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A Real-World Study on KC MeSempa for Type 2 Diabetes Patients in Routine Practice

Effectiveness, Safety, and Tolerability of Empagliflozin Sitagliptin Metformin ER (FDC) in Adults with Type 2 Diabetes: A 12-Week Prospective, Real-World, Non-Interventional Study - RWE_MeSempa

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/02/104842
Enrollment
700
Registered
2026-02-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Control Intervention1: NIL: NL

Sponsors

KollectCare Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients (more than 18 years) diagnosed with type 2 Diabetes Mallitus.Patients prescribed KC MeSEMPA as per treating physicians independent and participants willing to provide informed consent.

Exclusion criteria

Exclusion criteria: Participants fulfilling any of thr followinhg criteria are not eligible for inclusion in this study Patients with Tyoe 1 Diabetes Mellitus Pregnat or lactating women, or women planning pregnancy during the study Patients below 18 years or above75 years of age Patients with known contraindications or hypersensitivity to empagliflozin, sitagliptin, metformin, or excipients Patients with several renal impairment (eGFR less than 45) or end-stage renal disease Patients currently participating in any interventional clinical trial. Any medical condition which, in the investigators opinion, may interfere with study participation or interpretation of results. Patients with contraindication to any component of study drug. Patients enrolled in any interventional clinical trial. Any condition that, in the investigators opinion, makes the patient unsuitable

Design outcomes

Primary

MeasureTime frame
To assess the change in HbA1c from baseline to Week 12 in participants treated with KC MeSempa in routine clinical practice.Timepoint: 12 Weeks—

Secondary

MeasureTime frame
Secondary Objectives To evaluate changes in Fasting Plasma Glucose (FPG), Post-Prandial Glucose (PPG), EGFR and Serum Creatinine To assess change in body weight and blood pressure To evaluate physician-assessed Effectiveness, tolerability, and compliance To document patient-reported outcomes (energy levels and treatment satisfaction)Timepoint: 12 weeks—

Countries

India

Contacts

Public ContactDr Mukulesh Gupta

Udyan Health Care

Drmukulesh@yahoo.com9336046146

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026