Linagliptin plus metformin in patients with newly diagnosed type 2 diabetes and marked hyperglycemia

Autor: Stefano Del Prato, Stuart A. Ross, Hans-Juergen Woerle, Baptist Gallwitz, Sandra Thiemann, Diane J. Lewis-D'Agostino, Zelie Bailes, Maximilian von Eynatten, A. Enrique Caballero, Sanjay Patel
Rok vydání: 2016
Předmět:
Adult
Blood Glucose
Male
medicine.medical_specialty
endocrine system diseases
medicine.medical_treatment
Linagliptin
030209 endocrinology & metabolism
dipeptidyl peptidase 4 inhibitors
Type 2 diabetes
Newly diagnosed
drug therapy combination
030204 cardiovascular system & hematology
Kidney Function Tests
Body Mass Index
03 medical and health sciences
Diabetes mellitus type 2
0302 clinical medicine
Double-Blind Method
clinical trial
linagliptin
metformin
Medicine (all)
Internal medicine
medicine
Humans
Hypoglycemic Agents
Initial treatment
In patient
Aged
Glycated Hemoglobin
Dipeptidyl-Peptidase IV Inhibitors
business.industry
Insulin
Racial Groups
nutritional and metabolic diseases
General Medicine
Middle Aged
medicine.disease
Metformin
Clinical trial
Endocrinology
Diabetes Mellitus
Type 2
Hyperglycemia
Drug Therapy
Combination
Female
business
medicine.drug
Zdroj: Postgraduate Medicine. 128:747-754
ISSN: 1941-9260
0032-5481
Popis: Few studies of oral glucose-lowering drugs exist in newly diagnosed type 2 diabetes (T2D) patients with marked hyperglycemia, and insulin is often proposed as initial treatment. We evaluated the oral initial combination of metformin and linagliptin, a dipeptidyl peptidase-4 inhibitor, in this population.We performed a pre-specified subgroup analysis of a randomized study in which newly diagnosed T2D patients with glycated hemoglobin A1c (HbA1c) 8.5%-12.0% received linagliptin/metformin or linagliptin monotherapy. Subgroups of baseline HbA1c, age, body-mass index (BMI), renal function, race, and ethnicity were evaluated, with efficacy measured by HbA1c change from baseline after 24 weeks.HbA1c reductions from baseline (mean 9.7%) at week 24 in the overall population were an adjusted mean -2.81% ± 0.12% with linagliptin/metformin (n = 132) and -2.02% ± 0.13% with linagliptin (n = 113); treatment difference -0.79% (95% CI -1.13 to -0.46, P 0.0001). In patients with baseline HbA1c ≥9.5%, HbA1c reduction was -3.37% with linagliptin/metformin (n = 76) and -2.53% with linagliptin (n = 61); difference -0.84% (95% CI -1.32 to -0.35). In those with baseline HbA1c9.5%, HbA1c reduction was -2.08% with linagliptin/metformin (n = 56) and -1.39% with linagliptin (n = 52); difference -0.69% (95% CI -1.23 to -0.15). Changes in HbA1c and treatment differences between the linagliptin/metformin and linagliptin groups were of similar magnitudes to the overall population across patient subgroups based on age, BMI, renal function, and race. Drug-related adverse events occurred in 8.8% and 5.7% of linagliptin/metformin and linagliptin patients, respectively; no severe hypoglycemia occurred.Linagliptin/metformin combination in newly diagnosed T2D patients with marked hyperglycemia was well tolerated and elicited substantial improvements in glycemic control regardless of baseline HbA1c, age, BMI, renal function, or race. Thus, newly diagnosed, markedly hyperglycemic patients may be effectively treated by combinations of oral agents.www.clinicaltrials.gov identifier is NCT01512979.
Databáze: OpenAIRE
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