| CTRI Number |
CTRI/2017/08/009262 [Registered on: 04/08/2017] Trial Registered Prospectively |
| Last Modified On: |
03/08/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Non-interventional prospective observational study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the usage and safety of Teneligliptin versus Glimepiride in diabetic patients being treated with Metformin |
|
Scientific Title of Study
|
A Non-Interventional, Multicenter, Prospective, Observational, Comparative Study to Understand Usage, Safety and Effect of TENeligliptin Vs. GLImepiride as an Add-on to METformin Treatment in Indian Type 2 Diabetes Patients |
| Trial Acronym |
TENGLIMET |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ET1702001 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr L Sreenivasa Murthy |
| Designation |
Consultant Physician and Diabetologist |
| Affiliation |
Life Care Clinic and Research Centre |
| Address |
Life Care Clinic and Research Centre
2748/2152
M.L.N. Enclave
16th E Cross
8th Main
D Block
Next to Corporation Bank Sahakarnagar
Bengaluru
Bangalore
KARNATAKA
560092
India |
| Phone |
080-23631055 |
| Fax |
|
| Email |
drlsm@lcrc.in |
|
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 |
7069000554 |
| Fax |
|
| Email |
pankajjha@torrentpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Mandlik |
| Designation |
Manager - Medical Services |
| Affiliation |
Torrent Pharmaceuticals Ltd |
| Address |
Torrent Pharmaceuticals Ltd
Torrent House
Off Ashram Road
Ahmedabad
Ahmadabad
GUJARAT
380009
India |
| Phone |
7069000559 |
| Fax |
|
| Email |
rahulmandlik@torrentpharma.com |
|
|
Source of Monetary or Material Support
|
| Torrent Pharmaceuticals Ltd
Torrent House
Off Ashram Road,
Ahmedabad-38009,
Gujarat |
|
|
Primary Sponsor
|
| Name |
Torrent Pharmaceuticals Ltd |
| Address |
Torrent House
Off Ashram Road,
Ahmedabad-38009,
Gujarat, India
|
| 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 L Sreenivasa Murthy |
Life Care Clinic and Research Centre |
#2748/2152
M.L.N. Enclave,
16th E Cross,
8th Main,
D Block,
Next to Corporation Bank, Sahakarnagar,
Bengaluru- 560092
Bangalore
KARNATAKA |
080-23631055
drlsm@lcrc.in |
|
|
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 II Diabetes Mellitus , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Glimepiride Add on to Metformin |
Dose as per routine clinical practice |
| Intervention |
Teneligliptin Add on to Metformin |
Dose as per routine clinical practice |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing to provide informed consent
2.Female or male patient aged 18 years or above
3.Adult patients who had inadequately controlled type 2 diabetes mellitus despite using diet plus exercise and metformin:
– HbA1C: 7 to 9%
– FBG: ≥140 mg/dL
4.Physician prescribes teneligliptin or glimepiride as an add-on to metformin therapy
5.Patients must provide written consent to use personal and/or health data prior to the entry into the study
|
|
| ExclusionCriteria |
| Details |
1.Patients with Type 1 diabetes mellitus
2.Patient on antidiabetic therapy other than glimepiride, teneligliptin and metformin
3.Contraindications for teneligliptin and glimepiride as per respective approved prescribing information
4.Any reasons of medical and non-medical character, which in the opinion of the physician can prevent participant participation in the study
5.Pregnant and lactating woman and women of child bearing potential not ready to use an effective barrier contraceptive method during the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the occurrence of hypoglycemic episodes between two groups
2. To assess the change in HbA1c levels from baseline to week 24
3. To assess the effect of both the treatments on body weight
|
Baseline, Week 12 and Week 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the change in FBG and PPBG levels from baseline to week 24
2. To understand the utilization pattern of teneligliptin
3. To assess other adverse events during study duration |
Baseline, Week 12 and Week 24 |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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
|
N/A |
|
Date of First Enrollment (India)
|
07/08/2017 |
| 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
|
A Non-Interventional, Multicenter, Prospective,
Observational Comparative, Study to Understand Usage, Safety and Effect of
TENeligliptin Vs. GLImepiride as an Add-on to METformin Treatment in Indian
Type 2 Diabetes Patients (TENGLIMET Study). A total 500 patients are planned
from 10 sites across India. The primary objectives of the study are to assess
the occurrence of hypoglycemic episodes, change in HbA1c and body weight
between teneligliptin and glimepiride groups. The secondary objectives are to
assess change in Fasting Blood Glucose (FBG), Postprandial Blood Glucose
(PPBG) from baseline to week 24. Also, to understand the study drug usage
pattern and occurrence of adverse events.
|