Advanced

Efficacy and Safety Comparison of Liraglutide, Glimepiride, and Placebo, All in Combination With Metformin, in Type 2 Diabetes The LEAD (Liraglutide Effect and Action in Diabetes)-2 study

Nauck, Michael; Frid, Anders LU ; Hermansen, Kjeld; Shah, Nalini S.; Tankova, Tsvetalina; Mitha, Ismail H.; Zdravkovic, Milan; During, Maria and Matthews, David R. (2009) 68th Annual Meeting of the American-Diabetes-Association In Diabetes Care 32(1). p.84-90
Abstract
OBJECTIVE - The efficacy and Safety of adding liraglutide (a glucagon-like peptide-1 receptor agonist) to Metformin were compared with addition of placebo or glimepiride to metformin in subjects previously treated With oral antidiabetes (OAD) therapy. RESEARCH DESIGN AND METHODS - In this 26-week, double-blind, double-dummy, placebo- and active-controlled, parallel-group trial, 1,091 subjects were randomly assigned (2:2:2:1:2) to once-daily liraglutide (either 0.6, 1.2, or 1.8 mg/day injected subcutaneous ), to placebo, or to glimepiride (4 mg once daily). All treatments were in combination therapy with metformin (1g twice daily). Enrolled subjects (aged 25-79 years) had type 2 diabetes, A1C of 7-11% (previous OAD monotherapy for >= 3... (More)
OBJECTIVE - The efficacy and Safety of adding liraglutide (a glucagon-like peptide-1 receptor agonist) to Metformin were compared with addition of placebo or glimepiride to metformin in subjects previously treated With oral antidiabetes (OAD) therapy. RESEARCH DESIGN AND METHODS - In this 26-week, double-blind, double-dummy, placebo- and active-controlled, parallel-group trial, 1,091 subjects were randomly assigned (2:2:2:1:2) to once-daily liraglutide (either 0.6, 1.2, or 1.8 mg/day injected subcutaneous ), to placebo, or to glimepiride (4 mg once daily). All treatments were in combination therapy with metformin (1g twice daily). Enrolled subjects (aged 25-79 years) had type 2 diabetes, A1C of 7-11% (previous OAD monotherapy for >= 3 months) or 7-10% (previous OAD combination therapy for >= 3 months), and BMI <= 40 kg/m(2). RESULTS - A1C Values were significantly reduced in all liraglutide groups versus the placebo group (P<0.0001) with mean decreases of 1.0% for 1.8 mg liraglutide, 1.2 mg liraglutide and glimepiride and 0.7% for 0.6 mg liraglutide and -,in increase of 0.1% for placebo. Bod weight decreased in all liraglutide groups (1.8-2.8 kg) compared with an increase in the glimepiride group (1.0 kg; P < 0.0001). The incidence of minor hypoglycemia with liraglutide (similar to 3%) was comparable to that, with placebo but less than that with glimepiride (1,7%; P < 0.001). Nausea was reported by 11-19% of the liraglutide-treated subjects versus 3-4% in the placebo and glimepiride groups. The incidence of nausea declined over time. CONCLUSIONS - In subjects with type 2 diabetes, once-daily liraglutide induced similar glycemic control, reduced body weight, and lowered the Occurrence of hypoglycemia compared with glimepiride, when both had background therapy of metformin. (Less)
Please use this url to cite or link to this publication:
author
organization
publishing date
type
Chapter in Book/Report/Conference proceeding
publication status
published
subject
in
Diabetes Care
volume
32
issue
1
pages
84 - 90
publisher
American Diabetes Association
conference name
68th Annual Meeting of the American-Diabetes-Association
external identifiers
  • wos:000262188000018
  • scopus:62449169287
ISSN
0149-5992
DOI
10.2337/dc08-1355
language
English
LU publication?
yes
id
133625d7-eac2-46e6-bcde-14c1ffc23bab (old id 1313448)
date added to LUP
2009-03-09 15:41:24
date last changed
2017-12-10 04:14:28
@inproceedings{133625d7-eac2-46e6-bcde-14c1ffc23bab,
  abstract     = {OBJECTIVE - The efficacy and Safety of adding liraglutide (a glucagon-like peptide-1 receptor agonist) to Metformin were compared with addition of placebo or glimepiride to metformin in subjects previously treated With oral antidiabetes (OAD) therapy. RESEARCH DESIGN AND METHODS - In this 26-week, double-blind, double-dummy, placebo- and active-controlled, parallel-group trial, 1,091 subjects were randomly assigned (2:2:2:1:2) to once-daily liraglutide (either 0.6, 1.2, or 1.8 mg/day injected subcutaneous ), to placebo, or to glimepiride (4 mg once daily). All treatments were in combination therapy with metformin (1g twice daily). Enrolled subjects (aged 25-79 years) had type 2 diabetes, A1C of 7-11% (previous OAD monotherapy for &gt;= 3 months) or 7-10% (previous OAD combination therapy for &gt;= 3 months), and BMI &lt;= 40 kg/m(2). RESULTS - A1C Values were significantly reduced in all liraglutide groups versus the placebo group (P&lt;0.0001) with mean decreases of 1.0% for 1.8 mg liraglutide, 1.2 mg liraglutide and glimepiride and 0.7% for 0.6 mg liraglutide and -,in increase of 0.1% for placebo. Bod weight decreased in all liraglutide groups (1.8-2.8 kg) compared with an increase in the glimepiride group (1.0 kg; P &lt; 0.0001). The incidence of minor hypoglycemia with liraglutide (similar to 3%) was comparable to that, with placebo but less than that with glimepiride (1,7%; P &lt; 0.001). Nausea was reported by 11-19% of the liraglutide-treated subjects versus 3-4% in the placebo and glimepiride groups. The incidence of nausea declined over time. CONCLUSIONS - In subjects with type 2 diabetes, once-daily liraglutide induced similar glycemic control, reduced body weight, and lowered the Occurrence of hypoglycemia compared with glimepiride, when both had background therapy of metformin.},
  author       = {Nauck, Michael and Frid, Anders and Hermansen, Kjeld and Shah, Nalini S. and Tankova, Tsvetalina and Mitha, Ismail H. and Zdravkovic, Milan and During, Maria and Matthews, David R.},
  booktitle    = {Diabetes Care},
  issn         = {0149-5992},
  language     = {eng},
  number       = {1},
  pages        = {84--90},
  publisher    = {American Diabetes Association},
  title        = {Efficacy and Safety Comparison of Liraglutide, Glimepiride, and Placebo, All in Combination With Metformin, in Type 2 Diabetes The LEAD (Liraglutide Effect and Action in Diabetes)-2 study},
  url          = {http://dx.doi.org/10.2337/dc08-1355},
  volume       = {32},
  year         = {2009},
}