EUCTR2017-002449-31-AT
Active, not recruiting
Phase 1
A phase 3, randomized, double-blind, parallel trial to confirm the clinical efficacy and safety of dasiglucagon in the rescue treatment of hypoglycemia in subjects with type 1 diabetes mellitus (T1DM) compared to placebo and with reference to GlucaGen®
ConditionsType 1 diabetes mellitusMedDRA version: 20.0Level: SOCClassification code 10027433Term: Metabolism and nutrition disordersSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
DrugsGlucaGen Hypokit
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Type 1 diabetes mellitus
- Sponsor
- Zealand Pharma A/S
- Enrollment
- 176
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects will be entered into this trial only if they meet all of the following criteria:
- •1\. Informed consent obtained before any trial\-related activities (trial\-related activities are any procedure that would not have been performed during normal management of the subject).
- •2\. Female or male subjects with T1DM for at least 1 year, diagnostic criteria as defined by the American Diabetes Association (3\).
- •3\. Treated with insulin for T1DM for at least 1 year and with stable insulin treatment (defined as no more than a 10\-unit daily variation in total daily insulin dose) 30 days prior to screening
- •4\. Hemoglobin A1c \<10%.
- •5\. Aged between 18 and 75 years, both inclusive.
- •6\. A female subject must meet one of the following criteria:
- •a. Participant is of childbearing potential and agrees to use one of the
- •accepted contraceptive regimens throughout the entire duration of the trial from screening and until last follow\-up visit. An acceptable method of contraception includes one of the following:
- •i. Abstinence from heterosexual intercourse;
Exclusion Criteria
- •Subjects meeting any of the following criteria during screening evaluations will be excluded from trial participation:
- •1\. Previously treated with dasiglucagon (previously referred to as ZP4207\).
- •2\. Known or suspected allergy to trial product(s) or related products.
- •3\. History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema).
- •4\. Previous participation (randomization) in this trial.
- •5\. Females who are pregnant according to a positive pregnancy test, are actively attempting to get pregnant, or are lactating.
- •6\. History of hypoglycemic events associated with seizures in the last year prior to screening.
- •7\. History of severe hypoglycemia (defined as plasma glucose \<54 mg/dL \[3\.0 mmol/L]) in the last month prior to screening.
- •8\. Receipt of any investigational drug within 3 months prior to screening.
- •9\. Active malignancy within the last 5 years.
Outcomes
Primary Outcomes
Not specified
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