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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 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)
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author
; ; ; ; ; ; ; and
organization
publishing date
type
Chapter in Book/Report/Conference proceeding
publication status
published
subject
host publication
Diabetes Care
volume
32
issue
1
pages
84 - 90
publisher
American Diabetes Association
conference name
68th Annual Meeting of the American-Diabetes-Association
conference dates
2008-06-06 - 2008-06-10
external identifiers
  • wos:000262188000018
  • scopus:62449169287
  • pmid:18931095
ISSN
0149-5992
DOI
10.2337/dc08-1355
language
English
LU publication?
yes
additional info
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)
id
133625d7-eac2-46e6-bcde-14c1ffc23bab (old id 1313448)
date added to LUP
2016-04-01 14:14:56
date last changed
2021-10-10 03:46:55
@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},
  doi          = {10.2337/dc08-1355},
  volume       = {32},
  year         = {2009},
}