| CTRI Number |
CTRI/2018/06/014353 [Registered on: 01/06/2018] Trial Registered Prospectively |
| Last Modified On: |
30/05/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TO EVALUATE THE EFFICACY AND SAFETY OF TENELIGLIPTIN VERSUS VILDAGLIPTIN AS AN ADD-ON TO METFORMIN IN DIABETES |
|
Scientific Title of Study
|
A Comparative study to evaluate the Efficacy and Safety of Teneligliptin versus Vildagliptin as an add-on to Metformin in the treatment of Type 2 Diabetes Mellitus at a tertiary care hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Praveen A N |
| Designation |
Post graduate Department of Pharmacology |
| Affiliation |
Post Graduate |
| Address |
Room number 2, Pharmacology Department, College building Division, Bangalore Medical College and Research Institute, Fort Road, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
8880067200 |
| Fax |
|
| Email |
praveengowdadr@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
C R Jayanthi |
| Designation |
Professor and HOD, Department of Pharmacology |
| Affiliation |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, FORT ROAD, BANGALORE
Bangalore
KARNATAKA
560002
India |
| Phone |
9448292424 |
| Fax |
|
| Email |
drjaya19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Praveen A N |
| Designation |
Post graduate Department of Pharmacology |
| Affiliation |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
Room number 2, Department of Pharmacology, College Building Division, Bangalore Medical College and Research Institute, Fort Road, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
8880067200 |
| Fax |
|
| Email |
praveengowdadr@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Praveen A N
Post graduate Department of Pharmacology BMCRI, Bengaluru 560002 |
|
|
Primary Sponsor
|
| Name |
Praveen A N |
| Address |
Bangalore Medical College and Research Institute, Fort Road, Bangalore 560002 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| PRAVEEN A N |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Room number 2, Department of Pharmacology, College building Division, Bangalore Medical College and Research Institute, Fort Road, Bangalore 560002
Bangalore
KARNATAKA |
8880067200
praveengowdadr@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
3. Patients with Type 2 DM according to American Diabetes Association (ADA) criteria (FBS 126 mg/dl, PPBS 200 mg/dl.) HbA1c levels between 7% and 9% on monotherapy with Metformin 2g/day for 6 months, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Teneligliptin |
20mg once daily oral for 12 wweeks as an addon to Metformin |
| Comparator Agent |
Vildagliptin |
50mg twice daily oral for 12 weeks as an addon to Matformin |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1. Patients willing to give written informed consent.(Annexure 1)
2. Patients of either sex aged 18 -80 years
3. Patients with Type 2 DM according to American Diabetes Association (ADA) criteria (FBS >126 mg/dl, PPBS >200 mg/dl.)
4. Type 2 DM who do not achieve glycemic target with metformin alone (upto 2g/day) for 6 months.
5. Patients with HbA1c levels between 7% and 9% on monotherapy with Metformin 1.5 -2g/day for 6 months prior to visit |
|
| ExclusionCriteria |
| Details |
. Exclusion criteria :
1. Patients who suffered an attack of acute coronary syndrome, transient ischemic attack or stroke in the past three months.
2. Patients with hepatic disease (serum level of ALT, AST, Alkaline phosphatase >3times the upper limit of normal)
3. Patients with severe ketosis, coma or reduced level of consciousness within the past 6 months due to diabetes.
4. Severe infection, pre or post operative, severe trauma.
5. History of a chronic intestinal disease associated with absorption and digestive problems.
6. Moderate or severe renal dysfunction (creatinine clearance <50ml/min, serum creatine level>1.5mg/dl in men and 1.3mg/dl in females.
7. Subjects with history of type 1 DM or secondary form of diabetes due to pancreatic diseases, pancreatic tumors pheochromocytoma, cushings syndrome, haemochromatosis drugs ,insulin receptors etc.
8. Medical history of pancreatitis with history of alcohol and drug abuse.
9. Pregnant and lactating mothers |
|
|
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 |
| The primary endpoint of the study is to compare the percentage change in mean HbA1c levels from the baseline and the end of 12 weeks between Teneligliptin vs Vildagliptin as an add-on to Metformin in type 2 DM. |
From the baseline and the end of 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the percentage change in mean FBS and PPBS values from the baseline and at the end the 4th, 8th and of 12th weeks of Teneligliptin vs Vildagliptin as an add-on to Metformin in the treatment of type 2 DM. |
from the baseline to 4th, 8th and of 12th weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 4 |
|
Date of First Enrollment (India)
|
05/06/2018 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Objectives of study: 1. The primary endpoint of the study is to compare the percentage change in mean HbA1c levels from the baseline and the end of 12 weeks between Teneligliptin vs Vildagliptin as an add-on to Metformin in type 2 DM. 2. The secondary endpoint is to compare the percentage change in mean FBS and PPBS values from the baseline and at the end the 4th, 8th and of 12th weeks of Teneligliptin vs Vildagliptin as an add-on to Metformin in the treatment of type 2 DM. 3. Compare the safety parameters of Teneligliptin vs Vildagliptin in Type 2 DM. |