Low-dose Dasiglucagon for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes

NCT04449692 | Completed Phase 2

• 2 other identifiers: H-200132562020-000551-12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare the efficacy of low-dose dasiglucagon (Zealand Pharma, Denmark) to oral carbohydrate consumption for prevention of s.c. insulin-induced hypoglycemia in CSII- and MDI-treated people with type 1 diabetes.

Conditions

Type 1 Diabetes; Hypoglycemia

Keywords

Type 1 Diabetes; Hypoglycemia; Dasiglucagon

Outcome Measures

Primary Outcomes (1)

• Difference between study visits in time (min) in hypoglycemia (plasma glucose < 3.9 mmol/l) from 0-180 minutes post-intervention

  Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

Secondary Outcomes (24)

• Difference between study visits in incidence rate of hypoglycemia (plasma glucose < 3.9 mmol/l) from 0-180 minutes post-intervention

  Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

• Difference between study visits in incidence rate of level 2 hypoglycemia (plasma glucose < 3.0 mmol/l) from 0-180 minutes post-intervention

  Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

• Difference between study visits in incidence rate of rebound hyperglycemia (plasma glucose > 10 mmol/l) from 0-180 minutes post-intervention

  Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

• Difference between study visits in nadir plasma glucose concentration from 0-180 minutes post-intervention

  Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

• Difference between study visits in peak plasma glucose concentration from 0-180 minutes post-intervention

  Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

Study Arms (3)

80 µg s.c. dasiglucagon

EXPERIMENTAL

80 µg of dasiglucagon will be administered subcutaneously when plasma glucose levels reach 4.5 mmol/l

Drug: Dasiglucagon

120 µg s.c. dasiglucagon

EXPERIMENTAL

120 µg of dasiglucagon will be administered subcutaneously when plasma glucose levels reach 4.5 mmol/l

Drug: Dasiglucagon

15 g oral carbohydrate (dextrose tablets)

ACTIVE COMPARATOR

15 g of oral carbohydrate (dextrose tablets) will be administered when plasma glucose levels reach 4.5 mmol/l

Other: Carbohydrate (dextrose tablets)

Interventions

Dasiglucagon DRUG

Abdominal s.c. administration

120 µg s.c. dasiglucagon; 80 µg s.c. dasiglucagon

Carbohydrate (dextrose tablets) OTHER

Oral administration

15 g oral carbohydrate (dextrose tablets)

Eligibility Criteria

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

You may qualify if:

• Age 18-64 years
• Duration of T1D ≥ 3 years
• Use of CSII or MDI therapy for ≥ 6 months
• Current use of Novorapid (change from another fast-acting insulin to Novorapid prior to study initiation is allowed)
• HbA1c ≤ 8.0%
• Regular use of carbohydrate counting in the judgement of the investigator

You may not qualify if:

• Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
• History of allergy or intolerance to glucagon or glucagon-like products
• Patients with pheochromocytoma
• Clinically significant ECG abnormalities
• Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (sterilization, intrauterine device, contraceptive pill, patch or injection)
• Inability to understand the individual information and to give informed consent
• Current participation in another clinical trial that, in the judgment of the principle investigator, will compromise the results of the study or the safety of the subject
• Other concomitant medical or psychological condition 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. Low-Dose Dasiglucagon Versus Oral Glucose for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes: A Phase 2, Randomized, Three-Arm Crossover Study. Diabetes Care. 2022 Jun 2;45(6):1391-1399. doi: 10.2337/dc21-2304.

  PMID: 35475907 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Interventions

dasiglucagon; Carbohydrates; Glucose

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars

Study Officials

• Christian Laugesen, MD

  MD, PhD Candidate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Partially single-blinded (oral carbohydrate administration will not be blinded)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blinded, randomized (using blocks of 3/6 and stratification by treatment modality), three-arm crossover study

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 29, 2020
• Study Start: July 2, 2020
• Primary Completion: January 4, 2021
• Study Completion: January 4, 2021
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)