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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
Helle Linnebjerg, Eric Chen Quin Lam, Xin Zhang, Mary E Seger, David Coutant, Laiyi Chua, Christoph Kapitza, Tim Heise
AIMS: LY2963016 (LY IGlar) and Lantus (IGlar) are insulin glargine products manufactured by distinct processes, but with identical amino acid sequences. This study compared the duration of action of LY IGlar and IGlar in subjects with type 1 diabetes mellitus (T1DM). MATERIALS AND METHODS: This was a randomized, double-blind, single-dose, two-period, crossover study. Twenty subjects underwent 42-hour euglycaemic clamps after a single subcutaneous 0.3-U/kg dose of LY IGlar or IGlar...
January 2017: Diabetes, Obesity & Metabolism
Melanie J Davies, Divina Glah, Barrie Chubb, Gerasimos Konidaris, Phil McEwan
OBJECTIVES: Once-daily insulin degludec/liraglutide (IDegLira) is the first basal insulin and glucagon like peptide-1 receptor agonist combined in one delivery device. Our aim was to investigate the cost effectiveness of IDegLira vs. basal insulin intensification therapies for patients with type 2 diabetes mellitus uncontrolled on basal insulin (glycosylated haemoglobin; HbA1c >7.5 %; 58 mmol/mol) in a UK setting. RESEARCH DESIGN AND METHODS: Baseline cohort and clinical parameters were sourced from a pooled analysis comparing IDegLira with basal insulin plus liraglutide and basal-bolus therapy, and from the DUAL™ V trial comparing IDegLira with up-titrated insulin glargine (IGlar; Lantus(®))...
September 2016: PharmacoEconomics
Alexandra Shields, Sailesh Sankaranarayanan
An active 28-year-old man with type 1 diabetes mellitus reported a reduced number of hypoglycaemic episodes following change in basal regime insulin glargine from U100 Lantus to U300 Toujeo. Consequently, an improved quality of life was also reported. Flash-based glucose monitoring was utilised to record 24-hour continuous glucose levels throughout two comparable 60-day periods before and after the change in regimen. Low blood glucose was most likely between 03:00 and 08:00. Nocturnal hypoglycaemic episodes (≤3...
June 15, 2016: BMJ Case Reports
A J Scheen
This article presents a new formulation of insulin glargine concentrated at 300 U/mL (Gla-300). It is commercialized under the trade name of Toujeo® in an optimized pre-filled SoloStar™ pen for the treatment of type 1 and type 2 diabetes in adults. Besides a threefold higher concentration compared to the classical insulin Lantus® (100 U/mL or Gla-100), both pharmacokinetic and pharmacodynamic profiles of Gla-300 are flatter and longer (more than 24 hours) and have a lesser intra-/inter-variability, which makes them more reproducible...
February 2016: Revue Médicale de Liège
Albrecht Fiesselmann, Tobias Wiesner, Holger Fleischmann, Peter Bramlage
AIMS: The addition of a single injection of insulin to the oral drugs (basal supported oral therapy; BOT) has been shown to greatly reduce blood glucose levels. The intermediate-acting NPH insulin (NPH) and the long-acting insulin glargine (Lantus(®)) have been compared for use in BOT in numerous clinical trials; however, their efficacy and safety in a real-life setting have not been described. METHODS: TIP (therapeutic benefits of patients on insulin glargine vs...
October 2016: Acta Diabetologica
Hannah A Blair, Gillian M Keating
Insulin glargine 300 U/mL (Toujeo(®)) is a long-acting basal insulin analogue approved for the treatment of diabetes mellitus. Insulin glargine 300 U/mL has a more stable and prolonged pharmacokinetic/pharmacodynamic profile than insulin glargine 100 U/mL (Lantus(®)), with a duration of glucose-lowering activity exceeding 24 h. In several 6-month phase III trials, insulin glargine 300 U/mL achieved comparable glycaemic control to that seen with insulin glargine 100 U/mL in patients with type 1 or type 2 diabetes, albeit with consistently higher daily basal insulin requirements...
March 2016: Drugs
L L Ilag, M A Deeg, T Costigan, P Hollander, T C Blevins, S V Edelman, R J Konrad, R A Ortmann, R K Pollom, W J Huster, J S Zielonka, M J Prince
AIMS: To compare the immunogenicity profiles and the potential effects on clinical outcomes of LY2963016 insulin glargine (LY IGlar) and Lantus® insulin glargine (IGlar), products with identical primary amino acid sequences, in patients with type 1 or type 2 diabetes mellitus (T1DM or T2DM). METHODS: To assess immunogenicity, anti-insulin glargine antibodies (measured as percent binding) were compared between treatments in 52-week (open-label) and 24-week (double-blind) randomized studies in total study populations of patients with T1DM (N = 535) and T2DM (N = 756), respectively, and two subgroups of patients with T2DM: insulin-naïve patients and those reporting prestudy IGlar treatment (prior IGlar)...
February 2016: Diabetes, Obesity & Metabolism
Helle Linnebjerg, Eric Chen Quin Lam, Mary E Seger, David Coutant, Laiyi Chua, Chew Lan Chong, Maria M Ferreira, Danny Soon, Xin Zhang
OBJECTIVE: LY2963016 (LY IGlar) and Lantus (IGlar) are insulin glargine products manufactured by distinct processes but with identical amino acid sequences. Three studies evaluated the pharmacokinetic (PK) and pharmacodynamic (PD) similarity of LY IGlar and the European Union- and US-approved versions of IGlar. RESEARCH DESIGN AND METHODS: These were three single-site, randomized, double-blind, two-treatment, four-period, crossover, euglycemic clamp studies. In each study, fasted healthy subjects received 0...
December 2015: Diabetes Care
Shoko Tsukube, Yukio Ikeda, Takashi Kadowaki, Masato Odawara
INTRODUCTION: This study aimed to assess treatment satisfaction and self-reported health status in insulin-naïve patients with type 2 diabetes mellitus (T2DM) who started insulin glargine basal-supported oral therapy (BOT) with glycated hemoglobin (HbA1c) value of ≥6.5%, using data from Add-on Lantus(®) to Oral Hypoglycemic Agents 2 (ALOHA2) study, a 24-week single-arm, observational study of Japanese patients with T2DM, conducted as drug use surveillance in Japan. METHODS: Treatment satisfaction was measured using the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) and change version (DTSQc) and self-reported health status using EuroQol 5 Dimension (EQ-5D)...
June 2015: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
T C Blevins, D Dahl, J Rosenstock, L L Ilag, W J Huster, J S Zielonka, R K Pollom, M J Prince
AIMS: To compare the efficacy and safety of LY2963016 insulin glargine (LY IGlar) and the reference product (Lantus®) insulin glargine (IGlar) in patients with type 1 diabetes (T1D). METHODS: This phase III, randomized, open-label, 52-week study enrolled patients with T1D [glycated haemoglobin (HbA1c) ≤11%] being treated with basal (once-daily) and bolus insulin. Patients were randomized to receive once-daily LY IGlar (n = 268) or IGlar (n = 267) in combination with mealtime insulin lispro for 52 weeks...
August 2015: Diabetes, Obesity & Metabolism
J Rosenstock, P Hollander, A Bhargava, L L Ilag, R K Pollom, J S Zielonka, W J Huster, M J Prince
AIMS: To compare the efficacy and safety of LY2963016 insulin glargine (LY IGlar) and the reference product (Lantus(®)) insulin glargine (IGlar) in combination with oral antihyperglycaemic medications in patients with type 2 diabetes (T2D). METHODS: This phase III, randomized, double-blind, 24-week study enrolled patients with T2D who were insulin-naïve [glycated haemoglobin (HbA1c) ≥7 and ≤11.0%] or previously on IGlar (HbA1c ≤11%) and treated with ≥2 oral antihyperglycaemic medications...
August 2015: Diabetes, Obesity & Metabolism
Masato Odawara, Takashi Kadowaki, Yusuke Naito
AIMS: The aim of this study is to evaluate effectiveness and safety of basal supported oral therapy (BOT) using insulin glargine in insulin-naive Japanese patients, with and without microvascular complications. METHODS: This sub-group analysis of observational, non-interventional ALOHA study, assessed changes in glycemic parameters and glargine dose, at 24weeks or at glargine discontinuation. Count of hypoglycemic episodes was based on physicians' documentation of patient reports...
January 2015: Journal of Diabetes and its Complications
Denisa Janíčková Zďarská, Jan Brož, Bohumila Křivská, Zdeněk Rušavý, Milan Kvapil
OBJECTIVE: To evaluate the safety and efficacy of basal insulin glargine using a basal-bolus regimen in a common clinical practice setting in the Czech Republic. PATIENTS AND METHODS: The LINDA project was a non-interventional, multicenter (n = 255), national, observational project. A total of 4,998 patients with Type 1 and 2 diabetes mellitus (T1DM, T2DM) with predominantly insulin therapy (99,7 %), after switch on insulin glargine at basal-bolus regimen, were enrolled in this project...
September 2014: Vnitr̆ní Lékar̆ství
Yixuan Sun, Li Shao, Xianping Niu, Yue Liu, Jianli Ge, Hua Jiang, Hua Zhang
OBJECTIVE: To compare the treatment effects of Novolin® 30R(a), versus Lantus(®a) combined with acarbose (Glucobay®), in elderly patients with type 2 diabetes mellitus. METHODS: Patients (aged > 60 years) with type 2 diabetes mellitus were randomized to receive either Novolin® 30R(a) (initial dose 0.5 IU/kg) or Lantus(®a) (initial dose 0.2 IU/kg) combined with 50 mg acarbose. After a 32-week treatment period, the following parameters were measured: blood glucose control; blood lipid levels; body mass index; proportion of patients achieving a glycosylated haemoglobin (HbA1c) level <7...
August 2014: Journal of International Medical Research
A Steinstraesser, R Schmidt, K Bergmann, R Dahmen, R H A Becker
Insulin glargine is processed in vivo into soluble 21(A) -Gly-human insulin (M1), the principal moiety responsible for metabolic effects, and subsequently into M2. This sub-study compared metabolism and metabolite pharmacokinetic (PK) profiles of investigational new insulin glargine U300 (Gla-300) with insulin glargine 100 U/ml (Gla-100, Lantus®, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany) in people with type 1 diabetes. Participants received 0.4 (n = 18) or 0.6 U/kg Gla-300 (n = 12), and 0...
September 2014: Diabetes, Obesity & Metabolism
Masato Odawara, Takashi Kadowaki, Yusuke Naito
BACKGROUND: Add-on Lantus® to Oral Hypoglycemic Agents (ALOHA), an observational, non-interventional, 24-week post-marketing surveillance study in Japanese patients with type 2 diabetes (T2DM) having uncontrolled glycemic control, demonstrated that basal supported oral therapy (BOT) with insulin glargine was an effective and safe treatment in real-life clinical practice. We performed subgroup analysis to identify incidence and predictors associated with risk of hypoglycemia. METHODS: Among 4219 patients with T2DM, 3732 patients were insulin-naïve and 487 patients were insulin non-naïve who switched from other insulin to insulin glargine...
2014: Diabetology & Metabolic Syndrome
L Malardé, A Gratas-Delamarche, S Le Douairon-Lahaye, M S Zguira, S Vincent, S Lemoine-Morel, C Groussard
In type 1 diabetic subjects, hyperglycemia-induced oxidant stress (OS) plays a central role in the onset and development of diabetes complications. This study aimed to assess the benefits of an endurance training program and insulin therapy, alone or in combination, on the glycemic regulation, markers for OS, and antioxidant system in diabetic rats. Forty male Wistar rats were divided into diabetic (D), insulin-treated diabetic (D-Ins), diabetic trained (D-Tr), or insulin-treated diabetic trained (D-Ins+ Tr) groups...
April 2014: Free Radical Research
L Malardé, A Rebillard, S Le Douairon-Lahaye, S Vincent, M S Zguira, S Lemoine-Morel, A Gratas-Delamarche, C Groussard
Superoxide (O 2 (·-) ) overproduction, by decreasing the nitric oxide ((·)NO) bioavailability, contributes to vascular complications in type 1 diabetes. In this disease, the vascular O 2 (·-) can be produced by the NADPH oxidase (NOX), nitric oxide synthase (NOS), and xanthine oxidase (XO). This study aimed to determine the contribution of each enzymatic pathway in hyperglycemia-induced O 2 (·-) overproduction, and the effects of an endurance training program and insulin therapy, associated or not, on the O 2 (·-) production (amount and related enzymes) in diabetic rats...
April 2014: Molecular and Cellular Biochemistry
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