Novo Nord developed oral Somaglutide to target patients with diabetic nephropathy

The trial data showed that for people with type 2 diabetes and renal damage, the oral preparation of its GLP-1 similar somalutide provided better than HbA1c and reduced the weight of the placebo, Novo Nord said.
PIONEER 5 compared the efficacy and safety of 34 mg oral somaglutide with placebo in 324 patients with type 2 diabetes and patients with moderate renal insufficiability with metformin, or basic insulin alone or in combined with metformin. Two different statistical methods were applied in the trial to evaluate the effects of the drug. Recent regulatory guidance requires the main statistical methods, regardless of discontinuation of treatment and use of rescue drugs, assessment of effectiveness, and a second statistical method that describes the effectiveness of treatment and the non-use of rescue drugs.
the study achieved its key objectives based on the main statistical methods, oral somaglutide showed a significant and excellent HbA1c decrease in week 26 compared to placebo. In addition, patients treated with oral somaglutide were significantly heavier and in better condition than placebos. When the secondary statistical method was applied, the HbA1c reduction was significantly increased by 1 in people who were given oral somaglutide. 1% compared to 0.1% of placebos. Weight loss also increased significantly, by 3. 7 kg compared to 1.1 kg for placebo.
" during the trial, oral somaglutide was well-to-do with patients with moderate renal insufficiability and had an overview consistent with GLP-1-based therapies. "About 19 percent of the treatment group experienced nausea, compared with 8 percent of those who took a placebo, and 15 percent of those who stopped treatment because of adverse events, instead of 6 percent," Noor and Nord said. "
" PIONEER 5 results show that oral somaglutide is effective and has stable safety for patients with type 2 diabetes and moderate renal insufficiability. This further expands the clinical characteristics of oral somatroptide solids," said Mads Krogsgaard Thomsen, Executive Vice President and Chief Scientific Officer, "Nephrotic damage is a serious complication of diabetes, and populations with this disease have limited anti-diabetic treatment options, and if approved, oral Somatropeptide will provide effective new solutions for these people." As early as June,
, the company released data from the PIONEER 3 trial, showing that oral somaglutide was better at lowering blood sugar than MSD's DEP-4 inhibitor Januvia (staletin) in treating people with type 2 diabetes, followed by APIONEER 2 results showing a greater improvement in HbA1c reduction than Boehringer Ingel's Jardinance (empapagliance). (This web article)