| Trial ID: | L3772 |
| Source ID: | NCT03349840
|
| Associated Drug: |
Insulin Degludec U100
|
| Title: |
Randomised Open Label Study of Insulin Degludec Versus Insulin Glargine U100 in Ramadan
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type2 Diabetes
|
| Interventions: |
DRUG: Insulin Degludec U100|DRUG: Insulin Glargine
|
| Outcome Measures: |
Primary: Comparison of the glycemic control of insulin glargine U100 with insulin degludec in patients with type 2 diabetes from baseline to end of Ramadan., To measure HbA1c at the end of Ramadan between arms., 6 weeks | Secondary: Comparison of the glucose control of insulin glargine U100 with insulin degludec in patients with type 2 diabetes from baseline to end of Ramadan., To measure fasting glucose at the end of Ramadan between arms., 6 weeks|Hypoglycemia between arms, To measure the number hypoglycemia between arms to the end of Ramadan, 6 weeks|HbA1c end point achieved, To measure the number of subjects who achieve a HbA1c \<7.5% at the end of Ramadan between treatment arms, 6 weeks|Incidence of Treatment-Emergent Adverse Events, To measure the number of adverse events between the 2 treatment arms before and after Ramadan, 14-24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Weill Cornell Medical College in Qatar | Collaborators: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
273
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2018-01-07
|
| Completion Date: |
2018-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2020-06-09
|
| Locations: |
Hamad Medical Corporation, Doha, 3050, Qatar
|
| URL: |
https://clinicaltrials.gov/show/NCT03349840
|
