| CTRI Number |
CTRI/2020/12/030147 [Registered on: 31/12/2020] Trial Registered Prospectively |
| Last Modified On: |
25/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparative study of efficacy, safety and patient compliance of Dapagliflozin(anti diabetic drug) and Metformin(anti diabetic drug) Vs Vildagliptin(anti diabetic drug) and Metformin combination therapy in newly diagnosed Type 2 diabetes patients |
|
Scientific Title of Study
|
Comparative study of efficacy, safety and patient compliance of Dapagliflozin and Metformin Vs Vildagliptin and Metformin combination therapy in newly diagnosed Type 2 diabetes patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kumar Gautam |
| Designation |
Post graduate Tutor |
| Affiliation |
Kalinga Institute of Medical sciences |
| Address |
KIMS
Department of Pharmacology
Bhubaneswar
Odisha
Khordha
ORISSA
751024
India |
| Phone |
8448072805 |
| Fax |
|
| Email |
krgautam176@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manas Ranjan Mishra |
| Designation |
Associate Professor, Pharmacology |
| Affiliation |
kalinga institute of medical sciences |
| Address |
KIMS
Department of Pharmacology
Bhubaneswar
Odisha
Khordha
ORISSA
751024
India |
| Phone |
9338816676 |
| Fax |
|
| Email |
drmrmishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kumar Gautam |
| Designation |
Post graduate Tutor |
| Affiliation |
Kalinga Institute of Medical sciences |
| Address |
KIMS
Department of Pharmacology
Bhubaneswar
Odisha
Khordha
ORISSA
751024
India |
| Phone |
8448072805 |
| Fax |
|
| Email |
krgautam176@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute Of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Kumar Gautam |
| Address |
KIMS
Department Of Pharmacology
Bhubaneswar, Odisha-751024 |
| Type of Sponsor |
Private 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 |
| Kumar Gautam |
Department of Endocrinology, Kalinga Institute of Medical Sciences |
Kalinga Institute of Medical Sciences,Bhubaneswar,Odisha-751024
Khordha
ORISSA |
8448072805
krgautam176@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,KIMS(Kalinga Institute Of Medical Sciences) |
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 and Metformin |
Anti Diabetic Drug in newly diagnosed Type 2 diabetes patients |
| Comparator Agent |
Vildagliptin and Metformin |
Anti Diabetic Drug in newly diagnosed Type 2 diabetes patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1)Newly diagnosed T2DM patients with or without metformin therapy 2)HbA1C ≥7.5 3)Age 18-75 yrs
|
|
| ExclusionCriteria |
| Details |
1)Type 1DM, Patient taking metformin 1000mg/day with poor glycemic control
2)eGFR <45 ml/min/1.73m2
3)CHF
4)Pregnancy
5)Lactation
6)Patients with Child bearing potential
7)Active Malignancy 8)Chronic inflammatory disorders
9)Chronic alcoholism
10)History of pancreatitis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in HbA1C level after 24 weeks of treatment.
|
After 24 weeks of treatment.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Body weight
2)Anthropometric measurements (Hip circumference, Hip-Waist ratio)
3)Blood Pressure (SBP DBP)
4)ECG
5)FPG in mg/dl
6)Change in lipid profile (Total plasma Cholesterol, LDL,VLDL,HDL,Triglycerides)
7)Serum Uric acid
8)NAFLD fibrosis score (NFS)
9)Quality of life (DTR-QOL score) using DTR-QOL questionnaire.
10)Occurrence of Adverse events (Relative risk)
|
After 24 weeks of treatment. |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/01/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/01/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetes is one of the most common chronic and non communicable disease with more than 350 million cases wordwide. The disease burden contributed by India is steadily increasing from 26 million in 1990 to 65 million in 2016. The age standardized disease prevalence has increased by 39.6% during the same period. The treatment of the disease is costly and type 2 diabetes (T2DM) constitutes for approximately 90% of the disease burdeManagement of the disease is multimodal and focuses on lifestyle management, diabetes self management education and specific medication. For newly diagnosed T2DM patients choosing the appropriate drug or drug combination is crucial in achieving the goal of preventing or delaying complications and maintaining as well as improving quality of life.The management strategy must be specific, measurable, achievable, realistic and time limited.4 Choice of drugs for the treatment should be individualized taking in to consideration of the factors like HbA1c, body weight, hypoglycaemia, side effects, cost and convenience.4 |