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Tytuł:
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RESULTS OF A 24-WEEK TRIAL OF TECHNOSPHERE INSULIN VERSUS INSULIN ASPART IN TYPE 2 DIABETES.
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Autorzy:
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Hoogwerf BJ; Department of Endocrinology, Diabetes, and Metabolism (Emeritus), Cleveland, Ohio.
Pantalone KM; Endocrinology and Metabolism Institute, Cleveland Clinic, Cleveland, Ohio.
Basina M; Division of Endocrinology, Gerontology, and Metabolism, Stanford University School of Medicine, Stanford, California.
Jones MC; MannKind Corporation, Westlake Village, California. Electronic address: .
Grant M; MannKind Corporation, Westlake Village, California.
Kendall DM; MannKind Corporation, Westlake Village, California.
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Źródło:
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Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists [Endocr Pract] 2021 Jan; Vol. 27 (1), pp. 38-43. Date of Electronic Publication: 2020 Nov 17.
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Typ publikacji:
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Journal Article; Randomized Controlled Trial
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Język:
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English
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Imprint Name(s):
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Publication: 2021- : [New York] : Elsevier Inc.
Original Publication: Jacksonville, Fla. : The College and the Association,
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MeSH Terms:
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Diabetes Mellitus, Type 2*/drug therapy
Insulin Aspart*
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Blood Glucose ; Glycated Hemoglobin/analysis ; Humans ; Hypoglycemic Agents ; Insulin ; Insulin Glargine ; Insulin, Long-Acting ; Male ; Middle Aged ; Young Adult
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Contributed Indexing:
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Keywords: diabetes mellitus; drug effects; pharmacology; type 2
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Substance Nomenclature:
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0 (Blood Glucose)
0 (Glycated Hemoglobin A)
0 (Hypoglycemic Agents)
0 (Insulin)
0 (Insulin, Long-Acting)
2ZM8CX04RZ (Insulin Glargine)
D933668QVX (Insulin Aspart)
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Entry Date(s):
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Date Created: 20210120 Date Completed: 20210122 Latest Revision: 20221207
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Update Code:
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20240105
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DOI:
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10.1016/j.eprac.2020.11.002
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PMID:
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33471730
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Objective: To compare glycemic efficacy of Technosphere insulin (TI) versus that of insulin aspart (IA), each added to basal insulin, in type 2 diabetes.
Methods: This randomized, 24-week trial included subjects aged from 18 to 80 years who were treated with subcutaneous insulin for 3 months and had glycated hemoglobin (HbA1C) levels of 7.0% to 11.5%. After receiving stabilized insulin glargine doses during a 4-week lead in, the subjects were randomized to TI or IA. The primary end point was an HbA1C change from baseline, with the differences analyzed by equivalence analyses.
Results: In the overall cohort (N = 309; males, 23.3%), mean (SD) age was 58.5 (8.4) years, body mass index was 30.8 (4.7) kg/m 2 , weight was 82.2 (13.6) kg, and duration of diabetes was 12.2 (7.1) years. An intention-to-treat cohort had 150 subjects randomized to TI (mean [SD] HbA1C: 8.9% [1.1%]) and 154 randomized to IA (mean [SD] HbA1C: 9.0% [1.3%]). At 24 weeks, mean (SD) HbA1C value declined to 7.9% (1.3%) and 7.7% (1.1%) in the TI and IA cohorts, respectively. A treatment difference of 0.26% was not statistically significant, but the predefined equivalency margin was not met. Subjects receiving TI lost 0.78 kg compared to baseline; subjects receiving IA gained 0.23 kg (P =.0007). The incidence of mild/moderate hypoglycemia was lower for the TI cohort, though not statistically significant.
Conclusion: Both TI and IA resulted in significant and clinically meaningful HbA1C reductions. TI also resulted in significant and clinically meaningful weight reductions. These data support the use of inhaled insulin as a treatment option for individuals with type 2 diabetes.
(Copyright © 2020 AACE. Published by Elsevier Inc. All rights reserved.)
