A clinical trial to study the effect of Teneligliptin Tablet in the treatment of patients with Type 2 Diabetes Mellitus Inadequately Controlled with diet and exercise.

A Randomized, Double blind, Comparative, Prospective, Placebo-controlled, Parallel-Group, Multicentre Study to evaluate the Safety and Efficacy of Teneligliptin in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise Alone

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/01/004315

Enrollment

237

Registered

2014-01-16

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: null- Type 2 Diabetes Mellitus Inadequately Controlled with Diet and Exercise Alone

Interventions

Intervention1: Teneligliptin 20 mg Tablet: administered 1 tablet once daily for 16 weeks Control Intervention1: Placebo Tablet: administered 1 tablet once daily for 16 weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1. Type 2 Diabetes Mellitus patients aged >=18 to 2. Patient with inadequate glycaemic control [glycosylated haemoglobin (HbA1c) >7% to 3. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening. 4. Patients willing to comply with the protocol requirements.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women. 2. Female Patient of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy. 3. Patients with known hypersensitivity to any of the components of the formulation 4. Known cases of diabetic nephropathy, diabetic ketoacidosis, diabetic coma, hyperglycemia hyperosmolar state, retinopathy, neuropathy or other diabetic complications of sufficient severity to require treatment like severe Peripheral Neuropathy, Symptomatic Orthostatic Hypotension, Urinary Retention, Foot ulcers, or Gastric Stasis. 5. Patients who have a recent history or who are currently known to abuse alcohol or drugs. 6. Patients with clinically significant renal, hepatic, or cerebrovascular disease, known pituitary or gastric dysfunction, malignancy, thyroid dysfunction, chronic uncontrolled systemic diseases like asthma, hypertension, collagen disorders, severe infection etc. or any other medical illness that may affect patient safety or difficult to evaluate the efficacy of the product. 7. Patients receiving treatment with systemic corticosteroids. 8. Patients who have participated in any clinical trial in the past 1 month. 9. Any other condition that in the opinion of the Investigator that does not justify the patientâ??s participation in the study.

Design outcomes

Primary

Measure	Time frame
Mean Change in Glycosylated Haemoglobin (HbA1c) levelsTimepoint: 16 weeks	—

Secondary

Measure	Time frame
Mean Change in Fasting and Postprandial Plasma Glucose (FPG and PPG)Timepoint: 16 weeks;Proportion of patients achieving the goal of HbA1c â?¤7% levelTimepoint: 16 weeks	—

Countries

India

Contacts

Public ContactDr Shailendra Sachan

Glenmark Pharmaceuticals Ltd

piyusha@glenmarkpharma.com912240189999

Outcome results

None listed

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