Pre-diabetesPhase 2NCT01336322
Metformin and Sitagliptin in Women With Previous Gestational Diabetes
A Phase 2 study testing Metformin, Sitagliptin and Sitagliptin + Metformin in people with Pre-diabetes, run by University of Pisa at 1 site in Italy.
Trial summary
The goal of the present research is to compare the effects of treatment with metformin and sitagliptin, alone or in association, in women with previous gestational diabetes to evaluate the impact of the two drugs on beta-cell function. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- Metformin, Sitagliptin and Sitagliptin + Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- May 2011to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female subjects aged ≥18 and ≤45 years
- Caucasian race
- History of previous gestational diabetes (in the screening) during pregnancy.
- Female of childbearing potential must use effective contraceptive measures for at last 1 month prior to entry into the study and should continue to use the some contraceptive method during the overall study period
- Written informed consent obtained
Who cannot join
- Patients diagnosed with type 1 insulin dependent diabetes
- Diagnosis of diabetes in the 75g OGTT performed at entry
- BMI ≤18 or ≥50 Kg/m2
- Chronic impaired renal function
- Impaired liver function as shown by transaminase levels ≥ twice above the upper normal range
- History of hypersensitivity to metformin
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- Pregnant or breast-feeding women, or women planning to become pregnant during the study
- Failure to use adequate contraception (Women of current reproductive only)
- Mental condition rending the subject unable to understand the nature, scope and possible consequences of the study
- Any clinically significant major organ system disease
- Patients with underlying concomitant medication requiring a long-term use of drugs potentially acting on glucose metabolism (e.g. corticosteroids, diuretics, beta-adrenergic drugs or others)
- Treatment or likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
- History of drug or alcohol abuse within the last 2 years or current addiction to substances of abuse
- Any disease or condition that in the opinion of the investigator may interfere with the completion of the study
- Subjects unlikely to comply with the protocol
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Endocrinology and Metabolism, University of Pisa
Pisa, 56124
About this study
Official title: Effects of Treatment With Metformin and/or Sitagliptin on Beta-cell Function and Insulin Resistance in Women With Previous Gestational Diabetes
The goal of the present research is to compare the effects of treatment with metformin and sitagliptin, alone or in association, in women with previous gestational diabetes to evaluate the impact of the two drugs on beta-cell function. The study results may contribute to give a rational approach for future investigations.
Read the detailed description
A randomized, double blinded study, on 45 women with previous gestational diabetes and impaired glucose tolerance (IGT) or impaired fasting glucose (IFG) to assess the effects of a 4-month treatment with metformin and/or a dipeptidyl peptidase-4 inhibitor (sitagliptin) on beta-cell function and insulin resistance.
At baseline, all women will have a standardized medical history, physical, and laboratory examination. Plasma glucose, insulin, pro-insulin, C-peptide, glucagon, adipokines, pro-inflammatory molecules, and lipid profile will be determined in fasting condition. A 75g OGTT will be performed after an overnight fasting and sample will be drawn at 15, 30, 60, 90 and 120 minutes for plasma glucose, C-peptide, glucagon and GLP-1 determinations. Women with IFG or IGT will be recruited and undergo to a hyperglycemic clamp with arginin bolus at the end of the test. Then the women will be randomized in 3 treatment groups: metformin (850 mg bid), sitagliptin (100 mg qd)or metformin (850 mg bid) + sitagliptin (100 mg qd). After 4-month treatment, the baseline evaluation will be repeated.
- Conditions
- Pre-diabetes
- Being tested
- Metformin, Sitagliptin, Sitagliptin + Metformin
- Keywords
- beta-cell function, insulin resistance
- Medical subject headings
- Glucose Intolerance, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage
Metformin 850 mg bid
SitagliptinDrug
Also called januvia
Sitagliptin 100 mg qd
Sitagliptin + MetforminDrug
Also called janumet
sitagliptin 100mg + metformin 850mg
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | Metformin 850 mg bid Receives: Drug: Metformin |
| Sitagliptin | Active comparator | Sitagliptin 100 mg qd Receives: Drug: Sitagliptin |
| Sitagliptin+Metformin | Active comparator | Sitagliptin 100 mg qd plus Metformin 850 mg bid Receives: Drug: Sitagliptin + Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta-cell function
Sitagliptin and/or metformin effects on beta-cell function (ISR = Insulin Secretion Rate) evaluated by mathematical model by Mari A. (Am J Physiology 2002)
Measured: 4 months
Secondary outcomes (2)
Insulin resistance
Sitagliptin and/or metformin effects on insulin resistance, evaluated by clamp, HOMA-index and ISI-Method..
Measured: 4 months
Glucose control
Sitagliptin and/or metformin effects on glucose control evaluated by OGTT and HbA1c levels.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Prof. Stefano Del Prato, University of Pisa
- Investigators
- Stefano Del Prato, MD, Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336322
- Sponsor's protocol ID
- SITA-previousGDM
- Status last verified
- Mar 2019
- First submitted
- 13 Apr 2011
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Treatment With Metformin and/or Sitagliptin on Beta-cell Function and Insulin Resistance in Women With Previous Gestational Diabetes
- ClinicalTrials.gov ID
- NCT01336322
- Acronym / sponsor ID
- SITA-previousGDM
- Conditions
- Pre-diabetes
- Keywords
- beta-cell function, insulin resistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- May 2011
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 15 Apr 2011 (estimated)
- 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.
The goal of the present research is to compare the effects of treatment with metformin and sitagliptin, alone or in association, in women with previous gestational diabetes to evaluate the impact of the two drugs on beta-cell function. The study results may contribute to give a rational approach for future investigations.
Detailed description
A randomized, double blinded study, on 45 women with previous gestational diabetes and impaired glucose tolerance (IGT) or impaired fasting glucose (IFG) to assess the effects of a 4-month treatment with metformin and/or a dipeptidyl peptidase-4 inhibitor (sitagliptin) on beta-cell function and insulin resistance.
At baseline, all women will have a standardized medical history, physical, and laboratory examination. Plasma glucose, insulin, pro-insulin, C-peptide, glucagon, adipokines, pro-inflammatory molecules, and lipid profile will be determined in fasting condition. A 75g OGTT will be performed after an overnight fasting and sample will be drawn at 15, 30, 60, 90 and 120 minutes for plasma glucose, C-peptide, glucagon and GLP-1 determinations. Women with IFG or IGT will be recruited and undergo to a hyperglycemic clamp with arginin bolus at the end of the test. Then the women will be randomized in 3 treatment groups: metformin (850 mg bid), sitagliptin (100 mg qd)or metformin (850 mg bid) + sitagliptin (100 mg qd). After 4-month treatment, the baseline evaluation will be repeated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: MetforminMetformin 850 mg bid |
| Sitagliptin | Active comparator | Drug: SitagliptinSitagliptin 100 mg qd |
| Sitagliptin+Metformin | Active comparator | Drug: Sitagliptin + MetforminSitagliptin 100 mg qd plus Metformin 850 mg bid |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female subjects aged ≥18 and ≤45 years
- Caucasian race
- History of previous gestational diabetes (in the screening) during pregnancy.
- Female of childbearing potential must use effective contraceptive measures for at last 1 month prior to entry into the study and should continue to use the some contraceptive method during the overall study period
- Written informed consent obtained
Key exclusion criteria (15 listed)
- Patients diagnosed with type 1 insulin dependent diabetes
- Diagnosis of diabetes in the 75g OGTT performed at entry
- BMI ≤18 or ≥50 Kg/m2
- Chronic impaired renal function
- Impaired liver function as shown by transaminase levels ≥ twice above the upper normal range
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 |
|---|---|---|
| MetforminAlso: GlucophageMetformin 850 mg bid | Drug | Metformin |
| SitagliptinAlso: januviaSitagliptin 100 mg qd | Drug | Sitagliptin |
| Sitagliptin + MetforminAlso: janumetsitagliptin 100mg + metformin 850mg | Drug | Sitagliptin+Metformin |
Primary outcome
Beta-cell function
Time frame: 4 months
Sitagliptin and/or metformin effects on beta-cell function (ISR = Insulin Secretion Rate) evaluated by mathematical model by Mari A. (Am J Physiology 2002)
2 secondary outcomes
Insulin resistance
Time frame: 4 months
Glucose control
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
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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.
Stefano Del Prato, MD principal investigator
University of Pisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin, Sitagliptin and Sitagliptin + Metformin in people with Pre-diabetes, run by University of Pisa 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 15 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: finished, as of the sponsor's last update on 25 Mar 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Beta-cell function (time frame: 4 months). 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 25 Mar 2019.