IDegLira HIGH Trial

PHASE3CompletedINTERVENTIONAL
Enrollment

145

Participants

Timeline

Start Date

January 15, 2019

Primary Completion Date

July 8, 2022

Study Completion Date

July 8, 2022

Conditions
Diabetes Mellitus
Interventions
DRUG

IDegLira

Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).

DRUG

Insulin Degludec (U-100)

Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.

DRUG

Insulin Aspart

Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.

Trial Locations (2)

30303

Grady Health System, Atlanta

30322

Emory Clinic, Atlanta

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novo Nordisk A/S

INDUSTRY

lead

Emory University

OTHER