| CTRI Number |
CTRI/2018/02/012072 [Registered on: 22/02/2018] Trial Registered Prospectively |
| Last Modified On: |
13/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Non-interventional study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess effect of teneligliptin on heart rhythm in patients with diabetes |
|
Scientific Title of Study
|
A Non-INterventional, Multicenter, Prospective, ObserVational Study to UndErstaNd the Effect of Teneligliptin on QT Interval in Indian Type 2 Diabetes Patients |
| Trial Acronym |
INVENT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ET1705002 Version No. 00 Dated: 25-05-2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramesh Dargad |
| Designation |
Consulting cardiologist |
| Affiliation |
Dr. Ramesh Dargads Clinic |
| Address |
G-1/A Building, Mukund Nagar,
Andheri, Kurla Road
Andheri (E)
Mumbai
MAHARASHTRA
400069
India |
| Phone |
|
| Fax |
|
| Email |
rohitdargad@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Kumar Jha |
| Designation |
Asst. General Manager (Medical Services) |
| Affiliation |
Torrent Pharmaceuticals Ltd |
| Address |
Torrent Pharmaceuticals Ltd
Torrent House
Off Ashram Road
Ahmedabad
Ahmadabad
GUJARAT
380009
India |
| Phone |
|
| Fax |
|
| Email |
pankajjha@torrentpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Altaf Makwana |
| Designation |
Asst. Manager (Medical Services) |
| Affiliation |
Torrent Pharmaceuticals Ltd |
| Address |
Torrent Pharmaceuticals Ltd
Torrent House
Off Ashram Road
Ahmedabad
Ahmadabad
GUJARAT
380009
India |
| Phone |
|
| Fax |
|
| Email |
altafmakwana@torrentpharma.com |
|
|
Source of Monetary or Material Support
|
| Torrent Pharmaceuticals Ltd
Off Ashram Road
Ahmedabad-38009
Gujarat |
|
|
Primary Sponsor
|
| Name |
Torrent Pharmaceutical Ltd |
| Address |
Torrent House, Off Ashram Road,
Ahmedabad-38009, Gujarat
|
| 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 Ramesh Dargad |
Dr. Dargads Clinic |
Ground Floor,
Room No. 1/A
Mukund Nagar,
Marol Pipelines
Andheri, Kurla Road
Andheri (E)
Mumbai
MAHARASHTRA |
9820152828
rohitdargad@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sangini Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to provide informed consent
Female or male patient aged 60 years or above
Treatment naïve patients or patients who had inadequately controlled type 2 diabetes mellitus despite using diet plus exercise and/or OADs: a. HbA1C greater than 6.5% b. FBS more than or equal to 140 mg per dL
Patient is prescribed teneligliptin 40mg as a monotherapy or add on therapy
Patients must provide written consent to use personal and/or health data prior to the entry into the study
|
|
| ExclusionCriteria |
| Details |
Patients with Type 1 diabetes mellitus
Patient on DPP-4 inhibitor other than teneligliptin and GLP-1 analogue therapy
Contraindications for teneliglitpin as per approved prescribing information
Patients taking any other drug prolonging QT interval.
Any reasons of medical and non-medical character, which in the opinion of the physician can prevent participation of subject in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the change in QTc interval in ECG from baseline to week 4 and 12 |
At baseline, week 4 and week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the change in HbA1c, FBG and PPBG levels from baseline to week 12
To understand usage pattern of teneligliptin in diabetic patients as a monotherapy or add-on with other OADs
To assess adverse events during study duration
|
At baseline, week 4 and Week 12 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/03/2018 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet planned |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This Non-Interventional, Multicenter, Prospective, Observational Study to UNderstand the Effect of Teneligliptin on QT Interval in Indian Type 2 Diabetes Patients (INVENT Study). Total 200 patients are planned from 20 sites are planned. The primary objective is to assess the change in QTc interval in ECG of type 2 diabetic patients (age > 60yrs) treated in routine clinical practice with Teneligliptin 40 mg from baseline to week 4 and 12 treated with Teneligiptin. The secondary objectives of study are (i) to understand usage pattern of teneligliptin (ii) changes in HB1Ac, FBG and PPBG levels from baseline to week 12 and (iii) to assess adverse event during study medication |