None listed
Conditions
Interventions
Intervention1: Biocon'
s Insulin Glargine: Dose is Individualised for each Patient and decided by the investigator. Duration- 12 weeks
Control Intervention1: Sanofi'
s Insulin glargine: Dose is Individualised for each Patient and decided by the investigator. Duration- 16 weeks (4 weeks run-in, 12 weeks Treatment)
Sponsors
Biocon Limited
20th K M Hosur road,
Electronic city,
Bangalore 560100
Eligibility
Inclusion criteria
Inclusion criteria: . Age ≥18 to ≤70 years , either sex ? Established diagnosis of type 1 diabetes for more than 1 year (defined as, patients with a confirmed history of diabetic ketosis with the presence of GAD antibodies or by presence of a C-peptide value less than ng/ml at a time when the person is hyperglycemic) ? Three months on a stable insulin regimen that meets the current standard of care and that includes at least two daily insulin injections ? Body Mass Index 18 to 38 kg/m2 ? HbA1C ≤ 10.5% ? Women of child-bearing potential willing to using an effective method of contraception ? Ability and willingness to perform blood glucose monitoring using a blood glucose meter and to use a patient diary ? Willing to give informed consent
Exclusion criteria
Exclusion criteria: . Type 2 diabetes mellitus ? Two or more severe hypoglycemic episodes in the past 6 months ? An episode of moderate to severe Diabetic ketoacidosis in the last three months prior to screening ? Severe complications of diabetes mellitus including a history or finding of moderate to severe Non Proliferative Diabetic Retinopathy or Proliferative Diabetic retinopathy, proteinuria > 2+ by urine dipstick, serum creatinine of >1.8 mg/dl for males or >1.5mg/dl for females, history of renal transplant, severe peripheral vascular disease which has resulted in amputation, chronic foot ulcer, claudication or absent pulses ? Known history of autonomic neuropathy ? Pregnancy or women intending to become pregnant during study and Breast feeding ? Blood donation within the last 30 days ? History of cancer in the last 5 years ? Treatment by another investigational agent during the 3 months prior to inclusion in the trial ? History of hypersensitivity to the study drugs or to drugs with a similar chemical structure or excipients History of severe or multiple allergies ? Any condition which requires administration of systemic corticosteroid in the last 2 weeks prior to screening or any condition which requires chronic treatment with systemic corticosteroids ? Current significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the Investigator ? Impaired hepatic function as shown by an increased Alamine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal range and Bilirubin greater than 1.5 times the upper limit of normal range at study entry ? Abnormal ECG, safety lab or physical examination results which, in the opinion of the investigator, render the participation of the patients to be inappropriate or unsafe ? Current drug or alcohol abuse, or a history which in the opinion of the Investigator will impair patient safety or protocol compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Changes in HbA1c from baseline to the end of study after treatment with Recombinant Insulin Glargine manufactured by Biocon Ltd or LantusTMTimepoint: 8 and 12 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| . Changes in Fasting Plasma Glucose ? Change in Self-monitored 7-point blood glucose profile ? Changes in total daily insulin dose ? Changes in Body weight ? Proportion of patients reaching glycemic target ? Mean HbA1C achieved in each arm . Incidence and severity of hypoglycemic events ? Incidence of Adverse events and Serious Adverse Events ? Fundoscopic changes from baseline to end of study ? Immunogenicity of insulin preparations ? Injection site reaction Timepoint: 2, 4, 8 and 12 weeks | — |
Countries
India
Contacts
Public ContactManish Verma
Outcome results
None listed