The Effect of Simple Basal Insulin Titration, Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study

PHASE4CompletedINTERVENTIONAL
Enrollment

157

Participants

Timeline

Start Date

November 30, 2014

Primary Completion Date

December 31, 2017

Study Completion Date

December 31, 2017

Conditions
Diabetes Mellitus, Type 2Diabetes
Interventions
DRUG

Metformin

Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)

DRUG

Detemir

Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.

DRUG

Liraglutide

Initial dose of 0.6 mg/day with weekly increments of 0.6 mg until dose of 1.8 mg/day or maximal tolerated dose (at least 1.2 mg/day)is reached

DRUG

Insulin Aspart

Insulin aspart will be initiated at a dose of 0.3 units/kg/day divided among the number of meals taken daily and titrated based on physician clinical judgment with the goal of pre-prandial BG 70-130 mg/dL and post-prandial BG \<180

Trial Locations (1)

02720

UT Southwestern Medical Center, Dallas

All Listed Sponsors
lead

University of Texas Southwestern Medical Center

OTHER

NCT01966978 - The Effect of Simple Basal Insulin Titration, Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study | Biotech Hunter | Biotech Hunter