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NCT Number: NCT02117622

A Non-interventional, Post Marketing Surveillance (PMS) Study of Tresiba® (Insulin Degludec) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in India

This study is conducted in Asia. The aim of the study is to evaluate long term safety and efficacy of Tresiba® (insulin degludec) in patients with diabetes mellitus in routine clinical practice in India.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Guntur, Andhra Pradesh, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent obtained before any study-related activities (Study related activities are any procedure related to recording of data according to the protocol). The historical data including the data before informed consent obtained (e.g. glycosylated haemoglobin (HbA1c), fasting plasma glucose (FPG), severe hypoglycaemia before the start of Tresiba® therapy) can be used for baseline data
  • Patients with insulin requiring diabetes mellitus and who is scheduled to start treatment with Tresiba® based on the clinical judgment of their treating physician

Exclusion criteria

  • Known or suspected allergy to Tresiba®, the active substance or any of the excipients
  • Previous participation in this study
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
  • Patients who are or have previously been on Tresiba® therapy
  • Patients who are participating in other studies or clinical trials
  • Patients who are pregnant, breast feeding or have the intention of becoming pregnant within the following 12 months

Treatment and study plan

insulin degludec

Drug

Treatment according to routine clinical practice at the discretion of the treating physician. The assignment of the patient to Tresiba® is decided in advance of this study

Primary outcomes

  1. Incidence of adverse events (AEs) by preferred term

    Time frame: During 1 year of treatment

Secondary outcomes

  1. Incidence of serious adverse events (SAEs) by preferred term

    Time frame: During 1 year of treatment

  2. Incidence of serious adverse drug reactions (SADRs) by preferred term

    Time frame: During 1 year of treatment

  3. Incidence of adverse drug reactions (ADRs) by preferred term

    Time frame: During 1 year of treatment

  4. Incidence of severe hypoglycaemia

    Time frame: During 1 year of treatment

  5. Change from baseline in glycosylated haemoglobin (HbA1c)

    Time frame: Baseline (Visit 1, week 0), end of study (Visit 4, week 52)

  6. Change from baseline in fasting plasma glucose (FPG)

    Time frame: Baseline (Visit 1, week 0), end of study (Visit 4, week 52)

  7. Incidence of confirmed hypoglycaemia

    Time frame: During 1 year of treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Post Marketing Surveillance (PMS) Study of Tresiba® (Insulin Degludec) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in India

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 21, 2014
Registry last updated
Aug 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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