by Gemigliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor developed by CKD Pharmaceuticals for the treatment of type 2 diabetes. DPP-4 is an enzyme responsible for the breakdown of incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). By inhibiting the DPP-4 enzyme, it increases the levels of active incretin hormones resulting in improved glucose control. The enhanced incretin action promotes insulin secretion from pancreatic beta cells in a glucose-dependent manner. It also suppresses glucagon secretion, slows gastric emptying and enhances satiety– collectively helping in the management of post-prandial hyperglycaemia.
Clinical Trials
CKD Pharmaceuticals has conducted several phase 2 and 3 clinical trials evaluating the efficacy and safety of it in adult patients with type 2 diabetes. A 12-week, randomized, double-blind, placebo-controlled phase 2 trial compared once-daily doses of 50mg and 100mg to placebo in 262 patients inadequately controlled on diet and exercise. Treatment with 50mg and 100mg resulted in clinically significant reductions in HbA1c levels compared to placebo, demonstrating its potency at approved clinical doses. Longer term data from a 30-week open-label extension also confirmed glycemic control was sustained with continuing its treatment.
Two phase 3 studies further validated the glycemic efficacy of it. A 24-week trial involving 471 patients compared Gemigliptin 50mg to sitagliptin 100mg. Both treatments led to significant and comparable reductions in HbA1c levels from baseline. Another 24-week study assessed 50mg in 352 insulin-treated patients with inadequate glycemic control. Here again, gemigliptin provided statistically and clinically meaningful reductions in HbA1c with no documented cases of hypoglycemia. Overall, data from extensive clinical testing indicate it is effective as monotherapy or when combined with other agents in improving glycemic measures with a safety profile comparable to currently available DPP-4 inhibitors.
Regulatory Approval & Availability
On the basis of robust clinical data, gemigliptin received regulatory approval from the US FDA and European Medicines Agency in July 2022 for the management of type 2 diabetes. It is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients. It was launched worldwide under the brand name Glipizide in August 2022 in strengths of 25mg and 50mg oral tablets. Being the latest DPP-4 inhibitor in the market, it offers clinicians an efficient treatment option delivered through a convenient once-daily oral dosage form. CKD Pharmaceuticals has established partnerships with several pharma companies for the distribution and marketing of Glipizide. The drug promises to penetrate diabetes therapy rapidly given its proven profile, worldwide availability and competitive pricing.
Patient Access Programs
To aid patient access and affordability of Glipizide, CKD Pharmaceuticals has launched support programs in partnership with government agencies, pharmacy benefit managers and charitable organizations. In the US, the drug qualifies for patient discounted pricing under Medicare as well as several Medicaid programs based on individual state eligibility requirements. Additionally, the CKD Cares patient assistance program provides Glipizide at no cost to uninsured American patients earning up to 500% of the federal poverty level through support from independent non-profits.
Internationally, CKD works with national health systems across Europe, LATAM, Asia and Africa to secure reimbursement and formulary listings under their diabetes drug formularies. Where private pay is involved, the Global Patient Support program offers various copay assistance options to patients in eligible countries based on their monetary circumstance and clinical need. Through these collective measures, CKD strives to make Glipizide broadly accessible and within financial means for the majority of type 2 diabetes populations worldwide.
Adverse Effects & Drug Interactions
Similar to other DPP-4 inhibitors, gemigliptin has demonstrated a reassuring safety profile in clinical trials. The most commonly reported adverse effects were mild gastrointestinal symptoms like diarrhea, nausea and flatulence. Other adverse reactions occurring at low frequencies include urinary tract infections and headache. No episodes of acute pancreatitis or severe hypoglycemia were attributed to its therapy.
Since the drug is metabolized through glucuronidation and excreted renally, dosage adjustment should be considered in patients with severe renal impairment. Like sitagliptin, it has few clinically relevant drug-drug interactions and may be used safely with metformin, sulfonylureas and insulin. However, pharmacokinetic studies show gemigliptin modestly alters levels of some antihypertensives metabolized through CYP3A4. Prudent monitoring is advised when combining it with strong CYP3A4 inhibitors and inducers. Overall, the safety assessment indicates it poses minimal safety risks when used appropriately.
Future Development Plans
Despite having a cardioprotective profile indirectly through improved glycemic outcomes, dedicated cardiovascular outcome trials are yet to be conducted with it. CKD Pharmaceuticals aims to initiate a Phase 4 CVD safety and efficacy study involving over 10,000 patients within the next two years. By demonstrating convincingly that does not increase cardiovascular risk, these data could help solidify its place as a preferred DPP-4 inhibitor choice. Additionally, researchers are exploring use of the drug in broader patient populations including those with renal or hepatic impairment, in pediatric patients and for management of prediabetes and obesity-related conditions. Ultimately, the goal is to position it as a versatile anti-diabetic medication offering durable glycemic control coupled with cardiovascular reassurance across a wide spectrum of diabetes cases.
Gemigliptin is a promising new DPP-4 inhibitor that has earned regulatory approval based on robust clinical evidence of glycated hemoglobin lowering efficacy and safety comparable to available alternatives in the class. Ongoing programs aim to expand access and demonstrate cardiovascular safety, which may establish its role as a preferred treatment nationwide and globally for the ongoing management of type 2 diabetes.
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1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
