To compare the safety and effectiveness of teneligliptin with vildagliptin in patients of uncontrolled type 2 diabetes mellitus ,already on metformin drug.

To compare the Safety and Efficacy of Teneligliptin with Vildagliptin add-on, in patients of uncontrolled Type 2 diabetes mellitus (T2DM), on Metformin monotherapy.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2019/05/019345

Enrollment

Registered

2019-05-24

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: Metformin and Vildagliptin: Metformin 1000 mg twice a day and Vildagliptin 50 mg twice a day,both for six months duration. Control Intervention1: Metformin and teneligliptin: Metformin

Eligibility

Inclusion criteria

Inclusion criteria: 1. All willing patients of either sex. 2. Patients with type 2 diabetes mellitus (T2DM). 3. Patients with uncontrolled T2DM on 2 gram metformin dose. 4. Patients having HbA1c level >=7 %. 5. Patients fasting plasma glucose (FPG) levels >= 126 mg/dL or post prandial glucose (PPG) >= 200 mg/dL.

Exclusion criteria

Exclusion criteria: 1. All unwilling patients. 2. Acute complications of diabetes i. Hyperglycemic hyperosmolar state ii. Diabetic ketoacidosis 3. Liver Disease 4. Congestive heart failure 5. Acute coronary syndrome 6. Pregnancy and lactating mothers 7. Known hypersensitivity to study drugs 8. Patients already on study drugs

Design outcomes

Primary

Measure	Time frame
Glycosylated hemoglobin (HbA1c).Timepoint: After one month,three and six months of enrollment.	—

Secondary

Measure	Time frame
Fasting Blood sugar (FBS). Post prandial blood sugar (PPBS).Timepoint: After one month,three month and six months of enrollment.	—

Countries

India

Contacts

Public ContactDr Atal Sood

Dr. R.P.G.M.C Kangra at Tanda

dinesh.kansal56@gmail.com9418454624

Outcome results

None listed

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