Health Condition 1: null- Type 1 Diabetes Mellitus
Conditions
Interventions
Intervention1: Insugen N: Doses will be individualized based on the requirements of the patients, Treatment will be given approximately for 1 year.
Intervention2: Insugen R: Doses will be individualiz
Sponsors
Biocon S.A. Fid Borruat Sarl, Sous Maichereux 20 Case postale 2027 CH-2800, Delemont, Switzerland
Eligibility
Inclusion criteria
Inclusion criteria: 1. Provide written informed consent 2. Male and female patients between the ages of 18-80 years inclusive 3. Established diagnosis of T1DM for at least 1-year as per revised WHO criteria. Diagnosis of T1DM will be based on fasting plasma C-peptide 0.2 pmol/ml and / or history of initiation of insulin treatment within 6 months after diagnosis 4. Body mass index of 18.5-34.99 kg/m2 inclusive 5. Stable weight with no more than 5 kg gain or loss within 3 months of screening (obtained by patient history) 6. Glycosylated hemoglobin (HbA1c) ≤ 11.0% inclusive at screening 7. On stable daily doses (10% daily) of insulin or an insulin analogue for at least 3 months that requires two or more daily injections 8. Ability and willingness to perform blood glucose profiles using blood glucose meter at home during the study. Ability to perform blood glucose will be based on a completed 7-point glucose profile as described in Appendix C obtained over a single 24-hour period during the screening phase
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to any of the active or inactive ingredients of the test and/or reference products 2. Patient with a clinically significant abnormality (including laboratory values) at screening, on the basis of which the Investigator advises against study inclusion 3. An ECG abnormality at screening considered clinically significant by the Investigator 4. Use of insulin pump therapy in the past 2 months prior to screening 5. 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 prior to screening, except for well-controlled and stable conditions such as essential hypertension (blood pressure <130/80 mmHg), and well controlled hyperlipidemia for at least 3 months prior to screening 8. Evidence of severe secondary complications of diabetes (e.g. active proliferative retinopathy, severe peripheral vascular disease, nephropathy, neuropathy or diabetic retinopathy treated with laser coagulation / vitrectomy within 6 months of the screening visit) 9. Unstable coronary artery disease (unstable angina, myocardial infarction within the preceding 6 months), heart failure (NYHA Grade 2 or higher), history of stroke within the preceding 6 months 10. History of drug or alcohol dependence or abuse within 6 months prior to screening 11. Patients currently on systemic or inhaled glucocorticoids or other drugs, which may affect glycemic control 12. Patients treated with blood-glucose lowering drugs other than insulin or insulin analogues in the last 4 weeks prior to screening or during the study 13. History of two or more severe episodes of hypoglycemia (defined by ADA criteria) within 6 months prior to screening 14. Any hospitalization or emergency room visit due to poor diabetes control within 6 months prior to screening 15. Any electively planned surgery requiring hospitalization 16. Pregnancy, lactation, or planned pregnancy during the study duration. Women of childbearing potential (any women who is not surgically sterile or > 2 years post menopause) must give consent for using 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, but followed for pregnancy outcome 17. Impaired hepatic function (ALT or AST value greater than 2 times of upper limit of normal and/or serum bilirubin >1.5 times of upper limit of reference range at the screening visit) 18. Impaired renal function (serum creatinine &#8805;1.5 times of upper limit of reference range at screening) 19. Hemoglobinopathies, hemolytic anemia, anemia of chronic disease, or any factor affecting the measurement of HbA1c 20. The patient has received another investigational drug within 6 weeks prior to screening or within 5 half-lives of the drug, whichever is longer, or is scheduled for treatment with another investigational drug during the current study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean anti-insulin antibody % binding and mean antibody titer for Non Comparative PhaseTimepoint: baseline to end of Week 48;Change in mean anti-insulin antibody % binding for comparative phaseTimepoint: baseline to end of Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in average 7-point capillary blood glucose profile (before and 120 minutes after each meal and at bedtime)for Comparative PhaseTimepoint: from baseline to Weeks 12;Change in fasting plasma glucose for Comparative phase.Timepoint: Weeks 12 and 24;Change in fructosamine for Comparative PhaseTimepoint: from baseline to Weeks 1, 2, 3 and 4;Change in HbA1c, serum lipids LDL, HDL cholesterol, triglycerides, body weight,fasting plasma glucose,average 7-point capillary blood glucose profile (before and after each meal and at bedtime).Proportion of patients having hypoglycemic episodes.Frequency of hypoglycemic events per 100 patients per month .Change in the number of insulin injections per day for Non-Comparative PhaseTimepoint: from baseline to end of Week 48;Change in mean anti-insulin antibody % binding for Comparative PhaseTimepoint: at Week 12;Change in mean antibody titers for Comparative Phase.Timepoint: baseline to end of Week 12 and Week 24;Change in Mean daily regular (Insugen R or Actrapid) insulin doses ,Mean daily basal (Insugen N or Insulatard) insulin doses ,Frequency of injection site reactions ,Frequency of systemic allergic reactions For Comparative Phase.Timepoint: Week 12 and Week 24;Change in serum lipids LDL and HDL cholesterol, triglycerides, body weight for Comparative Phase.Timepoint: baseline to Weeks 12 and 24;Change in the number of insulin injections per day for Comparative phase.Timepoint: baseline to Weeks 12 and 24;DTSQs score for Comparative PhaseTimepoint: Baseline , Weeks 12 and 24.;Frequency of injection site reactions,systemic allergic reactions for Non-Comparative PhaseTimepoint: At week 48;Mean daily insulin doses for Non-comparative phaseTimepoint: baseline to end of Week 48;Percentage of patients achieving HbA1c < 7% For Non-Comparative Phase.Timepoint: Week 48;Proportion of patients having hypoglycemic episodes ,Frequency of hypoglycemic events per 100 patients per month , Percentage of patients achieving HbA1c, < 7% f | — |
Countries
India
Contacts
Public ContactManish Verma
Outcome results
None listed