The study is investigating Ryzodeg®,a medication prescribed to patients with type 2 diabetes mellitus.The study is being carried out to investigate the effect of Ryzodeg® on the change of glycated haemoglobin levels and other diabetes indicators. Participants participation will not affect their medical care. In this retrospective study, the study doctor will collect data from the participants patient files available at the study site. Participants will need to sign the informed consent form during a single visit. Participants files will be reviewed and data relevant to the study will be extracted, within 26 weeks before and after Ryzodeg® treatment initiation (total of 52 weeks). Chart review for all patients is expected to take approximately 12 weeks.
Study Type
OBSERVATIONAL
Enrollment
60
All patients have been treated at the discretion of the treating physician in accordance with the Ryzodeg® label in Lebanon. Decision to initiate treatment with commercially available Ryzodeg® 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.
Novo Nordisk Investigational Site
Beirut, Hamra, Beirut, Lebanon
Change in Glycated Haemoglobin (HbA1c)
Percent (%) point. For all primary and secondary outcome measures: Baseline values for effect assessment will be collected as close to and prior to Ryzodeg® initiation as possible (week 0) but none of these values may be more than 12 weeks old. For end of study a window of 6 weeks before and after week 26 is used.
Time frame: From baseline (defined as the time of Ryzodeg® initiation (week -12 to week 0)) to end-of-study (week 26 +/- 6 weeks)
HbA1c less than 7%
Percentage of patients
Time frame: At end-of-study week 26
HbA1c less than 7% without any severe hypoglycaemic episodes during period 2 (26 weeks after initiation of Ryzodeg®)
Percentage of patients
Time frame: At end-of-study week 26
Change in fasting plasma glucose (FPG)
mmol/L
Time frame: From baseline to end-of-study week 26
Change in insulin dose (total, basal, prandial)
units/day
Time frame: From baseline to end-of-study week 26
Change in body weight
Kilogram (Kg)
Time frame: From baseline to end-of-study week 26
Change in the occurrence of severe hypoglycaemic events before and after initiation of treatment
Number of patients experiencing severe hypoglycaemic events in period 1 versus period 2. Period 1 is defined as 26 weeks prior to initiation of Ryzodeg® and period 2 is defined as 26 weeks after initiation of Ryzodeg®.
Time frame: From week -26 to week 26
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