| CTRI Number |
CTRI/2024/08/072197 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating GLUBLOCâ„¢ for Better Blood Sugar Management in Type 2 Diabetes |
|
Scientific Title of Study
|
An Interventional Trial to Evaluate the Impact of GLUBLOCâ„¢ on HbA1c levels, Glycemic Variability and Time in Range in Type 2 diabetic individuals. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR K. Somnath Gupta |
| Designation |
Sr. Consultant Physician (MBBS, DNB, MHSC Diabetology) |
| Affiliation |
Yashoda Hospitals |
| Address |
Room No 135, Department of Internal Medicine, 1st Floor, Yashoda Hospitals, Hitech city, Cyber towers to JNTU road, Hyderabad
Hyderabad
TELANGANA
500084
India |
| Phone |
996911130 |
| Fax |
|
| Email |
somnath.gupta@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR K. Somnath Gupta |
| Designation |
Sr. Consultant Physician (MBBS, DNB, MHSC Diabetology) |
| Affiliation |
Yashoda Hospitals |
| Address |
Room No 135, Department of Internal Medicine, 1st Floor, Yashoda Hospitals, Hitech city, Cyber towers to JNTU road, Hyderabad
Hyderabad
TELANGANA
500084
India |
| Phone |
996911130 |
| Fax |
|
| Email |
somnath.gupta@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR K. Somnath Gupta |
| Designation |
Sr. Consultant Physician (MBBS, DNB, MHSC Diabetology) |
| Affiliation |
Yashoda Hospitals |
| Address |
Room No 135, Department of Internal Medicine, 1st Floor, Yashoda Hospitals, Hitech city, Cyber towers to JNTU road, Hyderabad
Hyderabad
TELANGANA
500084
India |
| Phone |
996911130 |
| Fax |
|
| Email |
somnath.gupta@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| INU Energy Pvt Ltd, 5th Floor, Salarpuria Sattva, Knowledge City, Hitech City, Madhapur, Inorbit Mall Rd, Hyderabad, Telangana, India. |
|
|
Primary Sponsor
|
| Name |
INU Energy Pvt Ltd |
| Address |
5th Floor, Salarpuria Sattva, Knowledge City, Hitech City, Madhapur, Inorbit Mall Rd, Hyderabad, Telangana, India |
| Type of Sponsor |
Other [For Profit company] |
|
|
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 K Somnath Gupta |
Yashoda Hopsital |
Room No 135, Department of Internal Medicine, 1st Floor, Yashoda Hospitals, Hitech city, Cyber towers to JNTU road, Hyderabad
Hyderabad
TELANGANA |
996911130
somnath.gupta@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee of Yashoda Academy of Medical Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GLUBLOCâ„¢ tablet |
Each tablet contains a proprietary blend of Morus alba L extract and Malus domestica peel extract (350 mg) along with the excipients.
The subjects will receive intervention twice daily before major meals for the duration of 180 days |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age: 25 - 65 years old male and non-pregnant females
Diagnosis of Type 2 Diabetes Mellitus for at least 6 months; treated with stable dose of oral anti-diabetic drugs (drugs permitted: metformin, sulfonylureas) for at least 3 months before screening.
Participants with HbA1c between 7 to 11 percent
Participant willing to provide informed consent and willing to comply with study procedures |
|
| ExclusionCriteria |
| Details |
Type 1 Diabetes Mellitus participants.
Type 2 Diabetes Mellitus participants on insulin, Thiazolidinediones, GLP-1 agonists, DPP-IV inhibitors, AGI’s and/or SGLT2 inhibitors.
Allergy to one or more components of the investigational product or history of food allergies
Participant receiving any diabetes specific nutritional food supplement apart from multivitamin/ mineral supplements (Ca/Vit D supplements and B complex syrups) within 15 days prior to study start.
Participant taking any herbal/ayurvedic/ alternative medicine preparations that could profoundly affect blood glucose.
Females who are nursing / pregnant / are of child - bearing potential and not practicing an acceptable method of birth control / or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
Participant has evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease, which in the opinion of the investigator, can adversely affect study outcome/s.
Participant with active infection in past 30 days.
Participant has a history of any episode(s) of severe hypoglycemia (requiring third party assistance), disabling diabetic neuropathy including autonomic neuropathy, gastroparesis or lower limb ulceration or amputation or evidence or history of diabetic complications with significant end organ damage.
Participants on any pharmacological therapy of modern or alternative medicine for management of obesity in past 6 months.
Participants with history of bariatric surgery.
Participant has any major or minor surgery within 30 days prior to screening |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A reduction in HbA1c levels, improvement in glycemic Variability and time in range (based on CGM measurements) with GLUBLOCâ„¢ treatment in Type 2 diabetic individuals. |
Day 0 (Baseline), day 60, day 90 and day 180. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A reduction in Weight, waist-hip ratio, BMI and subjective feeling of energy |
Baseline (day 0), day 60, day 90 and day 180. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
12/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
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)
|
In this investigator initiative study, Twenty, Type 2 diabetic individuals with HbA1c levels 6.5 to 11%, with or without any other potential comorbidities, as per the inclusion criteria will be enrolled for the study. After enrollment, A pre-treatment phase with Lifestyle libre will be done for 14 days to capture glycemic Variability and Time in range. After 14 day pre-treatment phase, subjects will be instructed to take two GLUBLOC tablets per day, along with two major meals (ie., lunch and dinner), for 180 days. Subjects will be administered Lifestyle libre device on Day 76 (Data will be captured till Day 90) and on Day 166 (Data will be captured till Day 180) to observe glycemic control while using GLUBLOC, when compared to baseline. HbA1c levels will be estimated at baseline, and at each subsequent months (Baseline (Day 0), Day 60, Day 90 and Day 180). At the end of treatment period, percentage change in HbA1C, Glycemic Variability and Time in range will be estimated. Blood biochemistry will be conducted at the time of baseline (Day 0) and the subsequent visits (Day 60, Day 90 & Day 180). Liver and Kidney function parameters will be assessed. At the baseline and during the subsequent follow-ups (Day 0, Day 60, Day 90 and Day 180), anthropometric parameters like Body weight, BMI, Height, Weight, waist-to-hip ratio and a self administered questionnaire to assess the subjective feeling of energy in the past one week will be collected. Questions related to gastrointestinal discomfort will be asked, such as, nausea, abdominal cramp, distension and flatulence. Any adverse events experienced during the study will be captured. |