a new kind of glucagon for the artificial pancreas

A stable glucagon analog administered by a bihormonal closed loop system; a feasibility study - STABLE1

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000427-20-NL

Enrollment

Registered

2022-02-16

Start date

2022-05-11

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes mellitus

Interventions

Product Name: Dasiglucagon Product Code: ZP4207 Pharmaceutical Form: Solution for injection INN or Proposed INN: Glucagon CAS Number: 16941-32-5 Current Sponsor code: ZP4207 Other descriptive name: Da

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Diagnosed with diabetes mellitus type 1; • Treated with the Inreda AP system for a minimum of 1 month; • Age between 18 and 75 years; • Adequate contraception is required (only applicable for female participants); Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 9 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3

Exclusion criteria

Exclusion criteria: • Impaired awareness of hypoglycemia • Pregnancy and/or breastfeeding; • Use of oral antidiabetic agents; • Pheochromocytoma; • Insulinoma; • Severe liver/heart/renal failure; • Alcohol abuse; • Hypersensitivity reactions to dasiglucagon.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to determine the feasibility of dasiglucagon in the Inreda AP-system. ;Secondary Objective: Secondary objectives are to assess safety parameters, differences in pharmacodynamics between dasiglucagon and GlucaGen® and differences in AP related outcomes.;Primary end point(s): Main parameter to express feasibility is the time in range (3.9 – 10.0 mmol/l), which will be compared between the dasiglucagon and reference glucagon.;Timepoint(s) of evaluation of this end point: End of the study	—

Measure

Time frame

Main Objective: The main objective is to determine the feasibility of dasiglucagon in the Inreda AP-system. ;Secondary Objective: Secondary objectives are to assess safety parameters, differences in pharmacodynamics between dasiglucagon and GlucaGen® and differences in AP related outcomes.;Primary end point(s): Main parameter to express feasibility is the time in range (3.9 – 10.0 mmol/l), which will be compared between the dasiglucagon and reference glucagon.;Timepoint(s) of evaluation of this end point: End of the study

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: End of the study;Secondary end point(s): Safety will be expressed as side effects of dasiglucagon compared to side effects of GlucaGen. Pharmacodynamics will be expressed in proportion of time spent in hypo-/hyperglycemia, median/mean glucose value, glycemic variability and PD curves, which will all be compared between the dasiglucagon and reference glucagon. AP related outcomes will be expressed in daily administered (maintenance) dosage of insulin/glucagon.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: End of the study;Secondary end point(s): Safety will be expressed as side effects of dasiglucagon compared to side effects of GlucaGen. Pharmacodynamics will be expressed in proportion of time spent in hypo-/hyperglycemia, median/mean glucose value, glycemic variability and PD curves, which will all be compared between the dasiglucagon and reference glucagon. AP related outcomes will be expressed in daily administered (maintenance) dosage of insulin/glucagon.

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Countries

Netherlands

Contacts

Public ContactMedical Department

Inreda Diabetic

0031547262628

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026