| 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
|
|
|
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
|
|
|
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
|
|
|
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. |