NCT02117622|Completed

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

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

Novo Nordisk A/S ClinicalTrials.gov

Compare

3 other identifiers

NN1250-4129U1111-1145-9828ENCEPP/SDPP/6318

Study Type

observational

Target

1,056

Locations

1 country

Sites

Timeline

RegisteredApr 2014

StartedJul 2015

CompletionApr 2017

Brief Summary

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.

Trial Health

On Track

Trial Health Score

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

Enrollment

1,056

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jul 2015

Geographic Reach

1 country

38 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

1.7 years study duration

First Submitted

Initial submission to the registry

April 16, 2014

Completed

5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed

1.3 years until next milestone

Study Start

First participant enrolled

July 24, 2015

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2017

Completed

Last Updated

August 2, 2017

Status Verified

July 1, 2017

Enrollment Period

1.7 years

First QC Date

April 16, 2014

Last Update Submit

August 1, 2017

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Incidence of adverse events (AEs) by preferred term
During 1 year of treatment

Secondary Outcomes (7)

Incidence of serious adverse events (SAEs) by preferred term
During 1 year of treatment
Incidence of serious adverse drug reactions (SADRs) by preferred term
During 1 year of treatment
Incidence of adverse drug reactions (ADRs) by preferred term
During 1 year of treatment
Incidence of severe hypoglycaemia
During 1 year of treatment
Change from baseline in glycosylated haemoglobin (HbA1c)
Baseline (Visit 1, week 0), end of study (Visit 4, week 52)
+2 more secondary outcomes

Study Arms (1)

Patients with diabetes mellitus requiring insulin therapy

Drug: insulin degludec

Interventions

insulin degludecDRUG

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

Patients with diabetes mellitus requiring insulin therapy

Eligibility Criteria

Sexall

Healthy VolunteersNo

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

Sampling MethodNon-Probability Sample

Study Population

Patients with diabetes mellitus requiring insulin therapy who qualify for starting treatment with Tresiba® based on the clinical judgment by their treating physician during enrolment period.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.