PMID- 12453951
OWN - NLM
STAT- MEDLINE
DCOM- 20030701
LR  - 20190515
IS  - 0149-5992 (Print)
IS  - 0149-5992 (Linking)
VI  - 25
IP  - 12
DP  - 2002 Dec
TI  - Nateglinide improves early insulin secretion and controls postprandial glucose 
      excursions in a prediabetic population.
PG  - 2141-6
AB  - OBJECTIVE: The purpose of this study was to evaluate the metabolic effectiveness, 
      safety, and tolerability of nateglinide in subjects with impaired glucose 
      tolerance (IGT) and to identify a dose appropriate for use in a diabetes 
      prevention study. RESEARCH DESIGN AND METHODS: This multicenter, double-blind, 
      randomized, parallel-group, fixed-dose study of 8 weeks' duration was performed 
      in a total of 288 subjects with IGT using a 2:2:2:1 randomization. Subjects 
      received nateglinide (30, 60, and 120 mg) or placebo before each main meal. 
      Metabolic effectiveness was assessed during a standardized meal challenge 
      performed before and after the 8-week treatment. All adverse events (AEs) were 
      recorded, and confirmed hypoglycemia was defined as symptoms accompanied by a 
      self-monitoring of blood glucose measurement < or =3.3 mmol/l (plasma glucose < 
      or =3.7 mmol/l). RESULTS: Nateglinide elicited a dose-related increase of insulin 
      and a decrease of glucose during standardized meal challenges, with the 
      predominant effect on early insulin release, leading to a substantial reduction 
      in peak plasma glucose levels. Nateglinide was well tolerated, and symptoms of 
      hypoglycemia were the only treatment-emergent AEs. Confirmed hypoglycemia 
      occurred in 28 subjects receiving nateglinide (30 mg, 0 [0%]; 60 mg, 5 [6.6%]; 
      120 mg, 23 [26.7%]) and in 1 (2.3%) subject receiving placebo. CONCLUSIONS: 
      Nateglinide was safe and effective in reducing postprandial hyperglycemia in 
      subjects with IGT. Preprandial doses of 30 or 60 mg nateglinide would be 
      appropriate to use for longer-term studies to determine whether a rapid-onset, 
      rapidly reversible, insulinotropic agent can delay or prevent the development of 
      type 2 diabetes.
FAU - Saloranta, Carola
AU  - Saloranta C
AD  - Helsinki University Hospital, Department of Medicine, Finland.
FAU - Guitard, Christiane
AU  - Guitard C
FAU - Pecher, Eckhard
AU  - Pecher E
FAU - De Pablos-Velasco, Pedro
AU  - De Pablos-Velasco P
FAU - Lahti, Kaj
AU  - Lahti K
FAU - Brunel, Patrick
AU  - Brunel P
FAU - Groop, Leif
AU  - Groop L
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Diabetes Care
JT  - Diabetes care
JID - 7805975
RN  - 0 (Blood Glucose)
RN  - 0 (Cyclohexanes)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - 41X3PWK4O2 (Nateglinide)
RN  - 47E5O17Y3R (Phenylalanine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Blood Glucose/drug effects/*metabolism
MH  - Body Mass Index
MH  - Cyclohexanes/*therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Glucose Tolerance Test
MH  - Humans
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Insulin/blood/*metabolism
MH  - Insulin Secretion
MH  - Male
MH  - Middle Aged
MH  - Nateglinide
MH  - Phenylalanine/analogs & derivatives/*therapeutic use
MH  - Postprandial Period
MH  - Prediabetic State/*blood/*drug therapy
EDAT- 2002/11/28 04:00
MHDA- 2003/07/02 05:00
CRDT- 2002/11/28 04:00
PHST- 2002/11/28 04:00 [pubmed]
PHST- 2003/07/02 05:00 [medline]
PHST- 2002/11/28 04:00 [entrez]
AID - 10.2337/diacare.25.12.2141 [doi]
PST - ppublish
SO  - Diabetes Care. 2002 Dec;25(12):2141-6. doi: 10.2337/diacare.25.12.2141.