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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02117622
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin degludec

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Study Type : Observational
Actual Enrollment : 1056 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : July 24, 2015
Actual Primary Completion Date : April 5, 2017
Actual Study Completion Date : April 5, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with diabetes mellitus requiring insulin therapy Drug: insulin degludec
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




Primary Outcome Measures :
  1. Incidence of adverse events (AEs) by preferred term [ Time Frame: During 1 year of treatment ]

Secondary Outcome Measures :
  1. Incidence of serious adverse events (SAEs) by preferred term [ Time Frame: During 1 year of treatment ]
  2. Incidence of serious adverse drug reactions (SADRs) by preferred term [ Time Frame: During 1 year of treatment ]
  3. Incidence of adverse drug reactions (ADRs) by preferred term [ Time Frame: During 1 year of treatment ]
  4. Incidence of severe hypoglycaemia [ Time Frame: During 1 year of treatment ]
  5. Change from baseline in glycosylated haemoglobin (HbA1c) [ Time Frame: Baseline (Visit 1, week 0), end of study (Visit 4, week 52) ]
  6. Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Baseline (Visit 1, week 0), end of study (Visit 4, week 52) ]
  7. Incidence of confirmed hypoglycaemia [ Time Frame: During 1 year of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117622


Locations
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India
Novo Nordisk Investigational Site
Guntur, Andhra Pradesh, India, 522001
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India, 500001
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India, 500004
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India, 500072
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India
Novo Nordisk Investigational Site
Vijayawada, Andhra Pradesh, India, 520002
Novo Nordisk Investigational Site
Guwahati, Assam, India, 781006
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, India, 380007
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, India
Novo Nordisk Investigational Site
Ghuma, Gujarat, India
Novo Nordisk Investigational Site
Gurgaon, Haryana, India
Novo Nordisk Investigational Site
Bangalore, Karnataka, India, 560092
Novo Nordisk Investigational Site
Thrissur, Kerala, India
Novo Nordisk Investigational Site
Bhopal, Madhya Pradesh, India, 462037
Novo Nordisk Investigational Site
Indore, Madhya Pradesh, India, 452010
Novo Nordisk Investigational Site
Indore, Madhya Pradesh, India
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400053
Novo Nordisk Investigational Site
Nagpur, Maharashtra, India, 440010
Novo Nordisk Investigational Site
Pune, Maharashtra, India, 411001
Novo Nordisk Investigational Site
Pune, Maharashtra, India, 411040
Novo Nordisk Investigational Site
Pune, Maharashtra, India
Novo Nordisk Investigational Site
Delhi, New Delhi, India, 110076
Novo Nordisk Investigational Site
Delhi, New Delhi, India
Novo Nordisk Investigational Site
Mohali, Punjab, India, 160062
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, India, 600037
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, India, 600040
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, India, 600086
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, India, 600100
Novo Nordisk Investigational Site
Coimbatore, Tamil Nadu, India, 641009
Novo Nordisk Investigational Site
Coimbatore, Tamil Nadu, India, 641018
Novo Nordisk Investigational Site
Madurai, Tamil Nadu, India, 625 020
Novo Nordisk Investigational Site
Noida, Uttar Pradesh, India, 201301
Novo Nordisk Investigational Site
Noida, Uttar Pradesh, India
Novo Nordisk Investigational Site
Kolkata, West Bengal, India, 700054
Novo Nordisk Investigational Site
Kolkata, West Bengal, India, 700094
Novo Nordisk Investigational Site
Chennai, India, 600008
Novo Nordisk Investigational Site
New Delhi, India, 110088
Novo Nordisk Investigational Site
Thriruvananthapuram, India, 695 032
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02117622    
Other Study ID Numbers: NN1250-4129
U1111-1145-9828 ( Other Identifier: WHO )
ENCEPP/SDPP/6318 ( Registry Identifier: EU PASS )
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs