FindTrial
Sign In

Study to assess effect of Teneligliptin on typical levels of blood sugar(glucose) through time in range parameter using CONTINUOUS GLUCOSE MONITORING.

A PROSPECTIVE MULTICENTER OPEN LABEL STUDY TO ASSESS EFFECT OF TENELIGLIPTIN ON GLYCEMIC CONTROL THROUGH TIME-IN-RANGE (TIR) PARAMETERS USING CONTINUOUS GLUCOSE MONITORING

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/10/028223
Enrollment
59
Registered
2020-10-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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: Teneligliptin: 20/40 mg tablet to be administered once a day orally till 47 days. Control Intervention1: Not applicable: Not Applicable

Sponsors

Dr A G Unnikrishnan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female patients having T2DM, aged 18 to 65 years 2. Type 2 DM patients uncontrolled on stable dose of Metformin therapy for more than or equal to 6 weeks having HbA1c >7.5% 3. Type 2 Diabetic patients who are gliptins naïve 4. Provide written informed consent 5. Willing and able to comply with all aspects of the protocol

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes 2. Patients on Insulin therapy 3. Severe diabetic complications such as ketoacidosis 4. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds (ms)) 5. A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) 6. The use of concomitant medications that prolong the QT/QTc interval 7. Liver dysfunction 8. Pregnant or nursing women 9. Patients of child bearing potential not willing to use effective method of contraception 10. Patients with a history of seizures 11. A history of stroke and cardiovascular events 12. Hypersensitivity to the study product 13. Any patient whom the investigator judged to be inappropriate for this study. 14. Patients who have participated in any clinical trial 30 days prior to enrolment

Design outcomes

Primary

MeasureTime frame
The primary study objective is to evaluate the percent of Time in Range (TIR) in patients treated with Teneligliptin.Timepoint: Day 1 to 4 (baseline), Day 5 to 14 (post treatment phase 1), Day 33 to 46 (post treatment phase 2).—

Secondary

MeasureTime frame
The secondary study objective is to evaluate 1. Glycemic variability 2. Time above range (TAR) 3. Time below range (TBR) 4. Glycemic control 5. TolerabilityTimepoint: Day 1 to 4 (baseline), Day 5 to 14 (post treatment phase 1), Day 33 to 46 (post treatment phase 2).—

Countries

India

Contacts

Public ContactMs Pranjal Ausekar

Chellaram Hospital Diabetes Care Multispeciality

uagcdi@cdi.org.in9960859366

Outcome results

None listed

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