Observational study on a tablet called Teneligliptin in reducing sugar levels in diabetic adults.

An Open Label, Prospective, Non-Randomised, Non-Comparative Observational Clinical Study of Tenefit 20 Teneligliptin 20mg Tablets of Systopic Laboratories Pvt. Ltd. in Adults with Diabetes Mellitus Type II, Inadequately Controlled with only OHA as a Real World Clinical Practice - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/07/113710

Enrollment

550

Registered

2026-07-08

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

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: Tenefit20: Dose - 20 mg tablets Dosage - 20 mg OD Treatment Duration - 90 Days Route of Administration - Oral Dose Control Intervention1: Not Applicable. Single Arm Non Comparative Stu

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects aged between 30 to 65 years, all genders with known history of diabetes mellitus type II, Inadequately controlled by OHA. i. HbA1C Levels greater than or equal to 7 percentage ii. Fasting Blood Glucose greater than or equal to 126 mg per dL or Post Prandial Glucose greater than or equal to 200 mg per dL 2. Subjects who are routinely being treated with Tenefit 20 Teneligliptin 20 mg Tablets of Systopic Laboratories Pvt. Ltd. with and without the combination of other Oral Hypoglycemic agents only. 3. Subjects with inadequate control of blood glucose levels despite lifestyle changes not limited to diet and exercise modifications. 4. Subjects who are willing to abstain from the use of herbal, allopathic or other nutritional supplements that are indicated at reducing blood sugar levels. 5. Subjects who have no other complications associated with diabetes mellitus type II. 6. Subjects who are willing to give informed consent for observation in real world setting, able to comprehend and understand the responsibilities during screening and treatment period. 7. Subjects who consent to use of their routine laboratory tests not limited to HbA1C, FBG, PPG etc for scientific analysis and reporting. 8. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.

Exclusion criteria

Exclusion criteria: 1. Subjects who are on insulin therapy for management of diabetes mellitus type II. 2. Subjects with known hypersensitivity to the ingredients of the investigational product. 3. Subjects who are on herbal, AYUSH or home remedies for the management of diabetes mellitus not limited to nutraceutical supplements. 4. Subjects on remission from cancer of any type less than 5 years at the time of screening. 5. Subjects who are planning a pregnancy and or or currently breastfeeding. 6. Subjects who have participated in a clinical study less than 1 month before screening. 7. Any significant medical condition e.g., significant psychiatric or neurological disorders, active alcohol or drug abuse, etc., any medical condition that is unstable or poorly controlled or other factor e.g., planned relocation that the Investigator felt would interfere with study evaluations and study participation. 8. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol. 9. Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.

Design outcomes

Primary

Measure	Time frame
1. HbA1C - Reduction of greater than or equal to 0.7 percentage by end of study. 2. HbA1C - Value of less than or equal to 7 percentage by end of study. 3. Fasting Blood Glucose - Reduction of greater than or equal to 20 mg per dL from baseline by end of study. 4. Fasting Blood Glucose - Blood glucose value of less than or equal to 127 mg per dL by end of study. 5. Post Prandial Glucose - Reduction of greater than or equal to 50 mg per dL by end of study. 6. Post Prandial Glucose - Reduction of less than or equal to 200 mg per dL by the end of study. 7. HOMA IR - Reduction greater than or equal to 1.0 by end of study. 8. SF12- Improvement of greater than or equal to 50 percentage by end of study. Timepoint: HbA1C - Day 1, Day 45 and Day 90 Fasting Blood Glucose - Day 1, Day 45 and Day 90 Post Prandial Glucose - Day 1, Day 45 and Day 90 HOMA IR - Day 1, Day 45 and Day 90 SF12 - Quality of Life Questionnaire: Day 1, Day 45 and Day 90	—

Measure

Time frame

1. HbA1C - Reduction of greater than or equal to 0.7 percentage by end of study. 2. HbA1C - Value of less than or equal to 7 percentage by end of study. 3. Fasting Blood Glucose - Reduction of greater than or equal to 20 mg per dL from baseline by end of study. 4. Fasting Blood Glucose - Blood glucose value of less than or equal to 127 mg per dL by end of study. 5. Post Prandial Glucose - Reduction of greater than or equal to 50 mg per dL by end of study. 6. Post Prandial Glucose - Reduction of less than or equal to 200 mg per dL by the end of study. 7. HOMA IR - Reduction greater than or equal to 1.0 by end of study. 8. SF12- Improvement of greater than or equal to 50 percentage by end of study. Timepoint: HbA1C - Day 1, Day 45 and Day 90 Fasting Blood Glucose - Day 1, Day 45 and Day 90 Post Prandial Glucose - Day 1, Day 45 and Day 90 HOMA IR - Day 1, Day 45 and Day 90 SF12 - Quality of Life Questionnaire: Day 1, Day 45 and Day 90

—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactDr Rajesh

Adhavvan Diabetes and Research Centre

doctorrpr@gmail.com9629394222

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026