| CTRI Number |
CTRI/2023/06/053737 [Registered on: 09/06/2023] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Prospective study Vildagliptin 100 mg
Sustained Release Tablet once daily compared to
Sitagliptin 100 mg Tablet in patients with Type 2 diabetes
mellitus
|
|
Scientific Title of Study
|
A Prospective, Multi-center, Parallel-Group study to
evaluate the Efficacy & Safety of Vildagliptin 100 mg
Sustained Release Tablet once daily compared to
Sitagliptin 100 mg Tablet in patients with Type 2 diabetes
mellitus not optimally controlled on metformin alone. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Someswara Rao Korla |
| Designation |
Vice President-Clinical Trials |
| Affiliation |
someswararao.korla@jeevanscientific.com |
| Address |
Jeevan Scientific Technology Limited
Plot No. 1 and 2, Sai Krupa Enclave,
Golconda Post, Near Lanco Hills, Hyderabad – 500008
Hyderabad
TELANGANA
500008
India |
| Phone |
9948591492 |
| Fax |
|
| Email |
someswararao.korla@jeevanscientific.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Someswara Rao Korla |
| Designation |
Vice President-Clinical Trials |
| Affiliation |
someswararao.korla@jeevanscientific.com |
| Address |
Jeevan Scientific Technology Limited
Plot No. 1 and 2, Sai Krupa Enclave,
Golconda Post, Near Lanco Hills, Hyderabad – 500008
Hyderabad
TELANGANA
500008
India |
| Phone |
9948591492 |
| Fax |
|
| Email |
someswararao.korla@jeevanscientific.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Someswara Rao Korla |
| Designation |
Vice President-Clinical Trials |
| Affiliation |
someswararao.korla@jeevanscientific.com |
| Address |
Jeevan Scientific Technology Limited
Plot No. 1 and 2, Sai Krupa Enclave,
Golconda Post, Near Lanco Hills, Hyderabad – 500008
Hyderabad
TELANGANA
500008
India |
| Phone |
9948591492 |
| Fax |
|
| Email |
someswararao.korla@jeevanscientific.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
USV Private Limited |
| Address |
Arvind Vithal Gandhi Chowk,
BSD Marg, Station Road,
Govandi East, Mumbai - 400 088,
India.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Binayak Sinha |
AMRI Hospital Salt Lake |
JC 16-17, Salt Lake City, Kolkata-700106, West Bengal, India
Kolkata
WEST BENGAL |
9830096410
binayak.sinha@gmail.com |
| Dr Sachin Yadav |
Chintamani Hospital |
53, Jadhe Nagar, Bibwewadi, Pune-411037, Maharashtra, India
Pune
MAHARASHTRA |
9370250050
drsachinyadav@yahoo.co.in |
| Dr Faraz Farishta |
FS Endocrine and Diabetes |
H.NO.17-1-197/T/2/A, Beside Pista House IS Sadan, BIN TRIF Nagar, Saidabad, Opp IOC, Telangana - 500059, India.
Hyderabad
TELANGANA |
9885035977
drfarazfarishta@gmail.com |
| Dr Chetan Patil |
Muktai Hospital |
11, Shivaji Nagar, Near Fame Adlabs, Bodhale Nagar, Nashik-422006, Maharashtra, India
Nashik
MAHARASHTRA |
9822651494
patilchetan@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| FS Independent Ethics Committee |
Approved |
| Muktai Hospital Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
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 |
| Comparator Agent |
Sitagliptin |
Sitagliptin 100 mg Tablet comparator drug administered as per randomization orally once daily from day 1 to 84 days |
| Intervention |
Vildagliptin |
Vildagliptin 100 mg Sustained Release Tablet Study drug will be administered orally once daily from day 1 to day 84 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female patients of >18 years of age diagnosed with type 2 diabetes using American
Diabetes Association Criteria; Treated with metformin monotherapy at a stable dose
(≥1,000 mg per day) for at least one month before randomization.
2.Patients who are willing to comply with continues glucose monitoring system will be included in CGMS group.
3.Patients who are uncontrolled on metformin with HbA1c of >7%.
4.Ability to understand and the willingness to sign and date a written informed consent
document at the screening visit before any protocol-specific procedures are performed.
5.Patients with body mass index (BMI) 18.0 to 35.0 kg/m2. |
|
| ExclusionCriteria |
| Details |
1. Type-1 diabetes mellitus.
2. Patients who are on more than two oral anti-diabetic drugs or on insulin.
3. Uncontrolled hypertension (systolic blood pressure >160 mm Hg or
diastolic blood pressure > 100 mm Hg).
4. Symptomatic heart failure.
5. Severe hepatic dysfunction (alanine aminotransferase or aspartate
aminotransferase levels more than three times the normal upper limit).
6. Patients with known hypersensitivity to Vildagliptin or Metformin HCl
or Sitagliptin to any of the excipients.
7. Patients with severe renal impairment.
8. Patients with acute or chronic metabolic acidosis, including lactic
acidosis or diabetic ketoacidosis, with or without coma.
9. Subjects who are pregnant or are currently breast-feeding.
10. Patient who is an employee of the Investigator or the Institution, or a
patient who has direct involvement with the trial or other trials under the
direction of the Investigator.
11. Patient who has been treated with other investigational agent or devices
within the previous 30 days, has planned use of drugs or devices, or has
been previously randomized in this trial.
12. Laboratory value abnormalities as defined by the protocol
13. Evidence of serious diabetic complications.
14. Patients who are Hepatitis B or C or HIV positive.
15. Patients who have undergone pancreatectomy or pancreas/islet cell
transplant.
16. Patient with history or evidence of active severe proliferative
retinopathy, nephropathy and/or neuropathy significant cardiovascular
disease, anemia or hemoglobinopathy, endocrinology, renal, hepatic,
pulmonary, gastrointestinal, musculoskeletal, peripheral vascular,
psychiatric, alcohol or drug abuse or any other medical condition that in
the opinion of Investigator can interfere with the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in HbA1C
|
Change in HbA1c at baseline(screening)and day 84
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage reduction of Fasting Blood Glucose (FBG) levels
Percentage reduction of Postprandial Blood Glucose (PPBG) levels
Continuous Glucose Measurements
The adverse effects of the study drug |
FBG & PBG levels at baseline Visit 1 (Day -14
to -1) Visit 3 (Day 21±3)Visit 4 (Day 63±3) and at Visit 5 (Day 84±3)
Continuous Glucose Measurements in 25 patients in each treatment arm at baseline and end of the study
The adverse effects of the study drug will be assessed by monitoring adverse events vital
signs physical examination and clinically significant changes in laboratory parameters |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="128" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
29/07/2023 |
| Date of Study Completion (India) |
07/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="9"
Days="12" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Vildagliptin 100 mg SR Tablet once daily formulation is developed to ensure better patient
compliance towards effective glycemic control while reducing the frequency of dosing. In this
context, a non-inferiority study is planned in type 2 diabetic patients in comparison with that of
sitagliptin 100 mg with or without metformin.
The key principle behind the development of Vildagliptin 100 mg SR once daily formulation is to
ensure better patient adherence towards effective glycemic control while reducing the frequency
of dosing.
Vildagliptin and Sitagliptin are the pioneer drugs in the DPP4i class and the most widely studied
as well. Therefore, a detailed study comparing the effectiveness of the 2 drugs would add sufficient
data in the scientific literature |