Diabetes, GestationalMetGDMNCT00681460
Metformin in Gestational Diabetes Mellitus
A study testing human recombined insulin and metformin in people with Diabetes, Gestational and Insulin Resistance, run by K. Marcinkowski University of Medical Sciences at 1 site in Poland.
Trial summary
Gestational diabetes (GDM) is a condition that manifests as high blood sugar levels (hyperglycemia) during pregnancy in previously healthy women. It develops as a result of increased maternal body's resistance to insulin - a major hormone that allows for utilisation of glucose (sugar taken in with food) within cells. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Gestational, Insulin Resistance
- What is being tested?
- human recombined insulin and metformin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 sitePoland
- Study dates
- May 2008to May 2013
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diabetes diagnosed during pregnancy
- single pregnancy
- ineffective diet therapy
Who cannot join
- pregestational diabetes
- fetal malformation
- multiple pregnancy
- contraindications to metformin therapy (liver or kidney disease)
Trial locations and contacts
1 site in 1 country.
Poland1 site
Div of Obstetrics and Women's Diseases, Dept of Obstetrics and Gynecology, K Marcinkowski Univ of Med Sciences
Poznan, 60-535
About this study
Official title: Effects of Insulin and/or Metformin Treatment on Perinatal Outcome and Metabolic Parameters in Women With Gestational Diabetes Mellitus: Prospective Randomized Trial.
Gestational diabetes (GDM) is a condition that manifests as high blood sugar levels (hyperglycemia) during pregnancy in previously healthy women. It develops as a result of increased maternal body's resistance to insulin - a major hormone that allows for utilisation of glucose (sugar taken in with food) within cells. It was found out that GDM occurs more frequently in overweight women but also in women with a history of certain conditions such as polycystic ovary syndrome (PCOS). Usually, GDM disappears after pregnancy is completed but it is associated with some serious hazards for women and her unborn child, if untreated properly. Diet is a first-choice treatment but sometimes insulin therapy must be initiated if keeping a diet alone is not enough to maintain blood sugar within recommended values. Insulin therapy is effective but it requires several injections during each day and insulin is a strong acting hypoglycemic agent that may induce rapid falls in blood sugar, also dangerous for mother and unborn child.
In the investigators study, the investigators would like to investigate if metformin that is a commonly used hypoglycemic drug can be effectively used for GDM treatment. Metformin has been used successfully for a long time to treat type 2 diabetes mellitus and PCOS and, according to current data, it is not dangerous neither for mother nor for baby when used during gestation.
- Conditions
- Diabetes, Gestational, Insulin Resistance
- Being tested
- human recombined insulin, metformin
- Keywords
- gestational diabetes, birth weight, fetal growth, insulin resistance, oxidative stress, inflammatory reaction, Fetal Development
- Medical subject headings
- Diabetes, Gestational, Insulin Resistance, Birth Weight, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human recombined insulinDrug
multiple injections protocol (functional intensive insulin therapy), variable doses following dietary conditions and current metabolic status
metforminDrug
pills given orally twice up to three times a day, a total daily dosage 1000-2400 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | gestational diabetes, insulin therapy Receives: Drug: human recombined insulin |
| 2 | Experimental | gestational diabetes, metformin therapy Receives: Drug: metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
newborn weight
Measured: first hour of life
Secondary outcomes (1)
parameters of metabolic control in mother and newborn, insulin resistance, inflammatory reaction, oxidative stress, fetal growth,
Measured: during pregnancy and up to twelve hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startMay 2008
- Primary completionApr 2013
- Study completionMay 2013
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- K. Marcinkowski University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnieszka Zawiejska, MD, PhD, K. Marcinkowski University of Medical Sciences
- Investigators
- Jacek Brazert, MD.PhD.prof, Study chair, K Marcinkowski University of Med Sciences, Poznan, PolandAntoni J Duleba, MD.prof, Study director, University of California at Davis, Sacramento, CA, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681460
- Sponsor's protocol ID
- KMUMS 705/07
- Acronym
- MetGDM
- Status last verified
- May 2015
- First submitted
- 19 May 2008
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Insulin and/or Metformin Treatment on Perinatal Outcome and Metabolic Parameters in Women With Gestational Diabetes Mellitus: Prospective Randomized Trial.
- ClinicalTrials.gov ID
- NCT00681460
- Acronym / sponsor ID
- MetGDM / KMUMS 705/07
- Conditions
- Diabetes, Gestational, Insulin Resistance
- Keywords
- gestational diabetes, birth weight, fetal growth, insulin resistance, oxidative stress, inflammatory reaction, Fetal Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- K. Marcinkowski University of Medical SciencesUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 21 May 2008 (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 (GDM) is a condition that manifests as high blood sugar levels (hyperglycemia) during pregnancy in previously healthy women. It develops as a result of increased maternal body's resistance to insulin - a major hormone that allows for utilisation of glucose (sugar taken in with food) within cells. It was found out that GDM occurs more frequently in overweight women but also in women with a history of certain conditions such as polycystic ovary syndrome (PCOS). Usually, GDM disappears after pregnancy is completed but it is associated with some serious hazards for women and her unborn child, if untreated properly. Diet is a first-choice treatment but sometimes insulin therapy must be initiated if keeping a diet alone is not enough to maintain blood sugar within recommended values. Insulin therapy is effective but it requires several injections during each day and insulin is a strong acting hypoglycemic agent that may induce rapid falls in blood sugar, also dangerous for mother and unborn child.
In the investigators study, the investigators would like to investigate if metformin that is a commonly used hypoglycemic drug can be effectively used for GDM treatment. Metformin has been used successfully for a long time to treat type 2 diabetes mellitus and PCOS and, according to current data, it is not dangerous neither for mother nor for baby when used during gestation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: human recombined insulingestational diabetes, insulin therapy |
| 2 | Experimental | Drug: metformingestational diabetes, metformin therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diabetes diagnosed during pregnancy
- single pregnancy
- ineffective diet therapy
Key exclusion criteria (4 listed)
- pregestational diabetes
- fetal malformation
- multiple pregnancy
- contraindications to metformin therapy (liver or kidney disease)
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 |
|---|---|---|
| human recombined insulinmultiple injections protocol (functional intensive insulin therapy), variable doses following dietary conditions and current metabolic status | Drug | 1 |
| metforminpills given orally twice up to three times a day, a total daily dosage 1000-2400 mg | Drug | 2 |
Primary outcome
newborn weight
Time frame: first hour of life
1 secondary outcome
parameters of metabolic control in mother and newborn, insulin resistance, inflammatory reaction, oxidative stress, fetal growth,
Time frame: during pregnancy and up to twelve hours after delivery
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 27 May 2015.
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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.
Jacek Brazert, MD.PhD.prof study chair
K Marcinkowski University of Med Sciences, Poznan, Poland
Antoni J Duleba, MD.prof study director
University of California at Davis, Sacramento, CA, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing human recombined insulin and metformin in people with Diabetes, Gestational and Insulin Resistance, run by K. Marcinkowski University of Medical Sciences at 1 site in Poland.
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 3 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: finished, as of the sponsor's last update on 27 May 2015. 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 Poland. 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.
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?
newborn weight (time frame: first hour of life). 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 May 2015.