Type 2 DiabetesPhase 4DIACHIRONCT06860841
Effects of D-Chiro-Inositol Combined with Metformin on Insulin Resistance in People with Overweight or Obesity and T2DM
A Phase 4 study testing D-Chiro-Inositol Combined with Metformin in people with Type 2 Diabetes and Overweight and Obese Adults, run by Campus Bio-Medico University at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Overweight and Obese Adults
- What is being tested?
- D-Chiro-Inositol Combined with Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2025to 10 Apr 2025
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes mellitus.
- Age between 18-75 years.
- BMI ≥25 kg/m².
- HbA1c < 9%.
- Stable dose of metformin for at least three months prior to enrollment.
Who cannot join
- Use of antidiabetic drugs other than metformin within three months prior to enrollment.
- History of ketoacidosis or severe hypoglycemia within six months prior to enrollment.
- Significant renal or hepatic impairment (eGFR <60 mL/min/1.73 m²; ALT/AST >2× ULN).
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, RM, 00128
About this study
Official title: Effects of D-Chiro-Inositol Combined with Metformin on Insulin Resistance in People with Overweight or Obesity and Type 2 Diabetes Mellitus: a Placebo-controlled Randomized Double-Blind Crossover Trial
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.
Read the detailed description
The DIACHIRO trial is a randomized, double-blind, crossover clinical trial assessing the impact of DCI combined with metformin versus metformin plus placebo on insulin resistance in people with overweight or obesity and T2DM. The primary outcome is the change in the HOMA index. Secondary outcomes include glycemic variability parameters (e.g., time in range), oxidative stress markers, indirect calorimetry, respiratory quotient, and HbA1c levels. Participants are monitored using Flash Glucose Monitoring (FGM) systems.
- Conditions
- Type 2 Diabetes, Overweight and Obese Adults
- Being tested
- D-Chiro-Inositol Combined with Metformin, Placebo in combination with metformin
- Keywords
- D-Chiro-Inositol, Type 2 Diabetes Mellitus, Insulin Resistance, Metformin, Glycemic Variability
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-Chiro-Inositol Combined with MetforminDrug
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 metforminDrug
placebo will be administerd for 14 days, 1 cp after lunch and 1 cp after dinner in addition to pre-existing metformin therapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental Intervention/Treatment | Experimental | D-Chiro-Inositol in combination with metformin Receives: Drug: D-Chiro-Inositol Combined with Metformin |
| Active Comparator Intervention/Treatment | Active comparator | Placebo in combination with metformin Receives: Drug: Placebo in combination with metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the HOMA index
fasting glucose and insulin will be measured
Measured: at the end of treatment phase (two weeks)
Secondary outcomes (4)
Time in Range in %
Time in range in % (time spent with a glucose level between 70-180 mg/dL expressed in %)
Measured: at the end of treatment (two weeks)
Changes in oxidative stress markers
D-ROM PAT
Measured: at the end of treatment (two weeks)
Indirect calorimetry measurements
Indirect calorimetry measurements
Measured: at the end of treatment (two weeks)
Respiratory quotient measurements.
Respiratory quotient measurements.
Measured: at the end of treatment (two weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start10 Jan 2025
- Primary completion10 Feb 2025
- Study completion10 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Manfrini, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860841
- Sponsor's protocol ID
- The DIACHIRO Study
- Acronym
- DIACHIRO
- Status last verified
- Mar 2025
- First submitted
- 21 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of D-Chiro-Inositol Combined with Metformin on Insulin Resistance in People with Overweight or Obesity and Type 2 Diabetes Mellitus: a Placebo-controlled Randomized Double-Blind Crossover Trial
- ClinicalTrials.gov ID
- NCT06860841
- Acronym / sponsor ID
- DIACHIRO / The DIACHIRO Study
- Conditions
- Type 2 Diabetes, Overweight and Obese Adults
- Keywords
- D-Chiro-Inositol, Type 2 Diabetes Mellitus, Insulin Resistance, Metformin, Glycemic Variability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 10 Apr 2025 (estimated)
- First posted
- 6 Mar 2025 (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 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.
Detailed description
The DIACHIRO trial is a randomized, double-blind, crossover clinical trial assessing the impact of DCI combined with metformin versus metformin plus placebo on insulin resistance in people with overweight or obesity and T2DM. The primary outcome is the change in the HOMA index. Secondary outcomes include glycemic variability parameters (e.g., time in range), oxidative stress markers, indirect calorimetry, respiratory quotient, and HbA1c levels. Participants are monitored using Flash Glucose Monitoring (FGM) systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Intervention/Treatment | Experimental | Drug: D-Chiro-Inositol Combined with MetforminD-Chiro-Inositol in combination with metformin |
| Active Comparator Intervention/Treatment | Active comparator | Drug: Placebo in combination with metforminPlacebo in combination with metformin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of type 2 diabetes mellitus.
- Age between 18-75 years.
- BMI ≥25 kg/m².
- HbA1c < 9%.
- Stable dose of metformin for at least three months prior to enrollment.
Key exclusion criteria (4 listed)
- Use of antidiabetic drugs other than metformin within three months prior to enrollment.
- History of ketoacidosis or severe hypoglycemia within six months prior to enrollment.
- Significant renal or hepatic impairment (eGFR <60 mL/min/1.73 m²; ALT/AST >2× ULN).
- Pregnancy or lactation.
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 |
|---|---|---|
| D-Chiro-Inositol Combined with MetforminD-chiro-Inositol will be administered for 14 days,1 cp after lunch and 1 cp after dinner in addition to preexisting metformin therapy | Drug | Experimental Intervention/Treatment |
| Placebo in combination with metforminplacebo will be administerd for 14 days, 1 cp after lunch and 1 cp after dinner in addition to pre-existing metformin therapy | Drug | Active Comparator Intervention/Treatment |
Primary outcome
Change in the HOMA index
Time frame: at the end of treatment phase (two weeks)
fasting glucose and insulin will be measured
4 secondary outcomes
Time in Range in %
Time frame: at the end of treatment (two weeks)
Changes in oxidative stress markers
Time frame: at the end of treatment (two weeks)
Indirect calorimetry measurements
Time frame: at the end of treatment (two weeks)
Respiratory quotient measurements.
Time frame: at the end of treatment (two weeks)
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 11 Mar 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing D-Chiro-Inositol Combined with Metformin in people with Type 2 Diabetes and Overweight and Obese Adults, run by Campus Bio-Medico University at 1 site in Italy.
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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the HOMA index (time frame: at the end of treatment phase (two weeks)). 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 11 Mar 2025.