A Research Study, Looking at How Ryzodeg® (Insulin Degludec/Insulin Aspart) Works in People With Type 2 Diabetes in Local Clinical Practice

Novo Nordisk A/S1,122 enrolled

Overview

The purpose of the study is to collect information on how Ryzodeg® works in real world patients and to see if Ryzodeg® can lower blood sugar levels. Participants will get Ryzodeg® as prescribed to them by their doctor. The study will last for about 6 to 9 months. Participants will be asked questions about their health and their diabetes treatment as part of their normal doctor's appointment.

Study Type

OBSERVATIONAL

Enrollment

1,122

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Degludec/Insulin AspartDRUG

Insulin Degludec/Insulin Aspart (Ryzodeg®) as prescribed by the patient's treating physician. The decision to initiate or switch into treatment with commercially available Ryzodeg® has been made before, and independently from, the decision to include the patient in this study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Informed consent obtained before any study-related activities. Study-related activities are any procedures related to recording of data according to the protocol. * The decision to initiate or switch into treatment with commercially available Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before, and independently from, the decision to include the patient in this study. * Male or female, age above or equal to 18 years at the time of signing informed consent. * Diagnosed with T2DM and treated with any anti-hyperglycaemic medication(s) other than Ryzodeg® for at least 26 weeks prior to signing informed consent. * Available and documented HbA1c value for 12 weeks or less prior to signing informed consent. Exclusion Criteria: * Hypersensitivity to the active substance or to any of the excipients as specified in the Ryzodeg® local label. * Previous participation in this study. Participation is defined as signed informed consent. * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. * Previous treatment with Ryzodeg®.

Locations (64)

Outcomes

Primary Outcomes

Change in local laboratory measured glycosylated haemoglobin (HbA1c)

Percentage point

Time frame: From baseline (week 0) to end of study (week 26-36)

Secondary Outcomes

HbA1c less than 7% (Yes/No)

Percentage of patients

Time frame: At the end of study (week 26-36)

HbA1c less than pre-defined individual treatment target (Yes/No)

Percentage of patients

Time frame: At the end of study (week 26-36)

Change in local laboratory measured fasting plasma glucose (FPG)

mg/dL

Time frame: From baseline (week 0) to end of study (week 26-36)

Change in local laboratory measured FPG

mmol/L

Time frame: From baseline (week 0) to end of study (week 26-36)

Change in insulin dose (total, basal, prandial)

units/day

Time frame: From baseline (week 0) to end of study (week 26-36)

Change in body weight

Time frame: From baseline (week 0) to end of study (week 26-36)

Number of patient recollection of non-severe hypoglycaemic episodes

Number of episodes

Time frame: At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg®

Data from ClinicalTrials.gov

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Royal North Shore Hospital

St Leonards, New South Wales, Australia

Illawarra Diabetes Service Clinical Trials & Research Unit

Wollongong, New South Wales, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Mater Hospital Brisbane

South Brisbane, Queensland, Australia

Lyell McEwin Hospital

Elizabeth Vale, South Australia, Australia

South Australian Endocrine Research

Keswick, South Australia, Australia

Hobart Cardiology

Hobart, Tasmania, Australia

Box Hill Specialist Consulting rooms

Box Hill, Victoria, Australia

Baker IDI Heart and Diabetes Institute

Melbourne, Victoria, Australia

Rockingham General Hospital

Cooloongup, Western Australia, Australia

...and 54 more locations

Number of patient recollection of non-severe hypoglycaemic episodes

Time frame: At the end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study

Number of patient recollection of nocturnal non-severe hypoglycaemic episodes

Number of episodes

Time frame: At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg®

Number of patient recollection of nocturnal non-severe hypoglycaemic episodes

Number of episodes

Time frame: At end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study

Number of patient recollection of overall severe hypoglycaemic episodes

Number of episodes

Time frame: At baseline (week 0). Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg®

Number of patient recollection of overall severe hypoglycaemic episodes

Number of episodes

Time frame: At the end of study (week 26-36). Episodes occurring within 26 weeks prior to end of study

Number of weekly self-measured plasma glucose (SMPG) measurements

Number of measurements

Time frame: At baseline (week 0). Measurements occurring within 7 days prior to initiation of treatment with Ryzodeg®

Number of weekly self-measured plasma glucose (SMPG) measurements

Number of measurements

Time frame: At end of study (week 26-36). Measurements occurring within 7 days prior to end of study

Reason for initiating Ryzodeg® (pre-specified response option(s))

Percentage of patients per response option

Time frame: At baseline (week 0)

Discontinue treatment with Ryzodeg® during the treatment period (Yes/No)

Percentage of patients

Time frame: At treatment discontinuation (week 0-36) or at end of study (week 26-36). After initiation of treatment with Ryzodeg® until treatment discontinuation

Reason for discontinuing treatment with Ryzodeg® during the treatment period, if applicable, (pre-specified response option(s))

Percentage of patients per response option

Time frame: At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation

Time period from initiation to discontinuation of treatment with Ryzodeg®

Days

Time frame: At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation