Cited by 487Diabetes Treatment and ManagementDiabetes Management and ResearchNatural Antidiabetic Agents Studies

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

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Ahrén, Bo, Gomis, Ramon, Standl, Eberhard, Mills, David, Schweizer, Anja·2004·Diabetes Care

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. 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.

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  1. [12]12. Mari A, Sallas WM, He YL, Watson C, Ligueros-Saylan M, Foley JE: LAF237 is a DPP-4 inhibitor that improves model-as- sessed ␤-cell function in drug-naive pa- tients with type 2 diabetes. Diabetologia. In press

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Authors
Ahrén, B., Gomis, R., Standl, E., Mills, D., & Schweizer, A.
Affiliations
  • Lund University, Lund, Sweden
  • Hospital Clinic, IDIBAPS, University of Barcelona, Barcelona, Spain
  • Institute of Diabetes Research (DE)
  • Novartis (Switzerland) (CH)
Venue
Diabetes Care
Published
2004-12-01
Volume
27
Issue
12
Pages
2874-2880
ISSN
  • 0149-5992 (ISSN-L)
  • 1935-5548
OpenAlex
W1991565451
Cited by
487
References
18
Citations by year
2026: 2 · 2025: 4 · 2023: 3 · 2022: 3 · 2021: 4 · 2020: 7 · 2019: 13 · 2018: 2 · 2017: 7 · 2016: 13 · 2015: 11 · 2014: 15 · 2013: 27 · 2012: 14
FWCI
41.13
Type
journal article
Language
en
Open access
Locations
  • Diabetes Care (publishedVersion)
  • PubMed (publishedVersion)
  • Lund University Publications (Lund University) (submittedVersion)
Funders
Vetenskapsrådet
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Natural Antidiabetic Agents Studies
Keywords
DPP-4 inhibitors, type 2 diabetes, metformin, combination therapy, glycemic control, HbA1c, fasting blood glucose, insulin, long-term efficacy, extension trial, antidiabetic drugs, adverse events, hypoglycemia
MeSH terms
Adamantane, Diabetes Mellitus, Type 2, Double-Blind Method, Female, Glucose Tolerance Test, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Male, Metformin, Middle Aged, Placebos, Protease Inhibitors, Pyrrolidines, Dipeptidyl Peptidase 4

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