| CTRI Number |
CTRI/2024/04/066007 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Linagliptin and Dapagliflozin versus Vildagliptin and Dapagliflozin in Diabetes patients |
|
Scientific Title of Study
|
Efficacy and safety of Linagliptin and Dapagliflozin versus Vildagliptin and Dapagliflozin in Type 2 Diabetes mellitus: A Randomized controlled trial |
| 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 Surjit Singh |
| Designation |
Professor, Department of Pharmacology, AIIMS, Jodhpur |
| Affiliation |
All India Institute of Medical Sciences, |
| Address |
Professor, Department of Pharmacology, AIIMS, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7973231984 |
| Fax |
|
| Email |
sehmby_ss@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Isha Yadav |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Pharmacology AIIMS, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8209302725 |
| Fax |
|
| Email |
yadavisha.2411@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Isha Yadav |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Pharmacology AIIMS, Jodhpur
RAJASTHAN
342005
India |
| Phone |
8209302725 |
| Fax |
|
| Email |
yadavisha.2411@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Jodhpur, 342005, Jodhpur, Rajasthan, India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Jodhpur |
| Address |
AIIMS Jodhpur, 2nd Phase MIA 1st phase, Basni, Jodhpur, Rajasthan 342005 |
| Type of Sponsor |
Government medical college |
|
|
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 Surjit Singh |
All India Institute of medical sciences, Jodhpur |
Department of Endocrinology and Department of Pharmacology AIIMS, Jodhpur
Jodhpur
RAJASTHAN |
7973231984
sehmby_ss@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Clinical Trial) |
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 plus Linagliptin |
Fixed drug combination of Dapagliflozin(10 mg) plus Linagliptin (5mg) will be given once daily via oral route for 3 months. |
| Comparator Agent |
Dapagliflozin plus Vildagliptin |
Fixed drug combination of Dapagliflozin (10mg) plus Vildagliptin (100mg)
will be given once daily via oral route for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 to 65yr
2. Diagnosis of type 2 diabetes mellitus as per ADA criteria.
3. Newly diagnosed Type 2 DM patients.
4. Previously diagnosed DM patient on lifestyle modifications and anti-diabetic drugs.
HbA1c more than 7 percentage.
|
|
| ExclusionCriteria |
| Details |
1. History of cardiac diseases (NYHA grade 3 – 4) or cardiac anomalies
2. Renal insufficiency - serum creatinine more than or equal to 1.8mg/dl
3. Patients with significant thyroid dysfunction and hepatic impairment (serum bilirubin more than 4. times, AST, ALT, and ALP more than three times the upper limit of normal)
5.Patient have any malignancy
6.Patient have any substance abuse(alcohol/drugs)
7.Pregnant & Lactating Woman
8.Those being treated with any investigational drug within the last 30 days
9.The patient is with severe illness/ infectionsÂ
HbA1c more than 11% |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of combination of dapagliflozin plus linagliptin versus dapagliflozin plus vildagliptin on HbA1c in T2 DM after 3 months from baseline |
3 months from baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect on fasting blood glucose (FBG) and HOMA index (HOMA-IR and HOMA- beta cell function) of dapagliflozin plus linagliptin versus dapagliflozin plus vildagliptin in T2 DM after 3 months from baseline. |
3 months from baseline |
| To evaluate the effect on QOL score (DQOL) of dapagliflozin plus linagliptin versus dapagliflozin plus vildagliptin in T2 DM after 3 months from baseline |
3 months from baseline |
| To evaluate the effect on lipid profile parameters of dapagliflozin plus linagliptin versus dapagliflozin plus vildagliptin in T2 DM after 3 months from baseline. |
3 months from baseline. |
| To evaluate the safety of dapagliflozin plus linagliptin versus dapagliflozin plus vildagliptin in T2 DM over 3 months |
3 months from baseline |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
29/04/2024 |
| 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="8"
Days="5" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Diabetes Mellitus is a disease that occurs because of excessively high blood glucose. Insulin is released from the pancreas when blood glucose levels rise, such as after a meal. Insulin promotes the removal of glucose from the blood by muscle and fat cells. There are three main types of diabetes mellitus: type 1 (also known as juvenile diabetes) is caused by insufficient insulin production by the pancreas; type 2 (also known as insulin resistance) is triggered by improper cell response to insulin; and the third type is called gestational diabetes, which is caused by elevated blood sugar levels in pregnant women who have never had diabetes before.
Type 2 diabetes mellitus is one of the major causes of metabolic disorders in the world and is caused by two main reasons which are defective secretion of insulin from pancreatic beta cells and the failure of insulin-sensitive tissue to respond to insulin. Dapagliflozin is a SGLT2 inhibitor which is approved for the treatment of T2DM in various countries in the world and Linagliptin and vildagliptin are DPP 4 inhibitors which are proven safe and efficacious in various trials. Most of the individuals required multiple drug therapy for treatment of DM. Hence fixed drug combinations are now being prescribed for the management of DM. As per our literature search, there were no studies that did head-to-head comparison of Dapagliflozin plus linagliptin versus Dapagliflozin plus vildagliptin. Hence, we planned to do a head-to-head comparison of Dapagliflozin plus linagliptin versus Dapagliflozin plus vildagliptin in the Indian population |