Randomised Open Label Study of Insulin Degludec Versus Insulin Glargine U100 in Ramadan

• Status: Terminated
• Trial end date: 2018-12-31
• Target enrollment: 0
• Participant gender: All

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, to determine whether better glycemic control with fewer hypoglycemic episodes can be achieved.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Cornell Medical College in Qatar
• Collaborator: Novo Nordisk A/S
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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