| CTRI Number |
CTRI/2023/05/052868 [Registered on: 18/05/2023] Trial Registered Prospectively |
| Last Modified On: |
30/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
single drug vs double drug in new diabetic adults.
|
|
Scientific Title of Study
|
A Randomised Open Label Study on the efficacy and safety of Metformin Monotherapy vs Metformin- Dapagliflozin combination therapy in the treatment of newly diagnosed type 2 diabetic patients in the urban population of chennai |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Drsri devi |
| Designation |
professor, Pharmacology |
| Affiliation |
ACS medical college and hospital |
| Address |
ACS MEDICAL COLLEGE AND HOSPITAL
velapanchavadi, poonamallee high road
Chennai
TAMIL NADU
600077
India |
| Phone |
09884477103 |
| Fax |
|
| Email |
sridevidakshya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B KALAISELVI |
| Designation |
professor, Pharmacology |
| Affiliation |
ACS medical college and hospital, DR MGR EDUCATIONAL AND RESEARCH INSTITUTE |
| Address |
ACS MEDICAL COLLEGE AND HOSPITAL
VELAPPANCHAVADI
velappanchavadi chennai 600077
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9840311021 |
| Fax |
|
| Email |
drbkalaiselvi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B KALAISELVI |
| Designation |
professor, Pharmacology |
| Affiliation |
Dr MGR EDUCATIONAL AND RESEARCH INSTITUTE |
| Address |
ACS MEDICAL COLLEGE AND HOSPITAL
VELAPPANCHAVADI
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9840311021 |
| Fax |
|
| Email |
drbkalaiselvi@gmail.com |
|
|
Source of Monetary or Material Support
|
| ACS MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
Dr Sridevi S A (self) |
| Address |
BF5 VINOTH VIRUKSHA, GANGAI AMMAN NAGAR, NOLAMBUR, CHENNAI 600107 |
| 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 |
| Dr SRIDEVI S A |
INDRA SRI CLINIC |
no 139, gangai amman nagar, nolambur
Chennai
TAMIL NADU |
9884477103
sridevidakshya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,ACSMCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
METFORMIN |
oral tablet metformin
dose : 500 mg
twice daily
after food morning and evening for 6 months |
| Intervention |
METFORMIN AND DAPAGLIFLOZIN |
oral tablet Metformin
500 mg twice daily after food, morning and evening for 6 months
oral tablet dapagliflozin
10 mg once daily in the morning after food for 6 months |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
newly diagnosed type 2 diabetes mellitus with HbA1C more than 6.5 % associated with hypertension, obesity, hyperlipidemia. |
|
| ExclusionCriteria |
| Details |
age less than 35 and more than 55 type 1 diabetes mellitus hypertensives, hyperlipidemics renal or hepatic disease pregnancy lactation |
|
|
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 |
| hbA1C |
3rd month, 6th month, 12th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
fasting blood sugar, post prandial blood sugar, lipid profile, BP, waist circumference ratio , urine routine
QOL(quality of life) index |
baseline, 6th month(investigations)
QOL at 6th month and 12th month |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "250"
Final Enrollment numbers achieved (India)="250" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/05/2023 |
| Date of Study Completion (India) |
09/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
09/05/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not yet...data submitted for analysis |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study mainly aims at introducing metformin- dapagliflozin combination therapy as compared to conventional metformin monotherapy in newly diagnosed type 2 diabetes mellitus patients associated with hypertension, obesity and hyperlipidemia. The study aims at bringing holistic approach to bring euglycemic control , reduce the duration of drug therapy and follow the latest american Diabetes Association (ADA) 2023 guidelines which states to target the associated factors causing peripheral insulin resistance. |