Indian Human Insulin Registry (INHIRIT)

Not Applicable

• Conditions: Health Condition 1: null- Diabetic

• Registration Number: CTRI/2017/10/010298
• Lead Sponsor: Biocon Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

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

Inclusion Criteria

1. As per the package insert

2. Diagnosed with DM and as per physicianâ??s assessment requires initiation of human insulin for treatment

3. Insulin naïve patients with DM or patients who are on insulin analogues

4. Patient agrees to sign patient Informed Consent Form (ICF)

Exclusion Criteria

1. Preferably avoid pregnant women and who desire to become pregnant during study period as per the history given by patients

2. Patients who are hypersensitive to human insulin or the excipients

3. Patients who are/was on human insulin therapy

4. Patients participating in a clinical trial of an investigational drug in the 3 months prior to first visit (part 1), or within 5 half-lives of an investigational drug at first visit (whichever is longer), or scheduled for another investigational drug during the current study period.

5. As per the discretion of the investigator

Study & Design

• Study Type: Observational
• Study Design: Not specified