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A study to see how two cholesterol medicines affect cholesterol levels, sugar control and blood vessel health in people with type 2 diabetes.

comparative Efficacy of Rosuvatatin Monotherapy and Rosuvastatin/Ezetimibe Combination Therapy on Insulin Sensitivity, Vascular Inflammation and Lipoprotein Response in Patients with Type 2 Diabetes Mellitus - A Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097905
Enrollment
90
Registered
2025-11-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E11- Type 2 diabetes mellitus

Interventions

Intervention1: Type: DRUG Combination Rosuvastatin 5mg + Ezetimibe 10mg: Participants in the intervention arm will receive Rosuvastatin 5 mg orally once daily plus Ezetimibe 10 mg orally once daily f

Sponsors

Dr Vidwath V
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age greater than 18 years 2) Type 2 Diabetes Mellitus with HbA1c 6.5% to 9% or FBS greater than 126mg/dl, RBS greater than 200mg/dl 3) LDL greater than 100mg/dl at baseline 4) Patient never on Statin or Insulin, or not on any Statin or Insulin therapy for the past 3 months. 5) AST and ALT within 1.5 times the upper normal limit at baseline.

Exclusion criteria

Exclusion criteria: 1) Those patients who do not consent to the study. 2) Any known allergy or hypersensitivity reaction to statin. 3) Familial Hypercholesterolemias. 4) Any patients who are known CKD Stage IIIB or worse (EGFR less than 45ml/min/1.73m ), Heart Failure, CAD, or have history of stroke.

Design outcomes

Primary

MeasureTime frame
To demonstrate that Statin/Ezetimibe combination is superior in improving Insulin sensitivity and reducing Vascular Inflammation in patients with Type 2 Diabetes Mellitus. Timepoint: Baseline and 3 months after administration of drug therapy.—

Secondary

MeasureTime frame
To demonstrate that 5mg of Rosuvastatin when given with Ezetimibe is non inferior to 10 mg Rosuvastatin therapy in lowering LDL levels.Timepoint: Baseline and 3 months after administration of drug therapy.—

Countries

India

Contacts

Public ContactVidya T A

SRM Medical College Hospital and Research Centre, SRM IST

vv2871@srmist.edu.in9446055007

Outcome results

None listed

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