A clinical trial to study the effect of atorvastatin on pancreatic beta-cell function & insulin resistence in patients with type 2 diabetes mellitus

A randomized double-blind placebo-controlled prospective evaluation of the effect of atorvastatin on pancreatic beta-cell function and insulin resistance in type-2 diabetes mellitus patients: A pilot study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000099

Enrollment

Registered

2008-07-21

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- Diabetes Mellitus Type 2 with Hyperlipidemia

Interventions

Intervention1: Tab. Atorvastatin: 10mg OD for 12 weeks Control Intervention1: Tab. Placebo: 1 tab OD for 12 weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patient with type 2 diabetes mellitus not taking insulin. 2.Patient should not have taken statins during past 3 months. 3.Patients of either sex aged 18 years and above. 4. Patient should not be on more than two anti-diabetic drugs(Sulphonylureas & Biguanides) 5.LDL >99 - 129 - 6.HbA1c >6.4 - <10

Exclusion criteria

Exclusion criteria: 1. Patient already taking statin or on insulin therapy 2. Deranged liver function test, renal function test 3. Clinically significant cardiovascular disease including history of myocardial infraction or Heart failure (NYHA class III or IV) 4.Pregnancy 5.Lactation 6.Drug abuse 7.Hypersensitivity to statins 8.Patients on drugs that can increase the incidence of statin induced myopathy 9.Patient on drugs causing hyperglycemia

Design outcomes

Primary

Measure	Time frame
Change in HOMA2 IR and HOMA2 %betaTimepoint: Baseline and at 12 weeks	—

Secondary

Measure	Time frame
Adverse event monitoring in type 2 diabetes mellitus patients receiving atorvastatinTimepoint: Baseline and at 12 weeks;Change in HbA1c in type 2 diabetes mellitus patients receiving atorvastatinTimepoint: Baseline and at 12 weeks;Change in oxidative stress markers in type 2 diabetes mellitus patients receiving atorvastatinTimepoint: Baseline and at 12 weeks;QOL in type 2 diabetes mellitus patients receiving atorvastatinTimepoint: Baseline and at 12 weeks	—

Measure

Time frame

Adverse event monitoring in type 2 diabetes mellitus patients receiving atorvastatinTimepoint: Baseline and at 12 weeks;Change in HbA1c in type 2 diabetes mellitus patients receiving atorvastatinTimepoint: Baseline and at 12 weeks;Change in oxidative stress markers in type 2 diabetes mellitus patients receiving atorvastatinTimepoint: Baseline and at 12 weeks;QOL in type 2 diabetes mellitus patients receiving atorvastatinTimepoint: Baseline and at 12 weeks

—

Countries

India

Contacts

Public ContactDr. Aman Goyal

All India Institute of Medical Sciences

Nikhil_Tandon@hotmail.com011-26593433

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 20, 2026

A clinical trial to study the effect of atorvastatin on pancreatic beta-cell function &amp; insulin resistence in patients with type 2 diabetes mellitus