Addition of Liraglutide to Insulin in Patients With Type 1 Diabetes: A Randomized Placebo-Controlled Clinical Trial of 12 Weeks
| العنوان: | Addition of Liraglutide to Insulin in Patients With Type 1 Diabetes: A Randomized Placebo-Controlled Clinical Trial of 12 Weeks |
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| المؤلفون: | Sartaj Sandhu, Natalie Bellini, Manav Batra, Husam Ghanim, Paresh Dandona, Aditya Mehta, Antoine Makdissi, Sandeep Dhindsa, Ajay Chaudhuri, Jeanne Hejna, Nitesh D. Kuhadiya, Kelly Green, Min Yang |
| المصدر: | Diabetes Care |
| بيانات النشر: | American Diabetes Association, 2016. |
| سنة النشر: | 2016 |
| مصطلحات موضوعية: | Adult, Blood Glucose, Male, medicine.medical_specialty, Time Factors, Emerging Technologies and Therapeutics, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, 030209 endocrinology & metabolism, 030204 cardiovascular system & hematology, Hypoglycemia, Placebo, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Weight loss, Diabetes mellitus, Internal medicine, Internal Medicine, medicine, Humans, Hypoglycemic Agents, Insulin, Obesity, Glycemic, Advanced and Specialized Nursing, Type 1 diabetes, Liraglutide, business.industry, Body Weight, Middle Aged, Overweight, Glucagon, Postprandial Period, medicine.disease, Diabetes Mellitus, Type 1, Treatment Outcome, Endocrinology, Drug Therapy, Combination, Female, medicine.symptom, business, medicine.drug |
| الوصف: | OBJECTIVE To investigate whether addition of three different doses of liraglutide to insulin in patients with type 1 diabetes (T1D) results in significant reduction in glycemia, body weight, and insulin dose. RESEARCH DESIGN AND METHODS We randomized 72 patients (placebo = 18, liraglutide = 54) with T1D to receive placebo and 0.6, 1.2, and 1.8 mg liraglutide daily for 12 weeks. RESULTS In the 1.2-mg and 1.8-mg groups, the mean weekly reduction in average blood glucose was −0.55 ± 0.11 mmol/L (10 ± 2 mg/dL) and −0.55 ± 0.05 mmol/L (10 ± 1 mg/dL), respectively (P < 0.0001), while it remained unchanged in the 0.6-mg and placebo groups. In the 1.2-mg group, HbA1c fell significantly (−0.78 ± 15%, −8.5 ± 1.6 mmol/mol, P < 0.01), while it did not in the 1.8-mg group (−0.42 ± 0.15%, −4.6 ± 1.6 mmol/mol, P = 0.39) and 0.6-mg group (−0.26 ± 0.17%, −2.8 ± 1.9 mmol/mol, P = 0.81) vs. the placebo group (−0.3 ± 0.15%, −3.3 ± 1.6 mmol/mol). Glycemic variability was reduced by 5 ± 1% (P < 0.01) in the 1.2-mg group only. Total daily insulin dose fell significantly only in the 1.2-mg and 1.8-mg groups (P < 0.05). There was a 5 ± 1 kg weight loss in the two higher-dose groups (P < 0.05) and by 2.7 ± 0.6 kg (P < 0.01) in the 0.6-mg group vs. none in the placebo group. In the 1.2- and 1.8-mg groups, postprandial plasma glucagon concentration fell by 72 ± 12% and 47 ± 12%, respectively (P < 0.05). Liraglutide led to higher gastrointestinal adverse events (P < 0.05) and ≤1% increases (not significant) in percent time spent in hypoglycemia ( CONCLUSIONS Addition of 1.2 mg and 1.8 mg liraglutide to insulin over a 12-week period in overweight and obese patients with T1D results in modest reductions of weekly mean glucose levels with significant weight loss, small insulin dose reductions, and frequent gastrointestinal side effects. These findings do not justify the use of liraglutide in all patients with T1D. |
| تدمد: | 1935-5548 0149-5992 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ae728c6d6ff482987b81e22e3615fa2cTest https://doi.org/10.2337/dc15-1136Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....ae728c6d6ff482987b81e22e3615fa2c |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 19355548 01495992 |
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