| CTRI Number |
CTRI/2026/04/109171 [Registered on: 23/04/2026] Trial Registered Prospectively |
| Last Modified On: |
09/09/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Compare Safety, Tolerability, and Efficacy of Oral Insulin Tablets (Test) with insulin glargine Injection (Reference) in Patients with Type 2 Diabetes Mellitus. |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Paturi Vishnupriya Rao |
| Designation |
Principal Investigator (PI) |
| Affiliation |
Diabetes Research Center |
| Address |
Diabetes Research Center
6-3-349 or 17B and 31, hindi Nagar Colony, Behind Panjagutta Saibaba Temple
Panjagutta,
Hyderabad 500082.
Telangana. India
Hyderabad
TELANGANA
500082
India |
| Phone |
9885051110 |
| Fax |
|
| Email |
hyd@diabaid.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Richa Shrivastava |
| Designation |
AVP Research and Patent |
| Affiliation |
NBI Biosciences Pvt Ltd |
| Address |
Registered Office, S4, SF, A 3, Unicom House, Local Shopping Centre,Janakpuri A3, West Delhi, New Delhi,
Delhi, India,
110058
New Delhi
DELHI
110058
India |
| Phone |
9212062514 |
| Fax |
|
| Email |
richa.shrivastava@nbielements.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Paturi Vishnupriya Rao |
| Designation |
Principal Investigator (PI) |
| Affiliation |
Diabetes Research Center |
| Address |
Diabetes Research Center
6-3-349,17B and 31, Hindi Nagar Colony, Behind Panjagutta Saibaba Temple,
Panjagutta,
Hyderabad 500082.
Telangana. India
Hyderabad
TELANGANA
500082
India |
| Phone |
9885051110 |
| Fax |
|
| Email |
hyd@diabaid.in |
|
|
Source of Monetary or Material Support
|
| NBI Biosciences Private Limited
S-4, S/F, A-3, Unicom House, Local Shopping Centre, Janakpuri A-3, West Delhi,
New Delhi, Delhi, India, 110058
|
|
|
Primary Sponsor
|
| Name |
NBI Biosciences Private Limited |
| Address |
S-4, S/F, A-3, Unicom House, Local Shopping Centre, Janakpuri A-3,
West Delhi New Delhi, Delhi, India, 110058
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Paturi Vishnupriya Rao |
Diabetes Research Center |
6-3-349/17B & 31, Hindi Nagar Colony, Behind Panjagutta Saibaba Temple,
Panjagutta,
Hyderabad-500082.
Telangana. India
Hyderabad
TELANGANA |
9885051110
hyd@diabaid.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Diabetes Research Center |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LANTUS ® insulin glargine Injection
(Comparator 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, 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)and Three (3) patients will receive LANTUS® SOLOSTAR® (insulin glargine) Refilled Pen (Reference treatment)
LANTUS® (insulin glargine) Injection 10 IU Patients who receive reference products will be instructed to administer the IP subcutaneously once daily at bedtime (9 PM ± 1 hour), from Day 1 to Day 28 and these patients will be instructed to have their dinner (7 PM plus or minus 1 hour) at a consistent time, at least 2 hours prior to the study medication administration.
Subjects who eat dinner at 7 PM can get a dose at 9 PM, and those who eat at 8 PM can take a dose at 10 PM.
|
| Intervention |
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, 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) and Three (3) patients will receive LANTUS® SOLOSTAR® (insulin glargine) Refilled Pen (Reference treatment)
Test Product 1 (Low-Dose Group): NBI42A Oral Insulin Tablet 50 IU.
Test Product 2 (Intermediate Dose Group): NBI42A Oral Insulin Tablet 100 IU.
Test Product 3 (High-Dose Group): NBI42A Oral Insulin Tablet 150 IU.
Mode of Administration:
Patients who receive test products will be instructed to administer the IP orally once daily at 4 PM ± 30 minutes evening from Day 1 to Day 28.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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 pancreas islet transplant or renal transplant.
17.Any concurrent disease or medical/surgical condition, which requires treatment of more than 3 months and which, in the opinion of the investigator, does not allow participation of the subject in this study.
18.Subjects who have a positive serology for hepatitis B virus (HBV) or hepatitis C (HCV), or human immunodeficiency virus (HIV) infections at screening.
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
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in FBS ,PPBS and GA levels from the baseline |
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 Outcome
|
| Outcome |
TimePoints |
-Change in HbAlc levels
-Change in GA levels
-Glycemic variability measured as coefficient of variance (CV) in percentage.
|
-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
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/05/2026 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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. |