Effects of Selected Statins on Blood Glucose Levels in Healthy Volunteers

NCT07378293 | Not Yet Recruiting Phase 1 DMC

• 2 other identifiers: SBBU/PHM-25-33SBBU/IREC-25-32
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

This Phase I randomized clinical trial aims to investigate the short-term effects of three commonly prescribed statins (atorvastatin, rosuvastatin, and simvastatin) at different dose levels on blood glucose homeostasis in healthy volunteers. The study will assess changes in fasting blood glucose, insulin, and C-peptide levels following two days of statin administration under controlled conditions. The research seeks to provide comparative data on the potential diabetogenic effects of these medications.

Conditions

Diabete Mellitus; Lipid Profile

Outcome Measures

Primary Outcomes (3)

• Blood Glucose Measurements

  Blood glucose of the subjects will be determined by glucometer in mg/dl

  before dosing and 2 days after dosing

• Insulin Levels Determination

  Blood insulin levels of each participants will be checked by using human insulin ELISA kit 96 wells on respective peak plasma concentration of respective statin

  Before dosing and two days after dosing

• C- Peptide determination

  Blood samples approx. 4 mL will be taken from the participants to check C- Peptide levels by using human peptide C ELISA kit on respective peak plasma concentration of respective statin

  Before dosing and after two days of Dosing

Study Arms (3)

Rosuvastatin (5mg, 20mg, 40mg)

EXPERIMENTAL

The assigned participants will be given Rosuvastatin 5mg, 20mg, 40mg OD for two days

Drug: Rosuvastatin (5mg, 20mg, 40mg)

Atorvastatin (10mg,20mg, 40mg)

EXPERIMENTAL

The assigned participants will be given Atorvastatin 10mg,20mg, 40mg OD for two days

Drug: Atorvastatin (10mg, 20mg, 40mg)

Simvastatin (10mg, 20mg, 40mg)

EXPERIMENTAL

The assigned participants will be given Simvastatin 10mg, 20mg, 40mg OD for two days

Drug: Simvastatin (10mg, 20mg, 40mg)

Interventions

Simvastatin (10mg, 20mg, 40mg) DRUG

The Simvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days

Also known as: Simvastatin

Simvastatin (10mg, 20mg, 40mg)

Rosuvastatin (5mg, 20mg, 40mg) DRUG

The Rosuvastatin (5mg, 20mg, 40mg) group participants will be given the drug orally OD for two days

Also known as: Rosuvastatin

Rosuvastatin (5mg, 20mg, 40mg)

Atorvastatin (10mg, 20mg, 40mg) DRUG

The Atorvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days

Also known as: Atorvastatin

Atorvastatin (10mg,20mg, 40mg)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy volunteers
• Non diabetic
• blood glucose level (less than140 mg/dl)

You may not qualify if:

• Participants with a history of diabetes mellitus
• With chronic diseases e.g heart disease, kidney disease
• participants taking other medications

Sponsors & Collaborators

• Shaheed Benazir Bhutto University Sheringal Dir Upper: lead
• Khyber Medical University Peshawar: collaborator

Study Sites (2)

Shaheed Benazir Bhutto University Sheringal Dir Upper

Dīr, Khyber Pakhtunkhwa, Pakistan

Location

Shaheed Benazir Bhutto University Sheringal Dir Upper

Dīr, Khyber Pakhtunkhwa, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Simvastatin; Rosuvastatin Calcium; Atorvastatin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Dr Abid Ullah, PhD

  Shaheed Benazir Bhutto University,sheringal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Abid Ullah, PhD

CONTACT

+92 302 8533155; abid@sbbu.edu.pk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The PI will give the assigned medication to each participant according to randomization and allocation. All the personnel involved in the study will be kept blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: The drugs Rosuvastatin (5mg, 20mg, 40mg), atorvastatin (10mg,20mg, 40mg) and simvastatin(10mg, 20mg, 40mg) will be given orally to the participants of different assigned groups in once daily dosing for two days to assess the effect on blood glucose.

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 30, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 20, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

PA (2)