Phase IV study to assess the safety, efficacy and immunogenicity of MJ Pharma-BIOSULIN® 30:70

Phase 4

Recruiting

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2020/03/024054
• Lead Sponsor: M J Biopharm Private Limited

Brief Summary

An open-label, prospective, multi centric,non-comparative, non-randomized phase IV clinical study to evaluate the postmarketing safety, efficacy and immunogenicity of BIOSULIN® 30:70 (insulin injection,biphasic isophane 100IU/ml of M. J. Biopharm Private Limited) inroutine clinical practice in patients with diabetes mellitus in India withcurrent applicable laws and regulations.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-25
• Last Update Posted: 2022-05-16

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 1.Patients who are willing to provide written, signed and dated informed consent (IEC/IRB approved) to participate in the study before initiating any study related procedures 2.
• Type II diabetic male or female adult patients, within 18 to 65 years of age(Inclusive) 3.
• Patients who are willing to comply with visit schedule and all aspects of the protocol requirements 4.
• Adult patients with type II diabetes mellitus who require Premix Human Insulin Biphasic 30/70 for the control of hyperglycemia according to the clinical judgment of the physician..
• Patients with glycosylated/glycated hemoglobin (HbA1c) level ≤ 11 % at screening 6.
• Ability to self-inject insulin and perform self-monitoring of blood glucose (SMBG) measurements.
• Patients whose injection is being administered by caregiver/family member (only in the case wherein the patient has fear to self-inject or does not prefer to self-inject) will be enrolled.

Exclusion Criteria

• 1.History of Type I Diabetes mellitus or secondary diabetes mellitus or diabetes insipidus 2.
• Type 2 diabetic patients with metabolic complication such as diabetic ketoacidosis within 6 months of baseline visit 3.
• Patients who have used any other investigational agent in the past 3 months 4.
• Patients with history or evidence of hypersensitivity to the active substance (insulin) or to any of the excipients as mentioned in the local prescribing information 6.
• Women who are pregnant or nursing mothers.
• Women of childbearing potential not willing to use acceptable method of contraception 7.
• Any disorder which in the opinion of the treating physician might jeopardize subject’s safety or compliance with the protocol 8.
• Patient who has received/receiving insulin of animal origin 9.
• Patient with history or evidence of recurrent severe hypoglycemia within 6 months at baseline visit 10.
• Patients with use of insulin pump within 6 months at baseline visit 11.
• Patient’s having the any of the following laboratory results at screening a.
• BUN > 30 mg/dL b.
• ALT/AST levels ≥ 2.5 X ULN of the normal laboratory range c.
• Serum creatinine level >2.0 mg/dL 12.
• Patients with known history of positive serology for hepatitis B virus (HBV) or hepatitis C (HCV) or human immunodeficiency virus (HIV) infections 13.
• Patients receiving glucagon-like peptide 1 mimetics (GLP-1) 14.
• Patients receiving treatment with thiazolidinedione (TZD) within the last 3 months at baseline visit 15.
• Patients with body mass index (BMI) <18 kg/m² and ≥40 kg/m² at screening 16.
• Patients who have undergone pancreatectomy or pancreas islet transplant or renal transplant 17.
• Patients receiving or have received within the last year any immunomodulation medications that would possibly modify antibody generation either at the enrollment or during the course of the study 18.
• Patients who have received/receiving (>14 consecutive days) glucocorticoids within 4 weeks prior to baseline visit 19.
• Patients with history or evidence of diabetic complications (diabetic retinopathy, diabetic neuropathy, or diabetic nephropathy), other complications related to T2DM other than those mentioned, or cardiac disorders, etc.
• Patients with alcohol or drug abuse or any other medical or surgical condition, including lifestyle (e.g. shift workers, irregularity with meal times, etc.) that in the opinion of investigator can interfere with the study protocol or affect patient’s safety in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Percentage of patients reporting adverse events	From baseline to week 24
2.Percentage of patients reporting serious adverse events	From baseline to week 24
3.Insulin antibody changes	From baseline to week 24

Secondary Outcome Measures

Name	Time	Method
1.Improvement in HbA1c levels	2.Improvement in fasting blood glucose

Trial Locations

Locations (8)

Dr. Ram Manohar Lohiya Institute of Medical Sciences; 🇮🇳 Lucknow, UTTAR PRADESH, India

Government Medical College; 🇮🇳 Nagpur, MAHARASHTRA, India

Indira Gandhi Institute of Medical Sciences; 🇮🇳 Patna, BIHAR, India

Mahatma Gandhi Missions Medical College & Hospital; 🇮🇳 Aurangabad, MAHARASHTRA, India

Neelima Hospital; 🇮🇳 Hyderabad, TELANGANA, India

NKP Salve Institute of Medical sciences and Lata Mangeshkar Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Redkar Hospital & Research Center; 🇮🇳 Goa, GOA, India

St. Theresas Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Dr. Ram Manohar Lohiya Institute of Medical Sciences

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Shobhit Shakya

Principal investigator

8618737280

mkhushi021@gmail.com