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    Home > Active Ingredient News > Endocrine System > The Lancet: A large cohort phase 3 clinical study shows that Tirzepatide is better than insulin glargine in the treatment of type 2 diabetes

    The Lancet: A large cohort phase 3 clinical study shows that Tirzepatide is better than insulin glargine in the treatment of type 2 diabetes

    • Last Update: 2021-11-14
    • Source: Internet
    • Author: User
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    According to data released by the World Health Organization, in 2019, there were 1.
    5 million direct deaths from diabetes
    .

    In recent years, the prevalence and mortality of diabetes has gradually increased, and it has become a major health issue worldwide
    .

    Type 2 diabetes is caused by the body's inability to use insulin effectively
    .

    GLP-1 receptor agonist treatment can achieve glycemic control similar to or even better than that of basal insulin.
    Therefore, current guidelines recommend that GLP-1 receptor agonists are the first choice for the treatment of patients with type 2 diabetes
    .

    However, the use of GLP-1 receptor agonists alone can frequently cause gastrointestinal side effects
    .

    The treatment of type 2 diabetes thus opens up the combined use of GIP and GLP-1 receptor agonists
    .

    Tirzepatide, a new GIP and GLP-1 dual receptor agonist, is currently being developed for the treatment of type 2 diabetes
    .

    Compared with GLP-1 receptor agonists, Tirzepatide acts on pancreatic β cells to enhance insulin secretion, reduce glucagon secretion, and improve insulin sensitivity, thereby improving blood sugar control
    .

    In addition, Tirzepatide is related to the improvement of fat and lipoprotein metabolism, blood pressure and other cardiovascular protection markers
    .

    Tirzepatide can also significantly reduce appetite and weight loss
    .

    However, its long-term efficacy and safety are still unclear
    .

    Recently, Professor Stefano Del Prato from the Department of Clinical and Experimental Medicine at the University of Pisa in Italy and Professor Steven E Kahn from the University of Washington published a paper in The Lancet: Tirzepatide versus insulin glargine in type 2 diabetes and increasedcardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial
    .

    The team evaluated the efficacy and safety of insulin glargine and Tirzepatide and found that in people with type 2 diabetes and high cardiovascular risk, compared with long-term insulin glargine treatment, long-term treatment of Tirzepatide has a more significant and lower blood sugar control effect.
    The incidence of blood sugar is lower and the safety is higher
    .

    DOI: https://doi.
    org/10.
    1016/S0140-6736(21)02188-7 Researchers conducted a randomized, open, controlled, parallel phase 3 clinical study in 187 cities in 14 countries on five continents
    .

    The study was launched on November 20, 2018 and completed on April 22, 2021
    .

    The included type 2 diabetes patients were adults with poor blood sugar control (glycated hemoglobin [HbA1c] 7.
    5-10.
    5% [58-91 mmol/mol]) and had a higher risk of cardiovascular events
    .

    The trial screened a total of 3045 patients, of which 2002 patients were randomly assigned to receive Tirzepatide or insulin glargine treatment
    .

    Tirzepatide is injected subcutaneously (5 mg, 10 mg, or 15 mg) once a week
    .

    Insulin glargine was injected subcutaneously once a day (3 mL, U100/mL), and was administered before going to bed
    .

    During the treatment, the dose is adjusted according to the situation
    .

    There were 329 cases in the Tirzepatide 5 mg group, 328 cases in the Tirzepatide 10 mg group, 338 cases in the Tirzepatide 15 mg group, and 1000 cases in the insulin glargine group
    .

    Among them, 1819 (91%) participants were still receiving study medication at 52 weeks
    .

    In total, 1801 (90%) of the 1995 participants completed the study, and 1706 (85%) completed the study treatment
    .

    At the end of the study, 109 participants had a MACE-4 event
    .

    Experimental design At 52 weeks, HbA1c decreased by 2.
    24% in the Tirzepatide 5 mg group, 2.
    43% in the 10 mg group, 2.
    58% in the 15 mg group, and 1.
    44% in the insulin glargine group
    .

    The HbA1c level in the Tirzepatide treatment group continued to decrease for 104 weeks
    .

    Compared with insulin glargine, the average daily, pre- and post-prandial blood glucose levels in the Tirzepatide group were lower than baseline
    .

    These results indicate that Tirzepatide is more effective than insulin glargine
    .

    In addition to blood sugar, the researchers found that at 52 weeks, the average systolic and diastolic blood pressure of the Tirzepatide group decreased, while the insulin glargine group increased
    .

    Serum triglycerides, low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol levels in the Tirzepatide group decreased in a dose-dependent manner
    .

    During the entire study period, 60 cases died, including 25 cases in the Tirzepatide group and 35 cases in the insulin glargine group; the researchers believed that they had nothing to do with the study drug
    .

    Compared with the insulin glargine group, the Trirzepatide group did not increase the risk of MACE-4 events (cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina)
    .

    The gastrointestinal side effects of patients in the Tirzepatide group, such as nausea, vomiting, and diarrhea, were mild to moderate
    .

    Moreover, compared with the dose escalation phase, the gastrointestinal side effects that occurred in the later stage of the study were less severe
    .

    In addition, 33-38% of Tirzepatide patients and 64% of insulin glargine patients developed severe hypoglycemia
    .

    Time of first appearance of MACE-4 Generally speaking, in people with type 2 diabetes and high cardiovascular risk, Tirzepatide has shown superiority and sustainability in overall blood sugar control and weight loss compared with insulin glargine
    .

    As the condition of type 2 diabetes continues to progress, evaluating the persistence of blood glucose and weight regulation of insulinotropic receptor agonists (such as Tirzepatide) is critical to the efficacy and prognosis
    .

    We hope that in the future, researchers will develop more drugs that are as safe, effective and affordable as Tirzepatide, which will benefit millions of diabetic patients
    .

    End Reference: [1]https://
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