Diabetes, GestationalPhase 3FIMMET201501NCT04222348
MeDiGes Study: Metformine Use in Gestational Diabetes
A Phase 3 study testing Metformin and Insulin Detemir in people with Diabetes, Gestational and Perinatal Disorder, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud.
Trial summary
Women with gestational diabete (GD) who do not meet glycemic control objectives with diet will be assigned to two treatment groups randomly. One: metformin at a dose of 850-2550mg every 24h; two: insulin detemir associated or not with rapid insulin analogue (aspart) according to your glycemic controls. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Diabetes, Gestational, Perinatal Disorder, Puerperal Disorder
- What is being tested?
- Metformin and Insulin Detemir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 26 Oct 2016to 1 Jul 2020
- Phase
- Phase 3
- 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
- 18-45 years old.
- Diagnosis of GD, with fasting glucose <120 mg / dL.
- not controlled by diet: fasting capillary blood glucose> 95 mg / dl in at least 2-3 times or 1 hour postprandial >140 mg / dl on, at least 2-3 times a week.
- 2nd or 3rd trimesters of pregnancy.
- Able to give informed consent.
Who cannot join
- Psychopathological situations that do not guarantee proper adhesion to follow up
- 1st trimester of pregnancy
- gastrointestinal diseases that may cause poorer tolerance or increased symptoms with metformin.
- Patients who can not attend the scheduled consultation.
- Language barrier limiting for understanding treatment settings
- Twin pregnancy.
About this study
Official title: Efficacy of Metformin Treatment in Not Controlled With Diet Gestational Diabetes Versus Use of Insulin Therapy
Women with gestational diabete (GD) who do not meet glycemic control objectives with diet will be assigned to two treatment groups randomly. One: metformin at a dose of 850-2550mg every 24h; two: insulin detemir associated or not with rapid insulin analogue (aspart) according to your glycemic controls. The Metformin group may additionally receive insulin in a second time in case the glycemic control is not appropriate with monotherapy.
Read the detailed description
Women with gestational diabete (GD) who do not meet glycemic control objectives with diet will be assigned to two treatment groups randomly. One: metformin at a dose of 850-2550mg every 24h; two: insulin detemir associated or not with rapid insulin analogue (aspart) according to your glycemic controls. The Metformin group may additionally receive insulin in a second time in case the glycemic control is not appropriate with monotherapy.
The objectives are: Demonstrate that treatment with metformin in women with GD (not controlled with diet) can get no lower obstetric and perinatal outcomes than those with standard treatment with insulin.
Demonstrate that glycemic control with metformin in properly selected women, can be equivalent to that obtained with insulin.
- Being tested
- Metformin, Insulin Detemir
- Medical subject headings
- Diabetes, Gestational, Puerperal Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
850-2550 mg every 24h.
Insulin DetemirDrug
Insulin detemir associated or not with rapid insulin analogue (aspart) according to individual glycemic controls.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | 850-2550 mg every 24h. Receives: Drug: Metformin; Drug: Insulin Detemir |
| Insulin Detemir | Active comparator | Individual doses according to glycemic controls. Receives: Drug: Metformin; Drug: Insulin Detemir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metformin benefits
Change of Weigth
Measured: 50 weeks
Good glycemic control
Change of glycemic levels
Measured: 50 weeks
Baby wellness
Weight
Measured: Delivery
Secondary outcomes (9)
Adverse event profile
Number of adverse events
Measured: 50 weeks
Fructosamine as a marker of insulinization
Concentration of fructosamine
Measured: 50 weeks
Satisfaction with the treatment
Questionnaire of satisfaction with the treatment. Range: 5 (worst)-16 (best)
Measured: 50 weeks
IL-6 profile
IL-6 levels
Measured: 50 weeks
IL-10 profile and oxidativge stress as well as in lipid profile
IL-10 (ultrasensitive PCR) levels
Measured: 50 weeks
Leptin profile
Leptin levels
Measured: 50 weeks
Ladiponectin and oxidativge stress as well as in lipid profile
Ladiponectin levels
Measured: 50 weeks
LPS profile
LPS levels
Measured: 50 weeks
LBP profile and oxidativge stress as well as in lipid profile
LBP levels
Measured: 50 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start26 Oct 2016
- Primary completion28 May 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, GestationalStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Inferiority, randomized, open, parallel arms, multicenter clinical trial
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222348
- Sponsor's protocol ID
- FIM-MET-2015-01
- Acronym
- FIMMET201501
- Status last verified
- Dec 2019
- First submitted
- 3 Dec 2019
- Last updated
- 15 May 2020
- 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 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Metformin Treatment in Not Controlled With Diet Gestational Diabetes Versus Use of Insulin Therapy
- ClinicalTrials.gov ID
- NCT04222348
- Acronym / sponsor ID
- FIMMET201501 / FIM-MET-2015-01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 26 Oct 2016 (actual)
- Primary completion
- 28 May 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 10 Jan 2020 (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.
Women with gestational diabete (GD) who do not meet glycemic control objectives with diet will be assigned to two treatment groups randomly. One: metformin at a dose of 850-2550mg every 24h; two: insulin detemir associated or not with rapid insulin analogue (aspart) according to your glycemic controls. The Metformin group may additionally receive insulin in a second time in case the glycemic control is not appropriate with monotherapy.
Detailed description
Women with gestational diabete (GD) who do not meet glycemic control objectives with diet will be assigned to two treatment groups randomly. One: metformin at a dose of 850-2550mg every 24h; two: insulin detemir associated or not with rapid insulin analogue (aspart) according to your glycemic controls. The Metformin group may additionally receive insulin in a second time in case the glycemic control is not appropriate with monotherapy.
The objectives are: Demonstrate that treatment with metformin in women with GD (not controlled with diet) can get no lower obstetric and perinatal outcomes than those with standard treatment with insulin.
Demonstrate that glycemic control with metformin in properly selected women, can be equivalent to that obtained with insulin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Inferiority, randomized, open, parallel arms, multicenter clinical trial
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: Metformin, Drug: Insulin Detemir850-2550 mg every 24h. |
| Insulin Detemir | Active comparator | Drug: Metformin, Drug: Insulin DetemirIndividual doses according to glycemic controls. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-45 years old.
- Diagnosis of GD, with fasting glucose <120 mg / dL.
- not controlled by diet: fasting capillary blood glucose> 95 mg / dl in at least 2-3 times or 1 hour postprandial >140 mg / dl on, at least 2-3 times a week.
- 2nd or 3rd trimesters of pregnancy.
- Able to give informed consent.
Key exclusion criteria (6 listed)
- Psychopathological situations that do not guarantee proper adhesion to follow up
- 1st trimester of pregnancy
- gastrointestinal diseases that may cause poorer tolerance or increased symptoms with metformin.
- Patients who can not attend the scheduled consultation.
- Language barrier limiting for understanding treatment settings
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 |
|---|---|---|
| Metformin850-2550 mg every 24h. | Drug | Insulin Detemir, Metformin |
| Insulin DetemirInsulin detemir associated or not with rapid insulin analogue (aspart) according to individual glycemic controls. | Drug | Insulin Detemir, Metformin |
Primary outcome
Metformin benefits
Time frame: 50 weeks
Change of Weigth
Good glycemic control
Time frame: 50 weeks
Change of glycemic levels
Baby wellness
Time frame: Delivery
Weight
9 secondary outcomes
Adverse event profile
Time frame: 50 weeks
Fructosamine as a marker of insulinization
Time frame: 50 weeks
Satisfaction with the treatment
Time frame: 50 weeks
IL-6 profile
Time frame: 50 weeks
IL-10 profile and oxidativge stress as well as in lipid profile
Time frame: 50 weeks
Leptin profile
Time frame: 50 weeks
Ladiponectin and oxidativge stress as well as in lipid profile
Time frame: 50 weeks
LPS profile
Time frame: 50 weeks
LBP profile and oxidativge stress as well as in lipid profile
Time frame: 50 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin and Insulin Detemir in people with Diabetes, Gestational and Perinatal Disorder, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud.
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 6 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: status not confirmed, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Metformin benefits (time frame: 50 weeks). 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 15 May 2020.