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

NCT ID: NCT02230618

Last Updated: 2018-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1029 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-24

Study Completion Date

2017-06-01

Brief Summary

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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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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ryzodeg™

insulin degludec/insulin aspart

Intervention Type 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.

Interventions

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insulin degludec/insulin aspart

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.

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Guntur, Andhra Pradesh, India

Site Status

Novo Nordisk Investigational Site

Vijayawada, Andhra Pradesh, India

Site Status

Novo Nordisk Investigational Site

Visakhapatnam, Andhra Pradesh, India

Site Status

Novo Nordisk Investigational Site

Ahmedabad, Gujarat, India

Site Status

Novo Nordisk Investigational Site

Ahmedabad, Gujarat, India

Site Status

Novo Nordisk Investigational Site

Ahmedabad, Gujarat, India

Site Status

Novo Nordisk Investigational Site

Gandhinagar, Gujarat, India

Site Status

Novo Nordisk Investigational Site

Ghuma, Gujarat, India

Site Status

Novo Nordisk Investigational Site

Surat, Gujarat, India

Site Status

Novo Nordisk Investigational Site

Bangalore, Karnataka, India

Site Status

Novo Nordisk Investigational Site

Bangalore, Karnataka, India

Site Status

Novo Nordisk Investigational Site

Mangalore, Karnataka, India

Site Status

Novo Nordisk Investigational Site

Angamaly, Kerala, India

Site Status

Novo Nordisk Investigational Site

Kochi, Kerala, India

Site Status

Novo Nordisk Investigational Site

Thrissur, Kerala, India

Site Status

Novo Nordisk Investigational Site

Trivandrum, Kerala, India

Site Status

Novo Nordisk Investigational Site

Indore, Madhya Pradesh, India

Site Status

Novo Nordisk Investigational Site

Indore, Madhya Pradesh, India

Site Status

Novo Nordisk Investigational Site

Mumbai, Maharashtra, India

Site Status

Novo Nordisk Investigational Site

Pune, Maharashtra, India

Site Status

Novo Nordisk Investigational Site

Amritsar, Punjab, India

Site Status

Novo Nordisk Investigational Site

Chandigarh, Punjab, India

Site Status

Novo Nordisk Investigational Site

Jaipur, Rajasthan, India

Site Status

Novo Nordisk Investigational Site

Jaipur, Rajasthan, India

Site Status

Novo Nordisk Investigational Site

Chennai, Tamil Nadu, India

Site Status

Novo Nordisk Investigational Site

Chennai, Tamil Nadu, India

Site Status

Novo Nordisk Investigational Site

Chennai, Tamil Nadu, India

Site Status

Novo Nordisk Investigational Site

Coimbatore, Tamil Nadu, India

Site Status

Novo Nordisk Investigational Site

Madurai, Tamil Nadu, India

Site Status

Novo Nordisk Investigational Site

Lucknow, Uttar Pradesh, India

Site Status

Novo Nordisk Investigational Site

Lucknow, Uttar Pradesh, India

Site Status

Novo Nordisk Investigational Site

Noida, Uttar Pradesh, India

Site Status

Novo Nordisk Investigational Site

Kolkata, West Bengal, India

Site Status

Novo Nordisk Investigational Site

Bilāspur, , India

Site Status

Novo Nordisk Investigational Site

Thriruvananthapuram, , India

Site Status

Countries

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India

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1157-0615

Identifier Type: OTHER

Identifier Source: secondary_id

ENCEPP/SDPP/6587

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN5401-4149

Identifier Type: -

Identifier Source: org_study_id

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