Efficacy and Safety of Technosphere Inhaled Insulin Compared With Technosphere Powder Placebo in Insulin-Naïve Type 2 Diabetes Suboptimally Controlled with Oral Agents

doi:10.2337/dc08-0315

Efficacy and Safety of Technosphere Inhaled Insulin Compared With Technosphere Powder Placebo in Insulin-Naïve Type 2 Diabetes Suboptimally Controlled with Oral Agents

Julio Rosenstock, MD (juliorosenstock{at}dallasdiabetes.com)¹,
Richard Bergenstal, MD²,
Ralph A. DeFronzo, MD³,
Irl B. Hirsch, MD⁴,
David Klonoff, MD⁵,
Anders Boss, MD⁶,
David Kramer, PhD⁶,
Richard Petrucci, MD⁶,
Wen Yu, MD⁶,
Brian Levy, MD, FACE⁷ and
for the 0008 Study Group

From the ¹Dallas Diabetes and Endocrine Center at Medical City, Dallas, Texas
the ²International Diabetes Center at Park Nicollet, Minneapolis, Minnesota
the ³University of Texas Health Science Center, San Antonio
the ⁴University of Washington Medical Center, Seattle
the ⁵Mills-Peninsula Health Services, San Mateo, California
⁶MannKind Corporation, Paramus, New Jersey
⁷Johnson & Johnson Pharmaceutical Services, LLC, Raritan, New Jersey (employed by MannKind Corporation during manuscript development)

Abstract

Objective— This double-blind, placebo-controlled, randomized, multicenter, parallel-group study compared the efficacy, safety, and tolerability of Technosphere® Insulin (TI) with Technosphere® powder (TP) as placebo in insulin-naïve type 2 diabetic patients suboptimally controlled with oral antidiabetic agents.

Research design and methods— Patients (n=126) were randomized to 12 weeks of therapy with TI or TP following lifestyle education on nutrition, exercise, and instructions on inhaler use. The primary efficacy outcome was change in glycosylated hemoglobin A1C (A1C) from baseline to study end, and the secondary efficacy outcome was area under the curve for postprandial glucose levels during a meal test at treatment weeks 4, 8, and 12.

Results— A1C reduction from a mean baseline of 7.9% was greater with TI than with TP (–0.72% vs. –0.30%; P=0.003). Postprandial glucose excursions were reduced by 56% with TI compared with baseline, and maximal postprandial glucose levels were reduced by 43% compared with TP. Incidences of hypoglycemia, hyperglycemia, cough, and other adverse events were low in both groups. Body weight was unchanged in both groups.

Conclusion— TI was well tolerated and demonstrated significant improvement in glycemic control with clinically meaningful reductions in A1C levels and postprandial glucose concentrations after 12 weeks of treatment.

Conclusion— NCT00511602—ClinicalTrials.gov