Type 1 Diabetes mellitus MedDRA version: 14.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Insugen R
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN HUMAN
CAS Number: 11061-68-0
Concentration unit: IU/ml international unit(s)/millilitre
Concentration typ
Sponsors
Biocon S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provide written informed consent 2. Male and female patients between the ages of 18 to 80 years, inclusive 3. Patient must have been diagnosed with T1DM before 40 years of age and must have been on treatment with insulin for at least one year (confirmed by interview with the patient). Patients should have a fasting plasma C-peptide =65 years) yes F.1.3.1 Number of subjects for this age range 58
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to any of the active or inactive ingredients of the test and/or reference products 2. A clinically significant abnormality (including laboratory values) at Screening, on the basis of which the Investigator advises against study inclusion 3. An electrocardiogram (ECG) abnormality at Screening considered clinically significant by the Investigator 4. Use of insulin pump therapy in the past 2 months before Screening 5. Moderate insulin resistance defined as requiring insulin of >/=1.4 IU/kg/day 6. Significant history of atopy or allergic drug reactions 7. Clinically significant major organ disease before Screening, except for well-controlled and stable conditions such as essential hypertension (blood pressure >130/80 mmHg), well controlled hyperlipidaemia, and thyroid disorders for at least 3 months before Screening. 8. Knowledge of secondary complications of diabetes: a. Retinopathy: moderate to severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy of any severity or history of treatment with laser surgery/vitrectomy within 6 months of the Screening visit b. Nephropathy: Proteinuria =1+ by urine dipstick in the absence of infection or vaginal contamination and/or serum creatinine =1.5 times of upper limit of reference range, one (1) re-test is permitted within the Screening timeline, if required; history of renal transplant c. Neuropathy: History or finding of severe form of sensorimotor, cardiac, gastrointestinal, or genitourinary autonomic neuropathy d. Peripheral vascular disease (PVD): Severe PVD that has resulted in amputation, chronic foot ulcer, claudication on walking 300 mg/day or chronic usage requiring uninterrupted administration for >14 days during the study; anabolic steroids; diltiazem; niacin; isoniazid; epinephrine; thiazide diuretics if >25 mg/day; and loop diuretics. 14. History of 2 or more episodes of hypoglycaemia requiring assistance by another person to administer glucose or glucagon (severe hypoglycaemia) within 6 months before Screening 15. Any hospitalisation or emergency department visit due to poor diabetes control within 6 months before Screening 16. Any electively planned surgery requiring hospitalisation 17. Pregnancy, breastfeeding, or planned pregnancy during the study duration. Women of childbearing potential (any woman who is not surgically sterile or > 2 years post menopause) must agree to use a reliable method of contraception (e.g., double-barrier, tubal ligation, or stable hormonal contraception) throughout the study period. Women who become pregnant during the study must be discontinued from the study and followed for pregnancy outcome 18. Impaired
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and immunogenicity of Insugen R plus Insugen N compared to European Union (EU) sourced Actrapid plus Insulatard in patients with Type 1 diabetes mellitus (T1DM);Secondary Objective: To evaluate the efficacy of Insugen R plus Insugen N compared to EU-sourced Actrapid plus Insulatard in patients with T1DM;Primary end point(s): Primary endpoints phase 1: Comparison of the change in mean anti-insulin antibody binding percentage from Baseline to Week 24 between Insugen R plus Insugen N and Actrapid plus Insulatard groups. Primary endpoints phase 2: Change in mean anti-insulin antibody binding percentage from Baseline (Visit 3) to the end of Week 48. ;Timepoint(s) of evaluation of this end point: At the end of the comparative phase (phase 1), at end of trial and as part of preparations for subsequent trials, exploratory analysis of subsets of data may be performed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints phase 1: - Comparison of the change in mean anti-insulin antibody titres from Baseline to the end of Week 24 - Comparison of the change in incidence of anti-inslin antibodies from Baseline to Week 24 Secondary endpoints phase 2: -Change in mean antibody titre from Baseline to Week 48 - Change in incidence of anti-insulin antibodies from Baseline to Week 48;Timepoint(s) of evaluation of this end point: At the end of the comparative phase (phase 1), at end of trial and as part of preparations for subsequent trials, exploratory analysis of subsets of data may be performed. | — |
Countries
Germany, Hungary, India, Italy, Romania, Ukraine
Contacts
Public ContactClinical Trial information
Biocon S.A.
Outcome results
None listed