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

Primary Purpose

Type 1 Diabetes, Hypoglycemia

Status

Completed

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Dasiglucagon

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Hypoglycemia, Dasiglucagon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Steno Diabetes Center Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Dasiglucagon

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

Sensor glucose level < 3.9 mmol/l

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

Sensor glucose level > 10 mmol/l

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

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

Initial sensor glucose level ≥ 2.2 mmol/l and ≤ 3.9 mmol/l AND sensor glucose level > 3.9 mmol/l 30 minutes post-treatment

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

Initial sensor glucose level ≥ 2.2 mmol/l and ≤ 3.9 mmol/l AND sensor glucose level > 3.9 mmol/l 30 minutes post-treatment AND sensor glucose level ≤ 10 mmol/l during the first two hours post-treatment

Difference in successful cases (%) of hypoglycemia prevention between the two study periods

Initial sensor glucose level > 3.9 mmol/l AND sensor glucose level < 3.9 for ≤ 15 consecutive minutes during the first two hours post-treatment

Difference in time from hypoglycemia treatment to euglycemia between the two study periods

Minutes from initial sensor glucose level ≥ 2.2 mmol/l and ≤ 3.9 mmol/l to sensor glucose level ≥ 3.9 mmol/l

Incidence rate of supplement carbohydrate administration during the first hour following dasiglucagon administration

Difference between the average daily carbohydrate intake between the two study periods

Registered on the insulin pump

Difference between the average total daily insulin dose between the two study periods

Difference in the number and intensity of episodes with nausea, headache, stomach-ache, palpitations and injection site pain between the two study periods

Intensity: mild/moderate/severe

Percentage of participants scoring a favorable outcome on the patient-reported outcome questionnaire

Scoring likely OR very likely on a four-point Likert scale

Percentage of participants with treatment-induced or treatment-boosted anti-dasiglucagon antibodies

Full Information

NCT ID

NCT04764968

First Posted

February 16, 2021

Last Updated

September 5, 2022

Sponsor

Steno Diabetes Center Copenhagen

1. Study Identification

Unique Protocol Identification Number

NCT04764968

Brief Title

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

Official Title

Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People With Type 1 Diabetes: A Randomized, Open-Label, Two-Period Crossover Outpatient Study

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

April 27, 2021 (Actual)

Primary Completion Date

December 30, 2021 (Actual)

Study Completion Date

January 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Steno Diabetes Center Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

A randomized, open-label, two-arm, two-week crossover study will be conducted to assess the study objectives. The study will enroll 24 participants with insulin pump-treated type 1 diabetes. Upon study enrollment, participants will complete two consecutive 2-week periods - a 'usual care' period and 'dasiglucagon' period. 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. During the 'dasiglucagon' period, participants will use pen-administered low-dose dasiglucagon to treat or prevent episodes of hypoglycemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes, Hypoglycemia

Keywords

Type 1 Diabetes, Hypoglycemia, Dasiglucagon

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

None (Open Label)

Masking Description

Open Label

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Usual care

Arm Type

No Intervention

Arm Description

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.

Arm Title

Dasiglucagon

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dasiglucagon

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Sensor glucose level < 3.9 mmol/l

Time Frame

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

Title

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

Description

Sensor glucose level > 10 mmol/l

Time Frame

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

Title

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

Time Frame

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

Title

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

Description

Initial sensor glucose level ≥ 2.2 mmol/l and ≤ 3.9 mmol/l AND sensor glucose level > 3.9 mmol/l 30 minutes post-treatment

Time Frame

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

Title

Description

Time Frame

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

Title

Difference in successful cases (%) of hypoglycemia prevention between the two study periods

Description

Initial sensor glucose level > 3.9 mmol/l AND sensor glucose level < 3.9 for ≤ 15 consecutive minutes during the first two hours post-treatment

Time Frame

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

Title

Difference in time from hypoglycemia treatment to euglycemia between the two study periods

Description

Minutes from initial sensor glucose level ≥ 2.2 mmol/l and ≤ 3.9 mmol/l to sensor glucose level ≥ 3.9 mmol/l

Time Frame

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

Title

Incidence rate of supplement carbohydrate administration during the first hour following dasiglucagon administration

Time Frame

2-week 'dasiglucagon' period

Title

Difference between the average daily carbohydrate intake between the two study periods

Description

Registered on the insulin pump

Time Frame

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

Title

Difference between the average total daily insulin dose between the two study periods

Time Frame

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

Title

Difference in the number and intensity of episodes with nausea, headache, stomach-ache, palpitations and injection site pain between the two study periods

Description

Intensity: mild/moderate/severe

Time Frame

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

Title

Percentage of participants scoring a favorable outcome on the patient-reported outcome questionnaire

Description

Scoring likely OR very likely on a four-point Likert scale

Time Frame

At the end-of-study visit (estimated week 6)

Title

Percentage of participants with treatment-induced or treatment-boosted anti-dasiglucagon antibodies

Time Frame

Measured 4 weeks after the 'dasiglucagon' period

Other Pre-specified Outcome Measures:

Title

Number of device failures/malfunctions

Time Frame

2-week 'dasiglucagon' period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Laugesen, MD

Organizational Affiliation

Steno Diabetes Center Copenhagen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Steno Diabetes Center Copenhagen

City

Gentofte

ZIP/Postal Code

2820

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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