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NCT Number: NCT02230618

Post Marketing Surveillance (PMS) Study of Ryzodeg™ (Insulin Degludec/Insulin Aspart) in Patients With Diabetes Mellitus in Routine Clinical Practice in India

This study is conducted in Asia. The aim of this study is to evaluate long term safety and efficacy 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

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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 procedures that are related to recording of data according to the protocol). The historical data including the data before informed consent obtained (e.g., HbA1c (Glycated Haemoglobin ), FPG (Fasting Plasma Glucose), PPPG (Postprandial Plasma Glucose), severe hypoglycaemia before the start of Ryzodeg™ therapy) can be used for baseline data
  • Patients with insulin requiring diabetes mellitus and who are scheduled to start treatment with Ryzodeg™ based on the clinical judgment of their treating physician

Exclusion criteria

  • Known or suspected allergy to Ryzodeg™ any of the active substances 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 Ryzodeg™ 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/insulin aspart

Drug

Ryzodeg™ will be prescribed by the physician under normal clinical practice conditions and will be obtained/purchased from the chemist based on physician prescription. No treatment given.

Primary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Weeks 0-52

Secondary outcomes

  1. Serious Adverse Events (SAEs)

    Time frame: Weeks 0-52

  2. Serious Adverse Drug Reactions (SADRs)

    Time frame: Weeks 0-52

  3. Adverse Drug Reactions (ADRs)

    Time frame: Weeks 0-52

  4. Severe or Blood glucose (BG) Confirmed hypoglycaemia

    Time frame: Weeks 0-52

  5. Change in HbA1c (glycosylated haemoglobin)

    Time frame: Week 0, week 52

  6. Change in Fasting Plasma Glucose (FPG)

    Time frame: Week 0, week 52

  7. Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)

    Time frame: Week 0, week 52

  8. The reason for initiating or intensifying treatment with Ryzodeg™

    Time frame: Week 0 - week 52

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 Ryzodeg™ (Insulin Degludec/Insulin Aspart) 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
Sep 3, 2014
Registry last updated
Mar 13, 2018

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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