Cargando…
Efficacy and Safety of Technosphere Inhaled Insulin Compared With Technosphere Powder Placebo in Insulin-Naive Type 2 Diabetes Suboptimally Controlled With Oral Agents
OBJECTIVE—This double-blind, placebo-controlled, randomized, multicenter, parallel-group study compared the efficacy, safety, and tolerability of Technosphere insulin with Technosphere powder as placebo in insulin-naive type 2 diabetic patients whose diabetes was suboptimally controlled with oral an...
Autores principales: | , , , , , , , , , |
---|---|
Formato: | Texto |
Lenguaje: | English |
Publicado: |
American Diabetes Association
2008
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2571070/ https://www.ncbi.nlm.nih.gov/pubmed/18678610 http://dx.doi.org/10.2337/dc08-0315 |
_version_ | 1782160205798178816 |
---|---|
author | Rosenstock, Julio Bergenstal, Richard DeFronzo, Ralph A. Hirsch, Irl B. Klonoff, David Boss, Anders H. Kramer, David Petrucci, Richard Yu, Wen Levy, Brian |
author_facet | Rosenstock, Julio Bergenstal, Richard DeFronzo, Ralph A. Hirsch, Irl B. Klonoff, David Boss, Anders H. Kramer, David Petrucci, Richard Yu, Wen Levy, Brian |
author_sort | Rosenstock, Julio |
collection | PubMed |
description | OBJECTIVE—This double-blind, placebo-controlled, randomized, multicenter, parallel-group study compared the efficacy, safety, and tolerability of Technosphere insulin with Technosphere powder as placebo in insulin-naive type 2 diabetic patients whose diabetes was suboptimally controlled with oral antidiabetic agents. RESEARCH DESIGN AND METHODS—Patients (n = 126) were randomly assigned to 12 weeks of therapy with Technosphere insulin or Technosphere powder after lifestyle education on nutrition, exercise, and instructions on inhaler use. The primary efficacy outcome was change in 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 Technosphere insulin than with Technosphere powder (−0.72 vs. −0.30%; P = 0.003). Postprandial glucose excursions were reduced by 56% with Technosphere insulin compared with baseline, and maximal postprandial glucose levels were reduced by 43% compared with Technosphere powder. Incidences of hypoglycemia, hyperglycemia, cough, and other adverse events were low in both groups. Body weight was unchanged in both groups. CONCLUSIONS—Technosphere insulin 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. |
format | Text |
id | pubmed-2571070 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2008 |
publisher | American Diabetes Association |
record_format | MEDLINE/PubMed |
spelling | pubmed-25710702009-11-01 Efficacy and Safety of Technosphere Inhaled Insulin Compared With Technosphere Powder Placebo in Insulin-Naive Type 2 Diabetes Suboptimally Controlled With Oral Agents Rosenstock, Julio Bergenstal, Richard DeFronzo, Ralph A. Hirsch, Irl B. Klonoff, David Boss, Anders H. Kramer, David Petrucci, Richard Yu, Wen Levy, Brian Diabetes Care Emerging Treatments and Technologies OBJECTIVE—This double-blind, placebo-controlled, randomized, multicenter, parallel-group study compared the efficacy, safety, and tolerability of Technosphere insulin with Technosphere powder as placebo in insulin-naive type 2 diabetic patients whose diabetes was suboptimally controlled with oral antidiabetic agents. RESEARCH DESIGN AND METHODS—Patients (n = 126) were randomly assigned to 12 weeks of therapy with Technosphere insulin or Technosphere powder after lifestyle education on nutrition, exercise, and instructions on inhaler use. The primary efficacy outcome was change in 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 Technosphere insulin than with Technosphere powder (−0.72 vs. −0.30%; P = 0.003). Postprandial glucose excursions were reduced by 56% with Technosphere insulin compared with baseline, and maximal postprandial glucose levels were reduced by 43% compared with Technosphere powder. Incidences of hypoglycemia, hyperglycemia, cough, and other adverse events were low in both groups. Body weight was unchanged in both groups. CONCLUSIONS—Technosphere insulin 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. American Diabetes Association 2008-11 /pmc/articles/PMC2571070/ /pubmed/18678610 http://dx.doi.org/10.2337/dc08-0315 Text en Copyright © 2008, American Diabetes Association https://creativecommons.org/licenses/by-nc-nd/3.0/Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details. |
spellingShingle | Emerging Treatments and Technologies Rosenstock, Julio Bergenstal, Richard DeFronzo, Ralph A. Hirsch, Irl B. Klonoff, David Boss, Anders H. Kramer, David Petrucci, Richard Yu, Wen Levy, Brian Efficacy and Safety of Technosphere Inhaled Insulin Compared With Technosphere Powder Placebo in Insulin-Naive Type 2 Diabetes Suboptimally Controlled With Oral Agents |
title | Efficacy and Safety of Technosphere Inhaled Insulin Compared With Technosphere Powder Placebo in Insulin-Naive Type 2 Diabetes Suboptimally Controlled With Oral Agents
|
title_full | Efficacy and Safety of Technosphere Inhaled Insulin Compared With Technosphere Powder Placebo in Insulin-Naive Type 2 Diabetes Suboptimally Controlled With Oral Agents
|
title_fullStr | Efficacy and Safety of Technosphere Inhaled Insulin Compared With Technosphere Powder Placebo in Insulin-Naive Type 2 Diabetes Suboptimally Controlled With Oral Agents
|
title_full_unstemmed | Efficacy and Safety of Technosphere Inhaled Insulin Compared With Technosphere Powder Placebo in Insulin-Naive Type 2 Diabetes Suboptimally Controlled With Oral Agents
|
title_short | Efficacy and Safety of Technosphere Inhaled Insulin Compared With Technosphere Powder Placebo in Insulin-Naive Type 2 Diabetes Suboptimally Controlled With Oral Agents
|
title_sort | efficacy and safety of technosphere inhaled insulin compared with technosphere powder placebo in insulin-naive type 2 diabetes suboptimally controlled with oral agents |
topic | Emerging Treatments and Technologies |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2571070/ https://www.ncbi.nlm.nih.gov/pubmed/18678610 http://dx.doi.org/10.2337/dc08-0315 |
work_keys_str_mv | AT rosenstockjulio efficacyandsafetyoftechnosphereinhaledinsulincomparedwithtechnospherepowderplaceboininsulinnaivetype2diabetessuboptimallycontrolledwithoralagents AT bergenstalrichard efficacyandsafetyoftechnosphereinhaledinsulincomparedwithtechnospherepowderplaceboininsulinnaivetype2diabetessuboptimallycontrolledwithoralagents AT defronzoralpha efficacyandsafetyoftechnosphereinhaledinsulincomparedwithtechnospherepowderplaceboininsulinnaivetype2diabetessuboptimallycontrolledwithoralagents AT hirschirlb efficacyandsafetyoftechnosphereinhaledinsulincomparedwithtechnospherepowderplaceboininsulinnaivetype2diabetessuboptimallycontrolledwithoralagents AT klonoffdavid efficacyandsafetyoftechnosphereinhaledinsulincomparedwithtechnospherepowderplaceboininsulinnaivetype2diabetessuboptimallycontrolledwithoralagents AT bossandersh efficacyandsafetyoftechnosphereinhaledinsulincomparedwithtechnospherepowderplaceboininsulinnaivetype2diabetessuboptimallycontrolledwithoralagents AT kramerdavid efficacyandsafetyoftechnosphereinhaledinsulincomparedwithtechnospherepowderplaceboininsulinnaivetype2diabetessuboptimallycontrolledwithoralagents AT petruccirichard efficacyandsafetyoftechnosphereinhaledinsulincomparedwithtechnospherepowderplaceboininsulinnaivetype2diabetessuboptimallycontrolledwithoralagents AT yuwen efficacyandsafetyoftechnosphereinhaledinsulincomparedwithtechnospherepowderplaceboininsulinnaivetype2diabetessuboptimallycontrolledwithoralagents AT levybrian efficacyandsafetyoftechnosphereinhaledinsulincomparedwithtechnospherepowderplaceboininsulinnaivetype2diabetessuboptimallycontrolledwithoralagents AT efficacyandsafetyoftechnosphereinhaledinsulincomparedwithtechnospherepowderplaceboininsulinnaivetype2diabetessuboptimallycontrolledwithoralagents |