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Insuline Glargin

Ajay Kumar, Edward Franek, Jonathan Wise, Marcus Niemeyer, Henriette Mersebach, Rafael Simó
PURPOSE: The efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily (OD) compared with insulin glargine U100 (IGlar) OD over 52 weeks in insulin-naïve adults with type 2 diabetes mellitus (T2DM) was investigated. METHODS: In this open-label, parallel-group treat-to-target trial, participants were randomized (1:1) to receive IDegAsp OD (breakfast, n = 266) or IGlar OD (as per label, n = 264). Participants then entered a 26-week extension phase (IDegAsp OD, n = 192; IGlar OD, n = 221)...
2016: PloS One
Alexandre Baptista, Inês Teixeira, Sónia Romano, António Vaz Carneiro, Julian Perelman
OBJECTIVE: To conduct a systematic review of cost-effectiveness, cost-utility, and cost-benefit studies of DPP-4 inhibitors for diabetes treatment versus other antidiabetics. METHODS: Three investigators searched the CRD York, Tufts CEA Registry, and MEDLINE databases through 2015. We reviewed all potentially relevant titles and abstracts, and screened full-text articles, according to inclusion criteria. We established a quality score for each study based on a 35-item list...
October 17, 2016: European Journal of Health Economics: HEPAC: Health Economics in Prevention and Care
Tatsuhiko Urakami, Yusuke Mine, Masako Aoki, Misako Okuno, Junichi Suzuki
This study implemented a randomized crossover design to evaluate the efficacy and safety of switching from insulin glargine (IGlar) to insulin degludec (IDeg) in 18 children (11 males, 7 females; age 11.0 ± 0.5 years) with type 1 diabetes. All subjects had previously used IGlar once daily at bedtime. We compared fasting plasma glucose (FPG) and HbA1c levels, frequencies of overall and nocturnal (2200 h - 0659 h) hypoglycemia, and basal insulin dose at the baseline with those measured during a 24-week period during which IGlar or IDeg was administered in combination with pre-meal rapid acting insulin analogues...
October 14, 2016: Endocrine Journal
Katsunori Suzuki, Yurie Mitsuma, Takaaki Sato, Takumi Anraku, Mariko Hatta
BACKGROUND: Some patients with type 2 diabetes mellitus (T2DM) on insulin have poor glycemic control and require add-on therapy to reach target glucose values. Increased insulin doses or the addition of an oral antidiabetic drug (OAD) may improve glycemic control, but many patients fail to achieve target values. The aim of this study was to compare the treatment efficacy and safety of three different therapies in such patients. METHODS: T2DM outpatients with poor glycemic control (HbA1c ≥ 7...
November 2016: Journal of Clinical Medicine Research
Mehul R Dalal, Mahmood R Kazemi, Fen Ye
OBJECTIVE: To evaluate the impact of 6-month hypoglycemia on treatment discontinuation and hospitalization of patients initiating basal insulin for type 2 diabetes (T2D) in real-world practice. METHODS: This was a retrospective cohort study of patient-level data using electronic medical records (EMR) in the Predictive Health Intelligence diabetes dataset. Data from adult patients with T2D initiating basal insulin glargine, insulin detemir, or Neutral Protamine Hagedorn insulin between January 2008 and March 2014 were analyzed...
October 14, 2016: Current Medical Research and Opinion
B S Bal, Ashok Duggal, Mandeep Kaur, Umar Farooq, Harman Preet Singh
No abstract text is available yet for this article.
January 2016: Journal of the Association of Physicians of India
S J Jacober, M J Prince, J M Beals, M L Hartman, Y Qu, H Linnebjerg, P Garhyan, A Haupt
Basal insulin peglispro (BIL) is a novel basal insulin with a flat, prolonged activity profile. BIL has been demonstrated in a dog model, in healthy men and in patients with type 1 diabetes (T1D) to have significant hepato-preferential action resulting from reduced peripheral activity. In the IMAGINE-Phase 3 clinical trial program, more than 6000 patients were included, of whom ~3900 received BIL. Of the 7 pivotal IMAGINE trials, 3 studies were double-blinded and 3 were in T1D patients. BIL consistently demonstrated a greater HbA1c reduction, less glycaemic variability and a clinically relevant reduction in the rates of nocturnal hypoglycaemia across comparator [glargine and isophane insulin (NPH)] studies...
October 2016: Diabetes, Obesity & Metabolism
K Cusi, A J Sanyal, S Zhang, B J Hoogwerf, A M Chang, S J Jacober, J M Bue-Valleskey, A N Higdon, E J Bastyr, A Haupt, M L Hartman
AIMS: To compare effects of basal insulin peglispro (BIL), a hepatopreferential insulin, to insulin glargine (glargine) on aminotransferases and liver fat content (LFC) in patients with type 1 and type 2 diabetes (T1D, T2D). MATERIALS AND METHODS: Data from two Phase 2 and five Phase 3 randomized trials comparing BIL and glargine in 1709 T1D and 3662 T2D patients were integrated for analysis of liver laboratory tests. LFC, measured by magnetic resonance imaging (MRI) at baseline, 26 and 52 weeks, was analyzed in 182 T1D patients, 176 insulin-naïve T2D patients and 163 T2D patients previously treated with basal insulin...
October 2016: Diabetes, Obesity & Metabolism
S Mudaliar, R R Henry, T P Ciaraldi, D A Armstrong, P M Burke, J H Pettus, P Garhyan, S L Choi, M P Knadler, E C Q Lam, M J Prince, N Bose, N K Porksen, V P Sinha, H Linnebjerg, S J Jacober
AIMS: Basal insulin peglispro (BIL), a novel PEGylated basal insulin with a large hydrodynamic size, has a delayed absorption and reduced clearance that prolongs the duration of action. The current study compared the effects of BIL and insulin glargine (GL) on endogenous glucose production (EGP), glucose disposal rate (GDR) and lipolysis in patients with type 1 diabetes. MATERIALS AND METHODS: This was a randomized, open-label, four-period, crossover study. Patients received intravenous infusions of BIL and GL, each at two dose levels selected for partial and maximal suppression of EGP, during an 8 to 10 h euglycemic clamp procedure with d-[3-(3) H] glucose...
October 2016: Diabetes, Obesity & Metabolism
Milan Flekač, Jan Šoupal
Basal insulin has a clearly defined position in the recommendations for the treatment of patients with type 2 diabetes mellitus. General most common indication for administration is the addition in situation of the failure of noninsulin antidiabetic therapy or early insulin treatment of diabetes, as one of the second choice after metformin. In the recent years there is significant expansion of the range of antidiabetic drugs, including basal insulin analogues. In connection with the introduction of concentrated long-acting basal insulin analogues into the clinical practice many questions regarding clinical efficacy and safety raises especially comparing with the "classical" basal insulin analogues...
2016: Vnitr̆ní Lékar̆ství
Kathryn M Hurren, Jessica L O'Neill
Glargine 300 units/ml (Gla-300) is a novel basal insulin formulation approved in 2015 for the treatment of diabetes. This more concentrated form of glargine causes delayed redissolution from the subcutaneous depot after injection and thus altered action profile. Areas covered: The pharmacokinetics, pharmacodynamics, efficacy, and safety of Gla-300 in patients with type 1 diabetes mellitus (T1DM) will be reviewed. Expert opinion: Gla-300 has a flatter and more prolonged pharmacokinetic profile compared to glargine 100 units/ml (Gla-100), but is less potent on a unit per unit basis...
October 6, 2016: Expert Opinion on Drug Metabolism & Toxicology
R F Pollock, C K Tikkanen
BACKGROUND AND AIMS: Insulin degludec is an insulin analog with an ultra-long duration of action that exhibits less intra-patient variability in its glucose-lowering activity, and reduces nocturnal, overall, and severe hypoglycaemia relative to insulin glargine. The aim of the present study was to evaluate the cost-effectiveness of insulin degludec relative to insulin glargine in patients with: type 1 diabetes (T1D), type 2 diabetes receiving basal-only therapy (T2DBOT), and type 2 diabetes receiving basal-bolus therapy (T2DBB) in Denmark...
October 5, 2016: Journal of Medical Economics
Jennifer N Clements, Tiffaney Threatt, Eileen Ward, Kayce M Shealy
Concentrated insulin analogs have recently been approved and are available for clinical use in the management of diabetes mellitus. One new product is insulin glargine U-300 (Sanofi), a basal concentrated insulin of 300 U/mL. Several studies have been conducted and completed evaluating blood samples for the pharmacokinetics of insulin glargine U-300 and euglycemic clamp procedures for the pharmacodynamics. This concentrated insulin has a low within-day variability and high day-to-day reproducibility, allowing for a more constant and prolonged duration of action, compared with insulin glargine U-100 (100 U/mL)...
October 4, 2016: Clinical Pharmacokinetics
Prasad S Nishtala, Mohammed Saji Salahudeen
BACKGROUND: The global burden of diabetes is increasing worldwide. The aim of the study was to investigate the trends in use of antidiabetic medicines among older New Zealanders between 2005 and 2013, and to perform a separate analysis by age, sex, ethnicity, district health board domicile and socioeconomic deprivation index. METHODS: The study population included individuals' aged 65 years and older living in New Zealand (NZ) captured in the pharmaceutical collections...
October 2016: Therapeutic Advances in Drug Safety
Gerry Oster, Sean D Sullivan, Mehul R Dalal, Mahmood R Kazemi, Maria Rojeski, Carol H Wysham, Jennifer Sung, Bryan Johnstone, Anna M G Cali, L J Wei, Louise Traylor, Henry Anhalt, Michelle Hull, John Van Vleet, Luigi F Meneghini
OBJECTIVE: This study aims to compare the effectiveness of insulin glargine 300 U/mL (Gla-300) with its accompanying patient support program with that of other basal insulin and available patient support programs in patients with type 2 diabetes (T2D) in a real-world setting in terms of achieving HEDIS (Healthcare Effectiveness Data and Information Set) individualized glycemic targets without documented symptomatic hypoglycemia. STUDY DESIGN AND METHODS: Achieve Control is a US-based, multicenter, randomized, open-label, active-controlled, parallel group pragmatic Phase IV trial in insulin-naïve patients with T2D uncontrolled on ≥2 oral antidiabetes drugs (OAD) and/or glucagon-like peptide-1 receptor antagonists (GLP-1 RA)...
October 3, 2016: Postgraduate Medicine
Wenying Yang, Zhaojun Yang, Jing Zhao, Hai Lu, Tianhong Luo
BACKGROUND: A large proportion of patients with T2DM in China do not meet accepted HbA1c targets despite the availability of guidelines that describe a treatment pathway for achieving glycemic control. The aim of this study is to identify the fasting plasma glucose (FPG) target that will provide the highest control rate of HbA1c <7 % in Chinese patients with T2DM treated with an insulin glargine-based regimen as an adjunct to an established OAD regimen. This information will support improvements in diabetes care management in China...
September 26, 2016: Trials
Bo Zhang, Jing Zhao, Wenying Yang
BACKGROUND: In some circumstances, the premixed insulin should be switched to alternative therapy. The effectiveness and safety of switching from premixed insulin to insulin glargine plus oral antidiabetic drugs (OADs) in Chinese patients with type 2 diabetes mellitus (T2DM) have not been clarified, and will be assessed in this study. METHODS: Chinese patients with T2DM (2,013 men and women aged 18 to 75 years) who had received premixed insulin ± OADs for ≥ 3 months with glycated hemoglobin (HbA1c) ≤ 10% were enrolled in a prospective, observational study conducted at 53 hospitals across China...
September 26, 2016: Diabetes/metabolism Research and Reviews
Harald Pohlmeier, Lori Berard, Claire Brulle-Wohlhueter, Junlong Wu, Raphael Dahmen, Irene Nowotny, David Klonoff
BACKGROUND: Insulin glargine 300 U/mL (Gla-300) contains the same active ingredient as glargine 100 U/mL (Gla-100), and provides the same number of units in one-third of the volume. The SoloSTAR(®) injector pen has been modified to ensure accurate administration of this reduced volume and to improve user experience. METHODS: Insulin- and pen-naïve adults with type 2 diabetes (T2DM) inadequately controlled with oral antihyperglycemic drugs, who had glycated hemoglobin (HbA1c) levels of 7...
September 23, 2016: Journal of Diabetes Science and Technology
Arturo Rojas, Georgina Sposetti, Jorge L Gross, Douglas Eugenio Barbieri, Ran Duan, Bruno Linetzky, Janaina Martins De Lana, Oded Stempa, Angel Rodriguez
BACKGROUND: This post hoc analysis examined the efficacy and safety of twice-daily insulin lispro low mixture (LM25) and once-daily basal insulin glargine plus once-daily prandial insulin lispro (IGL) in a Latin American subpopulation with type 2 diabetes mellitus (T2DM). METHODS: A phase 4, randomized, open-label, parallel-arm trial included participants aged 18-75 years with T2DM taking once-daily insulin glargine and stable doses of metformin and/or pioglitazone with glycated hemoglobin (HbA1c) 7...
2016: Diabetology & Metabolic Syndrome
Vanita R Aroda, Julio Rosenstock, Carol Wysham, Jeffrey Unger, Diego Bellido, Guillermo González-Gálvez, Akane Takami, Hailing Guo, Elisabeth Niemoeller, Elisabeth Souhami, Richard M Bergenstal
OBJECTIVE: This study was conducted to demonstrate the efficacy and safety of LixiLan (iGlarLixi), a novel, titratable, fixed-ratio combination of insulin glargine (iGlar) (100 units) and lixisenatide, compared with iGlar in patients with type 2 diabetes inadequately controlled on basal insulin with or without up to two oral glucose-lowering agents. RESEARCH DESIGN AND METHODS: After a 6-week run-in when iGlar was introduced and/or further titrated, and oral antidiabetic drugs other than metformin were stopped, 736 basal insulin-treated patients (mean diabetes duration 12 years, BMI 31 kg/m(2)) were randomized 1:1 to open-label, once-daily iGlarLixi or iGlar, both titrated to fasting plasma glucose <100 mg/dL (<5...
September 20, 2016: Diabetes Care
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