[Translation] Phase III study to evaluate the efficacy and safety of semaglutide injection (QLG2065) compared with Novotel® in patients with type 2 diabetes who have poor glycemic control after metformin treatment

评价司美格鲁肽注射液（QLG2065）对比诺和泰®对于二甲双胍治疗后血糖控制不佳的2型糖尿病患者（T2DM）的疗效相似性。

[Translation]

To evaluate the similarity of efficacy between semaglutide injection (QLG2065) and Novotel® in patients with type 2 diabetes mellitus (T2DM) whose blood sugar is poorly controlled after metformin treatment.

Start Date19 Jul 2023

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

NCT05950516 / Not yet recruitingPhase 3

Efficacy and Safety of Semaglutide Injection (QLG2065) vs. Ozempic® as add-on to Metformin in Type 2 Diabetics.

To evaluate the similarity of the efficacy and safety of semaglutide injection (QLG2065) vs. Ozempic® in patients with type 2 diabetes mellitus (T2DM) with poor blood glucose control after metformin treatment.

Start Date10 Jul 2023

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

CTR20230548 / CompletedNot Applicable

司美格鲁肽注射液人体药代动力学研究

[Translation] Study on the pharmacokinetics of semaglutide injection in healthy volunteers

主要研究目的研究空腹状态单次皮下注射受试制剂司美格鲁肽注射液与参比制剂司美格鲁肽注射液（诺和泰®）在健康成年受试者体内的药动学特征，评价两种制剂的生物等效性。次要研究目的研究受试制剂司美格鲁肽注射液与参比制剂“诺和泰®”在健康成年受试者中的安全性。

[Translation]

Main study objectives To study the pharmacokinetic characteristics of a single subcutaneous injection of the test preparation semaglutide injection and the reference preparation semaglutide injection (Novota®) in healthy adult subjects in the fasting state, and to evaluate the bioequivalence of the two preparations. Secondary study objectives To study the safety of the test preparation semaglutide injection and the reference preparation "Novota®" in healthy adult subjects.

Start Date28 Feb 2023

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

100 Clinical Results associated with Semaglutide (Qilu Pharmaceutical)

100 Translational Medicine associated with Semaglutide (Qilu Pharmaceutical)

100 Patents (Medical) associated with Semaglutide (Qilu Pharmaceutical)

Literatures (Medical) associated with Semaglutide (Qilu Pharmaceutical)

01 Oct 2023·Diabetology international

Glucose-lowering effects of semaglutide compared with dulaglutide using professional continuous glucose monitoring in outpatients with type 2 diabetes mellitus: a pilot study.

Article

Author: Saitoh, Momo ; Tanaka, Yoshiya ; Kurozumi, Akira ; Okada, Yosuke

ObjectiveCurrently, the most frequently prescribed once weekly glucagon-like peptide-1 receptor agonists (GLP-1RA) in Japan are dulaglutide (DG) and semaglutide (SG). However, little is known about the differences between these two compounds in clinical practice in Japan. This study compared the efficacy and safety of DG and SG using professional CGM in 12 patients attending our outpatient with poorly controlled type 2 diabetes mellitus (T2DM) while using GLP-1RA.MethodsThe study subjects were 12 T2DM patients with HbA1c ≥ 7.0% on treatment with 0.75 mg/week DG for at least 24 weeks. All patients wore the professional CGM twice, once while receiving DG and once when the SG dose was increased to 0.5 mg/week.ResultsTime in range was significantly better with SG than with DG, which was the main outcome measure. Regarding the secondary outcome measures, standard deviation of glucose, average sensor glucose, time above range, maximum sensor glucose, interquartile range, SD of glucose during the nocturnal period (0000-0559), and average nocturnal sensor glucose (0000-0559) were significantly better with SG than DG. In contrast, SG had no effect on the time below range and minimum sensor glucose compared to DG.ConclusionsSwitching from 0.75 mg DG to 0.5 mg SG in patients with T2DM improved glycemic variability, mean glycemic index, and daily variability without increasing the hypoglycemic index. The results suggest that switching to SG may be a useful option in patients experiencing inadequate glycemic control with DG.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13340-023-00640-2.

100 Deals associated with Semaglutide (Qilu Pharmaceutical)

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	NDA/BLA	CN	Qilu Pharmaceutical Co., Ltd.	15 Sep 2024

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