Titre du document / Document title

Efficacy of inhaled insulin in patients with type 2 diabetes not controlled with diet and exercise a 12-week, randomized, comparative trial

Auteur(s) / Author(s)

Exubera Phase III Study Group, ETATS-UNIS
DEFRONZO Ralph A. ⁽¹⁾ ; BERGENSTAL Richard M. ⁽²⁾ ; CEFALU William T. ⁽³⁾ ; PULLMAN John ⁽⁴⁾ ; LERMAN Sam ⁽⁵⁾ ; BODE Bruce W. ⁽⁶⁾ ; PHILLIPS Lawrence S. ⁽⁷⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ University of Texas Health Science Center, San Antonio, Texas, ETATS-UNIS
⁽²⁾ International Diabetes Center, Minneapolis, Minnesota, ETATS-UNIS
⁽³⁾ Pennington Biomedical Research Center, Baton Rouge, Louisiana, ETATS-UNIS
⁽⁴⁾ Mercury Street Medical, Butte, Montana, ETATS-UNIS
⁽⁵⁾ Center for Diabetes and Endocrine Care, University of Miami, Miami, Florida, ETATS-UNIS
⁽⁶⁾ Atlanta Diabetes Associates, Atlanta, Georgia, ETATS-UNIS
⁽⁷⁾ Division of Endocrinology, Emory University School of Medicine, Atlanta, Georgia, ETATS-UNIS

Résumé / Abstract

OBJECTIVE - Effective type 2 diabetes management requires prompt intervention if glycemic control is not achieved by nonpharmacological means. This study investigates whether inhaled insulin (INH; Exubera) can achieve target glycemic control in patients failing on diet and exercise. RESEARCH DESIGN AND METHODS- Patients with suboptimal control on diet and exercise (HbA_1c [A1C] 8-11%) were randomized to 3 months' treatment with either INH before meals (n = 76) or rosiglitazone 4 mg twice a clay (n = 69), in conjunction with a diet and exercise regimen. The primary end point was percentage of patients achieving A1C <8.0%. RESULTS - The INH and rosiglitazone groups had comparable baseline A1C values (9.5 vs. 9.4%, respectively). Significantly more patients achieved A1C <8.0% (83 vs. 58%, adjusted odds ratio 7.14 [95% Cl 2.48-20.58], P = 0.0003), A1C <7.0% (44 vs. 18%, 4.43 [1.94-10.12]), and A1C ≤6.5% (28 vs. 7.5% 5.34 [1.83-15.57]) with INH. A1C decrease was greater with INH (-2.3% vs. -1.4%, adjusted treatment group difference: -0.89% [95% CI-1.23 to -0.55]) with final mean A1C values of 7.2 and 8.0% for INH and rosiglitazone, respectively. Hypoglycemia (episodes per subject-month) was higher with INH (0.7 vs. 0.05, risk ratio 14.72 [95% Cl 7.51-28.83]), with no severe hypoglycemic episodes. Pulmonary function changes were small and comparable between groups. CONCLUSIONS - INH could be an effective therapy for people with type 2 diabetes early in the course of their disease.

Revue / Journal Title

Diabetes care   ISSN 0149-5992   CODEN DICAD2 

Source / Source

2005, vol. 28, n^o8, pp. 1922-1928 [7 page(s) (article)] (25 ref.)

Langue / Language

Anglais

Editeur / Publisher

American Diabetes Association, Alexandria, VA, ETATS-UNIS  (1978) (Revue)

Mots-clés anglais / English Keywords

Feeding ; Metabolic diseases ; Endocrinopathy ; Pancreatic hormone ; Comparative study ; Clinical trial ; Physical exercise ; Nutrition ; Diet ; Human ; Type 2 diabetes ; Inhalation ; Treatment efficiency ; Insulin ;

Mots-clés français / French Keywords

Alimentation ; Métabolisme pathologie ; Endocrinopathie ; Hormone pancréatique ; Etude comparative ; Essai clinique ; Exercice physique ; Nutrition ; Régime alimentaire ; Homme ; Diabète type 2 ; Inhalation ; Efficacité traitement ; Insuline ;

Mots-clés espagnols / Spanish Keywords

Alimentación ; Metabolismo patología ; Endocrinopatía ; Hormona pancreática ; Estudio comparativo ; Ensayo clínico ; Ejercicio físico ; Nutrición ; Régimen alimentario ; Hombre ; Diabetes de tipo 2 ; Inhalación ; Eficacia tratamiento ; Insulina ;

Localisation / Location

INIST-CNRS, Cote INIST : 18054, 35400013144846.0120