| CTRI Number |
CTRI/2023/01/049154 [Registered on: 23/01/2023] Trial Registered Prospectively |
| Last Modified On: |
21/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Empagliflozin versus Dapagliflozin on calcium-phosphate metabolism. |
|
Scientific Title of Study
|
A comparative study to assess the effect of Empagliflozin versus Dapagliflozin on circulating markers of calcium-phosphate metabolism in uncontrolled Type2 diabetic patients on Metformin. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shuvasree Payra |
| Designation |
PG Student |
| Affiliation |
AIIMS,PATNA |
| Address |
AIIMS,PATNA
ADMIN BUILDING, 2ND FLOOR
DEPARTMENT OF PHARMACOLOGY
AIIMS,PATNA
OPD BUILDING, 1ST FLOOR
DEPARTMENT OF MEDICINE
Patna
BIHAR
801507
India |
| Phone |
8942026986 |
| Fax |
|
| Email |
shuvasreepayra2019@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumar |
| Designation |
Assistant professor |
| Affiliation |
AIIMS,PATNA |
| Address |
Department Of Pharmacology
ADMIN BUILDING, 2ND FLOOR
AIIMS,PATNA
Aiims patna
phulwarisharif
Pin code-801507
Patna
BIHAR
801507
India |
| Phone |
9521642765 |
| Fax |
|
| Email |
drrajeshm@aiimspatna.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shuvasree Payra |
| Designation |
PG Student |
| Affiliation |
AIIMS,PATNA |
| Address |
AIIMS,PATNA
ADMIN BUILDING, 2ND FLOOR
DEPARTMENT OF PHARMACOLOGY
AIIMS,PATNA
OPD BUILDING, 1ST FLOOR
DEPARTMENT OF MEDICINE
Patna
BIHAR
801507
India |
| Phone |
8942026986 |
| Fax |
|
| Email |
shuvasreepayra2019@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences, Patna |
| Address |
All India Institute Of Medical Sciences, Patna, Bihar, Pin code-801507 |
| 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 SHUVASREE PAYRA |
AIIMS PATNA |
AIIMS,PATNA
OPD,2nd floor, Department Of Medicine
Admin building,2nd floor, Department of Pharmacology
AIIMS, PATNA
Patna
BIHAR |
8942026986
shuvasreepayra2019@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS,PATNA-Institutional Ethics Committee |
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 |
Tab. Dapagliflozin (10mg) oncedaily for 3months. |
| Comparator Agent |
Empagliflozin |
Tab. Empagliflozin (25mg) once daily for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Previously diagnosed type 2 Diabetes Mellitus patient already on Metformin
(1000mg/day) ≥3 month with FBS ≥130 mg/dl or PPBS ≥180mg/dl or HbA1C ≥7%
2. Age: ≥18years and ≤55 years
3. Gender: Both
|
|
| ExclusionCriteria |
| Details |
1.Patient already on diabetic treatment on drugs other than Metformin.
2.Patient with Renal disease (S. Creatinine ≥1.2mg/dl) Liver disease (ALT/AST >50IU)
3.Pregnant and lactating women
4.Patients unwilling/unable to give consent
5.Patient on drugs which may cause hyperglycaemia like (Steroids, Beta2 agonist, Thiazides, Antipsychotics) .
6.Patient on drugs causing hypoglycaemia (Beta blocker, Fluoroquinolones, Pentamidine).
7. Patient on drugs causing derangement of vitamin D, PTH level (Phenytoin, phenobarbital, warfarin, Cyclophosphamide, Tamoxifen, Rifampicin, Antiviral drugs).
8. Patient on vitamin D medication and calcium medication.
9. Patient on drugs which derange calcium metabolism (Thiazides, Loop diuretics).
10. Patient with vitamin D level less than 20 ng/ml.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Empagliflozin versus Dapagliflozin on circulating markers of calcium-phosphate metabolism |
0 month, 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i) Efficacy of Empagliflozin versus Dapagliflozin on blood glucose parameters.
ii) Adverse drug reaction profile (ADR Profile) in patients receiving Empagliflozin versus Dapagliflozin.
|
0 month, 1 month, 2 month, 3 month |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
27/01/2023 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
India is the emerging capital of Non-Communicable diseases (NCDs). Among NCDs the major share is contributed by Diabetes Mellitus (DM). American Diabetic Association(ADA) 2020 advises on starting SGLT2 inhibitors or DPP4 inhibitors as second line Oral Hypoglycemic Agent. SGLT2 inhibitors like Empagliflozin, Dapagliflozin mainly acts on proximal tubule by inhibiting sodium glucose cotransporter-2 which causes reabsorption of glucose via active cotransport with sodium in PCT. Although these group of drugs have many other therapeutic advantages other than control of blood sugar, several previous studies depict that it also exerts adverse effects on bone health . This necessitates further evaluation, especially comparing the effect of individual SGLT2 inhibitors on bone health. The main aim of the study is to compare the effect of Empagliflozin versus Dapagliflozin on circulating markers of calcium-phosphate metabolism, blood glucose and ADR profile in type2 diabetic patient. Study design: Open labelled Randomized Controlled Trial. The study will be conducted in department of Pharmacology in collaboration with department of General medicine of AIIMS-PATNA. We will include the patients of type 2 DM uncontrolled by Metformin alone. Study will be conducted on type2 diabetes patient who are previously taken Metformin (1000mg/day). Group A will be prescribed Tab. Empagliflozin (25mg) and Group B Tab. Dapagliflozin (10mg) as 2nd line OHA and each of the group will be followed for months and data will be collected for analysis. Sample Size: 64. Each group will have 32 patients. Laboratory findings: Fasting and 2hour Post prandial blood sugar, HbA1c value, Serum phosphate, Serum calcium, Serum PTH, 1,25dihydroxyvitaminD, KFT (S. Creatinine, S. urea, S. Uric acid), LFT (ALT, AST),Lipid Profile (S. Cholesterol, TG, HDL, LDL, VLDL) will be taken on 0 month and 3 month but on 1 month and 2 month , FBS , PPBS will be taken. After the collection of data, the data will be statistically analyzed.
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