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Indian Human Insulin Registry (INHIRIT)

A multi-centric, prospective, open label, single arm, observational, naturalistic post marketing study to prepare Indiaâ??s largest human insulin registry to understand knowledge, attitude and practice of timely initiation of human insulins by clinicians in India - Indian Human Insulin Registry (INHIRIT)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/10/010298
Enrollment
9000
Registered
2017-10-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Diabetic

Interventions

Intervention1: Human Insulin: to prepare Indiaâ??s largest human insulin registry to understand, knowledge, attitude and practice (KAP) of early initiation of human insulins by clinicians in India

Sponsors

Biocon Limited
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
to prepare Indiaâ??s largest human insulin registry to understand, knowledge, attitude and practice (KAP) of early initiation of human insulins by clinicians in IndiaTimepoint: After completion of 6th month follow up after starting from patientâ??s first visit to the doctor to the follow up call to the patient which he/she will receive till 6th month.

Secondary

MeasureTime frame
1. Assessment of the adherence of patients to human insulin therapy 2. Evaluation of treatment satisfaction of patients receiving human insulin therapy through Diabetes Treatment Satisfaction Questionnaire status version (DTSQs)Timepoint: 6th month follow up starting from patientâ??s first visit to the doctor to the follow up call to the patient which he/she will receive till 6th month.

Countries

India

Contacts

Public ContactDr Prameela Rani

Clinsync clinical research Pvt. Ltd.

prameelarani@clinsynccro.com04024203001

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026