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Comparing the Effectiveness of Common Add-on Diabetes Medicines Used with Metformin in Type 2 Diabetes Patients at a Gwalior Hospital

Comparative Effectiveness of Combination of Second-line oral anti-diabetic treatment among the patients of Type-2 DM: A Prospective, Observational, Hospital-based Study in JA group of Hospital of Gajra raja medical college, Gwalior. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/12/099000
Enrollment
240
Registered
2025-12-12
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: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: DAPAGLIFLOZIN: IT IS A SODIUM GLUCOSE CO TRANSPORTER 2 INHIBITOR USED IN THE DOSE OF 10mg to be given orally in the form of tablet Intervention2: SITAGLIPTIN: IT IS A DIPEPTIDYL PEPTIDA

Sponsors

Dr Tribeni Debbarma
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diabetic patients with age group:18-65yrs On Metformin Monotherapy for 3 months with inadequate glycemic control (HbA1c: 7-10% at baseline) will be given as an add-on therapy to Second-line drugs such as SUs (e.g.: glimepiride), DPP-4i (e.g.: Sitagliptin), SGLT-2i (e.g.: Dapagliflozin) as prescribed by treating physician. Patient willing to sign Informed and written consent.

Exclusion criteria

Exclusion criteria: TYPE 1 DIABETES OR GESTATIONAL DIABETES, HISTORY OF INSULIN USE OR HISTORY OF OTHER INJECTABLE ANTI DIABETIC DRUG USE, SEVERE RENAL IMPAIREMENT WHICH IS EGFR LESS THAN 30ML PER MINUTE, SEVERE HEPATIC IMPAIREMENT, SEVERE CARDIOVASCULAR EVENTS, HISTORY OF DIABETIC KETOACIDOSIS, PREGNANCY OR LACTATION

Design outcomes

Primary

MeasureTime frame
To evaluate the changes in Glycated Hemoglobin and body mass index from baseline, 3 months, 6 months and 9 months among sulfonyluraes, DPP 4 inhibitors and sglt 2c groupsTimepoint: BASELINE, 3 MONTHS, 6 MONTHS AND 9 MONTHS—

Secondary

MeasureTime frame
To Assess changes in Systolic BP & eGFR at Baseline, 3 months, 6 months & 9 months. To Compare Adverse Events (e.g. Hypoglycemia, weight gain) caused among different treatment groups. To Evaluate treatment Adherence by Morisky Medication adherence scale & discontinuation rates. Timepoint: BASELINE, 3 MONTHS, 6 MONTHS AND 9 MONTHS—

Countries

India

Contacts

Public ContactDr Tribeni Debbarma

Gajra Raja Medical College

dsdoneriya954@gmail.com8989415402

Outcome results

None listed

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