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A study to understand the combined effect of sitagliptin and teneligliptin with metformin in comparison to metformin alone treatment on blood glucose cotrol in patients with type 2 diabetes mellitus.

Comparative efficacy of Sitagliptin and Teneligliptin as add on therapy to Metformin in type 2 diabetes mellitus patients.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012413
Enrollment
90
Registered
2018-03-07
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

Interventions

Intervention1: Teneligliptin: Tablet Teneligliptin 20mg OD orally to be taken before breakfast and Metformin 500 mg BD with food for 24 weeks. Intervention2: 1. Sitagliptin 2. Teneligliptin : 1. Table

Sponsors

Department of Pharmacology and Therapeutics
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with 18-70 years of age. 2. Newly diagnosed patients with Type-2 Diabetes Mellitus. a. Patients with an HBA1c value above or equal to 6.5 percent. OR b. Patients with fasting glucose above or equal to 126 mg/dl.OR c. Patients with 2-hour glucose, following ingestion of 75 g glucose load, above or equal to 200 mg. OR d. Symptomatic patients with random plasma glucose above or equal to 200 mg.

Exclusion criteria

Exclusion criteria: 1. Patients with Type - 1 Diabetes Mellitus 2. Patients with a history of severe diabetic complications: Ketoacidosis, Retinopathy, Nephropathy, Neuropathy. 3. Hypersensitivity to any of the used drugs. 4. Pregnant and lactating females 5. Liver and kidney dysfunction or severe anemia 6. Patients with serious cardiovascular disease (NYHA class I-IV CHF or history of MI or stroke) or cerebrovascular conditions within 6 months before enrolment.

Design outcomes

Primary

MeasureTime frame
Change from baseline in HbA1cTimepoint: Baseline and 24 weeks—

Secondary

MeasureTime frame
Change from baseline in LDL CholesterolTimepoint: Baseline and 24 weeks;Change from baseline in Total CholesterolTimepoint: Baseline and 24 weeks;Change from baseline in TriglycerideTimepoint: Baseline and 24 weeks;Change from baseline in AdiponectinTimepoint: Baseline and 24 weeks;Change from baseline in BMITimepoint: Baseline and 24 weeks;Change from baseline in Fasting InsulinTimepoint: Baseline and 24 weeks;Change from baseline in Fasting Plasma Glucose Timepoint: Baseline and 24 weeks;Change from baseline in HDL CholesterolTimepoint: Baseline and 24 weeks;Change from baseline in hs-CRPTimepoint: Baseline and 24 weeks—

Countries

India

Contacts

Public ContactDr Nitesh Pati Tiwari

King Georgeâ??s Medical University

drsanjaykhattri@gmail.com9415008055

Outcome results

None listed

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