[Translation] A multicenter, randomized, open, parallel-group, NovoRapid 30-controlled, phase III clinical study to evaluate the efficacy and safety of insulin aspart 30 injection in the treatment of type 2 diabetes

以原研同类产品诺和锐30为对照评价试验药物门冬胰岛素30注射液治疗2型糖尿病的有效性和安全性

[Translation]

To evaluate the efficacy and safety of the experimental drug insulin aspart 30 injection in the treatment of type 2 diabetes using the original similar product NovoRapid 30 as a control

Start Date10 Oct 2018

Sponsor / Collaborator

Tonghua Dongbao Pharmaceutical Co., Ltd.

CTR20160331 / CompletedPhase 3

门冬胰岛素50注射液治疗糖尿病的有效性和安全性的Ⅲ期临床研究

[Translation] Phase III clinical study on the efficacy and safety of insulin aspart 50 injection in the treatment of diabetes mellitus

与诺和锐50对照评价门冬胰岛素50注射液治疗糖尿病的有效性和安全性

[Translation]

Comparison of the efficacy and safety of insulin aspart 50 injection with NovoRapid 50 in the treatment of diabetes mellitus

Start Date22 Jul 2016

Sponsor / Collaborator

Tonghua Dongbao Pharmaceutical Co., Ltd.

CTR20150361 / CompletedPhase 3

评价门冬胰岛素注射液治疗糖尿病的有效性和安全性的Ⅲ期临床研究

[Translation] Phase III clinical study to evaluate the efficacy and safety of insulin aspart injection in the treatment of diabetes mellitus

与诺和锐@相比较评价门冬胰岛素注射液治疗糖尿病的有效性和安全性

[Translation]

Comparison of the efficacy and safety of insulin aspart injection with NovoRapid in the treatment of diabetes mellitus

Start Date19 Jun 2015

Sponsor / Collaborator

Tonghua Dongbao Pharmaceutical Co., Ltd.

100 Clinical Results associated with Insulin aspart biosimilar(Tonghua Dongbao Pharmaceutical Co., Ltd.)

100 Translational Medicine associated with Insulin aspart biosimilar(Tonghua Dongbao Pharmaceutical Co., Ltd.)

100 Patents (Medical) associated with Insulin aspart biosimilar(Tonghua Dongbao Pharmaceutical Co., Ltd.)

Literatures (Medical) associated with Insulin aspart biosimilar(Tonghua Dongbao Pharmaceutical Co., Ltd.)

01 Nov 2003·Clinical TherapeuticsQ4 · MEDICINE

A multicenter, randomized, open-label, comparative, two-period crossover trial of preference, efficacy, and safety profiles of a prefilled, disposable pen and conventional vial/syringe for insulin injection in patients with type 1 or 2 diabetes mellitus

Q4 · MEDICINE

Article

Author: FlexPen® Study Team ; Carol Jacobsen ; David Bell ; Rudee Suwannasari ; Mary Korytkowski

BACKGROUNDThe accuracy and convenience of pen devices for insulin injection have improved quality of life for patients with insulin-treated diabetes mellitus (DM). Prefilled, disposable pens have the advantage of simplicity, with minimal training and attention required and no installation of new cartridges necessary.OBJECTIVEThe aim of this study was to assess patient preference, efficacy, and safety profiles of a prefilled, disposable pen (FlexPen) and conventional vial/syringe injection method for insulin injection therapy among patients with DM.METHODSIn a multicenter, randomized, open-label, crossover study, patients with type 1 or 2 DM were transferred from previous QD or BID conventional insulin therapy to a mixture of 70% insulin aspart protamine suspension and 30% insulin aspart injection (NovoLog Mix 7030) for 4 weeks of dose optimization using their usual type of syringe. Patients were then randomly assigned to use either vial/syringe or a prefilled, disposable pen to inject the biphasic insulin aspart 7030 mixture for the next 4 weeks, followed by 4 weeks of use of the other injection device. Efficacy, safety profiles, and patient preference for the delivery systems were compared.RESULTSA total of 121 patients (mean [SD] age, 57.0 [12.4] years; age range, 28-81 years; mean [SD] body mass index, 31 [5.5] kg/m(2)) were enrolled. One hundred three patients completed the study. Seventy-four percent of patients (78105) indicated a preference for the pen over the vial/syringe method (95% CI, 71%-87%), compared with 20% (21105) who preferred the vial/syringe. Eighty-five percent (88104) considered the pen more discreet for use in public (compared with 9% [9104] for the vial/syringe), 74% (77104) considered it easier to use overall (compared with 21% [22104] for the vial/syringe), and 85% (89105) found the insulin dose scale on the pen easier to read (compared with 10% [10105] for the vial/syringe). Patients had statistically significant improvement in glycosylated hemoglobin values during the study (P < 0.05). No statistically significant differences in fasting plasma glucose, mean 4-point blood glucose profiles, or serum fructosamine values were found between groups. Overall, the safety profiles during treatment periods with the pen were comparable to those with the vial/syringe.CONCLUSIONSIn this trial, differences in efficacy and safety profiles between the vial/syringe and prefilled, disposable pen appeared negligible. However, more patients expressed a preference to continue use of the pen.

100 Deals associated with Insulin aspart biosimilar(Tonghua Dongbao Pharmaceutical Co., Ltd.)

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	CN	Tonghua Dongbao Pharmaceutical Co., Ltd.	25 Oct 2021
Diabetes Mellitus, Type 1	CN	Tonghua Dongbao Pharmaceutical Co., Ltd.	19 Oct 2021

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