Diabete MellitusPhase 1[Statins]NCT07378293
Effects of Selected Statins on Blood Glucose Levels in Healthy Volunteers
A Phase 1 study testing Simvastatin (10mg, 20mg, 40mg), Rosuvastatin (5mg, 20mg, 40mg) and Atorvastatin (10mg, 20mg, 40mg) in people with Diabete Mellitus and Lipid Profile, run by Shaheed Benazir Bhutto University Sheringal Dir Upper at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabete Mellitus, Lipid Profile
- What is being tested?
- Simvastatin (10mg, 20mg, 40mg), Rosuvastatin (5mg, 20mg, 40mg) and Atorvastatin (10mg, 20mg, 40mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Mar 2026to 20 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers
- Non diabetic
- blood glucose level (less than140 mg/dl)
Who cannot join
- Participants with a history of diabetes mellitus
- With chronic diseases e.g heart disease, kidney disease
- participants taking other medications
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites
Shaheed Benazir Bhutto University Sheringal Dir Upper
Dīr, Khyber Pakhtunkhwa
Dr Shujaat Ahmad, PhD, 0944885400, shujat@sbbu.edu.pk
Prof Dr. Niaz Ali, PhD
Shaheed Benazir Bhutto University Sheringal Dir Upper
Dīr, Khyber Pakhtunkhwa
About this study
Official title: Effects of Selected Statins on Blood Glucose Levels in Healthy Volunteers: A Randomized Phase I Clinical Trial
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.
Read the detailed description
This study addresses emerging evidence suggesting statin therapy may modestly increase diabetes risk in a dose-dependent manner. The trial will enroll healthy volunteers who will be randomized to receive one of three statins at low, moderate, or high doses for two days. Blood glucose will be measured using standardized glucometers, while insulin and C-peptide levels will be determined using ELISA assays. The study aims to clarify whether different statins have varying effects on glucose metabolism during short-term exposure and to establish dose-response relationships.
- Conditions
- Diabete Mellitus, Lipid Profile
- Being tested
- Simvastatin (10mg, 20mg, 40mg), Rosuvastatin (5mg, 20mg, 40mg), Atorvastatin (10mg, 20mg, 40mg)
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin (10mg, 20mg, 40mg)Drug
Also called Simvastatin
The Simvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days
Rosuvastatin (5mg, 20mg, 40mg)Drug
Also called Rosuvastatin
The Rosuvastatin (5mg, 20mg, 40mg) group participants will be given the drug orally OD for two days
Atorvastatin (10mg, 20mg, 40mg)Drug
Also called Atorvastatin
The Atorvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin (5mg, 20mg, 40mg) | Experimental | The assigned participants will be given Rosuvastatin 5mg, 20mg, 40mg OD for two days Receives: Drug: Rosuvastatin (5mg, 20mg, 40mg) |
| Atorvastatin (10mg,20mg, 40mg) | Experimental | The assigned participants will be given Atorvastatin 10mg,20mg, 40mg OD for two days Receives: Drug: Atorvastatin (10mg, 20mg, 40mg) |
| Simvastatin (10mg, 20mg, 40mg) | Experimental | The assigned participants will be given Simvastatin 10mg, 20mg, 40mg OD for two days Receives: Drug: Simvastatin (10mg, 20mg, 40mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose Measurements
Blood glucose of the subjects will be determined by glucometer in mg/dl
Measured: 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
Measured: 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
Measured: Before dosing and after two days of Dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaheed Benazir Bhutto University Sheringal Dir Upper
- Sponsor type
- University, hospital or other
- Collaborators
- Khyber Medical University Peshawar
- Responsible party
- Principal investigator, Dr Abid Ullah, Shaheed Benazir Bhutto University Sheringal Dir Upper
- Investigators
- Dr Abid Ullah, PhD, Principal investigator, Shaheed Benazir Bhutto University,sheringal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378293
- Sponsor's protocol ID
- SBBU/PHM-25-33
- Other IDs
- SBBU/IREC-25-32
- Acronym
- [Statins]
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study results will be shared in Journals without the participant identifiers.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Selected Statins on Blood Glucose Levels in Healthy Volunteers: A Randomized Phase I Clinical Trial
- ClinicalTrials.gov ID
- NCT07378293
- Acronym / sponsor ID
- [Statins] / SBBU/PHM-25-33
- Conditions
- Diabete Mellitus, Lipid Profile
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shaheed Benazir Bhutto University Sheringal Dir UpperUniversity, hospital or other
- Collaborators
- Khyber Medical University Peshawar
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study addresses emerging evidence suggesting statin therapy may modestly increase diabetes risk in a dose-dependent manner. The trial will enroll healthy volunteers who will be randomized to receive one of three statins at low, moderate, or high doses for two days. Blood glucose will be measured using standardized glucometers, while insulin and C-peptide levels will be determined using ELISA assays. The study aims to clarify whether different statins have varying effects on glucose metabolism during short-term exposure and to establish dose-response relationships.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin (5mg, 20mg, 40mg) | Experimental | Drug: Rosuvastatin (5mg, 20mg, 40mg)The assigned participants will be given Rosuvastatin 5mg, 20mg, 40mg OD for two days |
| Atorvastatin (10mg,20mg, 40mg) | Experimental | Drug: Atorvastatin (10mg, 20mg, 40mg)The assigned participants will be given Atorvastatin 10mg,20mg, 40mg OD for two days |
| Simvastatin (10mg, 20mg, 40mg) | Experimental | Drug: Simvastatin (10mg, 20mg, 40mg)The assigned participants will be given Simvastatin 10mg, 20mg, 40mg OD for two days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy volunteers
- Non diabetic
- blood glucose level (less than140 mg/dl)
Key exclusion criteria (3 listed)
- Participants with a history of diabetes mellitus
- With chronic diseases e.g heart disease, kidney disease
- participants taking other medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simvastatin (10mg, 20mg, 40mg)Also: SimvastatinThe Simvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days | Drug | Simvastatin (10mg, 20mg, 40mg) |
| Rosuvastatin (5mg, 20mg, 40mg)Also: RosuvastatinThe Rosuvastatin (5mg, 20mg, 40mg) group participants will be given the drug orally OD for two days | Drug | Rosuvastatin (5mg, 20mg, 40mg) |
| Atorvastatin (10mg, 20mg, 40mg)Also: AtorvastatinThe Atorvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days | Drug | Atorvastatin (10mg,20mg, 40mg) |
Primary outcome
Blood Glucose Measurements
Time frame: before dosing and 2 days after dosing
Blood glucose of the subjects will be determined by glucometer in mg/dl
Insulin Levels Determination
Time frame: Before dosing and two days after dosing
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
C- Peptide determination
Time frame: Before dosing and after two days of Dosing
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: Yes. The study results will be shared in Journals without the participant identifiers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Abid Ullah, PhD principal investigator
Shaheed Benazir Bhutto University,sheringal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Simvastatin (10mg, 20mg, 40mg), Rosuvastatin (5mg, 20mg, 40mg) and Atorvastatin (10mg, 20mg, 40mg) in people with Diabete Mellitus and Lipid Profile, run by Shaheed Benazir Bhutto University Sheringal Dir Upper at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Abid Ullah, PhD (+92 302 8533155, abid@sbbu.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Glucose Measurements (time frame: before dosing and 2 days after dosing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.