Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Time spent in hypoglycaemia (IG < 3.9 mmol) |
The primary endpoint is the percentage of time in hypoglycaemia (IG <3.9 mmol/l) assessed by CGM during the out-patient part. |
During the four weeks of placebo and dasiglucagon treatment. |
|
Secondary |
Time (percent or minutes) spent in serious hypoglycaemia (IG <3.0 mmol/l) |
|
During the four weeks of placebo and dasiglucagon treatment. |
|
Secondary |
Frequency of hypoglycaemic events (IG <3.9 mmol/l and <3.0 mmol/l, respectively) |
|
During the four weeks of placebo and dasiglucagon treatment. |
|
Secondary |
Glycaemic time in range defined as: 1) hypoglycaemia (<3.9 mmol/l), 2) normoglycaemia (3.9-10.0 mmol/l), and 3) hyperglycaemia (>10.0 mmol/l) |
|
During the four weeks of placebo and dasiglucagon treatment. |
|
Secondary |
Frequency of hyperglycaemic events (IG >7.8 mmol/l and >10.0 mmol/l, respectively) |
|
During the four weeks of placebo and dasiglucagon treatment. |
|
Secondary |
Glycaemic variability assessed as coefficient of variance (CV) |
|
During the four weeks of placebo and dasiglucagon treatment. |
|
Secondary |
Glycaemic variability assessed as standard deviation (SD) |
|
During the four weeks of placebo and dasiglucagon treatment. |
|
Secondary |
Recovery of BG 15 minutes after trial drug administration (as measured by finger prick (BG >3.9 mmol/l)) |
|
During the four weeks of placebo and dasiglucagon treatment. |
|
Secondary |
Change in QoL as assessed by the World Health Organization's quality of life assessment (WHOQOL-BREF) |
likert scale, zero (very poor) to five (very good) |
During the four weeks of placebo and dasiglucagon treatment. |
|
Secondary |
Change in hypoglycaemic symptoms will be evaluated by Edinburgh Hypoglycaemia Symptom Scale (EHSS) |
likert scale, zero (not a all) to seven (a lot) |
During the four weeks of placebo and dasiglucagon treatment. |
|
Secondary |
Change in fear of hypoglycaemia as assessed by Hypoglycaemia Fear Scale (HFS-II) |
likert scale, zero (never) to four (always) |
During the four weeks of placebo and dasiglucagon treatment. |
|
Secondary |
Change in administration frequency (as measured by percentage) |
|
During the four weeks of placebo and dasiglucagon treatment. |
|
Secondary |
Nadir plasma glucose as assessed both as 1) absolute lowest value, and 2) a mean of three consecutive glucose measurements during the 240-minute MMT |
Nadir plasma glucose after the postprandial peak during the MMT in the in-patient part |
Two hundred forty minutes of mixed meal test |
|
Secondary |
Recovery of BG 15 minutes after administration (as measured by finger prick (BG >3.9 mmol/l)) |
After the postprandial peak during the MMT in the in-patient part |
Two hundred forty minutes of mixed meal test |
|
Secondary |
Time spent in level 1 and level 2 hypoglycaemia (<3.9 and <3.0 mmol/l, respectively) from study drug administration until 240 minutes |
After the postprandial peak during the MMT in the in-patient part |
Two hundred forty minutes of mixed meal test |
|
Secondary |
Glycaemic rescue intervention due to critically low plasma glucose concentration (<1.8 mmol/l) |
During the MMT in the in-patient part |
Two hundred forty minutes of mixed meal test |
|
Secondary |
Time spent in hyperglycaemia (>7.8 mmol/l) from study drug administration until 240 minutes |
During the MMT in the in-patient part |
Two hundred forty minutes of mixed meal test |
|
Secondary |
Peak plasma glucose concentration after study drug administration |
During the MMT in the in-patient part |
Two hundred forty minutes of mixed meal test |
|
Secondary |
Counter-regulatory hormonal response |
Measured as area under the curve (AUC) and / or incremental (iAUC) as appropriate, peak values and values at nadir plasma glucose concentration during the MMT in the in-patient part. glucagon-like peptide 1 (GLP-1), glucagon-like peptide 2 (GLP-2), glucose-dependent insulinotropic polypeptide (GIP) |
Two hundred forty minutes of mixed meal test |
|
Secondary |
Changes in blood pressure |
During the MMT in the in-patient part |
Two hundred forty minutes of mixed meal test |
|
Secondary |
Changes in heart rate |
During the MMT in the in-patient part |
Two hundred forty minutes of mixed meal test |
|
Secondary |
Frequency and severity of adverse events (AE)s and serious adverse events (SAE)s from signed consent form to end of study (visit 4 / follow-up visit) |
Safety endpoint |
Through study completion which is an average of 16 weeks |
|
Secondary |
Frequency and severity of adverse events (AE)s and serious adverse events (SAE)s during the in-patient part MMTs |
Safety endpoint |
During the in-patient part (MMTs) 0-240 minutes / Two hundred forty minutes of mixed meal test |
|
Secondary |
Percentage (%) of participants with treatment-induced or treatment-boosted anti-dasiglucagon antibodies who did not have anti-dasiglucagon antibodies at baseline |
Safety endpoint |
Through study completion which is an average of 16 weeks |
|
Secondary |
Device failures/ malfunctions occurring during the trial. |
Device endpoint |
Through study completion which is an average of 16 weeks |
|