A clinical study to compare effects and safety Of recombinant Insulin Glargine manufactured by BioconLtd Compared to marketed Glargine (Lantus) In patients of Type 1 Diabetes Mellitus.
- Registration Number
- CTRI/2008/091/000226
- Lead Sponsor
- Biocon Limited20th K M Hosur road,Electronic city,Bangalore 560100
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
. 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
. 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method . Changes in Fasting Plasma Glucose<br>? Change in Self-monitored 7-point blood glucose profile<br>? Changes in total daily insulin dose<br>? Changes in Body weight<br>? Proportion of patients reaching glycemic target<br>? Mean HbA1C achieved in each arm<br>. Incidence and severity of hypoglycemic events<br>? Incidence of Adverse events and Serious Adverse Events<br>? Fundoscopic changes from baseline to end of study<br>? Immunogenicity of insulin preparations<br>? Injection site reaction<br>Timepoint: 2, 4, 8 and 12 weeks