| Is your age between 18 yrs and 64 yrs? |
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| Gender: Male or Female |
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| Do you have any of these conditions: Autoimmune disease or Diabetes Mellitus Types I and II or Diabetes Mellitus or Insulin dependent diabetes mellitus or Diabetes Mellitus, Type 1 or Dia...? |
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| Do you have any of these conditions: diabetes type 1 or Diabetes Mellitus Types I and II or Diabetes Prevention or insulin-dependent diabetes or type 1 diabetes or Diabetes Mellitus, Type...? |
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| Male or female patient with diabetes mellitus type 1 on insulin therapy for at least 1 year before screening |
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| Age between 18 and 64 years, both inclusive |
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| Body Mass Index (BMI) between 18.5 and 29.0 kg/m2, both inclusive |
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| Body weight between 60 kg and 100 kg, both inclusive and a stable weight +/- 5% for at least 3 months prior to screening (evaluated by patient history or medical history documents) |
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| Beta-N-1-deoxy fructosyl haemoglobin (HbA1c) between 6.5 to 9%, both inclusive |
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| Total insulin dose of < 1.2 (I)U/kg/day |
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| Daily dose of prandial insulin analogues or regular human insulin not exceeding 70% of total daily insulin dose at screening |
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| Stable basal-bolus insulin regimen for at least 3 months prior to screening (stable as per Investigator's discretion) |
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| Age between 18 and 64 years, both inclusive |
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| Body Mass Index (BMI) between 18.5 and 29.0 kg/m2, both inclusive |
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| Beta-N-1-deoxy fructosyl haemoglobin (HbA1c) between 6.5 to 9%, both inclusive |
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| Fasting C-peptide <= 0.20 nmol/L |
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| Total insulin dose of < 1.2 (I)U/kg/day |
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| Daily dose of prandial insulin analogues or regular human insulin not exceeding 70% of total daily insulin dose at screening |
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| Daily dose of prandial insulin analogues or regular human insulin of at least 21 (I)U per day at screening |
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| Stable basal-bolus insulin regimen for at least 3 months prior to screening (stable as per Investigator's discretion) |
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| Patients with experience in insulin titration and self-treatment of hypoglycemic events |
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| Considered generally healthy (apart from conditions associated with T1DM) upon completion of medical history and screening safety assessments including safety lab results, as judged by the Investigator |
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| Use of continuous subcutaneous insulin infusion (CSII) in the last 3 months prior to screening |
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| History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction |
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| History of autoimmune disorders other than T1DM as judged clinically relevant by the Investigator (obtained by patient history), except a stable thyroid disorder treated with a stable dose of thyroxin |
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| Hospitalization for diabetic ketoacidosis during the previous 6 months |
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| More than one episode of severe hypoglycemia (as per American Diabetes Association classification) with seizure, coma or requiring assistance of another person during the past 6 months |
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| Hypoglycemic unawareness (defined as individuals with a score of 3 or more [reduced awareness and intermediate awareness] as assessed by the Clarke score) |
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| Presence of clinically significant acute gastrointestinal (GI) symptoms (e.g. nausea, vomiting, heartburn or diarrhea) within 2 weeks prior to dosing, as judged by the investigator |
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| Presence of chronic GI disorders or conditions known to significantly alter the absorption of orally administered drugs or significantly alter upper GI or pancreatic function, as judged by the Investigator |
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| Patient with previous gastrointestinal surgery, except patients that underwent uncomplicated surgical procedures such as appendectomy, hernia surgery, biopsies, as wells as colonic- and gastric endoscopy |
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| Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists within the last 12 weeks prior to screening visit |
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| The use of any prescribed medication that would interfere with trial endpoints or the safe completion of the trial procedures like e.g. warfarin, indomethacin or systemic non-selective -blocker, as judged by the investigator |
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| Any clinically significant abnormality in ECG or safety laboratory tests (liver function, renal function, hematology, urinalysis or any other laboratory result judged as clinically relevant by the investigator) at screening |
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| Clinically significant cardiovascular and/or cerebrovascular disease within 12 months before Screening, as judged by the Investigator |
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| Active proliferative retinopathy as confirmed by ophthalmoscopy / retinal photography examination performed (by a qualified person as per local legislation) within 6 months prior to screening |
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| Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 60 mL |
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| min/1.73m2 as defined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) |
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| History of severe form of neuropathy or clinically significant cardiac autonomic neuropathy (CAN) |
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| Patients who needed systemic (oral, intravenous, intramuscular) glucocorticoid therapy within 4 weeks prior to the screening visit OR expected of requiring during the study period |
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| Patients who have undergone pancreatectomy or pancreas/islet cell transplant or had any significant pancreatic disease that affects safety of the patient |
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| Inability or unwillingness to refrain from smoking and use of nicotine substitute products one day before and during the study |
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| Patients refusing/not capable to consume three major meals per day on routine basis |
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| If female, pregnancy or breast-feeding |
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| Women of childbearing potential who are not using a highly effective contraceptive method |
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| Men with non-pregnant partner(s) of childbearing potential not willing to use male contraception (condom) in addition to a highly effective contraceptive method until one month after last dosing |
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| Men of childbearing potential not willing to refrain from sperm donation for the duration of the study and for one month following last dose of study drug |
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| Men with pregnant partner not willing to use male contraception (condom) until one month after last dosing, in order to avoid exposure of the embryo/foetus to seminal fluid |
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| Patients unwilling to avoid heavy machinery work, driving within specified post dose interval during the study treatment period |
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