| CTRI Number |
CTRI/2018/08/015457 [Registered on: 24/08/2018] Trial Registered Retrospectively |
| Last Modified On: |
10/08/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Non inteventional prospective study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Observational Study to Understand Usage and Effectiveness of Teneligliptin in Indian Patients with Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
A Non-Interventional, Multicenter, Prospective, Observational Study to Understand Usage and EFFect of Teneligliptin as Monotherapy OR Add On Treatment in Indian Type 2 Diabetes Patients on other Antidiabetic Drugs (AFFORD Study) |
| Trial Acronym |
AFFORD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjeev R Phatak |
| Designation |
Diabetologist and Metabolic Physician |
| Affiliation |
Vijayratna Diabetes Diagnosis and Treatment Centre |
| Address |
Vijayratna Diabetes Diagnosis and Treatment Centre
First Floor
Sumeru Center
Nr Piramal Underbridge
Paldi
Ahmedabad
Ahmadabad
GUJARAT
380007
India |
| Phone |
07926741177 |
| Fax |
07926748899 |
| Email |
dhlresearch@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Kumar Jha |
| Designation |
Assistant General Manager Medical Services Department |
| Affiliation |
Torrent Pharmaceuticals Ltd |
| Address |
Torrent Pharmaceuticals Ltd Medical Services Department Torrent House Off Ashram Road Ahmedabad
Ahmadabad
GUJARAT
380009
India |
| Phone |
07069000554 |
| Fax |
|
| Email |
pankajjha@torrentpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Gajjar |
| Designation |
Asst. Manager Medical Services |
| Affiliation |
Torrent Pharmaceuticals Ltd |
| Address |
Torrent Pharmaceuticals Ltd
Medical Services Department Torrent House Off Ashram Road Ahmedabad
Ahmadabad
GUJARAT
380009
India |
| Phone |
07069000563 |
| Fax |
|
| Email |
amitgajjar@torrentpharma.com |
|
|
Source of Monetary or Material Support
|
| Torrent Pharmaceuticals Ltd
Torrent House
Off. Ashram road
Ahmedabad
380009 |
|
|
Primary Sponsor
|
| Name |
Torrent Pharmaceuticals Ltd |
| Address |
Torrent Pharmaceuticals Ltd 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 = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjiv Shah |
APOLLO SUGAR CLINICS |
1ST FLOOR
NO.4
ABOVE NOBEL MEDICAL LINK ROAD JUNCTION
MUMBAI
Mumbai
MAHARASHTRA |
9820948618
diabetesaction@gmail.com |
| Dr Banshi Saboo |
Dia Care |
1 - Gandhi Park
Near Nehru Nagar road
Ambawadi
Ahmedabad - 380015
Ahmadabad
GUJARAT |
7573049710
diacare@live.com |
| Dr Rajiv Kovil |
DR KOVILS DIABETES CARE CENTRE |
GROUND FLOOR
D/17 SHIV ASHISH
S.V.ROAD
MUMBAI-400058
Mumbai
MAHARASHTRA |
9820127777
drrajivkovil@hotmail.com |
| Dr Sushil Jindal |
Jindal Diabetes and Hormone Centre |
16, Zone -1
MP NAGAR
Madhyapradesh
Bhopal
MADHYA PRADESH |
9300033888
susjindal@gmail.com |
| Dr Ghanshyam Goyal |
S.V.S.DIABETES RESEARCH & EDUCATION CENTRE |
S.V.S
MARAWARI HOSPITAL 118
RAJA RAM MOHAN ROY SARANI KOLKATA-700009
Kolkata
WEST BENGAL |
9830400450
drgsgoyal@hotmail.com |
| Dr H M Krishnamurthy |
SANKET HEALTH CARE AND DIABETIC SERVICES |
70, SRINIDHI APARTMENTS VANIVILAS ROAD, BASAVANAGUDI BANGALORE-560004
Bangalore
KARNATAKA |
9980666489
rupu1964@yahoo.co.in |
| Dr Sanjeev R Phatak |
Vijayratna Diabetes Diagnosis & Treatment Centre |
First Floor
Sumeru Center
Nr Piramal Underbridge Paldi
Ahmedabad
380007
Ahmadabad
GUJARAT |
07926741177
07926748899
dhlresearch@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Sangini Hospital Ethics Committee |
Approved |
| Sangini Hospital Ethics Committee |
Approved |
| Sangini Hospital Ethics Committee |
Approved |
| Sangini Hospital Ethics Committee |
Approved |
| Sangini Hospital Ethics Committee |
Approved |
| Sangini Hospital Ethics Committee |
Approved |
| Sangini Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes Mellitus, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient willing to provide informed consent
2. Female or male patient aged 18 years or above
3. Treatment naïve adult patients or adult patients who had inadequately controlled type 2 diabetes mellitus despite using diet plus exercise and/or OADs:
a. HbA1C greater than 6.5%
b. FBG greter than or equal to 140 mg/dL
4. Requirement for teneligliptin as a monotherapy or add-on
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 DPP 4 inhibitor other than teneligliptin and GLP 1 analogue therapy
3. Any medical condition of the patient which in opinion of Investigator would interfere with safe completion of the study
4. Pregnant and lactating woman
5. Women of child bearing potential not ready to use an effective barrier contraceptive method during the study
6. Patients participating in any other clinical trials |
|
|
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 HbA1c levels from baseline to week 12 in Indian Type 2 diabetes mellitus patients |
Visit 1 at baseline
Visit 2 at week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the change in FBG and PPBG levels from baseline to week 12
2. To understand usage pattern of teneligliptin as monotherapy or add-on with other OADs
3. To assess the effect of teneligliptin treatment on body weight
4. To assess adverse events during study duration
5. To assess ECG pattern for QT/QTc prolongation
|
Visit 1 at baseline
Visit 2 at week 12 |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500"
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)
|
02/12/2016 |
| 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="2"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
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 Study to Understand Usage and EFFect of Teneligliptin as Monotherapy OR Add On Treatment in Indian Type 2 Diabetes Patients on other Antidiabetic Drugs (AFFORD Study) to be conducted across India. A total of 1500 patients are planned from 15 sites across India. The primary objective of the study is to assess the change in HbA1c levels from baseline to week 12 in Indian type 2 diabetes mellitus patients. The secondary end point includes assessment of change in FBG, PPBG levels and body weight from baseline to week 12. Also to understand usage pattern of teneligliptin as monotherapy or add-on with other oral antidiabetic drugs. It also includes assessment of rate of adverse events. |