NCT05806723 is a Phase 4 clinical trial of Atorvastatin 40 Mg Oral Tablet in Diabetes Mellitus, Type 2, sponsored by Hopital La Rabta.

Who is sponsoring NCT05806723?

NCT05806723 is sponsored by Hopital La Rabta.

What drugs are being tested in NCT05806723?

Interventions in NCT05806723: Atorvastatin 40 Mg Oral Tablet.

What condition does NCT05806723 study?

NCT05806723 studies Diabetes Mellitus, Type 2, Dyslipidemia Associated With Type II Diabetes Mellitus, Statin Adverse Reaction, Hypogonadism, Male, Adrenal Insufficiency, Vitamin D Deficiency.

Is NCT05806723 still recruiting?

NCT05806723 is currently completed. Last updated 10 April 2023.

Last reviewed 2023-04-10 · How we verify

NCT05806723

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effects of High Intensity Statin Therapy on Steroid Hormones and Vitamin D in Type 2 Diabetic Men

Completed Phase 4 Last updated 10 April 2023

What this trial tests

Phase 4 trial testing Atorvastatin 40 Mg Oral Tablet in Diabetes Mellitus, Type 2 in 104 participants. Completed in 15 September 2022.

Timeline

1 March 2021

Primary endpoint
30 July 2022

15 September 2022

Quick facts

Lead sponsor	Hopital La Rabta
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	104
Start date	1 March 2021
Primary completion	30 July 2022
Estimated completion	15 September 2022
Sites	1 location across Tunisia

Drugs / interventions tested

Atorvastatin 40 Mg Oral Tablet

Conditions studied

Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Dyslipidemia Associated With Type II Diabetes Mellitus — all drugs for Dyslipidemia Associated With Type II Diabetes Mellitus →
Statin Adverse Reaction — all drugs for Statin Adverse Reaction →
Hypogonadism, Male — all drugs for Hypogonadism, Male →

Sponsor

Hopital La Rabta — full company profile →

Who can join

Adults 40 to 65, male only, with Diabetes Mellitus, Type 2 or Dyslipidemia Associated With Type II Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of the study was to assess the effect of high intensity statin therapy on testicular and adrenal steroids and vitamin D levels in type 2 diabetes males.It is a prospective study, conducted between march 2021 and July 2022, including 60 men with type 2 diabetes, aged 40 - 65 years, statin-free, and in whom a treatment with high intensity statin was indicated. The patients had two visits, before and six months after a daily intake of 40 mg of atorvastatin. During each visit, they underwent a clinical examination including the Androgen Deficiency in the Aging Male (ADAM) questionnaire and a fasting blood sample was collected for biological and hormonal measurements.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Atorvastatin 40 Mg Oral Tablet

Trials testing the same drug.

NCT07508254 — Triple vs Dual Lipid-Lowering Therapy for LDL-C Reduction in Acute Coronary Syndrome · Phase 4 · not yet recruiting
NCT06360120 — Combining Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Large-vessel Ischemic Stroke · Phase 3 · recruiting
NCT05946122 — Effect of Atorvastatin as a Renal Protection in Patients With Systemic Inflammatory Response Syndrome Using Renal Arteri · Phase 1 · unknown
NCT04789057 — Atorvastatin Effect on Reduction of COPD Exacerbations · Phase 4 · recruiting
NCT04262206 — Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults · Phase 4 · recruiting

Other recruiting trials for Diabetes Mellitus, Type 2

Currently open trials in the same condition.

NCT07415954 — A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 · Phase 2 · recruiting
NCT07532863 — A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Part · recruiting
NCT07336329 — Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use · NA · recruiting
NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006) · Phase 1 · recruiting
NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0 · recruiting

Other Hopital La Rabta trials

Trials by the same sponsor.

NCT07367425 — Risks of Ramadan Fasting in Patients With Primary Adrenal Insufficiency Treated With Prednisolone. · NA · not yet recruiting
NCT06832566 — Ramadan Fasting Outcomes in Patients With Secondary Adrenal Insufficiency Before and After the Treatment of Hypotension. · Phase 4 · not yet recruiting
NCT06299020 — Risks of Intermittent Fasting in Patients With Primary Adrenal Insufficiency · NA · completed
NCT05827965 — Ramadan Fasting in Secondary Adrenal Insufficiency Patients · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05806723 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hopital La Rabta
Last refreshed: 10 April 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05806723.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing