Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People With Type 1 Diabetes

NCT04764968 | Completed Phase 2

• 3 other identifiers: 77119H-210000022020-005745-16
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the efficacy, safety and feasibility of outpatient-utilization of low-dose dasiglucagon administered via a multi-dose reusable pen injector in preventing and treating mild hypoglycemia in insulin pump-treated people with type 1 diabetes.

Conditions

Type 1 Diabetes; Hypoglycemia

Keywords

Type 1 Diabetes; Hypoglycemia; Dasiglucagon

Outcome Measures

Primary Outcomes (1)

• Difference in percentage of time in range between the two study periods

  Sensor glucose level ≥ 3.9 mmol/l and ≤ 10.0 mmol/l

  2-week 'usual care' period and 2-week 'dasiglucagon' period

Secondary Outcomes (13)

• Difference in percentage of time in hypoglycemia between the two study periods

  2-week 'usual care' period and 2-week 'dasiglucagon' period

• Difference in percentage of time in hyperglycemia between the two study periods

  2-week 'usual care' period and 2-week 'dasiglucagon' period

• Difference in coefficient of variation (%) between the two study periods

  2-week 'usual care' period and 2-week 'dasiglucagon' period

• Difference between successful cases (%) of hypoglycemia treatment between the two study periods

  2-week 'usual care' period and 2-week 'dasiglucagon' period

• Difference in successful cases (%) of hypoglycemia treatment without subsequent hyperglycemia [sensor glucose level > 10 mmol/l during the first two hours post-treatment] between the two study periods

  2-week 'usual care' period and 2-week 'dasiglucagon' period

Other Outcomes (1)

• Number of device failures/malfunctions

  2-week 'dasiglucagon' period

Study Arms (2)

Usual care

NO INTERVENTION

During the 'usual care' period, participants will manage episodes of manifest or impending hypoglycemia as usual, e.g. through carbohydrate consumption or manual insulin pump suspension.

Dasiglucagon

EXPERIMENTAL

During the 'dasiglucagon' period, participants will use pen-administered low-dose (80 µg) dasiglucagon to treat or prevent episodes of hypoglycemia.

Drug: Dasiglucagon

Interventions

Dasiglucagon DRUG

Abdominal s.c. administration using a multi-dose reusable pen injector

Dasiglucagon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• T1D ≥ 2 years
• Use of insulin pump therapy (without sensor-augmented insulin suspension/adjustment functionality) ≥ 6 months
• Use of CGM (real-time or intermittently scanned) ≥ 3 months and ≥ 70% during the previous 14 days
• HbA1c ≤ 70 mmol/l (8.5%)
• Performs aerobic exercise on a regular basis (≥ 2 times per week; self-reported) and desires to exercise per American Diabetes Association guidelines (150 minutes per week) during the study.
• Use of carbohydrate counting and bolus calculator (self-reported)
• Sensor glucose level \< 3.9 mmol/l on ≥ 4/14 previous days assessed by CGM data

You may not qualify if:

• Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period and within 30 days prior to study start
• Known or suspected allergies to glucagon or related products
• History of hypersensitivity or allergic reaction to dasiglucagon or any of the excipients
• Patients with pheochromocytoma or insulinoma
• Hypoglycemia unawareness
• Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
• Inability to understand the individual information and to give informed consent
• Current participation in another clinical trial that, in the judgment of the investigator, will compromise the results of the study or the safety of the subject
• Concomitant medical or psychological conditions identified through review of medical history, physical examination and clinical laboratory analysis that, according to the investigator's assessment, makes the individual unsuitable for study participation

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead

Study Sites (1)

Steno Diabetes Center Copenhagen

Gentofte Municipality, 2820, Denmark

Location

Related Publications (1)

• Laugesen C, Ranjan AG, Schmidt S, Norgaard K. Pen-administered low-dose dasiglucagon vs usual care for prevention and treatment of non-severe hypoglycaemia in people with type 1 diabetes during free-living conditions: a Phase II, randomised, open-label, two-period crossover trial. Diabetologia. 2023 Jul;66(7):1208-1217. doi: 10.1007/s00125-023-05909-4. Epub 2023 Apr 11.

  PMID: 37037948 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Interventions

dasiglucagon

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Christian Laugesen, MD

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Randomized, Open-Label, Two-Period, Two-Week Crossover Outpatient Study

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 21, 2021
• Study Start: April 27, 2021
• Primary Completion: December 30, 2021
• Study Completion: January 28, 2022
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)