Type 1 diabetes mellitus MedDRA version: 21.1 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Gan & Lee Pharmaceuticals USA Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or nonpregnant, non-lactating female subjects between the ages of 18 and 75 years, inclusive. 2. Female subjects of child-bearing potential, willing to use contraceptive method(s), agreed by the Investigator, to prevent pregnancy during the study. 3. Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH GCP Guideline E6 and all applicable regulations, before initiating any study-related procedures. 4. Ability to understand and fully comply with all study procedures and restrictions. 5. A confirmed diagnosis of T1DM and who have been on an approved basal-bolus insulin regimen for at least 6 months prior to Screening. The type or brand of insulins should not have changed in the 6 months before Screening. 6. Do not expect to change the brand or type of their basal insulin during the study 7. C-peptide = 1.0 ng/mL 8. HbA1c = 10.0% 9. Body mass index (BMI) = 19 kg/m2 and = 35 kg/m2 10. Adherence to a prudent diet and exercise regimen recommended by the medical provider in accordance with local standard of care or American Diabetes Association recommendations, and willingness to maintain this regimen consistently for the duration of the study 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 495 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical study within 30 days or 5 half-lives of last dose of experimental medication before Screening, whichever is longer 2. Previous use of Gan & Lee Insulin Lispro Injection 3. Use of insulin neutral protamine hagedorn or insulin detemir within 6 months prior to study entry 4. Current or expected use of an insulin pump or use of continuous glucose measurement to monitor blood glucose during the study 5. Diabetic ketoacidosis (DKA) within 6 months before Screening 6. Brittle T1DM within 1 year before Screening, defined as more than 2 hospitalizations related to diabetes mellitus (excluding hospitalizations for diagnostic purposes), and/or severe hypoglycemia for which the subject experiences severe cognitive impairment requiring external assistance for recovery 7. Renal replacement therapy required or with an estimated (or measured) glomerular filtration rate 160 mmHg or diastolic blood pressure (DBP) > 100 mmHg at Screening and/or Randomization 11. Inadequately controlled thyroid disease, as reflected by abnormal TSH and free T4 values. (Hypothyroid or hyperthyroid conditions should be resolved or stabilized before Screening according to local standard of care.) 12. Any clinically significant (in the opinion of the Investigator) hematology, chemistry, or urinalysis test results at Screening, including any liver function test > 3X of the upper limit of normal (ULN) or bilirubin > 1.5X of the ULN (subjects with elevated bilirubin due to Gilbert syndrome are eligible to participate, if such tests were performed in the past) 13. Autonomic neuropathy resulting in a diagnosis of gastroparesis 14. Hemoglobin < 12 g/dL for males or < 11 g/dL for females at Screening 15. Hospitalization within the 14 days before Screening, or planned hospitalization at any time during the study 16. Newly prescribed or high-dose (60 mg/day prednisone or equivalent) treatment with glucocorticosteroids, immunosuppressants, or cytostatic agents due to disorders of the immunological system, such as rheumatoid arthritis, psoriasis, spondyloarthritis, and asthma, within 60 days before Screening (Medications under following scenario are allowed: chronically administered oral, inhaled, topical, or intra-articular corticosteroids at a stable dosage; stable therapy with disease modifying agents [e.g., methotrexate, sulfasalazine]; disease is inactive [e.g., remission, well controlled stable phase]; and no significant changes in treatment scheme are expected.) 17. History of human immunodeficiency virus (HIV) or Hepatitis B or Hepatitis C infections 18. Any unresolved infection or a history of active infection within 30 days before screening other than mild viral illness (as judged by the Investigator) 19. Current use of other medications for diabetes treatment, such as dipeptidyl peptidase 4 inhibitor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the immunogenicity of Gan & Lee Insulin Lispro Injection and EU-authorized Humalog following treatment in adult subjects with T1DM;Secondary Objective: - To evaluate the safety of Gan & Lee Insulin Lispro Injection in comparison with that of EU-authorized Humalog following treatment in adult subjects with T1DM - To evaluate the efficacy of Gan & Lee Insulin Lispro Injection in comparison with that of EU-authorized Humalog following treatment in adult subjects with T1DM;Primary end point(s): The percentage of subjects in each treatment group who develop treatment-induced AIAs, defined as newly confirmed positive AIA development or important (at least a 4-fold) increase in titers after baseline and up to visit Week 26;Timepoint(s) of evaluation of this end point: 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity • The percentage of subjects in each treatment group with negative AIA at baseline who develop confirmed positive AIA after baseline and up to visit Week 26 • The percentage of subjects in each treatment group with confirmed positive AIA at baseline and at least a 4-fold increase in titers after baseline and up to visit Week 26 • The mean change from baseline in each treatment group in AIA titers after baseline and up to visit Week 26 • The percentage of subjects in each treatment group with confirmed positive AIA after baseline and up to visit Week 26 who develop any anti-insulin NAbs after baseline and up to visit Week 26 • The percentage of subjects in each treatment group with confirmed positive AIA after baseline and up to visit Week 26 Safety • The incidence and severity of all treatment-emergent adverse events and the following subgroups: o Adverse events of special interest o Serious adverse events, including fatal events o Adverse events leading to termination of the study treatment and/or early withdrawal from the study o Treatment-related adverse events o IP device-related adverse events o Injection site reactions • The incidence of clinically significant laboratory abnormalities in physical examination and vital signs Efficacy • Change from baseline in HbA1c at visit Week 26 in each treatment group • The number and percentage of subjects who achieve an HbA1c of = 7.0% at visit Week 26 in each treatment group;Timepoint(s) of evaluation of this end point: Week 26, Safety - throughout study | — |
Countries
Czech Republic, Germany, Hungary, Poland, Spain, United States
Contacts
Public ContactJia Lu, Director, Clinical Sciences
Gan & Lee Pharmaceuticals USA Corporation
Outcome results
None listed