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A study on Diabetes Mellitus patients for checking Kidney function.

A real-world observational study on Diabetes Mellitus patients administering dual combination therapy of Teneligliptin and MetformIn to evaluate REnal function. - ADMIRE STUDY

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/07/034834
Enrollment
30000
Registered
2021-07-14
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

None listed

Sponsors

Mankind Pharma Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female patients, age � 18 to � 85 years. 2. Uncontrolled Type 2 diabetes with a haemoglobin A1c (HbA1c) �7.0 percent. 3. eGFR (MDRD) at screening > 60 mL/min/1.73m2 4. Patients who are prescribed Teneligliptin and Metformin combination therapy as part of routine clinical practice.

Exclusion criteria

Exclusion criteria: 1. Female patients who are pregnant or breast feeding 2. Patients with known liver or kidney dysfunction 3. Patients who are suspected of or known to have an intolerance to Teneligliptin or Metformin. 4. Presence of any other clinically significant disease or laboratory findings that in the Investigators opinion may affect the study outcomes or continued participation of patient in the study. 5. Participation in another study concurrently or within 4 weeks prior to the Screening Visit

Design outcomes

Primary

MeasureTime frame
Evaluate the Change in eGFR as compared to baseline at 3 months and 6 monthsTimepoint: Evaluate the Change in eGFR as compared to baseline at 3 months and 6 months

Secondary

MeasureTime frame
1. Change in HbA1c as compared to baseline at 3 months and 6 months. 2. Change in Fasting Plasma Glucose (FPG) and Postprandial Plasma Glucose (PPG) as compared to baseline at 3 months and 6 months. 3. Number of patients with target HbA1c level of 7 percent at 3 months and 6 months. Timepoint: Baseline, 3 months and 6 months.

Countries

India

Contacts

Public ContactRitesh Khandelwal

K.G.N. Diabetes and Endocrinology Centre

shaikhsajidshehla@gmail.com

Outcome results

None listed

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