Pramlintide injection is an injection drug used to treat type 1 and type 2 diabetes. It is usually used as an auxiliary treatment of insulin to help patients better control their glycemic index level, especially after meals.
Usually administered by subcutaneous injection, the injection site can be chosen from the lower edge of the deltoid muscle in the upper arm, the abdominal walls on both sides, the back, or the front and outer thighs. During use, Pramlintide should not be mixed with insulin and should be administered separately. The dosage should be adjusted according to the specific situation of the patient. The initial dose is usually low, and then gradually increases based on the patient's tolerance and glycemic index control.
Products Description
Pramlintide COA
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| Certificate of Analysis | ||
| Compound name | Pramlintide | |
| Grade | Pharmaceutical grade | |
| CAS No. | 151126-32-8 | |
| Quantity | 60g | |
| Packaging standard | PE bag+Al foil bag | |
| Manufacturer | Shaanxi BLOOM TECH Co., Ltd | |
| Lot No. | 202601090066 | |
| MFG | Jan 9th 2026 | |
| EXP | Jan 8th 2029 | |
| Structure |
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| Item | Enterprise standard | Analysis result |
| Appearance | White or almost white powder | Conformed |
| Water content | ≤5.0% | 0.54% |
| Loss on drying | ≤1.0% | 0.42% |
| 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% | 0.52% |
| Total microbial count | ≤750cfu/g | 95 |
| E. Coli | ≤2MPN/g | N.D. |
| Salmonella | N.D. | N.D. |
| Ethanol (by GC) | ≤5000ppm | 500ppm |
| Storage |
Store in a sealed, dark, and dry place below -20°C |
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It is an artificially synthesized analog of amygdalin that plays multiple regulatory roles in glycemic index management by simulating the physiological effects of endogenous amygdalin. Its core use focuses on the adjuvant treatment of type 2 diabets patients, especially for patients who use insulin but have poor glycemic index control.
Clinical application: adjuvant treatment of type 2 diabetes
Pramlintide injection, as a synthetic analog of human amyloid polypeptide (Amylin), its core indication is an auxiliary drug for insulin treatment in patients with type 2 diabets, especially suitable for the following three special groups. By simulating the physiological effects of endogenous pancreatic amyloid peptides and regulating glycemic index metabolism from multiple targets, not only can glycemic index control be significantly improved, but also weight management and intervention for metabolic syndrome can be considered, providing an important supplement to traditional treatment plans.
1. Poor glycemic index control with insulin alone or in combination with oral medications (such as sulfonylureas, metformin)
Current Situation and Challenges
When type 2 diabets progresses to the middle and late stages, the function of pancreatic islet β cells declines significantly, and the insufficiency of endogenous insulin secretion becomes the main contradiction. At this point, oral hypoglycemic drugs alone (such as sulfonylureas stimulating insulin secretion and metformin reducing hepatic glucose output) often struggle to maintain glycemic index levels. Although combined insulin therapy can partially compensate for secretion deficiencies, some patients still cannot control glycated hemoglobin (HbA1c) below 7% even with a basal meal time insulin enhancement regimen (such as glargine insulin combined with aspart insulin).
In addition, as insulin dosage increases, the risk of hypoglycemia (especially nocturnal hypoglycemia) and weight gain become increasingly prominent, forming a vicious cycle of "hyperglycemia hypoglycemia weight gain".
Mechanism of action and advantages
This substance precisely fills the gaps in existing treatment plans by inhibiting glucagon secretion, delaying gastric emptying, and enhancing satiety through three mechanisms:
Inhibition of glucagon secretion: Directly blocking the secretion of glucagon by pancreatic alpha cells reduces liver glucose output, thereby reducing fasting glycemic index fluctuations.
Delayed gastric emptying: Through vagus nerve mediated relaxation of the gastric fundus and body, the absorption rate of carbohydrates is slowed down, resulting in a smoother postprandial glycemic index peak.
Central appetite suppression: activates the hypothalamic satiety center (such as the arcuate nucleus and paraventricular nucleus), reduces hunger, lowers daily calorie intake by approximately 300-500kcal, and assists in weight control.
Clinical evidence
In a 52 week randomized controlled trial (RCT, NCT00093456), 651 patients with type 2 diabets were enrolled. All patients received basic meal insulin treatment. One group was combined with praline peptide (target dose 120 μ g/time, three times a day), and the other group was given placebo. The results show that:
HbA1c reduction: The average reduction in this group was 0.62%, significantly better than the placebo group's 0.15% (P<0.001), and the compliance rate (HbA1c<7%) increased by 21%.
Insulin dose adjustment: The insulin dose during meals in this group was reduced by 30% (average reduction of 12U/day), while the placebo group increased by 5%, indicating that it can reduce exogenous insulin demand and lower the risk of hypoglycemia.
Weight change: The weight of this group decreased by 1.8kg, while the placebo group increased by 0.8kg (P<0.001), and the weight loss was positively correlated with the improvement of HbA1c (r=0.32).
Applicable scenarios
Suitable for patients with poor pancreatic function (such as C-peptide<1.1ng/mL), requiring high-dose insulin (>1U/kg/day) but still not meeting glycemic index standards, especially those with obesity (BMI ≥ 28kg/m ²) or insulin resistance (HOMA-IR ≥ 3.5). Please note that this substance needs to be injected before meals, and when used in combination with insulin, the injection sequence should be adjusted (this substance first, then insulin) to avoid interference with the efficacy.
2. Patients with large postprandial glycemic index fluctuations
Current Situation and Challenges
Postprandial hyperglycemia (>10.0 mmol/L) is an independent risk factor for cardiovascular complications (such as atherosclerosis, myocardial infarction) in patients with type 2 diabets. Traditional oral medications, such as alpha glucosidase inhibitors, only lower postprandial glycemic index by delaying carbohydrate absorption, but have no inhibitory effect on glucagon secretion; Short acting insulin analogs (such as aspart insulin) can quickly lower glycemic index, but they need to be accurately matched with meal times (within 10-15 minutes after injection), otherwise they may cause hypoglycemia or poor glycemic index control. In addition, some patients have difficulty adhering to traditional treatment plans due to gastrointestinal intolerance (such as bloating and diarrhea related to alpha glucosidase inhibitors) or injection phobia.
Advantage
It achieves a "dual target" control of postprandial glycemic index by delaying gastric emptying and inhibiting glucagon secretion in a synergistic manner.
Delayed gastric emptying:
Changes the carbohydrate absorption curve from a "steep peak" to a "gentle slope", avoiding sudden increases and decreases in glycemic index, reducing oxidative stress and endothelial damage.
Glucagon inhibition:
Postprandial glucagon levels can be reduced by 30% -50%, reducing liver glucose release and further lowering glycemic index fluctuations.
Clinical evidence
Data of type 1 diabets: a cross study (N=32) for type 1 diabets patients showed that pramlintide injection (60 μ g/time) could reduce glycemic index by 6.0 mmol/L at 1 hour after meal, 3.8 mmol/L at 2 hours, and reduce daily glycemic index curve amplitude (MAGE) by 30%. The incidence of hyperglycemia (glycemic index>10.0mmol/L) decreased from 59% to 48%, while the incidence of hypoglycemia (glycemic index<3.9mmol/L) did not significantly increase (12% vs. 10%).
Data of type 2 diabets: another study included type 2 diabets patients with large postprandial glycemic index fluctuations (MAGE>3.5mmol/L).
After 12 weeks of treatment with this substance, the peak postprandial glycemic index decreased from 12.1mmol/L to 9.7mmol/L, and the standard deviation (SD) of glycemic index decreased from 3.2mmol/L to 2.1mmol/L, and glycemic index fluctuations were positively correlated with the progress of carotid intima-media thickness (CIMT) (r=0.41).
Applicable scenarios:
Suitable for patients with significant postprandial glycemic index fluctuations (such as MAGE>2.8 mmol/L, postprandial glycemic index drift amplitude>4.4 mmol/L) or concomitant cardiovascular diseases (such as coronary heart disease, stroke), especially those who need to avoid the risk of hypoglycemia (such as elderly patients, those with concomitant autonomic neuropathy) or those who are intolerant to traditional drugs in the gastrointestinal tract.
3. Individuals requiring weight management or those with metabolic syndrome
Current Situation and Challenges
About 80% of type 2 diabets patients are overweight or obese (BMI ≥ 25kg/m ²), while traditional hypoglycemic drugs (such as insulin, sulfonylureas) may further increase weight gain by promoting fat synthesis or increasing appetite. Although GLP-1 receptor agonists such as liraglutide and semaglutide can achieve weight loss by delaying gastric emptying and central appetite suppression, they require injection and have a high cost (approximately 800-1500 yuan per month); Metformin has limited weight loss effect (average 1-2kg), and some patients find it difficult to use it for a long time due to gastrointestinal side effects such as nausea and diarrhea.
Mechanism of action and advantages
Weight loss achieved through central appetite suppression and peripheral fat metabolism regulation:
Appetite suppression:
Activates the hypothalamic melanocortin system (MC4 receptor), reduces ghrelin secretion, increases satiety, and reduces daily calorie intake by approximately 300-500kcal.
Improved fat metabolism:
Reduces the release of free fatty acids (FFA), inhibits key enzymes involved in fat synthesis (such as fatty acid synthase and acetyl CoA carboxylase), and promotes fat oxidation (such as increasing carnitine palmitoyltransferase-1 activity).
Clinical evidence
Weight loss effect: a 26 week RCT (N=336) was included in patients with type 2 diabets. The weight of the pramlintide injection group (120 μ g/time) decreased by 2.0 kg, and that of the placebo group increased by 0.5 kg (P<0.001). The weight loss effect is comparable to Liraglutide (1.8mg/day) (2.1kg vs. 2.0kg), but the risk of hypoglycemia is lower (2.1% vs. 4.3%), and the incidence of gastrointestinal adverse events is significantly lower than GLP-1 receptor agonists (15% vs. 32%).
Improvement of metabolic syndrome: After one year of combined treatment with this substance, the patient's waist circumference decreased by 3.2cm (P<0.01), triglyceride levels decreased by 15% (P<0.05), and high-density lipoprotein cholesterol (HDL-C) increased by 8% (P<0.05), significantly improving the metabolic syndrome components (according to the NCEP-ATP III standard, the metabolic syndrome remission rate increased by 27%).
Source of information
Clinical trial data:
Phase III studies conducted by Amlin Pharmaceuticals (NCT00093456, NCT00067572).
Riddle MC et al. Diabetes Care. 2007; 30(2):279-286.
Ratner RE et al. Diabetes Care. 2004; 27(11):2646-2651.
Guide recommendation:
American diabetes Association (ADA) Medical Diagnosis and Treatment Standards for diabetes (2023).
Chinese Guidelines for the Prevention and Treatment of Type 2 diabetes (2020).
Pharmacological basis:
Goodman&Gilman's Pharmaceutical Basis of Therapeutics (13th edition).
Ahren B. Diabetes Obes Metab. 2012; 14(Suppl 3):1-8.
FAQ
It is used with mealtime insulin to control glycemic index levels in people who have diabets. It is only used to treat patients whose glycemic index could not be controlled by insulin or insulin and an oral medication for diabets. It is in a class of medications called antihyperglycemics.
Symlin and Ozempic belong to different drug classes and work differently to lower glycemic index levels. Symlin is an amylin analog, while Ozempic is a glucagon-like peptide-1 receptor agonist.
It is an amylin analog used for the management of type 1 and type 2 diabets mellitus as an adjunct to preprandial insulin therapy in patients without adequate glycemic control of insulin therapy. Symlin. Generic Name Pramlintide.
It is a synthetic version of the naturally occurring pancreatic peptide called amylin. Amylin and product have similar effects on lowering postprandial glucose, lowering postprandial glucagon and delaying gastric emptying.
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