CTRI/2018/08/015519 [Registered on: 29/08/2018] Trial Registered Prospectively
Last Modified On:
14/05/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
A study to assess the safety and efficacy of USVCAP in patients with type II Diabetes Mellitus uncontrolled with Metformin Hydrochloride treatment.
Scientific Title of Study
A Phase II b, Open-label, Randomized, Comparative Study to Evaluate the Safety and Efficacy of USVCAP Formulation in Type II Diabetes Mellitus in Subjects Uncontrolled with Metformin Hydrochloride Treatment.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
USVCAP/USV/P2/001; Version 2.0 dated 14 Feb 2018
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Room No 303, 3rd Floor (Biotech Block), Department of Endocrinology and Metabolism,
Ansari Nagar, New Delhi-110029, India
South DELHI
9891418190
rajeshkhadgawat@hotmail.com
Dr Harshal N Bhitkar
B. J. Govt. Medical College and Sassoon General Hospital, Pune
Main building, 2nd floor, Research room, ward no: 15, B. J. Govt. Medical College and Sassoon General Hospital, Pune-station road, Pune-411001 Pune MAHARASHTRA
OPD no 2,ground floor,20, Reshimbag, Umred road, Sakkardara, Nagpur-440009, Maharashtra, India Nagpur MAHARASHTRA
8208575094
gillurkarhospital@gmail.com
Dr Hemant Ramsharan Gupta
Grant Government Medical College and Sir JJ Group of Hospitals
OPD 20, Department of Internal Medicine, Old OPD Building, Grant Government Hospital and Sir J J Group
of Hospitals, Byculla, Mumbai - 400008, Maharashtra, India
Mumbai MAHARASHTRA
9870456888
drhemantgupta@hotmail.com
Dr Subhankar Chowdury
IPGME&R and SSKM Hospital
Head, Department of Endocrinology,
Ronald Ross Building, 4th Floor, Room No.8
244, A.J.C.Bose Road,
Kolkata-700020
Kolkata WEST BENGAL
9831076501
subhankar.chowdhury@gmail.com
Dr Jitendra Kumar Someshwar Anand
Kanoria Hospital
Kanoria hospital & Research Centre, Ground floor, Department of medicine, Airport Gandhinagar Highway, Village Bhat, District-Gandhinagar, Gujarat-382428, India Gandhinagar GUJARAT
9824517101
Jkannad09@gmail.com
Dr Anupam Prakash
Lady Hardinge Medical College
Room No-1014, Dept. of Medicine,
Old Building - First Floor,
Shaheed Bhagat Singh Road-110001, India
Central DELHI
9868329333
prakashanupam@hotmail.com
Dr Amol Dange
Life point Mutispeciality Hospital
3rd floor, Clinical research department,145/1, Mumbai Banglore highway,Near hotel Sayaji,Waksd, Pune-411057, Maharashtra, India Pune MAHARASHTRA
9823912040
amoldange298@gmail.com
Dr Nalini Rajesh Humaney
N.K.P. Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Hospital
Department of Medicine
N.K.P. Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Hospital
Digdoh Hills, Hingna Road, Nagpur-440019
Nagpur MAHARASHTRA
9657874811
nrhumaney@gmail.com
Dr Piyush Desai
Nirmal Hospital Private Limited
1st floor OPD, Ring Road, Surat-395002, Gujarat, India Surat GUJARAT
02614089999
drpiyushdesai@gmail.com
Dr Pranab Kumar Sahana
NRS Medical College & Hospital
Department of Endocrinology,2nd floor,138, Acharya Jagdish Chandra Bose Road, Sealdah, Kolkata-700014, West Bengal, India Kolkata WEST BENGAL
9231523624
pranabsahana@gmail.com
Dr Vipul Chavda
Rudraksha Hospital
Rudraksha Specialty Hospital,1st floor, OPD no 2, Raj mandir complex, Bareja flyover, Bareja, Ahmedabad, Gujarat-382425, India Ahmadabad GUJARAT
9909979236
drvpchavda@gmail.com
Dr Sanjeev Bakshi
Sahyadri Speciality Hospital
Nagar Road,
Survey Number. 185A,
Shastri Nagar, Near MSEB Office, Yerwada Nagar Road-411006, India.
Pune MAHARASHTRA
9730307350 020-25459117 jsdem1@yahoo.com
Dr Gaurav Chaaya
Sanjivani Hospital
Sanjivani Super Speciality Hospital Pvt. Ltd.
1, Uday Park Society, Nr. Sunrise Park, Vastrapur, Ahmedabad – 380015
Ahmadabad GUJARAT
Vijay Vallabh Hospital and Medical Research Centre, 2nd Floor, 423, Tirupati
Nagar, Phase l, Bolinj, District- Palghar, Virar (West)-401303, Maharashtra, India
Mumbai MAHARASHTRA
The investigational product, USVCAP will be administered at doses 75 IU, 150 IU, and 300 IU, orally, twice daily
Inclusion Criteria
Age From
35.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
1. Male or female aged 35 to 60 years (both inclusive)
2. Type 2 diabetes mellitus diagnosed < 2 years prior to enrolment
3. Glycated haemoglobin level ≥ 7% and ≤ 9.5%
4. On stable oral monotherapy with metformin hydrochloride (1000 mg to 2500 mg/day) and regular diet and exercise regimen at least 12 weeks prior to enrolment
5. Body mass index between 18 to 30 kg/m2
6. Ability to perform capillary blood glucose measurements
7. Willing to provide informed and written consent for the clinical trial.
8. Able to comply with all requirements of clinical Trial protocol as per investigator opinion.
ExclusionCriteria
Details
1. Subject with history or evidence of hypersensitivity to insulin or metformin
hydrochloride or its excipients
2. Suffering from type 1 diabetes mellitus
3. Received treatment with sulphonylureas or alphaglucosidase inhibitors, Glucagon-like peptide-1 (GLP-1) receptor agonists or Sodium-glucose co-transporter 2 (SGLT2) inhibitors or meglitinides or pramlintide or thiazolidinediones within 3 months prior to enrolment
4. Previously treated with insulin within 3 months prior to enrolment
5. History of episodes of hypoglycaemia during 3 months prior to enrolment.
6. Reduced awareness of hypoglycaemia or inability to identify and tackle
hypoglycaemic episodes as per investigator’s discretion
7. History of substantial weight loss defined as 5% decrease in body weight within the last 6 months.
8. Medical history of unstable angina within 1 year prior to enrolment
9. History of tobacco or nicotine more than two packs/day within 3 months prior to enrolment.
10. Is, at the time of signing informed consent, a user of recreational or illicit drugs or 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 >3 drinks per day or >14 drinks per week, or binge drinking).
11. History of gastrointestinal disorders which may potentially interfere with absorption of the IP
12. Treatment with systemic corticosteroids or with inhalational corticosteroids (Beclomethasone or budesonide) within the 3 months prior to enrolment
13. Likelihood of requiring treatment during the study period with prohibited medications mentioned (as defined in this clinical trial protocol)
14. Female subject who is pregnant, lactating or planning pregnancy during the proposed course of the trial
15. Female subject of childbearing age who is not willing to use adequate method/s of contraception during the study period
16. Life expectancy of less than 6 months from screening as per investigator’s discretion
17. Elective surgery or any other surgical procedure/s requiring general anaesthesia during the clinical trial
18. Has participated in another research trial within 12 weeks prior to screening
19. History of diabetic ketoacidosis requiring hospitalization within 6 months prior to enrolment, case of proliferative retinopathy or advanced neuropathy
20. Subject having the any of the following laboratory results at screening
a. Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2
a. Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) >3 times of upper limit normal
b. Blood urea nitrogen (BUN) > 30 mg/dL
21. Subject who has a positive serology for hepatitis B virus (HBV) or hepatitis C (HCV) or human immunodeficiency virus (HIV) infections at screening
22. Subject who has undergone pancreatectomy or pancreas islet transplant or renal transplant.
23. Subject receiving or has received any immunomodulation medications within 1 year prior to enrolment
24. Subject with history or evidence of diabetic complications (e.g. diabetic retinopathy, diabetic neuropathy, or diabetic nephropathy, etc.), cardiac disorders, or any other systemic complication due to diabetes, which in the opinion of the investigator signifies subject’s ineligibility for the trial.
25. Has any concurrent disease or medical/surgical condition, which required treatment of more than 3 months and which in the opinion of the Investigator does not allow participation of the subject in this study
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Change in glycated hemoglobin (HbA1c) level
post 12-week administration of selected fixed dose of USVCAP
Secondary Outcome
Outcome
TimePoints
Comparison of change in HbA1c between the 3 fixed dose levels studied to examine dose response relationship post 12-week treatment with USVCAP
12 weeks
Change in FPG and 2-hour PPG levels in each treatment group post 12-week treatment with USVCAP
12 weeks
Treatment emergent adverse events (TEAEs) that occur during the study period, including hypoglycemic episodes in each treatment group
9 months
Change in laboratory investigations post 12-week treatment with USVCAP
12 weeks
5. To assess the immunogenicity of the investigational product
12 weeks & 16 weeks
Target Sample Size
Total Sample Size="195" Sample Size from India="195" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="153"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
USVCAP is an oral formulation of
insulin. The study is a Phase IIb, Open-label, Randomized, Comparative Study
to Evaluate the Safety and Efficacy of USVCAP Formulation in Type-2 Diabetes
Mellitus Subjects with Uncontrolled with Metformin Hydrochloride monotherapy.
The objective of the
study is to evaluate the safe and effective dose of USVCAP (75 IU, or 150 IU,
or 300 IU) after twice daily treatment with selected fixed dose (75 IU, or
150 IU, or 300 IU) of USVCAP for 12 weeks.
Primary end point
Change
in glycated hemoglobin (HbA1c) level post 12-week administration of
selected fixed dose of USVCAP (75 IU, 150 IU and 300 IU) from baseline.
Secondary end points:
Comparison
of change in HbA1c between the 3 fixed dose levels studied to examine
dose response relationship post 12-week treatment with USVCAP
Change
in FPG and 2-hour PPG levels in each treatment group post 12-week
treatment with USVCAP
Treatment
emergent adverse events (TEAEs) that occur during the study period,
including hypoglycemic episodes in each treatment group
Change
in laboratory investigations post 12-week treatment with USVCAP
Immunogenicity Endpoint
• Incidence of
treatment-emergent antibody response (TEAR)
The study will be conducted at approximately 5 sites
across India.