NCT02230618|Completed

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

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

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN5401-4149U1111-1157-0615ENCEPP/SDPP/6587

Study Type

observational

Target

1,029

Locations

1 country

Sites

Timeline

RegisteredSep 2014

StartedNov 2015

CompletionJun 2017

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,029

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Nov 2015

Geographic Reach

1 country

35 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

First Submitted

Initial submission to the registry

August 29, 2014

Completed

5 days until next milestone

First Posted

Study publicly available on registry

September 3, 2014

Completed

1.2 years until next milestone

Study Start

First participant enrolled

November 24, 2015

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed

Last Updated

March 13, 2018

Status Verified

March 1, 2018

Enrollment Period

1.5 years

First QC Date

August 29, 2014

Last Update Submit

March 12, 2018

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Incidence of Adverse Events (AEs)
Weeks 0-52

Secondary Outcomes (8)

Serious Adverse Events (SAEs)
Weeks 0-52
Serious Adverse Drug Reactions (SADRs)
Weeks 0-52
Adverse Drug Reactions (ADRs)
Weeks 0-52
Severe or Blood glucose (BG) Confirmed hypoglycaemia
Weeks 0-52
Change in HbA1c (glycosylated haemoglobin)
Week 0, week 52
+3 more secondary outcomes

Study Arms (1)

Ryzodeg™

Drug: insulin degludec/insulin aspart

Interventions

insulin degludec/insulin aspartDRUG

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.

Ryzodeg™

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-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™.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.