Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases
Conditions
Interventions
Intervention1: NBI42A Oral Insulin Tablets
(Test Product).
: Total Study duration of the study is approximately 64 days.
Patients will be assigned to one of three dose groups of Oral Insulin: 50 IU,
Sponsors
NBI Biosciences Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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. 9.Patients and or LAR who understand the study details and provide written informed consent to participate in the study. 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.
Exclusion criteria
Exclusion criteria: 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. (Note-Alcohol abuse includes heavy alcohol intake as defined by greater than 3 drinks per day or greater than 14 drinks per week, or binge drinking). 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 pancr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in FBS ,PPBS and GA levels from the baselineTimepoint: FBS and PPBS -Baseline (Day 1) at specified timepoint during the study and at Day 29 (end of study) GA-Baseline (Day 1) to end of study (Day 29) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Change in HbAlc levels -Change in GA levels -Glycemic variability measured as coefficient of variance (CV) in percentage. Timepoint: -HbAlc levels -From screening to day 29 end of study -GA levels-From baseline day 1 to day 5 -Glycemic variability as (CV in percentage)-Baseline day 1, day 5, and day 29 end of study | — |
Countries
India
Contacts
Public ContactDr Paturi Vishnupriya Rao
NBI Biosciences Pvt Ltd
Outcome results
None listed