Delving into the Latest Updates on Insulin glargine biosimilar(Tonghua Dongbao Pharmaceutical Co., Ltd.) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Hormone

Synonyms

Insulin Glargine, 甘精胰岛素生物类似药（通化东宝）, 长舒霖

Target

INSR

Mechanism

INSR agonists(Insulin receptor agonists)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus

Inactive Indication

Diabetes Mellitus, Type 2

Originator Organization

Tonghua Dongbao Pharmaceutical Co., Ltd.

Active Organization

Tonghua Dongbao Pharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (06 Dec 2019),

Diabetes Mellitus

Regulation-

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Gene Sequence

Sequence Code 4851

The sequence is quoted from: *****

Sequence Code 31960

The sequence is quoted from: *****

Over the past two decades, insulin glargine 100 U/mL (Gla-100) has emerged as the “standard of care” basal insulin for the management of type 1 diabetes mellitus (T1DM). Both formulations, insulin glargine 100 U/mL (Gla-100) and glargine 300 U/mL (Gla- 300) have been extensively studied against various comparator basal insulins across various clinical and real-world studies. In this comprehensive article, we reviewed the evidence on both insulin glargine formulations in T1DM across clinical trials and real-world studies.

Methods::

Evidence in T1DM for Gla-100 and Gla-300 since their approvals in 2000 and 2015, respectively, were reviewed.

Results::

Gla-100 when compared to the second-generation basal insulins, Gla-300 and IDeg-100, demonstrated a comparable risk of overall hypoglycemia, but the risk of nocturnal hypoglycemia was higher with Gla-100. Additional benefits of Gla-300 over Gla-100 include a prolonged (>24- hours) duration of action, a more stable glucose-lowering profile, improved treatment satisfaction, and greater flexibility in the dose administration timing.

Conclusion::

Both glargine formulations are largely comparable to other basal insulins in terms of glucose-lowering properties in T1DM. Further, risk of hypoglycemia is lower with Gla-100 than Neutral Protamine Hagedorn but comparable to insulin detemir.

01 Aug 2023·Diabetes care

Effects of Tirzepatide Versus Insulin Glargine on Cystatin C-Based Kidney Function: A SURPASS-4 Post Hoc Analysis.

Article

Author: Tuttle, Katherine R ; Pavo, Imre ; Hemmingway, Andrea ; Haupt, Axel ; Sattar, Naveed ; Heerspink, Hiddo J L ; Cherney, David Z I ; Duffin, Kevin L ; Wiese, Russell J ; Wilson, Jonathan M ; Yang, Zhengyu

OBJECTIVE:

Tirzepatide reduces HbA1c and body weight, and creatinine-based estimated glomerular filtration rate (eGFR) decline. Unlike creatine-derived eGFR (eGFR-creatinine), cystatin C-derived eGFR (eGFR-cystatin C) is unaffected by muscle mass changes. We assessed effects of tirzepatide on eGFR-creatinine and eGFR-cystatin C.

RESEARCH DESIGN AND METHODS:

Our primary outcome was eGFR change from baseline at 52 weeks with pooled tirzepatide (5, 10, and 15 mg) and titrated insulin glargine in adults with type 2 diabetes and high cardiovascular risk (SURPASS-4).

RESULTS:

Least squares mean (SE) eGFR-creatinine (mL/min/1.73 m2) changes from baseline with tirzepatide and insulin glargine were -2.5 (0.38) and -3.9 (0.38) (between-group difference, 1.4 [95% CI 0.3-2.4]) and -3.5 (0.37) and -5.3 (0.37) (between-group difference, 1.8 [95% CI 0.8-2.8]) for eGFR-cystatin C. Baseline, 1-year, and 1-year change from baseline values significantly correlated between eGFR-cystatin C and eGFR-creatinine. Measures of eGFR changes did not correlate with body weight changes.

CONCLUSIONS:

Tirzepatide slows the eGFR decline rate, supporting a kidney-protective effect.

01 Jul 2023·Clinical diabetes : a publication of the American Diabetes Association

Real-World Persistence, Adherence, Hypoglycemia, and Health Care Resource Utilization in People With Type 2 Diabetes Who Continued With the Second-Generation Basal Insulin Analog Insulin Glargine 300 Units/mL or Switched to a First-Generation Basal Insulin (Insulin Glargine 100 Units/mL or Detemir 100)

Article

Author: Preblick, Ronald ; Li, Xuan ; Edelman, Steven ; Goldman, Jennifer ; Gangi, Sumana ; Gill, Jasvinder ; Malone, Daniel C. ; Munaga, Kovida

People with type 2 diabetes receiving a second-generation basal insulin (BI) analog may be switched to a first-generation formulation for financial reasons or changes in health insurance. However, because second-generation BI analogs have more even pharmacokinetic profiles, longer durations of action (>24 vs. ≤24 hours), and more stable action profiles than first-generation BI analogs, such a change may result in suboptimal treatment persistence and/or adherence. This study compared treatment persistence, treatment adherence, rates of hypoglycemia, and health care resource utilization outcomes in people with type 2 diabetes who either continued treatment with the second-generation BI Gla-300 or switched to a first-generation BI. The study showed that continuing with Gla-300 was associated with a lower risk of discontinuing therapy, fewer emergency department visits, and lower hypoglycemia event rates than switching to a first-generation BI.

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

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