Clinical Trials Logo
  1. Home
  2. Hypoglycemia
  3. NCT03667053

Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children

Hypoglycemia Clinical Trial

Official title:
Phase 3, Randomized, Double-blind, Placebo/Active-controlled, Parallel-arm Trial to Assess Efficacy, Safety, and Pharmacokinetics of Dasiglucagon Relative to Placebo/GlucaGen® as Rescue Therapy for Severe Hypoglycemia in Children With T1DM Treated With Insulin

Clinical Trial Summary

A phase 3, randomized, double-blind, placebo- and active-controlled, parallel-arm trial to assess the efficacy, safety, and pharmacokinetics of dasiglucagon relative to placebo and GlucaGen® when administered as a rescue therapy for severe hypoglycemia in children with type 1 diabetes mellitus (T1DM) treated with insulin

Clinical Trial Description

At least 40 children ≥6 years and <18 years of age with T1DM were planned to be randomized into the trial (2:1:1 for dasiglucagon:placebo:GlucaGen) and stratified by age intervals: 6 years to <12 years, and 12 years to <18 years; and by injection site (abdomen or thigh). A minimum of 16 patients were enrolled into each age group, including a minimum of 8 patients in each age group in the dasiglucagon treatment arm. In Germany only, a staggered approach was applied, whereby a positive safety assessment needed to be available for at least 10 patients in the age group of 12 years to <18 years who had completed the dosing visit in the overall trial before younger patients (6 to 11 years of age) were allowed to be enrolled. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03667053
Study type Interventional
Source Zealand Pharma
Contact
Status Completed
Phase Phase 3
Start date September 28, 2018
Completion date June 28, 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT03482154 - Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population
Active, not recruiting NCT03422471 - Hypoglycemia and Autonomic Nervous System Function- B2 N/A
Recruiting NCT05379686 - Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes N/A
Completed NCT05597605 - The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects N/A
Not yet recruiting NCT05990933 - Role of Adrenaline in in the Inflammatory Response in Diabetes N/A
Withdrawn NCT03736083 - Introducing CGM at Type 1 Diabetes Diagnosis N/A
Completed NCT02966275 - Post Bariatric Closed Loop Glucagon Trial N/A
Not yet recruiting NCT02909881 - Dose Response Oxidation of a Sweet-corn Derived Sugar (PhytoSpherix) During Exercise in Endurance Trained Athletes N/A
Withdrawn NCT02518022 - How to be Safe With Alcoholic Drinks in Diabetes N/A
Completed NCT02213003 - Allogeneic Islet Cells Transplanted Onto the Omentum Phase 1/Phase 2
Completed NCT01176656 - Hypoglycemia: Physician and Patient Perspectives N/A
Completed NCT01147276 - Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes Phase 4
Completed NCT00998374 - Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge N/A
Terminated NCT01225159 - Tight Glycaemic Control During Cardiac Surgery N/A
Completed NCT00373854 - Study of How Low Blood Sugar Affects the Way Blood Vessels Work N/A
Completed NCT00285233 - Delayed Mycophenolate Mofetil in Single-Donor Islet Allotransplantation in Type 1 Diabetes Phase 1/Phase 2
Recruiting NCT05916131 - Pilot Feasibility Study for HypoPals, a Mobile Health Program for Improving Hypoglycemia Management. N/A
Terminated NCT04026750 - Insulin Tolerance Test Study in Patients With Type 1 Diabetes Phase 1
Completed NCT05133765 - The SMART B Exercise Study :''The SMART Study'' N/A
Recruiting NCT04192422 - DiGESTnewborn Study