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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03349840
• Date of registration: 02/11/2017
• Prospective Registration: Yes
• Primary sponsor: Weill Cornell Medical College in Qatar
• Public title: Randomised Open Label Study of Insulin Degludec Versus Insulin Glargine U100 in Ramadan
• Scientific title: Randomised Open Label Study of Insulin Degludec Versus Insulin Glargine U100 in Ramadan
• Date of first enrolment: January 7, 2018
• Target sample size: 273
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03349840
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Qatar

Contacts

• Name: Stephen Atkin, MD
• Affiliation: Weill Cornell Medicine Qatar

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type2 Diabetes

Intervention(s)

Drug: Insulin Degludec U100

Drug: Insulin Glargine

Primary Outcome(s)

Comparison of the glycemic control of insulin glargine U100 with insulin degludec in patients with type 2 diabetes from baseline to end of Ramadan. [Time Frame: 6 weeks]

Secondary Outcome(s)

Comparison of the glucose control of insulin glargine U100 with insulin degludec in patients with type 2 diabetes from baseline to end of Ramadan. [Time Frame: 6 weeks]

HbA1c end point achieved [Time Frame: 6 weeks]

Hypoglycemia between arms [Time Frame: 6 weeks]

Incidence of Treatment-Emergent Adverse Events [Time Frame: 14-24 weeks]

Secondary ID(s)

U1111-1192-2978

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novo Nordisk A/S