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Type 2 diabetes and basal insulin

Jeniece Trast Ilkowitz, Steven Choi, Michael L Rinke, Kathy Vandervoot, Rubina A Heptulla
BACKGROUND: Diabetes ketoacidosis (DKA) is a life-threatening complication of type 1 diabetes mellitus (T1DM). Reducing DKA admissions in children with T1DM requires a coordinated, comprehensive management plan. We aimed to decrease DKA admissions, 30-day readmissions, and length of stay (LOS) for DKA admissions. METHODS: A multipronged intervention was designed in 2011 to reach all patients: (1) increase insulin pump use and basal-bolus regimen versus sliding scales, (2) transform educational program, (3) increased access to medical providers, and (4) support for patients and families...
October 2016: Quality Management in Health 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
Nabil El Naggar, Sanjay Kalra
: Diabetes is a growing public health concern. Effective use of therapies for this chronic disease is necessary to improve long-term prognosis, but treatment adherence can be difficult to promote in clinical practice, and insulin, in particular, can impact both positively and negatively on patients' quality of life (QoL). Currently, guidelines advocate for QoL as a treatment goal in its own right, with treatment decisions based on patient concerns regarding injection frequency and adverse events, as well as glycemic control...
October 13, 2016: Advances in Therapy
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
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
G Grunberger, L Chen, A Rodriguez, F J Tinahones, S J Jacober, J Bue-Valleskey
AIMS: Basal insulin peglispro (BIL) has a longer duration of action than conventional insulin analogues and a hepato-preferential mechanism of action. This study assessed whether BIL was non-inferior to isophane insulin (NPH) in reducing HbA1c in insulin-naïve patients with type 2 diabetes, when added to pre-study oral anti-hyperglycaemic medications. MATERIALS AND METHODS: This was a Phase 3, open-label, treat-to-target (TTT), randomized trial with a 2-week lead-in, 26-week treatment and a 4-week safety follow-up period...
October 2016: Diabetes, Obesity & Metabolism
M S Abd El Aziz, M Kahle, J J Meier, M A Nauck
AIMS: To study differences in clinical outcomes between initiating glucagon-like peptide-1 receptor agonist (GLP-1 RAs) vs. insulin treatment in patients with type 2 diabetes treated with oral glucose-lowering medications (OGLM). METHODS: Prospective, randomized trials comparing GLP-1 RA and insulin treatment head-to-head as add-on to OGLM were identified (PubMed). Differences from baseline values were compared for HbA1c , fasting plasma glucose, body weight, blood pressure, heart rate and lipoproteins...
October 7, 2016: Diabetes, Obesity & Metabolism
Sonal Singh, Eugene E Wright, Anita Ym Kwan, Juliette C Thompson, Iqra A Syed, Ellen E Korol, Nathalie A Waser, Maria B Yu, Rattan Juneja
AIMS: Since 2005, several glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have been approved to treat people with type 2 diabetes. These agents are considered for use at the same point in the treatment paradigm as basal insulins. A comprehensive comparison of these drug classes, therefore, can help inform treatment decisions. This systematic review and meta-analysis assessed the clinical efficacy and safety of GLP-1 RAs compared with basal insulins. MATERIALS AND METHODS: MEDLINE, EMBASE, CENTRAL and PubMed databases were searched...
October 7, 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
Tim Heise, Eric Zijlstra, Leszek Nosek, Tord Rikte, Hanne Haahr
AIMS: Continuous subcutaneous insulin infusion (CSII) is increasingly used in patients with diabetes. Faster-acting insulin aspart (faster aspart) is insulin aspart (IAsp) in a new formulation with a faster time-action profile. We evaluated the pharmacological characteristics of faster aspart versus IAsp> during CSII. MATERIALS AND METHODS: In this randomised, double-blind, crossover trial, 48 men and women aged 18-64 years with type 1 diabetes mellitus (T1DM) received faster aspart and IAsp as a 0...
October 6, 2016: Diabetes, Obesity & Metabolism
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
Sang Ah Lee, Gwanpyo Koh, Suk Ju Cho, So Yeon Yoo, Sang Ouk Chin
BACKGROUND: Previous studies have reported that glypican-4 (GPC4) regulates insulin signaling by interacting with insulin receptor and through adipocyte differentiation. However, GPC4 has not been studied with regard to its effects on clinical factors in patients with type 2 diabetes mellitus (T2DM). We aimed to identify factors associated with GPC4 level in T2DM. METHODS: Between January 2010 and December 2013, we selected 152 subjects with T2DM and collected serum and plasma into tubes pretreated with aprotinin and dipeptidyl peptidase-4 inhibitor to preserve active gastric inhibitory polypeptide (GIP) and glucagon-like peptide 1 (GLP-1)...
September 2016: Endocrinology and Metabolism
Blake J Cochran, Liming Hou, Anil Paul Chirackal Manavalan, Benjamin M Moore, Fatiha Tabet, Afroza Sultana, Luisa Cuesta Torres, Shudi Tang, Sudichhya Shrestha, Praween Senanayake, Mili Patel, William J Ryder, Andre Bongers, Marie Maraninchi, Valerie C Wasinger, Marit Westerterp, Alan R Tall, Philip J Barter, Kerry-Anne Rye
Elevated pancreatic β-cell cholesterol levels impair insulin secretion and reduce plasma insulin levels. This study establishes that low plasma insulin levels have a detrimental effect on two major insulin target tissues: adipose tissue and skeletal muscle. Mice with increased β-cell cholesterol levels were generated by conditional deletion of the ATP binding cassette transporters, ABCA1 and ABCG1, in β-cells (β-DKO mice). Insulin secretion was impaired in these mice under basal and high glucose conditions and glucose disposal was shifted from skeletal muscle to adipose tissue...
October 4, 2016: Diabetes
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
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
Zulaykho Shamansurova, Paul Tan, Basma Ahmed, Emilie Pepin, Ondrej Seda, Julie L Lavoie
OBJECTIVE: We previously demonstrated that the handle-region peptide, a prorenin/renin receptor [(P)RR] blocker, reduces body weight and fat mass and may improve insulin sensitivity in high-fat fed mice. We hypothesized that knocking out the adipose tissue (P)RR gene would prevent weight gain and insulin resistance. METHODS: An adipose tissue-specific (P)RR knockout (KO) mouse was created by Cre-loxP technology using AP2-Cre recombinase mice. Because the (P)RR gene is located on the X chromosome, hemizygous males were complete KO and had a more pronounced phenotype on a normal diet (ND) diet compared to heterozygous KO females...
October 2016: Molecular Metabolism
Sanjay Kalra, Yashdeep Gupta
A variety of injectable therapies are now available for use in patients of type 2 diabetes mellitus, when metformin alone proves inadequate. These injectable therapies include basal insulins, glucagon-like peptide 1 receptor agonists (GLP1RA), co-formulations of basal insulin with GLP1RA, and premixed or co-formulated dual action insulins. This article helps choose appropriate first injectable therapy in a rational manner, and achieve glycaemic control in an efficient way. The discussion utilizes the pharmacokinetic and pharmacodynamic properties of various injectable drugs to match them with various clinical situations...
October 2016: JPMA. the Journal of the Pakistan Medical Association
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