Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Italy / NCT06860841
Active, not recruiting Phase 4

Effects of D-Chiro-Inositol Combined with Metformin on Insulin Resistance in People with Overweight or Obesity and T2DM

NCT06860841 · tracked via the Priya Life Science Italy tracker
Sponsor
Campus Bio-Medico University
Phase
Phase 4
Started
2025-01-10
Last updated
2025-03-11

Condition(s) studied

Type 2 DiabetesOverweight and Obese Adults

Investigational drug(s) / intervention(s)

D-Chiro-Inositol Combined with Metformin →Placebo in combination with metformin

D-Chiro-Inositol Combined with Metformin: D-chiro-Inositol will be administered for 14 days,1 cp after lunch and 1 cp after dinner in addition to preexisting metformin therapy

Placebo in combination with metformin: placebo will be administerd for 14 days, 1 cp after lunch and 1 cp after dinner in addition to pre-existing metformin therapy

Study summary

This study evaluates the efficacy of D-Chiro-Inositol (DCI) as an add-on therapy to metformin in improving insulin resistance, measured by the HOMA index, in people with overweight or obesity and type 2 diabetes mellitus (T2DM). Secondary outcomes include glycemic variability, indirect calorimetry, respiratory quotient, and other metabolic parameters.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Diagnosis of type 2 diabetes mellitus. 2. Age between 18-75 years. 3. BMI ≥25 kg/m². 4. HbA1c \< 9%. 5. Stable dose of metformin for at least three months prior to enrollment. Exclusion Criteria: 1. Use of antidiabetic drugs other than metformin within three months prior to enrollment. 2. History of ketoacidosis or severe hypoglycemia within six months prior to enrollment. 3. Significant renal or hepatic impairment (eGFR \<60 mL/min/1.73 m²; ALT/AST \>2× ULN). 4. Pregnancy or lactation.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario Campus Bio-Medico Rome RM

More Campus Bio-Medico University trials in Italy

Transcranial Static Magnetic Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis. Active, not recruiting
MRI-Based Assessment of Local Anesthetic Spread in the PENG Block Compartment Starting soon
SAPT Versus DAPT in Incomplete Revascularization After CABG Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception Recruiting
OM 85 to Prevent Respiratory Infections in Older At Risk Patients Recruiting

Other trials for the same condition

E-Health Literacy Intervention for Bangladeshi Migrants With Type 2 Diabetes in Italy Active, not recruiting
Study on the Predictive Value of High-sensitivity Cardiac Troponin I, N-terminal Pro-B-natriuretic Peptide, and Soluble Suppression of Tumorigenesis-2 for Mortality and the Development of Cardiovascular Events in Patients With Type 2 Diabetes (Diabetes-CV) Active, not recruiting
Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes Active, not recruiting
JACARDI: A eHealth and Health Literacy Educational Training to Support Older Patients With Type II Diabetes Recruiting
Self-care Behaviors of Type 2 Diabetes Mellitus Patients Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06860841 on ClinicalTrials.gov ↗ ← All trials in Italy