A clinical study to understand the combined effects of metformin in combination with sitagliptin & linagliptin, in comparison to metformin alone treatment on lipid profile level management in patients with type 2 diabetes mellitus.

A prospective, active-controlled, parallel group study to identify the superiority of oral gliptins and metformin compared to metformin monotherapy in lipid profile correction in newly diagnosed, treatment-naÃ¯ve type 2 diabetes mellitus patients.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/01/011284

Enrollment

300

Registered

2018-01-11

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- Dyslipidemia in Type 2 Diabetes Mellitus

Interventions

Intervention1: Sitagliptin 100mg OD and Linagliptin 5 mg OD: 1. Tablet Sitagliptin 100 mg OD orally to be taken before breakfast with Metformin 500 mg BD with food (breakfast & dinner). 2. Tablet Lina

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients must voluntarily sign and date an Informed Consent consistent with GCP-guidelines by ICMR. 2. Male and female patients, 30 years of age or older at Visit 1 (Screen), with newly diagnosed Type 2 Diabetes Mellitus. 3. Patients who are treatment-naÃ¯ve, defined as absence of any oral/ injectable antidiabetic therapy.

Exclusion criteria

Exclusion criteria: Patients with, who are, who have, or who have had: 1. Acute coronary syndrome (non-ST Elevation Myocardial Infarction (STEMI), STEMI, and unstable angina pectoris), stroke or transient ischemic attack within 3 months prior to informed consent. 2. Indication of liver disease determined during Screen defined by a serum level above 3 times the upper limit of normal (ULN) in any of the following: alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase. 3. Impaired renal function, defined as calculated creatinine clearance of less than 60 milliliters per minute ( 4. Any contraindication to metformin/ Sitagliptin/Linagliptin therapies, according to drug labels. 5. Treatment with anti-obesity drugs, including over-the-counter drugs such as Alli (orlistat), 3 months prior to informed consent leading to unstable body weight. 6. Pre-menopausal women who are nursing or pregnant. 7. Any other clinical condition that would jeopardize patient safety while participating in this clinical study.

Design outcomes

Primary

Measure	Time frame
Change from baseline in Serum Fasting Triglyceride Timepoint: 12 weeks	—

Secondary

Measure	Time frame
Change from baseline in HDL Cholesterol Change from baseline in LDL Cholesterol Change from baseline in Total Cholesterol Change from baseline in HbA1cTimepoint: 12 weeks	—

Countries

India

Contacts

Public ContactDr Pradeep Dwivedi

King George Medical university Lucknow

drskhattri@gmail.com9415008055

Outcome results

None listed

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