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Clinical Trials/CTRI/2017/10/010298
CTRI/2017/10/010298Recruiting未知

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)

Biocon Limited0 sites0 target enrollmentStarted: TBDLast updated:

Trial Snapshot

Phase
未知
Status
Recruiting

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility 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

  • 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

Investigators

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