Status:
TERMINATED
Randomised Open Label Study of Insulin Degludec Versus Insulin Glargine U100 in Ramadan
Lead Sponsor:
Weill Cornell Medical College in Qatar
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Type2 Diabetes
Eligibility:
All Genders
21-75 years
Phase:
PHASE4
Brief Summary
This is a study to be performed in Qatar that will look at the comparison of glycemic control in patients with type 2 diabetes on insulin glargine U100 with insulin degludec over the Ramadan period, t...
Detailed Description
This will be an open label randomised prospective study that will involve 280 insulin-treated patients with type 2 diabetes and who are receiving a basal insulin as part of their treatment regimen. Th...
Eligibility Criteria
Inclusion
- Male subjects with type 2 diabetes between the age of 20-75 years who can speak and understand Arabic or English
- Female subjects with type 2 diabetes between the age of 20-75 years who can speak and understand Arabic or English
- Patients must be on any basal insulin (once daily)
- Patients must be on any basal insulin (twice daily)
- Patients on stable dose of oral antidiabetes drugs can be included (No change in the dose for the previous 12 weeks)
- Body Mass Index \<40kg/m2
- Subjects who have signed informed consent form
- Patients will be fasting during Ramadan
Exclusion
- Type 1 diabetes
- Type 2 diabetes on a basal bolus regimen or those on premix insulin or on self-mix insulin
- On GLP-1 receptor agonists medication
- On glinide medication
- Ischaemic heart disease
- Left bundle branch block on ECG
- Active diabetic retinopathy or maculopathy requiring acute treatment
- Unwilling to follow the protocol
- Pregnancy, intention to become pregnant, breastfeeding
Key Trial Info
Start Date :
January 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
273 Patients enrolled
Trial Details
Trial ID
NCT03349840
Start Date
January 7 2018
End Date
December 31 2018
Last Update
June 9 2020
Active Locations (1)
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1
Hamad Medical Corporation
Doha, Qatar, 3050