 |
|
Inhaled Insulin Provides Improved Glycemic Control in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Agents
A Randomized Controlled Trial
Stuart R. Weiss, MD;
Shu-Lin Cheng, PhD;
Ione A. Kourides, MD;
Robert A. Gelfand, MD;
William H. Landschulz, MD, PhD; for the Inhaled Insulin Phase II Study Group
Arch Intern Med. 2003;163:2277-2282.
Background The long-term benefits of good glycemic control are well established. The aim of this proof-of-concept study was to determine whether glycemic control can be improved in patients with type 2 diabetes mellitus with suboptimal glycemic control, despite therapeutic dosages of oral antihyperglycemic agents (OHAs), by the addition of preprandial inhaled insulin (INH).
Methods Sixty-eight patients with inadequately controlled type 2 diabetes mellitus (glycosylated hemoglobin, 8.1%-11.9%), despite therapy with a sulfonylurea and/or metformin, were randomized to receive INH in addition to their prestudy OHA therapy (INH + OHA group, n = 32) or to continue taking their prestudy OHA alone for 12 weeks (OHA group, n = 36). Premeal INH doses were delivered in 1 to 2 inhalations of 1-mg or 3-mg doses (equivalent to 3 IU and 9 IU, respectively, of subcutaneously injected regular insulin).
Results At week 12, there was a significantly greater reduction in glycosylated hemoglobin for the INH + OHA cohort (mean reduction, -2.3%) compared with the OHA-only cohort (mean reduction, -0.1%, P<.001). Eleven patients (34%) receiving INH + OHA achieved glycosylated hemoglobin values of less than 7%, compared with none taking OHAs only. Fasting plasma glucose improved significantly more in the INH + OHA group compared with the OHA-only group (-60.69 mg/dL (-3.37 mmol/L] greater reduction, P<.001), and the postprandial increase in glucose was significantly lower in those patients receiving INH + OHA (P = .02). There was 1 report of severe hypoglycemia in the INH + OHA group (home blood glucose, 54 mg/dL [3.0 mmol/L]) and a greater increase in body weight. Pulmonary function was unchanged in both groups.
Conclusion The addition of preprandial INH to existing OHAs improves glycemic control without the need for injections in patients with type 2 diabetes mellitus failing to achieve satisfactory control with OHAs alone.
From the San Diego Endocrine and Medical Clinic, San Diego, Calif (Dr Weiss); Pfizer Global Research and Development, New London (Drs Cheng and Landschulz), and Yale University School of Medicine, New Haven (Dr Gelfand), Conn; and Pfizer Inc, New York, NY (Dr Kourides). Drs Weiss and Gelfand own stock in Pfizer Inc.
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
|
Effect of Inhaled Insulin on Fasting and Postprandial Plasma Glucose
Mikhail et al.
ANN INTERN MED 2007;146:821-821.
FULL TEXT
Effect of Inhaled Insulin on Fasting and Postprandial Plasma Glucose
Ceglia et al.
ANN INTERN MED 2007;146:821-822.
FULL TEXT
Inhaled insulins
Ghosh and Collier
Postgrad. Med. J. 2007;83:178-181.
ABSTRACT
| FULL TEXT
Meta-analysis: efficacy and safety of inhaled insulin therapy in adults with diabetes mellitus.
Ceglia et al.
ANN INTERN MED 2006;145:665-675.
ABSTRACT
| FULL TEXT
An Open, Randomized, Parallel-Group Study to Compare the Efficacy and Safety Profile of Inhaled Human Insulin (Exubera) With Glibenclamide as Adjunctive Therapy in Patients With Type 2 Diabetes Poorly Controlled on Metformin
Barnett et al.
Diabetes Care 2006;29:1818-1825.
ABSTRACT
| FULL TEXT
Exhuberance Over Exubera
Hite et al.
Clin. Diabetes 2006;24:110-114.
ABSTRACT
| FULL TEXT
An Open, Randomized, Parallel-Group Study to Compare the Efficacy and Safety Profile of Inhaled Human Insulin (Exubera) With Metformin as Adjunctive Therapy in Patients With Type 2 Diabetes Poorly Controlled on a Sulfonylurea.
Barnett et al.
Diabetes Care 2006;29:1282-1287.
ABSTRACT
| FULL TEXT
Inhaled insulin.
Morton-Eggleston and Barrett
BMJ 2006;332:1043-1044.
FULL TEXT
Efficacy and Safety of Inhaled Insulin Therapy
Rosenstock et al.
ANN INTERN MED 2006;144:533-534.
FULL TEXT
Inhaled Insulin Improves Glycemic Control When Substituted for or Added to Oral Combination Therapy in Type 2 Diabetes: A Randomized, Controlled Trial
Rosenstock et al.
ANN INTERN MED 2005;143:549-558.
ABSTRACT
| FULL TEXT
Antibody Response to Inhaled Insulin in Patients with Type 1 or Type 2 Diabetes. An Analysis of Initial Phase II and III Inhaled Insulin (Exubera) Trials and a Two-Year Extension Trial
Fineberg et al.
J. Clin. Endocrinol. Metab. 2005;90:3287-3294.
ABSTRACT
| FULL TEXT
Inhaled Insulin: Exubera
Odegard and Capoccia
The Annals of Pharmacotherapy 2005;39:843-853.
ABSTRACT
| FULL TEXT
Update in Endocrinology
Schlechte
ANN INTERN MED 2005;142:126-131.
FULL TEXT
Inhaled insulin
Amiel and Alberti
BMJ 2004;328:1215-1216.
FULL TEXT
Other articles noted: 14 Nov 2003 to 30 Jan 2004
Evid. Based Nurs. 2004;7:e2-e2.
FULL TEXT
Other articles noted
Evid. Based Med. 2004;9:63-64.
FULL TEXT
Inhaled Insulin Improves Glycemic Control In Patients With Type 2 Diabetes Mellitus
Robbins
AAP Grand Rounds 2004;11:5-6.
FULL TEXT
|
