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Non-interventional, Post Marketing Surveillance Study of Xultophy™ (Insulin Degludec/Liraglutide) to Evaluate Long Term Safety and Efficacy in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in India

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ClinicalTrials.gov Identifier: NCT03070704
Recruitment Status : Withdrawn (Request for the study waived by Indian Health Authorities)
First Posted : March 3, 2017
Last Update Posted : September 5, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study is conducted in Asia. The aim of this study is to evaluate long term safety and efficacy in patients with type 2 diabetes mellitus in routine clinical practice in India.

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

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Post Marketing Surveillance Study of Xultophy™ (Insulin Degludec/Liraglutide) to Evaluate Long Term Safety and Efficacy in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in India
Estimated Study Start Date : August 16, 2017
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : August 16, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Insulin degludec /liraglutide Drug: insulin degludec/liraglutide
Patients will be treated with commercially available Xultophy™ (insulin degludec / liraglutide) according to routine clinical practice at the discretion of the treating physician




Primary Outcome Measures :
  1. Incidence of treatment emergent Adverse Events (AEs) [ Time Frame: Year 0-1 ]
    Count and % of events


Secondary Outcome Measures :
  1. Number of Serious Adverse Events (SAEs) [ Time Frame: Year 0-1 ]
    Count and % of events

  2. Number of Serious Adverse Drug Reactions (SADRs) [ Time Frame: Year 0-1 ]
    Count and % of events

  3. Number of Adverse Drug Reactions (ADRs) [ Time Frame: Year 0-1 ]
    Count and % of events

  4. Number of confirmed hypoglycaemic episodes [ Time Frame: Year 0-1 ]
    Count of episodes

  5. Change from baseline in the level of glycosylated haemoglobin (HbA1c) [ Time Frame: Year 0, Year 1 ]
    Measured in %

  6. Change in the level of Fasting Plasma/Blood Glucose (FPG/FBG) from baseline [ Time Frame: Year 0, Year 1 ]
    Measured in mg/dl or other equivalent SI units

  7. Percentage of patients achieving the target level of HbA1c below 7% [ Time Frame: Year 1 ]
    Measured in %

  8. Change in body weight [ Time Frame: Year 0, Year 1 ]
    Measured in kg and/or %

  9. Number of patients withdrawn due to ineffective therapy [ Time Frame: Year 1 ]
    Count of withdrawals



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Based on the clinical judgement of their treating physician, patients with type 2 diabetes mellitus will be initiated on Xultophy™ according to routine clinical practice
Criteria

Inclusion Criteria:

  • Informed consent obtained before any study-related activities. Study-related activities are any procedures that are related to the recording of data and determining the suitability for the study according to the protocol. Some specific historical data collected before informed consent is obtained can be used as baseline data (HbA1c, FPG/FBG and others)
  • The decision to initiate treatment with commercially available Xultophy™ has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
  • Male or female, age at least 18 years at the time of signing the informed consent
  • Patients diagnosed with type 2 diabetes mellitus
  • Patients who are scheduled to start treatment with Xultophy™ based on the clinical judgement of their treating physician

Exclusion Criteria:

  • Known or suspected hypersensitivity to Xultophy™, any of the active substances, any of the excipients or any related products
  • Previous participation in this study. Participation is defined as signed informed consent
  • Mental incapacity, unwillingness or language barriers hindering adequate understanding or cooperation
  • Females who are pregnant, breast-feeding or intend to become pregnant within the following 12 months
  • Patients who are participating in other studies or clinical trials.
  • Any disorder which in the opinion of the Physician might jeopardise subject's safety or compliance with the protocol

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03070704     History of Changes
Other Study ID Numbers: NN9068-4331
U1111-1185-0871 ( Other Identifier: WHO )
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Liraglutide
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists