Long-term efficacy and safety comparison of liraglutide, glimepiride and placebo, all in combination with metformin in type 2 diabetes: 2-year results from the LEAD-2 study

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Long-term efficacy and safety comparison of liraglutide, glimepiride and placebo, all in combination with metformin in type 2 diabetes: 2-year results from the LEAD-2 study. / Nauck, M.; Frid, Anders; Hermansen, K.; Thomsen, A. B.; During, M.; Shah, N.; Tankova, T.; Mitha, I.; Matthews, D. R.

I: Diabetes, Obesity and Metabolism, Vol. 15, Nr. 3, 2013, s. 204-212.

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Nauck, M. ; Frid, Anders ; Hermansen, K. ; Thomsen, A. B. ; During, M. ; Shah, N. ; Tankova, T. ; Mitha, I. ; Matthews, D. R. / Long-term efficacy and safety comparison of liraglutide, glimepiride and placebo, all in combination with metformin in type 2 diabetes: 2-year results from the LEAD-2 study. I: Diabetes, Obesity and Metabolism. 2013 ; Vol. 15, Nr. 3. s. 204-212.

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TY - JOUR

T1 - Long-term efficacy and safety comparison of liraglutide, glimepiride and placebo, all in combination with metformin in type 2 diabetes: 2-year results from the LEAD-2 study

AU - Nauck, M.

AU - Frid, Anders

AU - Hermansen, K.

AU - Thomsen, A. B.

AU - During, M.

AU - Shah, N.

AU - Tankova, T.

AU - Mitha, I.

AU - Matthews, D. R.

N1 - The information about affiliations in this record was updated in December 2015. The record was previously connected to the following departments: Endocrinology (013241500), Pediatrics/Urology/Gynecology/Endocrinology (013240400)

PY - 2013

Y1 - 2013

N2 - Aims To investigate efficacy and safety of dual therapy with liraglutide and metformin in comparison to glimepiride and metformin, and metformin monotherapy over 2?years in patients with type 2 diabetes. Methods In the 26-week the Liraglutide Effect and Action in Diabetes (LEAD)-2 core trial, patients (n?=?1091) were randomized (2?:?2?:?2?:?1:?2) to liraglutide (0.6, 1.2 or 1.8?mg once-daily), placebo or glimepiride; all with metformin. Patients were enrolled if they were 1880?years old with HbA1c 7.011.0% (previous monotherapy =3?months), or 7.010.0% (previous combination therapy =3?months), and body mass index =40?kg/m2. Patients completing the 26-week double-blinded phase could enter an 18-month open-label extension. Results HbA1c decreased significantly with liraglutide (0.4% with 0.6?mg, 0.6% with 1.2 and 1.8?mg) versus 0.3% increase with metformin monotherapy (p?<?0.0001). HbA1c decrease with liraglutide was non-inferior versus 0.5% decrease with glimepiride. Liraglutide groups experienced significant weight loss (2.1, 3.0 and 2.9?kg with 0.6, 1.2 and 1.8?mg, respectively) compared to weight gain (0.7?kg) with glimepiride (p?<?0.0001). Weight loss with liraglutide 1.2 and 1.8?mg was significantly greater than with metformin monotherapy (1.8?kg; p?=?0.0185 and p?=?0.0378 for 1.2 and 1.8?mg, respectively). The occurrence of minor hypoglycaemia was <5.0% in all liraglutide groups, significantly less than with glimepiride (24.0%; p?<?0.0001). Liraglutide was well tolerated overall: gastrointestinal events were more common than with glimepiride or metformin monotherapy, but occurrence decreased with time. Conclusions Liraglutide provided sustained glycaemic control over 2?years comparable to that provided by glimepiride. Liraglutide was well tolerated, and was associated with weight loss and a low rate of hypoglycaemia.

AB - Aims To investigate efficacy and safety of dual therapy with liraglutide and metformin in comparison to glimepiride and metformin, and metformin monotherapy over 2?years in patients with type 2 diabetes. Methods In the 26-week the Liraglutide Effect and Action in Diabetes (LEAD)-2 core trial, patients (n?=?1091) were randomized (2?:?2?:?2?:?1:?2) to liraglutide (0.6, 1.2 or 1.8?mg once-daily), placebo or glimepiride; all with metformin. Patients were enrolled if they were 1880?years old with HbA1c 7.011.0% (previous monotherapy =3?months), or 7.010.0% (previous combination therapy =3?months), and body mass index =40?kg/m2. Patients completing the 26-week double-blinded phase could enter an 18-month open-label extension. Results HbA1c decreased significantly with liraglutide (0.4% with 0.6?mg, 0.6% with 1.2 and 1.8?mg) versus 0.3% increase with metformin monotherapy (p?<?0.0001). HbA1c decrease with liraglutide was non-inferior versus 0.5% decrease with glimepiride. Liraglutide groups experienced significant weight loss (2.1, 3.0 and 2.9?kg with 0.6, 1.2 and 1.8?mg, respectively) compared to weight gain (0.7?kg) with glimepiride (p?<?0.0001). Weight loss with liraglutide 1.2 and 1.8?mg was significantly greater than with metformin monotherapy (1.8?kg; p?=?0.0185 and p?=?0.0378 for 1.2 and 1.8?mg, respectively). The occurrence of minor hypoglycaemia was <5.0% in all liraglutide groups, significantly less than with glimepiride (24.0%; p?<?0.0001). Liraglutide was well tolerated overall: gastrointestinal events were more common than with glimepiride or metformin monotherapy, but occurrence decreased with time. Conclusions Liraglutide provided sustained glycaemic control over 2?years comparable to that provided by glimepiride. Liraglutide was well tolerated, and was associated with weight loss and a low rate of hypoglycaemia.

KW - GLP-1 analogue

KW - type 2 diabetes

U2 - 10.1111/dom.12012

DO - 10.1111/dom.12012

M3 - Article

VL - 15

SP - 204

EP - 212

JO - Diabetes, Obesity and Metabolism

T2 - Diabetes, Obesity and Metabolism

JF - Diabetes, Obesity and Metabolism

SN - 1462-8902

IS - 3

ER -