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Impact of patient education using medication educational audio-visual aid in type 2 diabetes mellitus patients on insulin

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100259
Enrollment
284
Registered
2026-01-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications Health Condition 2: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: 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 (Inter

Sponsors

Navami K S
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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 Timepoint: 0,6 and 12 months—

Secondary

MeasureTime frame
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.Timepoint: 0, 6 and 12 months—

Countries

India

Contacts

Public ContactDr Roopa Satyanarayan Basutkar

NGSM Institute of Pharmaceutical Sciences

roopasatyanarayan@gmail.com9047155003

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026