Advanced

Twelve- and 52-Week Efficacy of the Dipeptidyl Peptidase IV Inhibitor LAF237 in Metformin-Treated Patients With Type 2 Diabetes.

Ahrén, Bo LU ; Gomis, Ramon; Standl, Eberhard; Mills, David and Schweizer, Anja (2004) In Diabetes Care 27(12). p.2874-2880
Abstract
OBJECTIVE—To assess the 12- and 52-week efficacy of the dipeptidyl peptidase IV inhibitor LAF237 versus placebo in patients with type 2 diabetes continuing metformin treatment.



RESEARCH DESIGN AND METHODS—We conducted a 12-week, randomized, double-blind, placebo-controlled trial in 107 patients with type 2 diabetes with a 40-week extension in those completing the core study and agreeing, together with the investigator, to extend treatment to 1 year. Placebo (n = 51) or LAF237 (50 mg once daily, n = 56) was added to ongoing metformin treatment (1,500–3,000 mg/day). HbA1c and fasting plasma glucose (FPG) were measured periodically, and standardized meal tests were performed at baseline, week 12, and week 52.

... (More)
OBJECTIVE—To assess the 12- and 52-week efficacy of the dipeptidyl peptidase IV inhibitor LAF237 versus placebo in patients with type 2 diabetes continuing metformin treatment.



RESEARCH DESIGN AND METHODS—We conducted a 12-week, randomized, double-blind, placebo-controlled trial in 107 patients with type 2 diabetes with a 40-week extension in those completing the core study and agreeing, together with the investigator, to extend treatment to 1 year. Placebo (n = 51) or LAF237 (50 mg once daily, n = 56) was added to ongoing metformin treatment (1,500–3,000 mg/day). HbA1c and fasting plasma glucose (FPG) were measured periodically, and standardized meal tests were performed at baseline, week 12, and week 52.



RESULTS—In patients randomized to LAF237, baseline HbA1c averaged 7.7 ± 0.1% and decreased at week 12 (Δ = −0.6 ± 0.1%), whereas HbA1c did not change from a baseline of 7.9 ± 0.1% in patients given placebo (between-group difference in ΔHbA1c = −0.7 ± 0.1%, P < 0.0001). Mean prandial glucose and FPG were significantly reduced in patients receiving LAF237 versus placebo by 2.2 ± 0.4 mmol/l (P < 0.0001) and 1.2 ± 0.4 mmol/l (P = 0.0057), respectively, but plasma insulin levels were not affected. At end point of the extension, the between-group differences in change in mean prandial glucose, insulin, and FPG were −2.4 ± 0.6 mmol/l (P = 0.0001), 40 ± 16 pmol/l (P = 0.0153), and −1.1 ± 0.5 mmol/l (P = 0.0312), respectively. HbA1c did not change from week 12 to week 52 in LAF237-treated patients (n = 42) but increased in participants given placebo (n = 29). The between-group difference in ΔHbA1c after 1 year was −1.1 ± 0.2% (P < 0.0001).



CONCLUSIONS—Data from this study demonstrate that LAF237 effectively prevents deterioration of glycemic control when added to metformin monotherapy in type 2 diabetes. (Less)
Please use this url to cite or link to this publication:
author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Diabetes Care
volume
27
issue
12
pages
2874 - 2880
publisher
American Diabetes Association
external identifiers
  • pmid:15562200
  • wos:000225331900017
  • scopus:9444285818
ISSN
1935-5548
DOI
10.2337/diacare.27.12.2874
language
English
LU publication?
yes
id
f36fb257-7225-4ca1-8858-5f6b29da8f63 (old id 130668)
alternative location
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15562200&dopt=Abstract
date added to LUP
2007-06-27 08:55:25
date last changed
2017-10-01 04:46:03
@article{f36fb257-7225-4ca1-8858-5f6b29da8f63,
  abstract     = {OBJECTIVE—To assess the 12- and 52-week efficacy of the dipeptidyl peptidase IV inhibitor LAF237 versus placebo in patients with type 2 diabetes continuing metformin treatment.<br/><br>
<br/><br>
RESEARCH DESIGN AND METHODS—We conducted a 12-week, randomized, double-blind, placebo-controlled trial in 107 patients with type 2 diabetes with a 40-week extension in those completing the core study and agreeing, together with the investigator, to extend treatment to 1 year. Placebo (n = 51) or LAF237 (50 mg once daily, n = 56) was added to ongoing metformin treatment (1,500–3,000 mg/day). HbA1c and fasting plasma glucose (FPG) were measured periodically, and standardized meal tests were performed at baseline, week 12, and week 52.<br/><br>
<br/><br>
RESULTS—In patients randomized to LAF237, baseline HbA1c averaged 7.7 ± 0.1% and decreased at week 12 (Δ = −0.6 ± 0.1%), whereas HbA1c did not change from a baseline of 7.9 ± 0.1% in patients given placebo (between-group difference in ΔHbA1c = −0.7 ± 0.1%, P &lt; 0.0001). Mean prandial glucose and FPG were significantly reduced in patients receiving LAF237 versus placebo by 2.2 ± 0.4 mmol/l (P &lt; 0.0001) and 1.2 ± 0.4 mmol/l (P = 0.0057), respectively, but plasma insulin levels were not affected. At end point of the extension, the between-group differences in change in mean prandial glucose, insulin, and FPG were −2.4 ± 0.6 mmol/l (P = 0.0001), 40 ± 16 pmol/l (P = 0.0153), and −1.1 ± 0.5 mmol/l (P = 0.0312), respectively. HbA1c did not change from week 12 to week 52 in LAF237-treated patients (n = 42) but increased in participants given placebo (n = 29). The between-group difference in ΔHbA1c after 1 year was −1.1 ± 0.2% (P &lt; 0.0001).<br/><br>
<br/><br>
CONCLUSIONS—Data from this study demonstrate that LAF237 effectively prevents deterioration of glycemic control when added to metformin monotherapy in type 2 diabetes.},
  author       = {Ahrén, Bo and Gomis, Ramon and Standl, Eberhard and Mills, David and Schweizer, Anja},
  issn         = {1935-5548},
  language     = {eng},
  number       = {12},
  pages        = {2874--2880},
  publisher    = {American Diabetes Association},
  series       = {Diabetes Care},
  title        = {Twelve- and 52-Week Efficacy of the Dipeptidyl Peptidase IV Inhibitor LAF237 in Metformin-Treated Patients With Type 2 Diabetes.},
  url          = {http://dx.doi.org/10.2337/diacare.27.12.2874},
  volume       = {27},
  year         = {2004},
}