Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM
NCT03688711 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2021-05-19
Summary
A randomized, double-blind, parallel-group 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
Conditions
- Hypoglycemia
- Diabetes Mellitus, Type 1
Interventions
- DRUG
-
Dasiglucagon
Glucagon analogue
- DRUG
-
Placebo for dasiglucagon
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Christina M Sylvest, MSc Pharm · Zealand Pharma A/S
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-11-01
- Primary Completion
- 2019-03-11
- Completion
- 2019-03-11
- FDA Drug
- Yes
Countries
- United States
Study Locations
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