| CTRI Number |
CTRI/2025/12/099000 [Registered on: 12/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the Effectiveness of Common Add-on Diabetes Medicines Used with Metformin in Type 2 Diabetes Patients at a Gwalior Hospital |
|
Scientific Title of Study
|
Comparative Effectiveness of Combination of Second-line oral anti-diabetic treatment among the patients of Type-2 DM: A Prospective, Observational, Hospital-based Study in JA group of Hospital of Gajra raja medical college, Gwalior. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tribeni Debbarma |
| Designation |
Post Graduate Trainee |
| Affiliation |
Gajra Raja Medical College, Gwalior, M.P. |
| Address |
Gajra Raja Medical college, Department of Pharmacology, Gwalior, M.P.
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
8787784441 |
| Fax |
|
| Email |
momi.tridb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devendra Singh Doneriya |
| Designation |
Designated Associate Professor |
| Affiliation |
Gajra Raja Medical College |
| Address |
Gajra Raja Medical College, Gwalior, M.P.
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
8989415402 |
| Fax |
|
| Email |
dsdoneriya954@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tribeni Debbarma |
| Designation |
Post Graduate Trainee |
| Affiliation |
Gajra Raja Medical College, Gwalior, M.P. |
| Address |
Gajra Raja Medical College, Veer Savarkar Marg, Lashkar, Gwalior, M.P.
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
8787784441 |
| Fax |
|
| Email |
momi.tridb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gajra Raja Medical College, Veer Savarkar Marg, Gwalior, Madhya Pradesh, 474009 |
|
|
Primary Sponsor
|
| Name |
Dr Tribeni Debbarma |
| Address |
Gajra Raja Medical College, Veer Savarkar Marg, Gwalior, Madhya Pradesh, 474009 |
| 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 Tribeni Debbarma |
J.A Group of Hospitals |
GAJRA RAJA MEDICAL COLLEGE, J.A. Group of Hospitals, Block B Block, Out Patient Department, Department of Medicine, Gwalior, M.P.
Gwalior
MADHYA PRADESH |
9612498113
momi.tridb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GAJRA RAJA MEDICAL COLLEGE, GWALIOR,M.P. |
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 |
| Intervention |
DAPAGLIFLOZIN |
IT IS A SODIUM GLUCOSE CO TRANSPORTER 2 INHIBITOR USED IN THE DOSE OF 10mg to be given orally in the form of tablet |
| Comparator Agent |
GLIMEPIRIDE |
It is a Sulfonylurea drug used in the dose of 1mg to 2mg and will be given orally in the form of a tablet |
| Intervention |
SITAGLIPTIN |
IT IS A DIPEPTIDYL PEPTIDASE 4 INHIBITOR USED IN THE DOSE OF 100mg to be given orally in the form of a tablet |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• Diabetic patients with age group:18-65yrs
• On Metformin Monotherapy for 3 months with inadequate glycemic control (HbA1c: 7-10% at baseline) will be given as an add-on therapy to Second-line drugs such as SUs (e.g.: glimepiride), DPP-4i (e.g.: Sitagliptin), SGLT-2i (e.g.: Dapagliflozin) as prescribed by treating physician.
• Patient willing to sign Informed and written consent.
|
|
| ExclusionCriteria |
| Details |
TYPE 1 DIABETES OR GESTATIONAL DIABETES, HISTORY OF INSULIN USE OR HISTORY OF OTHER INJECTABLE ANTI DIABETIC DRUG USE, SEVERE RENAL IMPAIREMENT WHICH IS EGFR LESS THAN 30ML PER MINUTE, SEVERE HEPATIC IMPAIREMENT, SEVERE CARDIOVASCULAR EVENTS, HISTORY OF DIABETIC KETOACIDOSIS, PREGNANCY OR LACTATION |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the changes in Glycated Hemoglobin and body mass index from baseline, 3 months, 6 months and 9 months among sulfonyluraes, DPP 4 inhibitors and sglt 2c groups |
BASELINE, 3 MONTHS, 6 MONTHS AND 9 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Assess changes in Systolic BP & eGFR at Baseline, 3 months, 6 months & 9 months.
To Compare Adverse Events (e.g. Hypoglycemia, weight gain) caused among different treatment groups.
To Evaluate treatment Adherence by Morisky Medication adherence scale & discontinuation rates.
|
BASELINE, 3 MONTHS, 6 MONTHS AND 9 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
26/12/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to compare 3 groups of second line oral hypoglycaemic drugs which are dpp 4 inhibitors, sulfonylureas and sodium glucose cotransporter 2 inhibitors which among these drugs provide the best glycaemic control among the diabetic patients with a hbaic values between seven to 10 percentage. |