Clinical trial NCT02230618: Post Marketing Surveillance (PMS) Study of Ryzodeg™ (Insulin Degludec/Insulin Aspart) in Patients With Diabetes Mellitus in Routine Clinical Practice in India
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-09-03
Enrollment: 1029
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diabetes where the treating physician has decided to start Ryzodeg™ according to routine clinical practice will qualify for starting treatment with Ryzodeg™.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Weeks 0-52
Secondary outcomes:
measure: Serious Adverse Events (SAEs)
timeFrame: Weeks 0-52
measure: Serious Adverse Drug Reactions (SADRs)
timeFrame: Weeks 0-52
measure: Adverse Drug Reactions (ADRs)
timeFrame: Weeks 0-52
measure: Severe or Blood glucose (BG) Confirmed hypoglycaemia
timeFrame: Weeks 0-52
measure: Change in HbA1c (glycosylated haemoglobin)
timeFrame: Week 0, week 52
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: Week 0, week 52
measure: Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)
timeFrame: Week 0, week 52
measure: The reason for initiating or intensifying treatment with Ryzodeg™
timeFrame: Week 0 - week 52
Other outcomes:
Locations:
city: Guntur
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Vijayawada
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Visakhapatnam
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Novo Nordisk Investigational Site
state: Gujarat
city: Ahmedabad
country: India
facility: Novo Nordisk Investigational Site
state: Gujarat
city: Ahmedabad
country: India
facility: Novo Nordisk Investigational Site
state: Gujarat
city: Gandhinagar
country: India
facility: Novo Nordisk Investigational Site
state: Gujarat
city: Ghuma
country: India
facility: Novo Nordisk Investigational Site
state: Gujarat
city: Surat
country: India
facility: Novo Nordisk Investigational Site
state: Gujarat
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Mangalore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Angamaly
country: India
facility: Novo Nordisk Investigational Site
state: Kerala
city: Kochi
country: India
facility: Novo Nordisk Investigational Site
state: Kerala
city: Thrissur
country: India
facility: Novo Nordisk Investigational Site
state: Kerala
city: Trivandrum
country: India
facility: Novo Nordisk Investigational Site
state: Kerala
city: Indore
country: India
facility: Novo Nordisk Investigational Site
state: Madhya Pradesh
city: Indore
country: India
facility: Novo Nordisk Investigational Site
state: Madhya Pradesh
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Amritsar
country: India
facility: Novo Nordisk Investigational Site
state: Punjab
city: Chandigarh
country: India
facility: Novo Nordisk Investigational Site
state: Punjab
city: Jaipur
country: India
facility: Novo Nordisk Investigational Site
state: Rajasthan
city: Jaipur
country: India
facility: Novo Nordisk Investigational Site
state: Rajasthan
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Coimbatore
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Madurai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Lucknow
country: India
facility: Novo Nordisk Investigational Site
state: Uttar Pradesh
city: Lucknow
country: India
facility: Novo Nordisk Investigational Site
state: Uttar Pradesh
city: Noida
country: India
facility: Novo Nordisk Investigational Site
state: Uttar Pradesh
city: Kolkata
country: India
facility: Novo Nordisk Investigational Site
state: West Bengal
city: Bilaspur
country: India
facility: Novo Nordisk Investigational Site
city: Thriruvananthapuram
country: India
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: