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

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin degludec/insulin aspart

• Registration Number: NCT02230618
• Lead Sponsor: 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 diabetes mellitus in routine clinical practice in India.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-29
• Study First Submitted QC: 2014-08-29
• Study First Posted: 2014-09-03
• Study Start: 2015-11-24
• Primary Completion: 2017-06-01
• Study Completion: 2017-06-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-12
• Last Update Posted: 2018-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1029

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ryzodeg™	insulin degludec/insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs)	Weeks 0-52

Secondary Outcome Measures

Name	Time	Method
Adverse Drug Reactions (ADRs)	Weeks 0-52
Change in Fasting Plasma Glucose (FPG)	Week 0, week 52
Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)	Week 0, week 52
Severe or Blood glucose (BG) Confirmed hypoglycaemia	Weeks 0-52
Change in HbA1c (glycosylated haemoglobin)	Week 0, week 52
Serious Adverse Events (SAEs)	Weeks 0-52
Serious Adverse Drug Reactions (SADRs)	Weeks 0-52
The reason for initiating or intensifying treatment with Ryzodeg™	Week 0 - week 52

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇮🇳 Thriruvananthapuram, India