutes | |
Secondary | Frequency and severity of adverse events and serious adverse events recorded during the meal test | Frequency | from t= minus thirty to t=Two hundred forty minutes |
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