Comparing Treatment Strategies for Patients with Very Elevated HbA1c—A Randomized Trial
| Autor: | Anna Tumyan, Ahmed Elhassan, Marconi Abreu, Laurentiu M. Pop, Perihan Dimachkie, Ildiko Lingvay, Xilong Li, Olivia Papacostea, Beverley Adams-Huet, Katherine Peicher, Muhammad S. Siddiqui |
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| Rok vydání: | 2018 |
| Předmět: |
medicine.medical_specialty
Liraglutide business.industry Endocrinology Diabetes and Metabolism Insulin medicine.medical_treatment Hypoglycemia medicine.disease 030226 pharmacology & pharmacy Metformin law.invention Insulin aspart 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Internal medicine Internal Medicine medicine 030212 general & internal medicine business medicine.drug Glycemic Insulin detemir |
| Zdroj: | Diabetes. 67 |
| ISSN: | 1939-327X 0012-1797 |
| DOI: | 10.2337/db18-124-or |
| Popis: | Basal-bolus insulin (BBI) is the most established treatment strategy for patients with very elevated HbA1c (>10%), especially if symptomatic. The combination of metformin (Met), GLP-1 receptor agonist (GLP-1RA) and basal insulin (BI) is a very effective glucose lowering strategy, but it has not been evaluated in patients with very elevated HbA1c. This is the first randomized trial comparing a GLP-1RA+BI treatment regimen to a BBI treatment regimen in patients with very uncontrolled (HbA1c>10%) T2D. Basal insulin detemir was either continued at the prior dose or initiated at 0.3 units/kg and self-titrated. GLP-1RA liraglutide was titrated according to label to 1.8 mg/day. Meal-time insulin aspart was initiated at 0.1 units/kg/meal and self-titrated. Metformin was continued or (re)initiated if tolerated, all other hypoglycemic agents were discontinued. The primary outcome was change in HbA1c at 6 months, analyzed using a mixed model repeated measures analysis. We randomized 120 patients with a mean age (SD) 47.4 (9.5) years, Hispanic 48%, diabetes duration of 10.54 (7.19) years, 76% were already treated with insulin, HbA1c 12.1 (1.4) %, BMI 37.2 (10.3) kg/m2, 86% had one or more symptoms of hyperglycemia. Both treatment strategies lead to dramatic improvements in HbA1c, treatment with GLP-1RA+BI, compared with BBI, resulted in significantly better glycemic control, weight, insulin dosage, and hypoglycemia (Table).Table. Effects of treatment with GLP-1RA + basal insulin (GLP1RA+BI) compared with basal-bolus insulin (BBI) on primary & secondary outcomes.VariableGLP1RA+BI GroupBBI GroupEstimated Treatment DifferenceP value between groupsBaseline6 monthsBaseline6 monthsHbA1c(%)12.2 (11.8 to 12.6)8.1 (7.4 to 8.7)11.8 (11.5 to 12.2)8.8 (6.0 to 9.1)1.1 (0.1 to 2.0)0.03Weight (kg)98.2 (89.7 to 106.6)97.5 (89.1 to 106.0)104.5 (96.2 to 112.8)107.6 (99.3 to 115.9)3.7 (1.53 to 5.9) Disclosure M. Abreu: None. A. Tumyan: None. A. Elhassan: None. O. Papacostea: None. K. Peicher: None. P. Dimachkie: None. M.S. Siddiqui: None. B. Adams-Huet: None. X. Li: None. L. Pop: None. I. Lingvay: Advisory Panel; Self; Novo Nordisk A/S, Eli Lilly and Company, AstraZeneca, Intarcia Therapeutics, Inc., Sanofi-Aventis. Research Support; Self; Novo Nordisk A/S, Merck Sharp & Dohme Corp., Pfizer Inc., GI Dynamics Inc., Novartis AG. Other Relationship; Self; Sanofi, AstraZeneca, Boehringer Ingelheim GmbH, Novo Nordisk A/S. |
| Databáze: | OpenAIRE |
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