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CTRI Number  CTRI/2026/01/100259 [Registered on: 02/01/2026] Trial Registered Prospectively
Last Modified On: 29/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Other (Specify) [Patient education]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Impact of patient education using medication educational audio-visual aid in type 2 diabetes mellitus patients on insulin 
Scientific Title of Study   Integration of an educational audio-visual aid with therapeutic evaluation of dapagliflozin and vildagliptin add-on therapy among inadequately controlled type 2 diabetes mellitus patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Navami K S 
Designation  PhD Research Scholar 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Paneer, Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7356707798  
Fax    
Email  navamisathiananth1996@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Roopa Satyanarayan Basutkar 
Designation  Assistant Professor 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Paneer, Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9047155003  
Fax    
Email  roopasatyanarayan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Roopa Satyanarayan Basutkar 
Designation  Assistant Professor 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Paneer, Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9047155003  
Fax    
Email  roopasatyanarayan@gmail.com  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  Navami K S 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Paneer, Deralakatte, Mangaluru, Dakshina Kannada, Karnataka, 575018 
Type of Sponsor  Other [Funded by investigator itself] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Navami K S  Justice K.S Hegde Charitable Hospital  Departments of Endocrinology and General Medicine, Justice K S Hegde Charitable Hospital, Deralakatte, Mangaluru, 575018
Dakshina Kannada
KARNATAKA 
7356707798

navamisathiananth1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central Ethics Committee, Nitte (Deemed to be University)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group 1  Inadequately controlled type 2 diabetes mellitus patients on insulin with newly added Dapagliflozin-10 mg (Standard care) 
Comparator Agent  Control group 2  Inadequately controlled type 2 diabetes mellitus patients on insulin with newly added fixed dose combination of Dapagliflozin-10 mg plus Vildagliptin-100 mg (Standard care) 
Intervention  MEAVA 1  Among inadequately controlled type 2 diabetes mellitus patients on insulin with newly added Dapagliflozin-10 mg(Standard care), a Medication educational audio visual aid (Intervention - MEAVA I) will be administered.  
Intervention  MEAVA 2  Among inadequately controlled type 2 diabetes mellitus patients on insulin with newly added fixed dose combination of Dapagliflozin-10 mg plus Vildagliptin-100 mg (Standard care), a Medication educational audio-visual aid (Intervention - MEAVA II) will be administered. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inadequately controlled T2DM patients, aged between 18-60 years, with HbA1c 7-9, patients on Insulin plus newly added Dapagliflozin 10 mg, patients on Insulin + newly added Vildagliptin (100 mg) plus Dapagliflozin (10 mg) FDC, with or without cardiovascular and renal comorbidities and patients who can provide informed consent, participate and follow study procedures. 
 
ExclusionCriteria 
Details  Patients with other forms of diabetes, patients on OHAs other than Dapagliflozin and fixed dose combination of Dapagliflozin plus Vildagliptin with a history of drug abuse, psychosis, personality disorder or another emotional, psychological or intellectual problem, pregnant or lactating, or plan to become pregnant during the study period, with terminal illness and currently involved in another study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
At baseline-HbA1c, Systolic Blood Pressure, Diastolic Blood Pressure, Lipid Profile, BMI, Serum Creatinine, eGFR, CVD Risk score, MKAQ, MARS-10, ADD QoL-19
At 6th and 12th month- HbA1c, SBP, DBP, Lipid Profile, BMI, MKAQ, MARS-10, ADD QoL-19

 
0,6 and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
At baseline-Waist circumference and duration of physical activity
At 6th and 12th month-Waist circumference, duration of physical activity, incidence of hypoglycemia and other side effects, emergency visits, additional visits other than follow-up visits and hospitalizations. 
0, 6 and 12 months 
 
Target Sample Size   Total Sample Size="284"
Sample Size from India="284" 
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)   12/01/2026 
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="2"
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  

Type 2 Diabetes Mellitus is a progressive metabolic disorder, and a significant proportion of patients remain inadequately controlled despite insulin therapy. Intensification of insulin alone is often associated with hypoglycemia, weight gain, and poor adherence. Newer oral hypoglycemic agents such as sodium–glucose cotransporter 2 inhibitors and dipeptidyl peptidase 4 inhibitors provide complementary mechanisms of action and may improve glycemic control without increasing insulin-related adverse effects. This randomized controlled study aims to evaluates the impact of structured medication education on medication knowledge, adherence, quality of life, and clinical outcomes among inadequately controlled T2DM patients on insulin with newly added dapagliflozin 10 mg versus the fixed-dose combination of dapagliflozin 10 mg plus vildagliptin 100 mg. A novel Medication Knowledge Assessment Questionnaire will be developed and validated to assess drug-specific knowledge of newly added therapies. Furthermore, a culturally adapted Medication Educational Audio-Visual Aid in local languages will be developed to enhance patient understanding of these medications. The study addresses critical gaps in evidence regarding head to head comparison of these add on therapies and the role of targeted medication education in insulin-treated inadequately controlled T2DM patients in the Indian population.

 
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