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A research study, Looking at how Ryzodeg works in people with type 2 diabetes in local clinical Practice.

Not Applicable
Conditions
Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications
Registration Number
CTRI/2019/07/020371
Lead Sponsor
ovo Nordisk India Private Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Informed consent obtained before any study-related activities. Study-related activities are any procedures related to recording of data according to the protocol.

2.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.

3.Male or female, age above or equal to 18 years at the time of signing informed consent.

4.Diagnosed with T2DM and treated with any anti-hyperglycaemic medication(s) other than Ryzodeg® for at least 26 weeks prior to signing informed consent.

5.Available and documented Glycosylated haemoglobin (HbA1c) value less than or equal to 12 weeks prior to signing informed consent.

Exclusion Criteria

1.Hypersensitivity to the active substance or to any of the excipients as specified in the Ryzodeg® local label.

2.Previous participation in this study. Participation is defined as signed informed consent.

3.Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

4.Previous treatment with Ryzodeg®.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in local laboratory measured HbA1cTimepoint: baseline (week 0) to end of study (week 26-36)
Secondary Outcome Measures
NameTimeMethod
1.Percentage of patients achieved HbA1c less than 7%/pre-defined individual treatment targets at the end of study (week 26-36) <br/ ><br>2.Change in local laboratory measured FPG,body weight,insulin dose (total, basal, prandial) from baseline (week 0) to end of the study (week 26-36) <br/ ><br>3.Number of patient recollection of severe and non-severe hypoglycaemic episodes (overall and nocturnal) occurring within 4 weeks prior to baseline and 4 weeks prior to end of the study Timepoint: occurring within 4 weeks prior to baseline and 4 weeks prior to end of the study,26 weeks prior at baseline and end of the study
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