A study to check reduction in blood glucose level over 24 hours after consuming anti-diabetic medicines- Teneligliptin 20 mg - Dapagliflozin 10 mg or Sitagliptin 100 mg - Dapagliflozin 10 mg or Linagliptin 5 mg - Empagliflozin 25 mg using continuous glucose monitoring device.

Triple Arm, Prospective Multicentre, Randomized, Open Label, Active Controlled Study To Assess Effect on FDC of Teneligliptin 20 mg + Dapagliflozin 10 mg compared to FDC of Sitagliptin 100 mg + Dapagliflozin 10 mg and FDC of Linagliptin 5 mg + Empagliflozin 25 mg on 24 Hour Glucose Profile Assessed By Continuous Glucose Monitoring In Indian Patients of Type 2 Diabetes Mellitus In Real World Setting (AMPLIFY-TIR STUDY)

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/05/053178

Enrollment

Registered

2023-05-29

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

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: FDC of Teneligliptin 20 mg Dapagliflozin 10 mg: Dose- Teneligliptin 20 mg + Dapagliflozin 10 mg Frequency- Once a day Route of Administration: oral Total duration: 85 days Control Inte

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults (= 18 years) of either gender 2. Type 2 DM patients with HbA1c between = 7.5 % to = 10% 3. On stable therapy ( >6 weeks prior to screening) of Metformin monotherapy = 1000 mg 4. Random blood glucose levels 5. On complaint dietary regimen for >6 weeks prior to screening. 6. Patients who is able to understand & willing to comply with study requirements and provide written informed consent for participation.

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to study medications 2. Presence or evidence of diabetic ketosis or non-ketotic hyperosmolar coma, T1DM 3. Presence of cardiac arrhythmias, acute coronary syndrome 4. Liver enzyme levels > 3 ULN 5. Estimated glomerular filtration rate (eGFR) 6. Evidence of acute infection 7. Anemia and/or using erythropoiesis stimulating agents 8. Pregnant or lactating women 9. Patient with known dietary irregular patterns 10. A patient who in opinion of investigator would not be suitable for study participation

Design outcomes

Primary

Measure	Time frame
Mean change from baseline in each of parameters of glycemic variability at Immediate post randomizationTimepoint: Visit 6 Day 49	—

Secondary

Measure	Time frame
Mean change from baseline in HbA1c, FPG and PPG Mean change from baseline in UACR, eGFR, serum creatinine, BUN Incidence of any treatment emergent adverse events in terms of abnormal signs, or laboratory reportsTimepoint: Visit 6 (day 49) and visit 7 (day 90) Visit 7 (day 90)	—

Countries

India

Contacts

Public ContactDr Ashwini Kumar

Glenmark Pharmaceuticals Limited

sumit.bhushan@glenmarkpharma.com8800352225

Outcome results

None listed

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