The aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus insulin detemir in combination with insulin aspart and metformin in subjects with very uncontrolled Type 2 Diabetes (A1c \> 10%).
The aim of this study is to compare a GLP-1 plus basal insulin and metformin treatment regimen to a basal-bolus plus metformin treatment regimen in patients with very uncontrolled (HbA1c\>10%) type 2 diabetes. The investigators will compare the two regimens with respect to efficacy in improving glycemic control, rate of hypoglycemia, change in weight, effect on patient quality of life, treatment burden, physician time, as well as healthcare related cost. The investigators hypothesize that at 26 weeks from randomization the two treatment regimens will have similar percentage of patients reaching A1c levels \<7.0%, while more patients on the GLP-1 plus basal insulin strategy will achieve the composite end point of A1c levels \<7.0% without severe hypoglycemia or significant weight gain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
157
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)
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.
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
UT Southwestern Medical Center
Dallas, Texas, United States
Mean Change From Randomization in A1c at Week 26
Change in glycosylated Hemoglobin A1c (A1c) from randomization to 26 weeks of therapy
Time frame: Baseline and Week 26
Composite End-point
Percentage of participants with glycosylated Hemoglobin A1c (A1c)\<8% AND no documented severe hypoglycemia (\<56 mg/dL) during the study AND no significant weight gain (\>3% from baseline)
Time frame: Week 0 (Randomization) , Week 26
Percentage of Participants Reaching Target A1c of <7% at Week 26
Time frame: Week 26
Percentage of Participants Reaching Pre-specified "Treatment Failure" Outcome
Treatment Failure defined as A1c\>10% at week 13 (visit 5)
Time frame: week 13
Mean Change From Randomization in Body Weight
Change in body weight from randomization to end of study.
Time frame: Week 0 (Randomization) , Week 26
Hypoglycemic Episodes
Percentage of participants experiencing any episodes of documented hypoglycemia defined as CBG reading of \<70 mg/dl
Time frame: Week 0 (Randomization) , Week 2, week 4, week 13, Week 26
Change in Diabetes Quality of Life (DQOL)Questionnaire Score- Least Squares Means
Diabetes Quality of Life (DQOL) questionnaires will be completed by the patient at the randomization and end-of study visits. ALL D-QOL domains are scored on a 1-5 scale, with a lower number representing better quality of life or treatment satisfaction. Outcome reported is difference between mean baseline and mean Week 26 score.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: Week 0 (Randomization) , Week 26
Change in Short Form-36 (SF-36) Questionnaire Score
Quality of life questionnaires will be completed by the patient at the randomization and end-of study visits. SF-36 is scored on a 1-100 scale; a higher score represents a better self-assessed health - for all domains.
Time frame: Week 0 (Randomization) , Week 26