Comparison of Pharmacokinetics Safety Tolerability and Pharmacodynamics of Biocon Insulin Tregopil and Insulin Aspart

  • STATUS
    Recruiting
  • End date
    Jan 25, 2022
  • participants needed
    60
  • sponsor
    Biocon Limited
Updated on 26 January 2021
diabetes
insulin
body mass index
fasting
treatment regimen
hemoglobin a1c
hypoglycaemic
c-peptide
hypoglycemic agents

Summary

Multi-centre, open label, multiple ascending dose trial in patients with type 1 diabetes mellitus

Description

This is a Phase 1, open-label, multiple dose trial with two parts in patients with type 1 diabetes mellitus (T1DM). Part 1 consists of four cohorts with multiple ascending doses of insulin Tregopil and comprises a sentinel dosing design. Part 2 consists of a randomised, 2-treatment, crossover design with mixed meal tests (MMTs) of different compositions followed by parallel design titrated treatment period. Both parts include dosing during an in-house period and during a subsequent outpatient period.

Details
Condition Diabetes Mellitus, Insulin dependent diabetes mellitus, Autoimmune disease, Diabetes Mellitus, Type 1, Diabetes Prevention, Diabetes Mellitus Types I and II, Diabetes (Pediatric), type 1 diabetes mellitus, type 1 diabetes, diabetes type 1, diabetes mellitus type 1, insulin-dependent diabetes, iddm, type i diabetes mellitus
Treatment Tregopil
Clinical Study IdentifierNCT04141423
SponsorBiocon Limited
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 64 yrs?
Gender: Male or Female
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...?
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...?
Male or female patient with diabetes mellitus type 1 on insulin therapy for at least 1 year before screening
Age between 18 and 64 years, both inclusive
Body Mass Index (BMI) between 18.5 and 29.0 kg/m2, both inclusive
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)
Beta-N-1-deoxy fructosyl haemoglobin (HbA1c) between 6.5 to 9%, both inclusive
Total insulin dose of < 1.2 (I)U/kg/day
Daily dose of prandial insulin analogues or regular human insulin not exceeding 70% of total daily insulin dose at screening
Stable basal-bolus insulin regimen for at least 3 months prior to screening (stable as per Investigator's discretion)
Age between 18 and 64 years, both inclusive
Body Mass Index (BMI) between 18.5 and 29.0 kg/m2, both inclusive
Beta-N-1-deoxy fructosyl haemoglobin (HbA1c) between 6.5 to 9%, both inclusive
Fasting C-peptide <= 0.20 nmol/L
Total insulin dose of < 1.2 (I)U/kg/day
Daily dose of prandial insulin analogues or regular human insulin not exceeding 70% of total daily insulin dose at screening
Daily dose of prandial insulin analogues or regular human insulin of at least 21 (I)U per day at screening
Stable basal-bolus insulin regimen for at least 3 months prior to screening (stable as per Investigator's discretion)
Patients with experience in insulin titration and self-treatment of hypoglycemic events
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

Exclusion Criteria

Use of continuous subcutaneous insulin infusion (CSII) in the last 3 months prior to screening
History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
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
Hospitalization for diabetic ketoacidosis during the previous 6 months
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
Hypoglycemic unawareness (defined as individuals with a score of 3 or more [reduced awareness and intermediate awareness] as assessed by the Clarke score)
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
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
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
Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists within the last 12 weeks prior to screening visit
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
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
Clinically significant cardiovascular and/or cerebrovascular disease within 12 months before Screening, as judged by the Investigator
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
Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 60 mL
min/1.73m2 as defined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
History of severe form of neuropathy or clinically significant cardiac autonomic neuropathy (CAN)
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
Patients who have undergone pancreatectomy or pancreas/islet cell transplant or had any significant pancreatic disease that affects safety of the patient
Inability or unwillingness to refrain from smoking and use of nicotine substitute products one day before and during the study
Patients refusing/not capable to consume three major meals per day on routine basis
If female, pregnancy or breast-feeding
Women of childbearing potential who are not using a highly effective contraceptive method
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
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
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
Patients unwilling to avoid heavy machinery work, driving within specified post dose interval during the study treatment period
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