CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 180 enrolled
Drug / intervention
Degludec +2 moredrug
Likely dose
Degludec 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03336528
NCT03336528Phase 4Completed
CompareCT.gov

A Randomized Controlled Trial Comparing Insulin Degludec and Glargine U100 for the Inpatient and Post-Hospital Discharge Management of Medicine and Surgery Patients With Type 2 Diabetes

Emory University·interventional·Posted Nov 8, 2017·Updated Mar 31, 2022

In Brief

A Phase 4 clinical trial evaluating Degludec, Glargine, and 1 other intervention for Type 2 Diabetes. Completed, enrolled 180 participants across 4 sites.

Detailed Summary

The purpose of this study is to find out if treatment with degludec insulin when compared to glargine U100 insulin will result in similar blood sugar control in patients with diabetes who are admitted to the hospital and then transition to home after discharge from the hospital.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesUnited States
CollaboratorsNovo Nordisk A/S

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedNov 8, 2017
Enrollment StartJan 2, 2018
Primary CompletionMar 1, 2021
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 8.7 years ago

Interventions

Degludecdrug

Degludec is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. Patients will be treated with bolus regimen given half of total daily dose (TDD) as basal once daily and half as aspart divided in three equal doses before meals. Patients with poor oral intake or with medical instruction to withhold oral intake (NPO) will receive the basal dose, but prandial dose will be held. Insulin dose will be adjusted daily to maintain a fasting and pre-dinner blood glucose (BG) between 100 mg/dL and 180 mg/dL.

Glarginedrug

Glargine is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. Patients will be treated with bolus regimen given half of total daily dose (TDD) as basal once daily and half as aspart divided in three equal doses before meals. Patients with poor oral intake or with medical instruction to withhold oral intake (NPO) will receive the basal dose, but prandial dose will be held. Insulin dose will be adjusted daily to maintain a fasting and pre-dinner BG between 100 mg/dL and 180 mg/dL.

Aspartdrug

Aspart insulin will be given in three equally divided doses before each meal. To prevent hypoglycemia, if a subject is not able to eat, aspart insulin dose will be held.