Last update 21 Nov 2024

Recombinant human insulin(Zhuhai United Laboratories Co. Ltd.)

Last update 21 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Biosimilar, Hormone

Synonyms

Isophane Protamine Recombinant Human Insulin, Premixed Protamine Recombinant Human Insulin (30/70), Premixed Protamine Recombinant Human Insulin(50/50)

+ [10]

Target

INSR

Mechanism

INSR agonists(Insulin receptor agonists)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus

Inactive Indication-

Originator Organization

Zhuhai United Laboratories Co., Ltd.

Active Organization

Zhuhai United Laboratories Holding Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (25 Nov 2009),

Diabetes Mellitus

Regulation-

100 Clinical Results associated with Recombinant human insulin(Zhuhai United Laboratories Co. Ltd.)

100 Translational Medicine associated with Recombinant human insulin(Zhuhai United Laboratories Co. Ltd.)

100 Patents (Medical) associated with Recombinant human insulin(Zhuhai United Laboratories Co. Ltd.)

Literatures (Medical) associated with Recombinant human insulin(Zhuhai United Laboratories Co. Ltd.)

01 Nov 2014·Journal of the Medical Association of Thailand = Chotmaihet thangphaet

A prospective, longitudinal, multicenter, observational study to assess insulin treatment patterns in diabetic patients in Thailand: results from the TITAN Study.

Article

Author: Tannirandorn, Poj ; Pattanaungkul, Somchai ; Rawdaree, Petch ; Sarinnapakorn, Veerasak ; Khovidhunkit, Weerapan ; Peerapatdit, Thavatchai

OBJECTIVETo assess usage patterns, effectiveness, andsafety of newly prescribed insulin treatment in patients with diabetes in ThailandMATERIAL AND METHODType 1 or type 2 diabetes mellitus patients who failed achievement of HbA1c <7%, and were about to start or switch to a new insulin treatment were enrolled into this prospective, longitudinal, multicenter observational study. Data regarding insulin usage pattern, HbA1c, fasting plasma glucose (FPG), and hypoglycemia were collected at enrollment, three and six-month.RESULTSBetween July 2008 and February 2010, 751 patients were recruited Mean (SD) age was 57.0 (12.8) years. Mean BMI was 26.1 (5.0) kg/m2. At enrollment, 269 (35.8%), 241 (32.1%), 206 (27.4%), and 35 (4.7%) patients were prescribed neutral protamine Hagedorn (NPH) insulin, long-acting insulin analogues (LAA), premixed insulin (Premixed), and insulin combinations, respectively. Significant HbA1c and FPG reductions were noted at six-month (-1.4% and -56.2 mg/dl, respectively, p<0.01). After stratifying patients into three subgroups according to insulin, the patients could continue throughout six months (588 patients, 211 NPH-group, 201 LAA-group, and 176 Premixed-group). Patients in LAA-group attained higher rate of achievement HbA1c <7% without any hypoglycemia (18.9%) than NPH-group (7.1%) and Premixed-group (6.3%; p<0. 001). Mild-to-moderate hypoglycemic events were reported at 638 events (1.9 events/patient-year) while severe hypoglycemia was reported at 10 events (3.0 event/l00 patient-year).CONCLUSIONIn this observational study of real-life clinical practice in Thailand, most common newly prescribed insulin for patients having inadequate glycemic control was NPH, followed by LAA and premixed insulin. More patients on LAA achieved target HbA1c without hypoglycemic events than those on NPH and premixed insulin.

01 Jan 2005·Clinical TherapeuticsQ4 · MEDICINE

Efficacy of biphasic insulin aspart in patients with type 2 diabetes

Q4 · MEDICINE

Review

Author: Andreas Liebl ; Gao Yan ; Ryuzo Kawamori ; Philip Raskin ; Greg Fulcher ; Serge Halimi

BACKGROUNDIt is estimated that 39% of people with diabetes worldwide who use insulin are prescribed premixes, largely because of the practical advantages of addressing both prandial and basal insulin needs with a single product. Rapid-acting premixed insulin analogues such as biphasic insulin aspart 30 (BIAsp 30 [30% soluble insulin aspart and 70% protamine-crystallized insulin aspart], NovoLog Mix 70/30, Novo Nordisk, Bagsvaerd, Denmark) have been developed recently to overcome the pharmacokinetic limitations of regular human insulin used in the most commonly prescribed premix, biphasic human insulin 30 (BHI 30, 30% human insulin and 70% neutral protamine Hagedorn [NPH] insulin). It would be expected that these pharmacokinetic improvements would enhance clinical performance. However, the efficacy of BIAsp 30 compared with other common treatment regimens has not yet been systematically reviewed.OBJECTIVEThe aim of this paper is to review current data on the efficacy of BIAsp 30 in comparison with other treatment strategies in type 2 diabetes, including oral antidiabetic drugs (eg, metformin, sulfonylureas, meglitinides, thiazolidinediones), conventional insulins (eg, BHI 30, NPH insulin), and other analogue insulins (eg, insulin glargine, biphasic insulin lispro 25 [Mix 25, 25% biphasic insulin lispro and 75% protaminated lispro]). The focus will be on comparative efficacy (ie, postprandial glucose [PPG], blood glucose profiles, and glycosylated hemoglobin [HbA1c]).METHODSWe identified human clinical studies published through February 2005 involving BIAsp 30 in patients with type 2 diabetes by performing a MEDLINE search (key words: biphasic insulin aspart, BIAsp 30, biphasic insulin, and premixed insulin). Additional papers were identified by assessing (1) the reference lists in these studies, (2) published conference proceedings, and (3) our reference files. A total of 21 relevant papers were retrieved: 13 were published as full manuscripts, 1 as a short communication, 5 as abstracts, and 1 as a poster. One paper is currently in press. Novo Nordisk supplied data from an unpublished trial (Study 1536, 2004), as well as data from a trial published in abstract form only (Study 1269, 2002).RESULTSA regimen of BIAsp 30 BID, at breakfast and dinner, provides improved PPG control compared with BHI 30 BID, NPH BID, and insulin glargine OD for patients with type 2 diabetes. Fasting plasma glucose (FPG) with BIAsp 30 was not significantly different from FPG with insulin glargine; however, FPG was higher with BIAsp 30 than with NPH. BIAsp 30 prevented excessive PPG excursions whether it was injected at the beginning of a meal or < or =15 minutes after starting a meal. BIAsp 30 was not associated with an increased risk of major hypoglycemia compared with other insulin regimens used in the studies reviewed. The incidence of minor hypoglycemic events with BIAsp 30 varied across studies but occurred with frequency or risk similar to BHI 30, Mix 25, or NPH. Treat-to-target trials reported that BIAsp 30 can be used to intensify insulin therapy and to reach the glycemic target recommended by the American Diabetes Association (ie, HbA1c <7.0%). One study reported a greater lowering of postprandial triglyceride levels with BIAsp 30 than with BHI 30.CONCLUSIONSBIAsp 30 BID can reduce PPG levels to a greater extent than other common treatment regimens, including basal insulin OD. Using BIAsp 30, even once daily, may allow some patients to reach glycemic targets with a degree of convenience and tolerability that may not be achievable with other treatment regimens.

100 Deals associated with Recombinant human insulin(Zhuhai United Laboratories Co. Ltd.)

External Link

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	CN	Zhuhai United Laboratories Holding Ltd.	25 Nov 2009

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Recombinant human insulin(Zhuhai United Laboratories Co. Ltd.)

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Translational Medicine

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