Abstract:
BACKGROUND:Long-term treatment is necessary to slow the progression of type 2 diabetes (T2D). Here, we examined the safety and efficacy of 6 years of treatment with exenatide once weekly (QW) among patients with T2D in the DURATION-1 trial. METHODS:The study enrolled patients aged ≥16 years with T2D treated primarily with metformin and sulfonylureas. Following 30 weeks of randomized treatment with exenatide QW 2 mg or exenatide twice daily 10 μg, patients entered an uncontrolled, open-label, open-ended study phase in which all patients received exenatide QW 2 mg. Restrictions on concomitant medication use were eased over time. RESULTS:Of the original 295 patients in the intent-to-treat population, 136 (46%) completed 6 years of treatment. Six-year completers had sustained significant improvements from baseline in glycated hemoglobin (HbA1c; least-squares mean [LSM] change, -1.6%), with 46.3% achieving HbA1c <7.0%, 33.1% achieving HbA1c ≤6.5%, and significant improvements from baseline in fasting plasma glucose (-28 mg/dL) and body weight (-4.2 kg) at 6 years. The 78 completers who added no glucose-lowering medications had numerically greater body weight reductions than the overall cohort (6-year LSM change, -6.1 kg) with more stability over time. No unexpected adverse events were observed during 1202.4 patient-years of exposure. Most minor hypoglycemia events occurred with concomitant sulfonylurea use. CONCLUSIONS:Exenatide QW was associated with clinically significant, sustained improvements in glycemic control and weight in patients who continued therapy for up to 6 years, without unexpected safety findings. ClinicalTrials.gov registration: NCT00308139.
journal_name
Diabetes Technol Therjournal_title
Diabetes technology & therapeuticsauthors
Henry RR,Klein EJ,Han J,Iqbal Ndoi
10.1089/dia.2016.0107subject
Has Abstractpub_date
2016-11-01 00:00:00pages
677-686issue
11eissn
1520-9156issn
1557-8593journal_volume
18pub_type
临床试验,杂志文章abstract:BACKGROUND:Continuous glucose monitoring (CGM) has been shown to be a valuable tool to improve glycemic control in patients with diabetes. The objective of this pilot study was to develop and implement CGM in an existing diabetes clinic for low-income patients on multiple daily injections. SUBJECTS AND METHODS:This wa...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1089/dia.2013.0072
更新日期:2013-10-01 00:00:00
abstract:: Background: Glycemic variability (GV) is an important component of glycemic control for patients with type 1 diabetes (T1D). The inadequacy of existing measurements lies in the fact that they view the variability from different aspects, so that no consensus has been reache...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2019.0250
更新日期:2020-04-01 00:00:00
abstract:OBJECTIVE:We sought to cross validate several metrics for quality of glycemic control, hypoglycemia, and hyperglycemia. RESEARCH DESIGN AND METHODS:We analyzed the mathematical properties of several metrics for overall glycemic control, and for hypo- and hyperglycemia, to evaluate their similarities, differences, and ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2017.0416
更新日期:2018-05-01 00:00:00
abstract:AIM:Insulin therapy induces remission in subjects with newly diagnosed type 2 diabetes mellitus (T2DM). This study assessed the insulin and C-peptide levels in newly diagnosed T2DM subjects during low-dose insulin therapy. SUBJECTS AND METHODS:Twenty newly diagnosed, drug-naive, T2DM patients without acute or chronic ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2010.0187
更新日期:2011-04-01 00:00:00
abstract:BACKGROUND:SAR342434 is a biosimilar follow-on of insulin lispro-Humalog®. This study aimed to show similar efficacy, safety, and immunogenicity of SAR342434 (SAR-Lis) versus insulin lispro-Humalog (Ly-Lis) in adult patients with type 1 diabetes (T1DM) treated with multiple daily injections while using basal insulin gl...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1089/dia.2017.0117
更新日期:2017-09-01 00:00:00
abstract::We report the first case of the use of continuous subcutaneous insulin infusion (CSII) in a patient with Shwachman-Bodian-Diamond syndrome (SBDS) and diabetes. An Italian boy received diagnosis of SBDS at the age of 7 months (SBDS gene mutation: c.183-184TA → CT and c.258 + 2 T → C in compound heterozygous). The patie...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2014.0184
更新日期:2015-01-01 00:00:00
abstract::Maintaining optimal blood glucose (BG) control is difficult for type 1 diabetes mellitus (T1DM) patients when typical daily regimens of food, insulin and exercise are altered. Artificial intelligence (AI) systems consisting of treatment algorithms calibrated through large datasets of patient specific information may o...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/15209150050501989
更新日期:2000-01-01 00:00:00
abstract:BACKGROUND:The efficacy of short-term professional continuous glucose monitoring (CGM) for glycemic control in patients with diabetes remains unclear. METHODS:We performed a 3-month study to evaluate the benefits of CGM in 64 patients. RESULTS:The overall glycemic control of patients who underwent CGM improved signif...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2018.0164
更新日期:2018-09-01 00:00:00
abstract:: Background: The Medtronic MiniMed™ 670G system adjusts basal insulin delivery in response to continuous glucose monitoring levels and is already in use in clinical practice. We tested the home-based feasibility of the new MiniMed advanced hybrid closed-loop (AHCL) system, ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2020.0448
更新日期:2020-12-08 00:00:00
abstract:BACKGROUND:Previous studies of aerobic exercise have found lower sensor accuracy during exercise. Whether or not resistance exercise would also be associated with lower sensor accuracy has not yet been examined. This study sought to investigate the accuracy of continuous glucose monitoring sensor values at rest, during...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2012.0182
更新日期:2013-01-01 00:00:00
abstract:PURPOSE:This study investigated reasons for the rejection and discontinuation of insulin pump therapy and explored general attitudes towards this mode of therapy among young patients with type 1 diabetes. METHODS:A questionnaire was developed using a focus group of young people with diabetes. It was then used to surve...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2009.0080
更新日期:2010-01-01 00:00:00
abstract:BACKGROUND:The objective of this investigation was to evaluate the test-retest repeatability of insulin sensitivity and secretion indices derived from liquid meal tolerance tests (MTTs) in subjects with normal fasting glucose (NFG) (n = 20), impaired fasting glucose (IFG) (n = 20), or type 2 diabetes mellitus (n = 38)....
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1089/dia.2010.0083
更新日期:2010-11-01 00:00:00
abstract:OBJECTIVE:The purpose of the present study was to determine the effectiveness of a fluorescent contact lens glucose sensor in monitoring glucose in patients with diabetes. METHODS:Under an institutional review board-approved protocol, five fasting patients with type II diabetes were given a challenge consisting of 75 ...
journal_title:Diabetes technology & therapeutics
pub_type: 临床试验,杂志文章
doi:10.1089/dia.2004.6.782
更新日期:2004-12-01 00:00:00
abstract::Continuous glucose monitoring (CGM) is a new tool that has recently become available to people with diabetes. Properly designing and conducting trials in order to answer important questions regarding the clinical usefulness of CGM is very difficult and fraught with many confounding variables and unique challenges. Ini...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2009.0012
更新日期:2009-06-01 00:00:00
abstract::Use of the Medtronic MiniMed Continuous Glucose Monitoring System (CGMS) in non-diabetic children has revealed many low and high sensor glucose (SG) values, suggesting that the original analytical algorithm (Solutions 2.0) might be overreading glycemic excursions. A revised algorithm (Solutions 3.0) was introduced in ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/152091503765691866
更新日期:2003-01-01 00:00:00
abstract:BACKGROUND:Adherence to established standards (e.g., International Organization for Standardization [ISO] 15197) is important to ensure comparable and sufficient accuracy of systems for self-monitoring of blood glucose (SMBG). Accuracy evaluation was performed for different SMBG systems available in Europe with three r...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2015.0085
更新日期:2015-09-01 00:00:00
abstract:BACKGROUND:Glucose variability has been identified as a predictor of hypoglycemia and has been associated with mortality in critically ill patients without diabetes. A popular metric to quantify glucose variability is the mean amplitude of glycemic excursions (MAGE). The "ruler and pencil" approach to calculate MAGE is...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2013.0138
更新日期:2014-02-01 00:00:00
abstract:BACKGROUND:Persistent use of real-time continuous glucose monitoring (CGM) improves diabetes control in individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D). METHODS:PRECISE II was a nonrandomized, blinded, prospective, single-arm, multicenter study that evaluated the accuracy and safety of the implantable...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,多中心研究
doi:10.1089/dia.2017.0142
更新日期:2018-03-01 00:00:00
abstract::AIDA is a diabetes-computing program freely available from www.2aida.org on the Web. The software is intended to serve as an educational support tool, and can be used by anyone who has an interest in diabetes, whether they be patients, relatives, health-care professionals, or students. In previous "Diabetes Informatio...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/152091503763816490
更新日期:2003-01-01 00:00:00
abstract::The Exubera system (Pfizer, New York, NY/Nektar Therapeutics, San Carlos, CA) is an integration of five major new technologies: protein formulation, powder processing, powder filling, drug packaging, and delivery device. The product provides a simple interface, where the patient interacts only with the delivery device...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2007.0222
更新日期:2007-06-01 00:00:00
abstract:: Background: We aimed to explore insulin pump settings in breastfeeding women with type 1 diabetes. Methods: Thirteen unselected breastfeeding women with type 1 diabetes on insulin pump therapy were included consecutively from A...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2019.0280
更新日期:2020-04-01 00:00:00
abstract:BACKGROUND:Diabetic foot ulcer area is a basic parameter used for monitoring the wound healing and effectiveness of the treatment applied. TeleDiaFoS (developed earlier in collaboration with the Department and Clinic of Gastroenterology and Metabolic Diseases, Medical University of Warsaw, Warsaw, Poland) is one of jus...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2011.0082
更新日期:2011-11-01 00:00:00
abstract:BACKGROUND:Continuous glucose monitoring (CGM) has been shown to improve glycemic control and reduce hypoglycemia with consistent use. Youth, however, are unlikely to use CGM consistently. We compared psychological characteristics of youth with type 1 diabetes, their parents, and adults with type 1 diabetes randomized ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1089/dia.2011.0201
更新日期:2012-06-01 00:00:00
abstract:BACKGROUND:Weight gain often occurs when insulin therapy is initiated. The long-acting insulin analog insulin detemir has been shown to be effective and well tolerated when used in basal-bolus regimens or as an add-on to oral antidiabetic drugs (OADs) and causes less weight gain than other insulins. The aim of this exp...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1089/dia.2008.0282
更新日期:2008-08-01 00:00:00
abstract:BACKGROUND:Insulin pumps (for continuous subcutaneous insulin infusion [CSII]) are used widely in type 1 diabetes mellitus. Although there has been considerable study of outcomes, there are few recent data on CSII-associated adverse events and no data on family perceptions of adverse events and their confidence in deal...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2013.0315
更新日期:2014-04-01 00:00:00
abstract::The microdialysis technique allows extraction of substances (e.g., glucose) from fluids in the human body for quantitative measurements ex vivo. The microdialysis catheter can be inserted in many different tissues; for continuous glucose monitoring it is most often implanted in the subcutaneous fat tissue in the abdom...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/152091503322250578
更新日期:2003-01-01 00:00:00
abstract:OBJECTIVE:Hemoglobin A1c (A1C) has recently been recommended for diagnosing diabetes mellitus and diabetes risk (prediabetes). Its performance compared with fasting plasma glucose (FPG) and 2-h post-glucose load (2HPG) is not well delineated. We compared the performance of A1C with that of FPG and 2HPG in preoperative ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2011.0074
更新日期:2011-12-01 00:00:00
abstract:BACKGROUND:Lipohypertrophy (LH) is a complication of insulin therapy. We assessed LH prevalence, risk factors, insulin usage, and clinical and health economic effects in China. METHODS:In four cities, 401 adult patients injecting insulin ≥1 year were surveyed for diabetes/insulin injection history and practices, pen n...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2016.0334
更新日期:2017-01-01 00:00:00
abstract::On May 26, 1976, the Food and Drug Administration (FDA) began implementing the Medical Device Amendments to the Federal Food Drug and Cosmetic Act. These amendments give FDA specific authority to regulate "medical devices." Additional authority was provided in the Safe Medical Devices Act of 1990. The pathways to get ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/152091502321118784
更新日期:2002-01-01 00:00:00
abstract::Treatments for type 1 diabetes have advanced significantly over recent years. There are now multiple hybrid closed-loop systems commercially available and additional systems are in development. Challenges remain, however. This review outlines the recent advances in closed-loop systems and outlines the remaining challe...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2019.0469
更新日期:2020-07-01 00:00:00