| CTRI Number |
CTRI/2021/11/038226 [Registered on: 24/11/2021] Trial Registered Prospectively |
| Last Modified On: |
14/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Phase-IV Clinical Trial of Oral Tablets of Fixed-dose Combination of Alogliptin & Metformin Hydrochloride vs Alogliptin in the treatment of type-2 Diabetic mellitus |
|
Scientific Title of Study
|
A Phase-IV, Multi-centric, Open Label, Comparative Clinical Trial to Evaluate Safety, Tolerability and Efficacy of Oral Tablets of Fixed-dose Combination of Alogliptin & Metformin Hydrochloride vs Alogliptin in the treatment of type-2 Diabetic mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No:Indoco/CT/AloMet/042020 Dt: 01-09-2020 Ver: 01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Panda Jayanta Kumar |
| Designation |
Professor and Head |
| Affiliation |
SCB Medical College & Hospital |
| Address |
SCB Medical College & Hospital
Mangalabag
Cuttack
ORISSA
753007
India |
| Phone |
|
| Fax |
|
| Email |
drjayantpanda1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RABINARAYAN SAHOO |
| Designation |
CONSULTANT |
| Affiliation |
INDOCO REMEDIES LIMITED |
| Address |
R 92 93 TTC MIDC Industrial Area Thane Belapur Road
Navi Mumbai
Thane
MAHARASHTRA
400701
India |
| Phone |
|
| Fax |
|
| Email |
drsahoo@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Rahul Hiware |
| Designation |
Business Development |
| Affiliation |
INDOCO REMEDIES LIMITED |
| Address |
R 92 93 TTC MIDC Industrial Area Thane Belapur Road
Navi Mumbai
Thane
MAHARASHTRA
400701
India |
| Phone |
|
| Fax |
|
| Email |
rahulhiware2017@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indoco Remedies Limited |
| Address |
R 92 93 TTC MIDC Industrial Area Thane Belapur Road
Rabale Navi Mumbai 400701
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chintan Bharatkumar Patel |
Aatman Hospital Ahmedabad |
Dept of Medicine
5, Anveshan Row House, Bopal
Ahmedabad-380058, Gujarat
Ahmadabad
GUJARAT |
9825182251
chintanpatel7691@gmail.com |
| Dr Amit Suresh Bhate |
Jeevan Rekha Hospital |
DEPT OF MEDICINE
Dr BR Ambedkar Road, Belgavi-590002
Karnataka
Belgaum
KARNATAKA |
9695237796
dr.amitsureshbhate@gmail.com |
| Dr Prabhat Kumar Sharma |
Maharaja Agarsen Sperspeciality Hospital |
DEPT OF MEDICINE
Maharaja Agarsen Sperspeciality Hospital,
Central Spine, Agarsen Aspatal Marg, Sector-7
Vidyadhar Nagar, Jaipur, Rajasthan-302039. India
Jaipur
RAJASTHAN |
9983995050
agrasenhospital2003@gmail.com |
| Dr Jayanta Kumar Panda |
SCB Medical College & Hospital |
PG DEPARTMENT OF MEDICINE
Manglabag, Mangalabag, Cuttack, Odisha 753007
Cuttack
ORISSA |
9439129178
drjayantpanda1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| IEC, Maharaja Agarsen Hospital |
Approved |
| Institutional Ethics Committee Aatman Hospital |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE JEEVAN REKHA HOSPITAL |
Approved |
| Institutional Ethics Committee SCB Medical College |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Alogliptin |
Alogliptin 12.5mg orally twice a day with food for 180 days |
| Intervention |
Fixed-dose Combination of Alogliptin & Metformin Hydrochloride |
Metformin Hydrochloride 500/1000 mg & Alogliptin 12.5/12.5mg twice a day with food for 180 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients with duly filled in ICFs [Informed Consent Forms]
Patients with Type 2 Diabetes new or inadequately controlled (HbA1c>7-9 %) by diet alone , exercise or not responding to monotherapy
|
|
| ExclusionCriteria |
| Details |
Type-1 diabetes mellitus
Patients already on Insulin therapy
Patients already on triple oral anti-diabetic drug therapy
New York Heart Association Class III–IV heart failure; receiving alogliptin in a previous investigational study
History of coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, stroke or transient ischaemic attack in the previous 3months
Planning for Pregnancy or lactating women
Patients known, or thought to be hypersensitivity to study drugs
Any medication or indication that might point to an increased risk, associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the study personnel, would make the subject inappropriate for inclusion
Participation in other clinical trials the last three months and during study participation
Patients with severe renal impairment, including those receiving dialysis.
Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective of this phase-IV trial is to find out safety & tolerability of the product |
180 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objective of this phase-IV trial is to find out efficacy of the product |
180 days |
|
|
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)
|
20/12/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study drug is oral tablet formulation, which is a fixed-dose combination of Metformin Hydrochloride 500/1000 mg & Alogliptin 12.5/12.5mg. This fixed-dose combination is designed to act in the treatment of Type-2 Diabetes mellitus, which is one of the most commonly faced complaints all around the world. This is a 180-day trial to test the safety and efficacy of fixed-dose combination |