Immunogenicity and safety of Insulin in patients of Diabetes Mellitus

Phase 4

• Conditions: Health Condition 1: E108- Type 1 diabetes mellitus with unspecified complicationsHealth Condition 2: E118- Type 2 diabetes mellitus with unspecified complications

• Registration Number: CTRI/2022/06/043563
• Lead Sponsor: Wockhardt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Adult Subjects of 18 years age and above

2.Subjects who have been diagnosed with either type 1 or type 2 Diabetes Mellitus

3.Subjects with HbA1c levels = 7% & = 10%

4.A. T1DM patients diagnosed at least for 12 months receiving stable insulin regimen (recombinant human insulin or analogs) for 6 months before screening who can be shifted to study basal bolus regimen of premixed insulin (insulin 30/70) & regular insulin (insulin R) according to investigator as standard of care (A stable insulin regimen is define as the insulin dose within +/- 10%)

OR

B. T2DM insulin naïve patients uncontrolled on oral antidiabetic drugs (OADs) requiring human premixed insulin (insulin 30/70) according to investigator as standard of care

OR

C. T2DM insulin naïve patients uncontrolled on oral antidiabetic drugs (OADs) requiring basal human insulin NPH (insulin N) according to investigator as standard of care

OR

D. T2DM patients uncontrolled on oral antidiabetic drugs (OADs) and Lantus (basal insulin glargine) who may have received Lantus at least for 3 months and requiring human regular insulin (insulin R) to be added according to investigator as standard of care.

5.Subjects who are co-operative and agree to have regular injections of insulin and are willing to comply with protocol procedures.

6.Ability to use the self-glucose-monitoring device and to self- administer insulin and willing to record FBG & PPBG values and the insulin dose in a subject diary

7.Subjects who understand the nature of trial and provide written informed consent for the trial

Exclusion Criteria

1.Women of child-bearing potential who are pregnant or lactating or not following adequate contraceptive measures.

2.Subjects with secondary diabetes or maturity-onset diabetes

3.History or evidence of allergy to insulin preparations

4.History or evidence of severe hypoglycemia (characterized by altered mental and/or physical status requiring assistance for treatment of hypoglycemia) in last six months from day of consenting

5.Currently receiving or has received any immunomodulator medications including corticosteroids (except topical corticosterioids) that would possibly modify antibody generation.

6.Any medical condition that in the opinion of Investigator can interfere with the study treatment.

7.Presence of Hepatitis B or C or human immunodeficiency virus (HIV) positive status

8.A subject who has been treated with other investigational agent or devices within the previous 30 days of screening.

9.A subject who is judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above.

Study & Design

• Study Type: Interventional
• Study Design: Not specified