CTRI/2026/04/109171尚未招募2 期
An Open-Label Randomized Single Center, Dose Finding Investigator-Initiated Study to Compare Safety Tolerability and Efficacy of NB142A Oral Insulin Tablets (Test) with LANTUS SOLOSTAR® (insulin glargine) Refilled Pen (Reference) in Patients with Type 2 Diabetes Mellitus
NBI Biosciences Private Limited1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年5月2日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
This is an open-label, single-center, dose-finding clinical trial designed to evaluate the safety, tolerability, and efficacy of oral insulin compared to insulin glargine in with T2DM. Total of 30 patients with type 2 Diabetes Mellitus enrolled in the study. Patients will be assigned to one of three dose groups of Oral Insulin: 50 IU, 100 IU, and 150 IU. Each dose group will consist of 10 patients, of whom-
-Seven (7) patients will receive the NBI42A Oral Insulin Tablets (Test treatment)
-Three (3) patients will receive LANTUS® SOLOSTAR® (insulin glargine) Refilled Pen (Reference treatment)
Study duration of the study is approximately 64 days at a one site in India. It includes total of six scheduled visits undergo periodic assessments such as Continuous Glucose Monitoring (CGM), Monitoring of Glycated albumin (GA), HbA1c, High-sensitivity C-reactive protein (hs-CRP) during which participant will be monitored routine laboratory tests and the documentation of any adverse events or SAE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients aged from 18 to 65 years (both inclusive) with a BMI ranging from 18.5 to 30.0 kg/m2 (both inclusive).
- •2.Patients diagnosed with Type 2 diabetes for at least 2 months, with insufficient glycemic control on oral antidiabetic drugs (OADs).
- •3.HbA1c levels must be between greater than or equal to 7.5 percent and less than or equal to 10.5 percent and FBS greater than 150 miligram per deciliter.
- •4.Patients must have been on a stable regimen of OAD therapy specifically metformin (up to 2.5 gram per day) and or a DPP4 inhibitor and or a sulfonylurea, consistently maintained for at least 2 months prior to enrollment.
- •5.Liver and kidney function within normal or abnormal non-clinically significant limits as per laboratory values.
- •6.Patients with no diabetic ketoacidosis requiring third-party intervention or hospitalization within the past 12 months.
- •7.Participants must be willing to wear a Continuous Glucose Monitoring System (CGMS) throughout the study period and agree to comply with all data collection procedures.
- •8.Patients who agree to maintain a stable diet and exercise regimen throughout the entire study period.
- •10.Patients who have the ability to comprehend the full nature and purpose of the study, including possible risks and AEs the ability to co-operate with the Investigator and comply with the entire study requirements.
- •11.Patients willing to use appropriate birth control methods throughout the duration of the study.
排除标准
- •1.History of an allergic reaction to insulin or other insulin formulations.
- •2.History of type 1 diabetes or other forms of diabetes.
- •3.Patients on insulin secretagogues like sulfonylureas, Glucagon-like peptide-1 (GLP-1) receptor agonists, Sodium-glucose co-transporter 2 (SGLT2) inhibitors, meglitinides, pramlintide, or thiozolidinediones.
- •4.Major surgery or trauma within the last 3 months.
- •5.Patients who were previously treated with insulin within 3 months prior to enrolment.
- •6.History of episodes of hypoglycaemia during the 3 months prior to enrolment.
- •7.History of weight loss, defined as a reduction of at least 5 percent in body weight within the past 6 months, attributable to thyroid disorders or other systemic illnesses, excluding type 2 diabetes mellitus (T2DM).
- •8.Subjects having any of the following laboratory results at screening a.Hemoglobin less than 10 gram per deciliter , leukocytes less than 3.0 times 109 per liter, or platelets less than 100 times109 per liter.
- •b.Estimated glomerular filtration (eGFR) less than 60 mililiter per min per 1.73 meter square.
- •c.Alanine aminotransferase (ALT) and or Aspartate aminotransferase (AST) greater than 3 times of upper limit of normal.
- •d.Blood urea nitrogen (BUN) greater than 30 miligram per deciliter e.Total bilirubin greater than 1.5 times the Upper Limit of Normal (unless due to Gilberts) 9.Patients with uncontrolled hypertension (i.e., Systolic Blood Pressure [SBP] greater than or equal to 160 mmHg or Diastolic Blood Pressure (DBP) greater than or equal to 100 mmHg) at the time of screening, or those whose hypertension is not controlled with stable medication for at least 3 months.
- •10.Patients with a history of clinically significant cardiovascular disease, including unstable angina, myocardial infarction, transient ischemic attack, or coronary artery interventions, including coronary artery bypass surgery, inflammatory or rheumatologic disease, cerebrovascular incident, or chronic hepatic disease, within 6 months prior to the consent date.
- •11.Pregnant or breastfeeding women, or planning to become pregnant, or unwilling to use an adequate method of contraception during the trial.
- •12.Patients who are excessive smokers (greater than or equal to 10 cigarettes per day or equivalent tobacco use) within 3 months prior to enrolment.
- •13.Use of recreational or illicit drugs at the time of signing informed consent, or has had a recent history (within 1 year prior to enrolment) of drug or alcohol abuse or dependence.
- •14.History of GI disorders, pulmonary, renal, neurological, or psychiatric disease that, in the investigators opinion, would interfere with participation or confound interpretation of results.
- •15.History or evidence of diabetic complications (e.g diabetic retinopathy, diabetic neuropathy, or diabetic nephropathy, etc.) or any other systemic complication due to diabetes, which, in the opinion of the investigator, signifies patients ineligibility for the trial.
- •16.Endocrine disorders other than T2DM that may affect glucose metabolism (e.g. untreated thyroid disease, Cushing syndrome, acromegaly) and subjects who have undergone pancreatectomy or pancreas islet transplant or renal transplant.
- •19.Treatment with systemic corticosteroids or with inhalational corticosteroids (beclomethasone or budesonide) within the 3 months prior to enrolment.
- •20.Patients who have participated in another clinical trial within the last 90 days.
- •21.Any condition or other factor (at the Investigators discretion) that is deemed unsuitable for the study by the investigators judgment.
研究者
Dr Paturi Vishnupriya Rao
Diabetes Research Center
研究点 (1)
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