Insulin aspart

BEIJING and BRIDGEWATER, N.J., March 31, 2026 /PRNewswire/ -- Gan & Lee Pharmaceuticals (SSE: 603087) today announced that two pivotal phase 3 clinical trials, SUPER-1 and SUPER-2, evaluating investigative once-weekly insulin GZR4 Injection, have successfully met their pre-specified primary endpoints. After 26 weeks of treatment, once-weekly GZR4 demonstrated statistically significant superior efficacy in reducing glycated hemoglobin A1c (HbA1c)* compared with once-daily insulin glargine U100 (Lantus®) and once-daily insulin degludec (Tresiba®). SUPER-1: Trial in Insulin-Naïve Patients with Type 2 Diabetes Mellitus SUPER-1 is a 52-week (26-week main phase plus 26-week extension phase), phase 3, treat-to-target trial investigating the efficacy and safety of once-weekly GZR4 versus once-daily insulin glargine U100 (Lantus®), both in combination with non-insulin anti-diabetic treatment, in 588 insulin-naïve Chinese adults with type 2 diabetes mellitus (T2DM) across 84 medical sites in China (ClinicalTrials.gov Identifier: NCT06767735). The trial met its primary endpoint. GZR4 demonstrated statistically significant superiority in HbA1c reduction versus insulin glargine U100: after 26 weeks of treatment, the estimated mean change in HbA1c from baseline was -1.45% in the GZR4 group versus -1.22% in the insulin glargine U100 group, with a statistically significant estimated between-group treatment difference of -0.23%. GZR4 also achieved a significantly higher rate of safe glycemic target attainment: the treatment group outperformed the insulin glargine U100 group on the clinically relevant composite endpoint of achieving HbA1c <7.0% or ≤6.5% without experiencing clinically significant (Level 2) or severe (Level 3) hypoglycemia. Once-weekly GZR4 demonstrated a favorable safety and tolerability profile. No severe (Level 3) hypoglycemic events occurred in either treatment group. SUPER-2: Trial in Patients with Type 2 Diabetes Mellitus Previously Treated with Basal Insulin SUPER-2 is a 26-week, phase 3, treat-to-target trial investigating the efficacy and safety of once-weekly GZR4 versus once-daily insulin degludec (Tresiba®), with or without concomitant non-insulin anti-diabetic treatment, in 631 Chinese adult patients with T2DM previously treated with basal insulin across 82 medical centers in China (ClinicalTrials.gov Identifier: NCT06767748). The trial met its primary endpoint. GZR4 demonstrated statistically significant superiority in HbA1c reduction versus insulin degludec: after 26 weeks of treatment, the estimated mean change in HbA1c from baseline was -1.00% in the GZR4 group versus -0.58% in the insulin degludec group, a statistically significant estimated between-group treatment difference of -0.42%. GZR4 also delivered a significantly higher rate of safe glycemic target attainment, outperforming the insulin degludec group on the composite endpoint of achieving HbA1c <7.0% or ≤6.5% without clinically meaningful (Level 2) or severe (Level 3) hypoglycemia. Once-weekly GZR4 demonstrated a favorable safety and tolerability profile. No severe (Level 3) hypoglycemic events occurred in either treatment group. Detailed results from SUPER-1 and SUPER-2 are planned for presentation at this year's scientific conference and will be submitted for publication in peer-reviewed international academic journals. Additional findings from the GZR4 Injection's ongoing clinical program are expected to be released over the following 12 months. *Glycated hemoglobin A1c (HbA1c): A biomarker that reflects average blood glucose levels over the preceding 2 to 3 months and is the gold-standard endpoint for evaluating the efficacy of anti-diabetic treatment. The above data are derived from the modified Intention-to-treat (mITT) Set and Safety Set (SS) under the treatment policy. Dr. Chen Wei from Gan & Lee Pharmaceuticals remarked: "We are thrilled to report positive top-line results from the SUPER-1 and SUPER-2 trials. This robust dataset confirms that GZR4 delivers statistically significant superiority over the active comparators on the primary endpoint of HbA1c reduction, with an overall safety profile closely aligned with that of marketed once-daily basal insulins. These findings position GZR4 as a promising, enhanced option for patients with T2DM who require basal insulin therapy. As a novel once-weekly insulin, GZR4 Injection has demonstrated compelling best-in-class potential. The SUPER phase 3 pivotal clinical program includes four randomized, active-controlled, treat-to-target trials conducted across China in approximately 2,120 adults with inadequately controlled T2DM, to deliver a systematic evaluation of the efficacy and safety of once-weekly GZR4 versus once-daily basal insulins. Compared with once-daily formulations, once-weekly GZR4 delivers a more than 85% reduction in annual injection frequency, with no need for an additional loading dose. This simplified regimen is engineered to improve treatment adherence, optimize long-term glycemic control, and drive meaningful, sustained improvements in the quality of life for people living with diabetes. At a time when industry players are scaling back investment in insulin research and development, Gan & Lee Pharmaceuticals is accelerating the development of GZR4. This progress fully embodies our unwavering commitment to pioneering innovation in diabetes care, and our steadfast dedication to safeguarding patient health." About the SUPER Clinical Program The SUPER program is a large-scale global phase 3 clinical development program for GZR4 Injection, a proposed once-weekly basal insulin by Gan & Lee. To date, four phase 3 clinical trials have been initiated in China: SUPER-1: A 52-week trial enrolling 588 insulin-naïve adults with T2DM, comparing the efficacy and safety of once-weekly GZR4 Injection versus once-daily insulin glargine U100 (Lantus®), both in combination with non-insulin anti-diabetic treatment. SUPER-2: A 26-week trial enrolling 631 adults with T2DM previously treated with basal insulin, comparing the efficacy and safety of once-weekly GZR4 Injection versus once-daily insulin degludec (Tresiba®), with or without concomitant non-insulin anti-diabetic treatment. SUPER-3: A 26-week trial enrolling 580 patients with T2DM previously treated with basal-bolus insulin therapy, comparing the efficacy and safety of once-weekly GZR4 Injection versus once-daily insulin glargine U100 (Lantus®) in combination with insulin aspart, with or without concomitant non-insulin anti-diabetic treatment. SUPER-8: A 26-week trial enrolling 300 patients with T2DM previously treated with basal insulin, comparing the efficacy and safety of GZR4 Injection versus insulin icodec (Awiqili®), with or without concomitant non-insulin anti-diabetic treatment. About GZR4 Injection GZR4 Injection is an investigational ultra-long-acting once-weekly basal insulin analog independently developed by Gan & Lee Pharmaceuticals to cover the basal insulin requirements for a full week with a single subcutaneous injection. GZR4 Injection is designed to help people with diabetes overcome barriers to injection, initiate and sustain insulin therapy earlier, optimize long-term diabetes management, and improve quality of life. Completed phase 3 clinical trial results show that once-weekly GZR4 Injection is superior to once-daily insulin glargine U100 and insulin degludec in reducing HbA1c levels in adult patients with T2DM. The global clinical development of GZR4 Injection is currently in the phase 3 stage. Forward-looking statements Forward-looking statements are based on our expectations and assumptions as of the date of the statements. Actual results may differ materially from those expressed in these forward-looking statements due to a variety of factors, and we can give no assurance that such results will be achieved in the future. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 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The US FDA has approved Awiqli (insulin icodec-abae) injection 700 units/mL, developed by Novo Nordisk, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The decision makes Awiqli the first and only once-weekly basal insulin approved by the US FDA, reducing the injection frequency from seven times per week to one. It is also the first change to basal insulin dosing frequency in more than two decades, since the introduction of once-daily long-acting analogs such as insulin glargine around the year 2000. Awiqli is already approved in the EU and 13 additional countries. The approval covers use of the weekly insulin in combination with mealtime insulin or with common oral anti-diabetic agents and GLP-1 receptor agonists. It is administered via the Awiqli FlexTouch pen on the same day each week. The product is not approved for use in children or adolescents. Novo Nordisk said Awiqli will be available nationwide in the US in the coming months. The insulin icodec FDA approval is supported by the ONWARDS Phase IIIa clinical program, which comprised four randomized, active-controlled, treat-to-target trials enrolling approximately 2,680 adults with uncontrolled type 2 diabetes. These trials evaluated once-weekly Awiqli against daily basal insulins, including insulin glargine U-100 (ONWARDS 1) and insulin degludec (ONWARDS 2, ONWARDS 3), across both insulin-naive patients and those switching from daily basal or basal-bolus regimens (ONWARDS 4). The primary endpoint across the program was reduction of HbA1c, and the company reported that Awiqli demonstrated efficacy on this measure. The safety profile was described as consistent with the daily basal insulin class. Common adverse events included hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, itching, rash, peripheral edema, and weight gain. The approval of Novo Nordisk insulin icodec addresses a long-recognized gap in type 2 diabetes management. Despite the availability of effective daily basal insulins, adherence remains a persistent challenge. Injection fatigue, missed doses, and what clinicians term “psychological insulin resistance” — reluctance among patients and providers to initiate insulin therapy — contribute to suboptimal glycemic control in a substantial proportion of the estimated 37 million Americans living with type 2 diabetes. Research has indicated that weekly injectable diabetes medications may be associated with improved adherence, and Awiqli’s once-weekly dosing is designed to reduce the burden that daily injections impose. The weekly insulin for type 2 diabetes enters a treatment landscape that has been reshaped in recent years by the arrival of GLP-1 receptor agonists such as semaglutide and dual GIP/GLP-1 agonists such as tirzepatide, both of which offer HbA1c reduction alongside weight loss and cardiovascular benefits. Awiqli occupies a distinct niche as a basal insulin rather than an incretin-based therapy, targeting patients who require insulin but may benefit from a less frequent dosing schedule. Eli Lilly is developing insulin efsitora alfa, another once-weekly basal insulin currently in late-stage clinical development, which would make this a directly competitive space if approved. For Novo Nordisk, securing the first-mover position with Awiqli adds to a diabetes portfolio that already includes insulin degludec (Tresiba), insulin aspart (NovoLog), and the combination product Xultophy. The approval does not resolve all unmet needs in basal insulin therapy. Hypoglycemia risk remains present, weight gain is listed among common side effects, and the US approval does not include type 1 diabetes. Whether the reduction in injection frequency translates into measurable improvements in real-world adherence and long-term glycemic outcomes will require post-marketing data. Nonetheless, the availability of a once-weekly basal insulin option represents a structural shift in how insulin therapy can be delivered to the large population of adults with type 2 diabetes who need it. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website