Efficacy and safety of Technosphere inhaled insulin compared with Technosphere powder placebo in insulin-naive type 2 diabetes suboptimally controlled with oral agents.

Abstract:

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.

journal_name

Diabetes Care

journal_title

Diabetes care

authors

Rosenstock J,Bergenstal R,Defronzo RA,Hirsch IB,Klonoff D,Boss AH,Kramer D,Petrucci R,Yu W,Levy B,0008 Study Group.

doi

10.2337/dc08-0315

subject

Has Abstract

pub_date

2008-11-01 00:00:00

pages

2177-82

issue

11

eissn

0149-5992

issn

1935-5548

pii

dc08-0315

journal_volume

31

pub_type

杂志文章,随机对照试验
  • Maternal and cord blood adiponectin multimeric forms in gestational diabetes mellitus: a prospective analysis.

    abstract:OBJECTIVE:To analyze the relationship between maternal adiponectin (mAdiponectin) and cord blood adiponectin (cbAdiponectin) multimeric forms (high molecular weight [HMW], medium molecular weight [MMW], and low molecular weight [LMW]) in a cohort of gestational diabetes mellitus (GDM) and normal glucose-tolerant (NGT) ...

    journal_title:Diabetes care

    pub_type: 杂志文章

    doi:10.2337/dc11-0788

    authors: Ballesteros M,Simón I,Vendrell J,Ceperuelo-Mallafré V,Miralles RM,Albaiges G,Tinahones F,Megia A

    更新日期:2011-11-01 00:00:00

  • The hypertensions of diabetes.

    abstract::Patients with diabetes mellitus may have any one of several forms of hypertension. These include essential hypertension, systolic hypertension of three varieties, the hypertension associated with diabetic nephropathy ("diabetic hypertension"), and the hypertension associated with neuropathy (supine hypertension with o...

    journal_title:Diabetes care

    pub_type: 杂志文章

    doi:10.2337/diacare.5.1.50

    authors: Christlieb AR

    更新日期:1982-01-01 00:00:00

  • HOMA-estimated insulin resistance is an independent predictor of cardiovascular disease in type 2 diabetic subjects: prospective data from the Verona Diabetes Complications Study.

    abstract:OBJECTIVE:To evaluate whether homeostasis model assessment-estimated insulin resistance (HOMA-IR) is an independent predictor of cardiovascular disease (CVD) in type 2 diabetes. RESEARCH DESIGN AND METHODS:Conventional CVD risk factors (sex, age, smoking, plasma lipids, blood pressure, and metabolic control) and insul...

    journal_title:Diabetes care

    pub_type: 杂志文章,多中心研究

    doi:10.2337/diacare.25.7.1135

    authors: Bonora E,Formentini G,Calcaterra F,Lombardi S,Marini F,Zenari L,Saggiani F,Poli M,Perbellini S,Raffaelli A,Cacciatori V,Santi L,Targher G,Bonadonna R,Muggeo M

    更新日期:2002-07-01 00:00:00

  • Impact of BMI and the metabolic syndrome on the risk of diabetes in middle-aged men.

    abstract:OBJECTIVE:The existence of an obese subgroup with a healthy metabolic profile and low diabetes risk has been proposed; yet long-term data are lacking. We aimed to investigate associations between combinations of BMI categories and metabolic syndrome and risk of type 2 diabetes in middle-aged men. RESEARCH DESIGN AND M...

    journal_title:Diabetes care

    pub_type: 杂志文章

    doi:10.2337/dc10-0955

    authors: Arnlöv J,Sundström J,Ingelsson E,Lind L

    更新日期:2011-01-01 00:00:00

  • Ethnic variation in adiponectin and leptin levels and their association with adiposity and insulin resistance.

    abstract:OBJECTIVE:To investigate ethnic differences in adiponectin and leptin concentration and to determine whether these adipokines and a high-glycemic index diet account for ethnic variation in insulin resistance. RESEARCH DESIGN AND METHODS:In 1,176 South Asian, Chinese, Aboriginal, and European Canadians, fasting blood s...

    journal_title:Diabetes care

    pub_type: 杂志文章

    doi:10.2337/dc09-1392

    authors: Mente A,Razak F,Blankenberg S,Vuksan V,Davis AD,Miller R,Teo K,Gerstein H,Sharma AM,Yusuf S,Anand SS,Study of the Health Assessment And Risk Evaluation.,Study of the Health Assessment And Risk Evaluation in Aboriginal Peoples Inv

    更新日期:2010-07-01 00:00:00

  • Glimepiride versus metformin as monotherapy in pediatric patients with type 2 diabetes: a randomized, single-blind comparative study.

    abstract:OBJECTIVE:To compare the efficacy and safety of glimepiride versus metformin in pediatric subjects with type 2 diabetes inadequately controlled with diet and exercise alone or oral monotherapy. RESEARCH DESIGN AND METHODS:This 26-week, single-blind, active-controlled, multinational study randomized 285 subjects to rec...

    journal_title:Diabetes care

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.2337/dc06-1554

    authors: Gottschalk M,Danne T,Vlajnic A,Cara JF

    更新日期:2007-04-01 00:00:00

  • Serum lipids and the progression of nephropathy in type 1 diabetes.

    abstract:OBJECTIVE:Dyslipidemia contributes to the progression of microvascular disease in diabetes. However, different lipid variables may be important at different stages of nephropathy. This study examines the pattern of dyslipidemia associated with the progression of nephropathy in patients with type 1 diabetes. RESEARCH D...

    journal_title:Diabetes care

    pub_type: 杂志文章,多中心研究

    doi:10.2337/diacare.29.02.06.dc05-0809

    authors: Thomas MC,Rosengård-Bärlund M,Mills V,Rönnback M,Thomas S,Forsblom C,Cooper ME,Taskinen MR,Viberti G,Groop PH

    更新日期:2006-02-01 00:00:00

  • Nephropathy in NIDDM is associated with cellular markers for hypertension.

    abstract:OBJECTIVE:To determine if nephropathy in NIDDM is associated with cellular markers for hypertension. RESEARCH DESIGN AND METHODS:We compared 11 patients with clinical diabetic nephropathy with 15 control subjects with no diabetic nephropathy. The patients were white and had had NIDDM for > or = 9 yr and serum creatini...

    journal_title:Diabetes care

    pub_type: 杂志文章

    doi:10.2337/diacare.16.5.815

    authors: Herman WH,Prior DE,Yassine MD,Weder AB

    更新日期:1993-05-01 00:00:00

  • The effect of oral antidiabetic agents on A1C levels: a systematic review and meta-analysis.

    abstract:OBJECTIVE:Previous reviews of the effect of oral antidiabetic (OAD) agents on A1C levels summarized studies with varying designs and methodological approaches. Using predetermined methodological criteria, we evaluated the effect of OAD agents on A1C levels. RESEARCH DESIGN AND METHODS:The Excerpta Medica (EMBASE), the...

    journal_title:Diabetes care

    pub_type: 杂志文章,meta分析,评审

    doi:10.2337/dc09-1727

    authors: Sherifali D,Nerenberg K,Pullenayegum E,Cheng JE,Gerstein HC

    更新日期:2010-08-01 00:00:00

  • Elevation of N-(carboxymethyl)valine residue in hemoglobin of diabetic patients. Its role in the development of diabetic nephropathy.

    abstract:OBJECTIVE:Advanced glycation end products (AGEs) are a risk factor for diabetic complications. We have developed an assay method for N-(carboxymethyl)valine (CMV) of the hemoglobin (CMV-Hb), which is an AGE generated from HbA1c. Herein we describe the clinical utility of CMV-Hb measurement for the diagnosis of diabetic...

    journal_title:Diabetes care

    pub_type: 杂志文章

    doi:10.2337/diacare.24.5.891

    authors: Uchimura T,Nakano K,Hashiguchi T,Iwamoto H,Miura K,Yoshimura Y,Hanyu N,Hirata K,Imakuma M,Motomiya Y,Maruyama I

    更新日期:2001-05-01 00:00:00

  • Prediction of the relative blood glucose response of mixed meals using the white bread glycemic index.

    abstract::Unexpected plasma glucose responses to different mixed meals fed to normal and diabetic volunteers have recently been reported. We have therefore examined in normal volunteers the effect of mixing carbohydrate foods of different glycemic indices (GIs) without the addition of fat and protein. The observed GI of the mix...

    journal_title:Diabetes care

    pub_type: 杂志文章

    doi:10.2337/diacare.8.5.418

    authors: Wolever TM,Nuttall FQ,Lee R,Wong GS,Josse RG,Csima A,Jenkins DJ

    更新日期:1985-09-01 00:00:00

  • Effects of Vitamin D Supplementation on Insulin Sensitivity and Insulin Secretion in Subjects With Type 2 Diabetes and Vitamin D Deficiency: A Randomized Controlled Trial.

    abstract:OBJECTIVE:In observational studies, low vitamin D levels are associated with type 2 diabetes (T2D), impaired glucose metabolism, insulin sensitivity, and insulin secretion. We evaluated the efficacy of vitamin D supplementation on insulin sensitivity and insulin secretion in subjects with T2D and low vitamin D (25-hydr...

    journal_title:Diabetes care

    pub_type: 杂志文章,随机对照试验

    doi:10.2337/dc16-2302

    authors: Gulseth HL,Wium C,Angel K,Eriksen EF,Birkeland KI

    更新日期:2017-07-01 00:00:00

  • Release of platelet plasminogen activator inhibitor 1 in whole blood is increased in patients with type II diabetes.

    abstract:OBJECTIVE:To compare platelet plasminogen activator inhibitor 1 (PAI-1) release in type II diabetic patients and healthy control subjects. RESEARCH DESIGN AND METHODS:We studied a group of 27 diabetic patients and a group of 16 nondiabetic control subjects. Whole-blood platelet aggregation, defined as a decrease in pl...

    journal_title:Diabetes care

    pub_type: 杂志文章

    doi:10.2337/diacare.18.8.1150

    authors: Jokl R,Klein RL,Lopes-Virella MF,Colwell JA

    更新日期:1995-08-01 00:00:00

  • Risk factors for myocardial infarction case fatality and stroke case fatality in type 2 diabetes: UKPDS 66.

    abstract:OBJECTIVE:Patients with diabetes have a higher case fatality rate in myocardial infarction (MI) or stroke than those without diabetes: that is, MI and stroke are more often fatal if diabetes is present. We investigated whether the risk of MI or stroke being fatal in type 2 diabetes can be estimated using information av...

    journal_title:Diabetes care

    pub_type: 杂志文章,多中心研究

    doi:10.2337/diacare.27.1.201

    authors: Stevens RJ,Coleman RL,Adler AI,Stratton IM,Matthews DR,Holman RR

    更新日期:2004-01-01 00:00:00

  • Increased Liver Fatty Acid Uptake Is Partly Reversed and Liver Fat Content Normalized After Bariatric Surgery.

    abstract:OBJECTIVE:Changes in liver fatty acid metabolism are important in understanding the mechanisms of diabetes remission and metabolic changes after bariatric surgery. RESEARCH DESIGN AND METHODS:Liver fatty acid uptake (LFU), blood flow, and fat content (LFC) were measured in 25 obese subjects before bariatric surgery an...

    journal_title:Diabetes care

    pub_type: 临床试验,杂志文章

    doi:10.2337/dc17-0738

    authors: Immonen H,Hannukainen JC,Kudomi N,Pihlajamäki J,Saunavaara V,Laine J,Salminen P,Lehtimäki T,Pham T,Iozzo P,Nuutila P

    更新日期:2018-02-01 00:00:00

  • Can new-onset diabetes after kidney transplant be prevented?

    abstract::Because the negative consequences of new-onset diabetes mellitus after transplantation (NODAT) diminish the significant gains of kidney transplantation, it is imperative to develop clinical interventions to reduce the incidence of NODAT. In this review, we discuss whether intensive lifestyle interventions that delay o...

    journal_title:Diabetes care

    pub_type: 杂志文章,评审

    doi:10.2337/dc12-2067

    authors: Chakkera HA,Weil EJ,Pham PT,Pomeroy J,Knowler WC

    更新日期:2013-05-01 00:00:00

  • Incomplete elimination of the ABBOS epitope of bovine serum albumin under simulated gastrointestinal conditions of infants.

    abstract:OBJECTIVE:Because the bovine serum albumin residues 126-144 (ABBOS) have been reported to be responsible for the autoimmune reaction directed against pancreatic islet cells, it was our aim to study the potential survival of the ABBOS epitope during digestion in the gastrointestinal tract. RESEARCH DESIGN AND METHODS:E...

    journal_title:Diabetes care

    pub_type: 杂志文章

    doi:10.2337/diacare.20.5.875

    authors: Alting AC,Meijer RJ,van Beresteijn EC

    更新日期:1997-05-01 00:00:00

  • Effect of case-based training for medical residents on inpatient glycemia.

    abstract:OBJECTIVE:To determine whether an educational intervention for medical house staff improves blood glucose (BG) in hospitalized patients. RESEARCH DESIGN AND METHODS:All 116 medicine residents at an academic medical center were assigned to online or classroom training on inpatient dysglycemia in fall 2008. Both groups ...

    journal_title:Diabetes care

    pub_type: 杂志文章

    doi:10.2337/dc11-0517

    authors: Tamler R,Green DE,Skamagas M,Breen TL,Looker HC,Babyatsky M,Leroith D

    更新日期:2011-08-01 00:00:00

  • A simple meal plan emphasizing healthy food choices is as effective as an exchange-based meal plan for urban African Americans with type 2 diabetes.

    abstract:OBJECTIVE:To compare a simple meal plan emphasizing healthy food choices with a traditional exchange-based meal plan in reducing HbA(1c) levels in urban African Americans with type 2 diabetes. RESEARCH DESIGN AND METHODS:A total of 648 patients with type 2 diabetes were randomized to receive instruction in either a he...

    journal_title:Diabetes care

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.2337/diacare.26.6.1719

    authors: Ziemer DC,Berkowitz KJ,Panayioto RM,El-Kebbi IM,Musey VC,Anderson LA,Wanko NS,Fowke ML,Brazier CW,Dunbar VG,Slocum W,Bacha GM,Gallina DL,Cook CB,Phillips LS

    更新日期:2003-06-01 00:00:00

  • Increased cardiometabolic risk factors and inflammation in adipose tissue in obese subjects classified as metabolically healthy.

    abstract:OBJECTIVE:It has been suggested that individuals with the condition known as metabolically healthy obesity (MHO) may not have the same increased risk for the development of metabolic abnormalities as their non-metabolically healthy counterparts. However, the validity of this concept has recently been challenged, since ...

    journal_title:Diabetes care

    pub_type: 杂志文章

    doi:10.2337/dc14-0937

    authors: Gómez-Ambrosi J,Catalán V,Rodríguez A,Andrada P,Ramírez B,Ibáñez P,Vila N,Romero S,Margall MA,Gil MJ,Moncada R,Valentí V,Silva C,Salvador J,Frühbeck G

    更新日期:2014-10-01 00:00:00

  • Hypertriglyceridemia enhances monocyte binding to endothelial cells in NIDDM.

    abstract:OBJECTIVE:The mechanisms by which diabetes leads to rapidly progressive atherosclerosis are not fully understood. Adherence of monocytes to the arterial wall is an early event in the development of atherosclerotic lesions. RESEARCH DESIGN AND METHODS:The binding of freshly isolated monocytes from patients with NIDDM, ...

    journal_title:Diabetes care

    pub_type: 杂志文章

    doi:10.2337/diacare.19.10.1122

    authors: Hoogerbrugge N,Verkerk A,Jacobs ML,Postema PT,Jongkind JF

    更新日期:1996-10-01 00:00:00

  • Association of waist circumference with risk of hypertension and type 2 diabetes in Nigerians, Jamaicans, and African-Americans.

    abstract:OBJECTIVE:Prior studies have supported that waist circumference correlates better with visceral adipose tissue and is a better predictor of cardiovascular disease than are BMI and waist-to-hip ratio. In this study, we reexamine the role of waist size on the risk of hypertension and type 2 diabetes in African-origin pop...

    journal_title:Diabetes care

    pub_type: 杂志文章

    doi:10.2337/diacare.21.11.1836

    authors: Okosun IS,Cooper RS,Rotimi CN,Osotimehin B,Forrester T

    更新日期:1998-11-01 00:00:00

  • Fatty Liver Among Adolescent Offspring of Women With Type 1 Diabetes (the EPICOM Study).

    abstract:OBJECTIVE:Intrauterine exposure to maternal type 1 diabetes is associated with a less favorable metabolic profile later in life. Nonalcoholic fatty liver disease is the hepatic manifestation of a cluster of metabolic abnormalities linked to insulin resistance. This study aimed to evaluate the effect of maternal pregest...

    journal_title:Diabetes care

    pub_type: 杂志文章

    doi:10.2337/dc19-0571

    authors: Knorr S,Bytoft B,Lohse Z,Boisen AB,Clausen TD,Jensen RB,Damm P,Beck-Nielsen H,Holst JJ,Hartmann B,Møller HJ,Højlund K,Gravholt CH,Jensen DM

    更新日期:2019-08-01 00:00:00

  • Fat replacers: their use in foods and role in diabetes medical nutrition therapy.

    abstract::The scientific literature demonstrates that fat replacers have a reasonable certainty of no harm. Whether they help produce desired health outcomes, i.e., decreased risk of coronary heart disease and certain types of cancer related to excess fat intake, weight reduction, changes in lipid profile, improved glycemic con...

    journal_title:Diabetes care

    pub_type: 杂志文章,评审

    doi:10.2337/diacare.19.11.1294

    authors: Warshaw H,Franz M,Powers MA,Wheeler M

    更新日期:1996-11-01 00:00:00

  • Haptoglobin genotype is predictive of major adverse cardiac events in the 1-year period after percutaneous transluminal coronary angioplasty in individuals with diabetes.

    abstract:OBJECTIVE:The goal of this study was to determine whether the haptoglobin (Hp) genotype was predictive of restenosis and major adverse cardiac events (MACEs) after percutaneous transluminal coronary angioplasty (PTCA) in individuals with diabetes. RESEARCH DESIGN AND METHODS:A consecutive series of 935 diabetic patien...

    journal_title:Diabetes care

    pub_type: 杂志文章

    doi:10.2337/diacare.26.9.2628

    authors: Roguin A,Koch W,Kastrati A,Aronson D,Schomig A,Levy AP

    更新日期:2003-09-01 00:00:00

  • Time-action profile of inhaled insulin in comparison with subcutaneously injected insulin lispro and regular human insulin.

    abstract:OBJECTIVE:This study compares the time-action profile of inhaled insulin (INH; Exubera) with that of subcutaneously injected insulin lispro (ILP) or regular human insulin (RHI) in healthy volunteers. RESEARCH DESIGN AND METHODS:In this open-label, randomized, three-way, crossover study, 17 healthy male volunteers were...

    journal_title:Diabetes care

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.2337/diacare.28.5.1077

    authors: Rave K,Bott S,Heinemann L,Sha S,Becker RH,Willavize SA,Heise T

    更新日期:2005-05-01 00:00:00

  • Linagliptin lowers albuminuria on top of recommended standard treatment in patients with type 2 diabetes and renal dysfunction.

    abstract:OBJECTIVE:Preclinical data suggest that linagliptin, a dipeptidyl peptidase-4 inhibitor, may lower urinary albumin excretion. The ability of linagliptin to lower albuminuria on top of renin-angiotensin-aldosterone system (RAAS) inhibition in humans was analyzed by pooling data from four similarly designed, 24-week, ran...

    journal_title:Diabetes care

    pub_type: 杂志文章,随机对照试验

    doi:10.2337/dc13-0323

    authors: Groop PH,Cooper ME,Perkovic V,Emser A,Woerle HJ,von Eynatten M

    更新日期:2013-11-01 00:00:00

  • Twelve- and 52-week efficacy of the dipeptidyl peptidase IV inhibitor LAF237 in metformin-treated patients with type 2 diabetes.

    abstract:OBJECTIVE:To assess the 12- and 52-week efficacy of the dipeptidyl peptidase IV inhibitor LAF237 versus placebo in patients with type 2 diabetes continuing metformin treatment. RESEARCH DESIGN AND METHODS:We conducted a 12-week, randomized, double-blind, placebo-controlled trial in 107 patients with type 2 diabetes wi...

    journal_title:Diabetes care

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.2337/diacare.27.12.2874

    authors: Ahrén B,Gomis R,Standl E,Mills D,Schweizer A

    更新日期:2004-12-01 00:00:00

  • Effects of metformin on insulin resistance, risk factors for cardiovascular disease, and plasminogen activator inhibitor in NIDDM subjects. A study of two ethnic groups.

    abstract:OBJECTIVE:To investigate the effects of metformin on glycemic control, insulin resistance, and risk factors for cardiovascular disease in NIDDM subjects from two ethnic groups (Caucasian and Asian) with different risks of cardiovascular disease. RESEARCH DESIGN AND METHODS:A total of 27 subjects with NIDDM (17 Caucasi...

    journal_title:Diabetes care

    pub_type: 临床试验,评论,杂志文章,随机对照试验

    doi:10.2337/diacare.16.4.621

    authors: Nagi DK,Yudkin JS

    更新日期:1993-04-01 00:00:00

  • Differences in Regional Brain Responses to Food Ingestion After Roux-en-Y Gastric Bypass and the Role of Gut Peptides: A Neuroimaging Study.

    abstract:OBJECTIVE:Improved appetite control, possibly mediated by exaggerated gut peptide responses to eating, may contribute to weight loss after Roux-en-Y gastric bypass (RYGB). This study compared brain responses to food ingestion between post-RYGB (RYGB), normal weight (NW), and obese (Ob) unoperated subjects and explored ...

    journal_title:Diabetes care

    pub_type: 杂志文章

    doi:10.2337/dc15-2721

    authors: Hunt KF,Dunn JT,le Roux CW,Reed LJ,Marsden PK,Patel AG,Amiel SA

    更新日期:2016-10-01 00:00:00