The study is conducted to compare the effectiveness and safety of saroglitazar and metformin combination therapy to that of fenofibrate and metformin combination therapy in Indian patients with type 2 diabetes mellitus and increased plasma triglyceride level

Comparison of effectiveness and safety of add on therapy of saroglitazar and fenofibrate with metformin in Indian patients with type 2 diabetes mellitus and predominant hypertriglyceridemia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/10/005131

Enrollment

Registered

2014-10-22

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- Indian patients with type 2 diabetes mellitus and predominant hypertriglyceridemia Health Condition 2: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Saroglitazar and metformin: Metformin (1000 mg/day) + Saroglitazar (4 mg/day) for 12 weeks Control Intervention1: Fenofibrate and metformin: Metformin (1000 mg/day) + Fenofibrate (160 m

Eligibility

Inclusion criteria

Inclusion criteria: 1.Newly diagnosed cases of type 2 diabetes mellitus with predominant hypertriglyceridemia 2.Plasma triglyceride level >= 150 mg/dl 3.HbA1C >= 6.5 &

Exclusion criteria

Exclusion criteria: 1Female patients who are pregnant or lactating 2.Patients on any oral anti-diabetic drug 3.FPG > 250mg/dl, PPPG > 350mg/dl, LDL-C > 130 mg/dl 4.Co-morbid cardiovascular, renal and psychiatric diseases 5.Co-administration of drugs that are likely to interact with saroglitazar, fenofibrate or metformin and drugs that are likely to alter lipid profile and glycemic status 6.Past history of cardiovascular disease 7.Patients with rising FPG and PPPG levels at week 4 or 8.

Design outcomes

Primary

Measure	Time frame
Change in TGTimepoint: At week 12 visit	—

Secondary

Measure	Time frame
Change in TC, HDL, LDL, HbA1C, FPG & PPPGTimepoint: At week 12	—

Countries

India

Contacts

Public ContactDr Arijit Ghosh

Nilratan Sircar Medical College

drarijitghosh@gmail.com919874727137

Outcome results

None listed

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