Gestational DiabetesPhase 2NCT01756105
Efficacy of Metformin in Achieving Glycaemia Goals as Recommended for the Treatment of Gestational Diabetes in Non Obese Women
A Phase 2 study testing Metformin and Rapid acting analog insulin Intermediate acting NPH Insulin in people with Gestational Diabetes and Metformin, run by University Hospital, Strasbourg, France at 5 sites in France.
Trial summary
Gestational diabetes (GD) is defined by a hyperglycemia discovered during pregnancy, leading to fetal and maternal complications which may be prevented by reaching very strict glycaemia targets. Prevalence depends on patient's ethnic group and is about 6 to 14%. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Gestational Diabetes, Metformin, Treatment
- What is being tested?
- Metformin and Rapid acting analog insulin Intermediate acting NPH Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 5 sitesFrance
- Study dates
- Jun 2012to Jun 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women.
- Age more than 18 and less than 40 years.
- Unique spontaneous pregnancy.-BMI less than 30kg/m2 before pregnancy.
- 24 to 30 weeks of amenorrhea or 22 to 28 weeks of gestation.
- Gestational diabetes.
- Social Security affiliated subject.- Patient able to understand and signed informed consent.
Who cannot join
- Contraindications to metformin.
- Metformin treatment prior to protocol inclusion.
- Multiple pregnancies.
- Diabetes diagnosed prior to pregnancy.
- High blood pressure prior to pregnancy.
- Pregnancy hepatic complication
- High blood pressure prior to study inclusion.
- Pre or eclampsia.- Premature membranes rupture.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Hôpitaux Civils de Colmar
Colmar, 68024
CHU Dijon,
Dijon, 21030
Centre hospitalier de Mulhouse
Mulhouse, 68070
CHU de Reims
Reims, 51092
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Official title: Gestational Diabetes in Non Obese Women and Metformine
Gestational diabetes (GD) is defined by a hyperglycemia discovered during pregnancy, leading to fetal and maternal complications which may be prevented by reaching very strict glycaemia targets. Prevalence depends on patient's ethnic group and is about 6 to 14%. This prevalence is increasing due to increased GD risk factors (obesity, pregnancy over 35) and also because criteria of screening have been strengthened after the results of last studies. Usual treatment is diet and in case of failure insulin therapy with multiple injections which may lead to hypoglycemia and weight gain and is very difficult to manage for patients. Some studies have shown the comparable effect of metformin and insulin in about 50% of GD obese patients. The aim of our study is to evaluate efficacy of metformin, outcomes in mother and fetus and baby of metformin. In case of metformin failure, insulin will be added in order to obtain glycaemia in desired goals.Oxidative stress will be assessed in mother blood, baby umbilical cord blood, baby umbilical cord and placenta in 90 women and the oxidative stress compared between insulin and metformin alone treated patients.
- Conditions
- Gestational Diabetes, Metformin, Treatment, Oxidative Stress
- Being tested
- Metformin, Rapid acting analog insulin Intermediate acting NPH Insulin
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Metformin: from 500 mg 2 time per day to 2500 mg per day; with increment of 500 mg every 5 days until abstention of
Rapid acting analog insulin Intermediate acting NPH InsulinDrug
Insulin therapy:If post meal (2 hours after meal) glycaemia is > to 120 mg/dl introduce Insulin rapid acting analog (Humalog*, Novorapid*) before the meal concerned and according to the weight. If weight is < 80 kg: breakfast 5U, lunch time 3U, and dinner 4U. If weight is > 80 kg :breakast 6U, lunch time 4U, dinner 5U.If post meal glycaemia stay over 120 mg/dl but lower than130 mg/dl: do 1 U more.If post meal glycaemia stay over 140 mg/dl : do 2 UI moreIf fasting glycaemia is over 95 mg/dl : introduce NPH Insulin (Umuline NPH*, insulatard*) before sleeping : 5U if weight is < 80 kg - 6U if weight is > 80 kgIf fasting glycaemia stay over 95 mg/dl increase NPH Insulin for 1 U and for 2 U if fasting glycaemia is over 110 mg/dl.
| Study group | Role | What they receive |
|---|---|---|
| treatment by Metformin plus insulin if needed | Experimental | Metformin: from 500 mg 2 time per day to 2500 mg per day; with increment of 500 mg every 5 days until abstention of Receives: Drug: Metformin; Drug: Rapid acting analog insulin Intermediate acting NPH Insulin |
| treatment by insulin | Active comparator | Insulin therapy:If post meal (2 hours after meal) glycaemia is > to 120 mg/dl introduce Insulin rapid acting analog (Humalog*, Novorapid*) before the meal concerned and according to the weight. If weight is < 80 kg: breakfast 5U, lunch time 3U, and dinner 4U. If weight is > 80 kg :breakast 6U, lunch time 4U, dinner 5U.If post meal glycaemia stay over 120 mg/dl but lower than130 mg/dl: do 1 U more.If post meal glycaemia stay over 140 mg/dl : do 2 UI moreIf fasting glycaemia is over 95 mg/dl : introduce NPH Insulin (Umuline NPH*, insulatard*) before sleeping : 5U if weight is < 80 kg - 6U if weight is > 80 kgIf fasting glycaemia stay over 95 mg/dl increase NPH Insulin for 1 U and for 2 U if fasting glycaemia is over 110 mg/dl. Receives: Drug: Rapid acting analog insulin Intermediate acting NPH Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of metformin in treatment of gestational diabetes based on capillary glycaemia with an objective of less than 6 measures out of range
Measured: After diagnosis of gestational diabetes and until 3 months after delivery; screening made between 22th and 28th week of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startJun 2012
- Primary completionFeb 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie Jeandidier, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756105
- Sponsor's protocol ID
- 4965
- Status last verified
- Aug 2018
- First submitted
- 19 Dec 2012
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gestational Diabetes in Non Obese Women and Metformine
- ClinicalTrials.gov ID
- NCT01756105
- Acronym / sponsor ID
- 4965
- Conditions
- Gestational Diabetes, Metformin, Treatment, Oxidative Stress
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 24 Dec 2012 (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.
Gestational diabetes (GD) is defined by a hyperglycemia discovered during pregnancy, leading to fetal and maternal complications which may be prevented by reaching very strict glycaemia targets. Prevalence depends on patient's ethnic group and is about 6 to 14%. This prevalence is increasing due to increased GD risk factors (obesity, pregnancy over 35) and also because criteria of screening have been strengthened after the results of last studies. Usual treatment is diet and in case of failure insulin therapy with multiple injections which may lead to hypoglycemia and weight gain and is very difficult to manage for patients. Some studies have shown the comparable effect of metformin and insulin in about 50% of GD obese patients. The aim of our study is to evaluate efficacy of metformin, outcomes in mother and fetus and baby of metformin. In case of metformin failure, insulin will be added in order to obtain glycaemia in desired goals.Oxidative stress will be assessed in mother blood, baby umbilical cord blood, baby umbilical cord and placenta in 90 women and the oxidative stress compared between insulin and metformin alone treated patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment by Metformin plus insulin if needed | Experimental | Drug: Metformin, Drug: Rapid acting analog insulin Intermediate acting NPH InsulinMetformin: from 500 mg 2 time per day to 2500 mg per day; with increment of 500 mg every 5 days until abstention of |
| treatment by insulin | Active comparator | Drug: Rapid acting analog insulin Intermediate acting NPH InsulinInsulin therapy:If post meal (2 hours after meal) glycaemia is > to 120 mg/dl introduce Insulin rapid acting analog (Humalog*, Novorapid*) before the meal concerned and according to the weight. If weight is < 80 kg: breakfast 5U, lunch time 3U, and dinner 4U. If weight is > 80 kg :breakast 6U, lunch time 4U, dinner 5U.If post meal glycaemia stay over 120 mg/dl but lower than130 mg/dl: do 1 U more.If post meal glycaemia stay over 140 mg/dl : do 2 UI moreIf fasting glycaemia is over 95 mg/dl : introduce NPH Insulin (Umuline NPH*, insulatard*) before sleeping : 5U if weight is < 80 kg - 6U if weight is > 80 kgIf fasting glycaemia stay over 95 mg/dl increase NPH Insulin for 1 U and for 2 U if fasting glycaemia is over 110 mg/dl. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women.
- Age more than 18 and less than 40 years.
- Unique spontaneous pregnancy.-BMI less than 30kg/m2 before pregnancy.
- 24 to 30 weeks of amenorrhea or 22 to 28 weeks of gestation.
- Gestational diabetes.
Key exclusion criteria (8 listed)
- Contraindications to metformin.
- Metformin treatment prior to protocol inclusion.
- Multiple pregnancies.
- Diabetes diagnosed prior to pregnancy.
- High blood pressure prior to pregnancy.
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 |
|---|---|---|
| MetforminMetformin: from 500 mg 2 time per day to 2500 mg per day; with increment of 500 mg every 5 days until abstention of | Drug | treatment by Metformin plus insulin if needed |
| Rapid acting analog insulin Intermediate acting NPH InsulinInsulin therapy:If post meal (2 hours after meal) glycaemia is > to 120 mg/dl introduce Insulin rapid acting analog (Humalog*, Novorapid*) before the meal concerned and according to the weight. If weight is < 80 kg: breakfast 5U, lunch time 3U, and dinner 4U. If weight is > 80 kg :breakast 6U, lunch time 4U, dinner 5U.If post meal glycaemia stay over 120 mg/dl but lower than130 mg/dl: do 1 U more.If post meal glycaemia stay over 140 mg/dl : do 2 UI moreIf fasting glycaemia is over 95 mg/dl : introduce NPH Insulin (Umuline NPH*, insulatard*) before sleeping : 5U if weight is < 80 kg - 6U if weight is > 80 kgIf fasting glycaemia stay over 95 mg/dl increase NPH Insulin for 1 U and for 2 U if fasting glycaemia is over 110 mg/dl. | Drug | treatment by Metformin plus insulin if needed, treatment by insulin |
Primary outcome
Efficacy of metformin in treatment of gestational diabetes based on capillary glycaemia with an objective of less than 6 measures out of range
Time frame: After diagnosis of gestational diabetes and until 3 months after delivery; screening made between 22th and 28th week of gestation
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
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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.
Nathalie Jeandidier, MD principal investigator
University Hospital, Strasbourg, France
5 sites 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 and Rapid acting analog insulin Intermediate acting NPH Insulin in people with Gestational Diabetes and Metformin, run by University Hospital, Strasbourg, France at 5 sites in France.
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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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 was stopped early. 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?
Efficacy of metformin in treatment of gestational diabetes based on capillary glycaemia with an objective of less than 6 measures out of range (time frame: After diagnosis of gestational diabetes and until 3 months after delivery; screening made between 22th and 28th week of gestation). 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 27 Aug 2018.