Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
180

Summary

Conditions
Type 2 Diabetes
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Several outpatient trials have reported that treatment with degludec results in comparable improvement in HbA1c levels and in lower rates of hypoglycemia compared to glargine U100 insulin. However, no previous studies have compared the safety and efficacy of the long-acting basal insulin degludec in...

Several outpatient trials have reported that treatment with degludec results in comparable improvement in HbA1c levels and in lower rates of hypoglycemia compared to glargine U100 insulin. However, no previous studies have compared the safety and efficacy of the long-acting basal insulin degludec in the inpatient management of patients with diabetes. It is expected that a large number of patients with diabetes will be started or transitioned to this new insulin formulation; so acquiring knowledge on their safety and efficacy is of great clinical interest. Accordingly, the proposed study will provide novel and clinically useful information on the efficacy (blood glucose control) and safety (hypoglycemia) of degludec in the inpatient setting and after hospital discharge in general medicine and surgery patients with Type 2 Diabetes (T2D).

Tracking Information

NCT #
NCT03336528
Collaborators
Novo Nordisk A/S
Investigators
Principal Investigator: Guillermo Umpierrez, MD Emory University