The purpose of this study is to determine the effect of adding liraglutide to high dose insulin therapy compared to high dose insulin therapy alone in patients with insulin-treated Type 2 diabetes with insulin requirements of \> 100 units of insulin per day.
40 subjects with Type 2 diabetes using \> 100 units of insulin per day with or without metformin with HbA1c \> 6.5% will be randomized into 2 treatment groups: treatment group will have liraglutide added to insulin and control group will have insulin uptitration only for 6 months. Primary endpoint to be compared between groups will be HbA1c at 6 months. Secondary endpoints will include weight, total daily insulin dose, percent time in euglycemic, hyperglycemic, and hypoglycemic ranges by continuous glucose monitor (CGM), and effect on GlycoMark and hs-CRP. Safety endpoints will include incidence of hypoglycemia and incidence of gastrointestinal side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
SC, 1.8mg,QD, six months to one year
SC, will be titrated during the study, 4 times a day, 1 year
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, United States
Change from baseline in HbA1c at six months
Glycemic control as measured by HbA1c
Time frame: baseline and six months
Hypoglycemia
The frequency and severity of hypoglycemia in each treatment arm by glucose meter download and by percent time spent in the hypoglycemic range (BG \< 70 mg/dl) by CGM will be assessed at six and 12 months
Time frame: 6 months and 12 months
Total Daily Insulin Dose (TDID)
TDID will be determined in each treatment arm for statistical comparisons at three and six months, and for entire cohort at nine and 12 months.
Time frame: 3, 6, 9, and 12 months
Weight
Weight will be statistically compared to baseline and between treatment arms at three and six months, and for entire cohort between baseline, six, nine and 12 months.
Time frame: baseline, 3, 6, 9, and 12 months
GlycoMark
Postprandial glycemic control as assessed by GlycoMark and CGM will be compared between study groups at three and six months, and for entire cohort compared to baseline at nine and 12 months.
Time frame: baseline, 3, 6, 9, and 12 months
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