Type 2 diabetes (T2DM) is a chronic metabolic disease characterized by insulin resistance and progressive decline of beta cell function. According to the data of International diabetes Federation (IDF) in 2024, the number of T2DM patients in the world has exceeded 537 million, while the number of Chinese patients has reached 143 million, ranking first in the world. In this vast patient population, relying solely on dietary control and exercise intervention often fails to achieve blood glucose targets - especially when the disease progresses to the middle and late stages of significant decline in beta cell function, drug intervention becomes an unavoidable necessity.
Lixisenatide injection emerged in response to this clinical demand. As a short acting GLP-1 receptor agonist developed by Sanofi Aventis, it contains 44 amino acids, with a molecular weight of approximately 4858.55 and a molecular formula of C215H347N61O65S1. Since its approval in Europe in 2013 and by the US FDA in 2016, the use of liraglutide has expanded from a single blood glucose control to a multi scenario, multi combination regimen covering the entire course of T2DM.
Lixisenatide COA
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| Certificate of Analysis | ||
| Compound name | Lixisenatide | |
| Grade | Pharmaceutical grade | |
| CAS No. | 320367-13-3 | |
| Quantity | 50g | |
| Packaging standard | PE bag+Al foil bag | |
| Manufacturer | Shaanxi BLOOM TECH Co., Ltd | |
| Lot No. | 202601090067 | |
| MFG | Jan 9th 2026 | |
| EXP | Jan 8th 2029 | |
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| Item | Enterprise standard | Analysis result |
| Appearance | White or almost white powder | Conformed |
| Water content | ≤5.0% | 0.58% |
| Loss on drying | ≤1.0% | 0.49% |
| Heavy Metals | Pb≤0.5ppm | N.D. |
| As≤0.5ppm | N.D. | |
| Hg≤0.5ppm | N.D. | |
| Cd≤0.5ppm | N.D. | |
| Purity (HPLC) | ≥99.0% | 99.98% |
| Single impurity | <0.8% | 0.68% |
| Total microbial count | ≤750cfu/g | 140 |
| E. Coli | ≤2MPN/g | N.D. |
| Salmonella | N.D. | N.D. |
| Ethanol (by GC) | ≤5000ppm | 400ppm |
| Storage | Store in a sealed, dark, and dry place below 2-8°C | |
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Use
Single drug therapy: blood glucose control based on diet and exercise
The primary indication of risilade is clearly marked as: as an auxiliary treatment of diet and exercise, it is used to improve the blood sugar control of adult patients with type 2 diabetes.
This positioning means that Liraglutide is not a substitute for lifestyle interventions, but rather provides additional medication support while patients have already implemented dietary control and regular exercise. This design concept is in line with the core principle of current T2DM treatment - lifestyle intervention is always the cornerstone, and medication is the 'bonus point' on this basis.
Its safety and effectiveness were systematically evaluated in 10 clinical trials, and 5400 patients with type 2 diabetes were recruited. In these trials, when used as a monotherapy, liraglutide significantly improved glycated hemoglobin (HbA1c) levels, with a reduction typically ranging from 0.4% to 0.6%.
The administration method is subcutaneous injection, once a day, and it is recommended to inject within 60 minutes before the first meal of the day. The design of this time window is not arbitrary - the pharmacokinetic characteristics of levocetirizine determine that it can maximize its ability to delay gastric emptying and inhibit postprandial blood glucose spikes when injected before meals. In addition, Liraglutide can also be used in conjunction with other medications or insulin, suitable for patients whose blood sugar levels can only be controlled through medication.
It is worth mentioning that the incidence of hypoglycemia is extremely low when treated with levocetirizine monotherapy. This is due to its glucose dependent mechanism of promoting insulin secretion - it only stimulates insulin release when blood sugar is elevated, and automatically "stops" when blood sugar is normal. This characteristic enables it to demonstrate safety advantages over sulfonylurea drugs in single drug scenarios.
Combination Metformin: The Optimal Solution for Frontline Upgrades
Metformin is the "gold standard" first-line medication for the treatment of T2DM, but about 30% -40% of patients still cannot achieve the goal of HbA1c<7% after monotherapy with metformin. At this point, the addition of levocetirizine has become one of the recommended upgrade strategies in clinical guidelines.
For patients who still have poor blood glucose control after receiving metformin monotherapy or combination therapy with sulfonylureas, liraglutide can be an effective complementary treatment. The combination logic of two drugs is clear: metformin inhibits glucose output from the liver and improves peripheral insulin resistance; Lixilalai delays glucose absorption from the intestine and promotes glucose dependent insulin secretion - the two mechanisms complement each other, intercepting high blood sugar from both the "source" and "end" simultaneously.
The key data comes from subgroup analysis of the GetGoal-M study:
| Indicator | Lixilalai+Metformin | Placebo+Metformin |
| Significant decrease in HbA1c | baseline | maintenance |
| Weight loss | without | change |
| Incidence of symptomatic hypoglycemia | 5% | extremely low |
More convincing is a head to head comparative study: only 5% of patients treated with liraglutide combined with metformin experienced symptomatic hypoglycemic events; During the same time period, the proportion of patients treated with exenatide combined with metformin was as high as 14.6%.
This comparison clearly indicates that the combination of liraglutide and metformin reduces the risk of hypoglycemia to an extremely low level while lowering blood sugar.
The reason lies in the short acting nature of Liraglutide - it quickly takes effect after a meal and is cleared within a few hours, unlike long-acting GLP-1RA which maintains a high blood concentration before the next meal, thus avoiding excessive suppression of blood sugar before the next meal.
This is one of the most distinctive and clinically valuable uses of Liraglutide, and it is also its core differentiation from other GLP-1 receptor agonists.
When the course of T2DM progresses to the stage where basal insulin therapy (such as glargine insulin and detemir insulin) is needed, patients often face a dilemma: increasing insulin dosage can lower fasting blood glucose, but it can increase weight and the risk of hypoglycemia; However, relying solely on basal insulin often cannot control the surge in postprandial blood sugar - this is precisely the "main battlefield" of Lisila.
A 24 week randomized controlled study of 495 patients with type 2 diabetes who used basic insulin but had poor blood glucose control gave a clear answer:
Indicator
The extent of HbA1c decrease
Weight changes
Daily insulin dosage
Symptomatic hypoglycemia
Severe hypoglycemia
Lixilalai+basal insulin
Significantly larger
decline
reduce
28%
1.2%
placebo+basal insulin
smaller
Unchanged/slightly increased
unchanged
22%
extremely low
P-value
<0.001
<0.001
0.023
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There are three core findings:
Firstly
The compliance rate has doubled. 28% vs. 12%, This means that with the addition of levocetirizine, more patients achieve the goal of HbA1c<7%.
Secondly
The dosage of insulin is reduced. Lysimab reduces the burden of basal insulin by controlling postprandial blood sugar, resulting in a decrease in daily insulin dosage - which directly lowers the risk of insulin related weight gain and hypoglycemia.
Thirdly
For participants with a history of basal insulin therapy, the incidence of symptomatic hypoglycemia in the liraglutide treatment group was approximately half that of the placebo group.
This counterintuitive result indicates that the combination of liraglutide and basal insulin is not a risk superposition of "1+1=2", but a risk hedge of "1+1<2".
Researchers have clearly pointed out that Liraglutide may serve as an alternative treatment to fast acting insulin or other hypoglycemic drugs, optimizing blood glucose control while reducing the need for multiple daily insulin injections. This conclusion provides a practical alternative pathway for the large number of patients in clinical practice who have poor basal insulin control but are unwilling/unable to increase postprandial insulin.
The core mechanism is that insulin glargine controls fasting blood glucose, while liraglutide controls postprandial blood glucose, with complementary time windows between the two; The glucose dependent secretagogue and weight loss effects of Lysimab perfectly offset the risk of hypoglycemia and weight gain caused by insulin - this is a synergistic strategy of "1+1>2".
Combination sulfonylurea drugs: strategic management is required
Sulfonylurea drugs (such as glimepiride and gliclazide) are classic second-line medications for T2DM, but their biggest weakness lies in non glucose dependent insulin secretion - regardless of blood sugar levels, they forcefully stimulate beta cells to release insulin, thus increasing the risk of hypoglycemia.
Hypoglycemia is indeed a side effect that needs attention in patients treated with combination therapy of liraglutide and/or basal insulin. But the data shows that this risk is not uncontrollable:
Hypoglycemic manifestations in subgroups of the population
Individuals with a history of sulfonylurea use have an increased risk and need to reduce their sulfonylurea dosage
The incidence of symptomatic hypoglycemia in patients with a history of basal insulin therapy in the Liraglutide group is about half of that in the placebo group.
Clear strategic points:
Patients with a history of sulfonylurea use:
When adding liraglutide, it should be considered to reduce the dosage of sulfonylureas by 25% -50% to avoid hypoglycemia caused by the combination of two secretion promoting mechanisms.
The initial dose is determined by reverse titration:
Starting from 10 μ g per day (1-2 weeks), gradually increasing to 20 μ g (starting from week 3), this progressive dosing strategy can minimize the risk of initial gastrointestinal reactions and hypoglycemia.
Not recommended to exceed 20 μ g/day:
Higher doses do not bring additional hypoglycemic benefits, but instead increase the risk of side effects.
The concept of "strategic combination" enables Lixilar to achieve safe and effective blood glucose control through reasonable dosage management even when used in combination with high and low blood glucose risk drugs.
In the multi drug combination therapy of T2DM, thiazolidinedione (TZD) drugs such as pioglitazone improve insulin resistance by activating PPAR γ receptors and are another important class of oral hypoglycemic drugs. However, the risk of weight gain and edema when used alone limits its application.
In the GetGoal Duo2 study, the combination therapy of liraglutide and pioglitazone also successfully achieved the primary endpoint, effectively improving HbA1c levels.
Indicator: Lixilalai+Pioglitazone placebo+Pioglitazone
The significant decrease in HbA1c is relatively small
Weight loss/stable increase (pioglitazone monotherapy effect)
The incidence of edema did not significantly increase compared to the baseline
The brilliance of this combination lies in the fact that pioglitazone improves insulin resistance but leads to weight gain, while liraglutide promotes weight loss - the two form a perfect hedge in weight management. At the same time, the gastrointestinal delaying effect of liraglutide and the insulin sensitizing effect of pioglitazone do not overlap in the hypoglycemic pathway, achieving multi mechanism synergistic hypoglycemic effects.
References
[1] Lixisenatide Injection
https://medlineplus.gov/druginfo/meds/a617005.html
[2] Lixisenatide
https://en.wikipedia.org/wiki/Lixisenatide
[5] ChemicalBook. Lixiralai, Lixisenatide, 320367-13-3. 2026-03-19 https://www.chemicalbook.com/SupplyInfo_958203.htm
[6] Dingxiangyuan The FDA approved Sanofi and Cicla for the treatment of type 2 diabetes 2016-07-29. http://yao.dxy.cn/article/500260
[8] ChemicalBook. Type 2 diabetes: Licila is the escort for safety 2020-11-14. https://www.chemicalbook.com/NewsInfo_17813.htm
[12] Diabetes Branch of Chinese Medical Association The combination of Liragliflozin and insulin glargine has a good hypoglycemic effect 2013-04-05. https://diab.cma.org.cn/cn/ncontent.aspx?oid=1530
Frequently Asked Questions
Is lixisenatide still available?
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Lixisenatide (Lyxumia®) 20micrograms/0.2ml solution for injection 3ml pre-filled disposable devices are being discontinued and stock will be exhausted by w/c 18th December 2023.
Does lixisenatide cause weight loss?
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The combined findings from a random-effects model demonstrated a significant reduction in body weight (WMD: -0.97 kg, 95 % CI: -1.10, -0.83, p < 0.001) and BMI (WMD: -0.48 kg/m2, 95 % CI: -0.67, -0.29, P < 0.001) after subcutaneous administration of Lixisenatide.
What is the other name for lixisenatide?
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Lixisenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist used in the treatment of type II diabetes mellitus (T2DM). It is sold by Sanofi-Aventis under the brand name Adlyxin in the US 3 and Lyxumia in the EU.
What does lixisenatide do?
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Lixisenatide injection is used to treat type 2 diabetes mellitus. Lixisenatide is used together with diet and exercise to help control your blood sugar. This medicine is a glucagon-like peptide-1 (GLP-1) receptor agonist. This medicine is available only with your doctor's prescription.
Is lixisenatide like Ozempic?
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Adlyxin (lixisenatide) and Ozempic (semaglutide) are both medications used to treat Type 2 diabetes and belong to the glucagon-like peptide-1 (GLP-1) receptor agonist class.
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