Gestational DiabetesPhase 3NCT03841591
Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin
A Phase 3 study testing Insulin, Metformin and Assessment of weight gain in people with Gestational Diabetes, run by Ain Shams University at 1 site in Egypt.
Trial summary
Insulin has many disadvantages for mothers with GDM including the need to give injections, frequent daily testing for monitoring, and risks of hypoglycemia, increase in appetite, weight gain and high cost. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Insulin, Metformin and Assessment of weight gain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 15 Jan 2019
- 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 19 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged (19-35) years
- BMI 18-30 kg/m2
- Gestational age >24 weeks
- Singleton pregnancy
- Gestational diabetes mellitus with failure to achieve adequate glucose control on diet therapy alone (FBG > 105) OR patients with gestational diabetes who are controlled with either metformin alone or insulin alone.
Who cannot join
- Pregnant women with preexisting diabetes mellitus
- Women who have contraindication to take metformin e.g.: impaired renal function, hepatic cirrhosis, hepatitis).
- Patients with other medical disorders that could affect perinatal outcome (e.g., hypertension, SLE etc).
- Fetal anomalies identified on ultrasound prior to initiation of therapy.
- Patients who refused to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin: A Randomized Controlled Trial
Insulin has many disadvantages for mothers with GDM including the need to give injections, frequent daily testing for monitoring, and risks of hypoglycemia, increase in appetite, weight gain and high cost. Metformin, an oral biguanide, may be a more logical alternative to insulin for women with GDM who are unable to cope with the increasing insulin resistance of pregnancy.
This study aim to compare maternal weight gain during pregnancy in women with gestational diabetes, treated by insulin versus metformin.
- Conditions
- Gestational Diabetes
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Women with GDM will receive insulin and tailored according to their blood glucose levels to achieve glycemic control. Starting dose will be 30unit (20 unit intermediate dose + 10 unit rapid acting insulin) in the morning and before breakfast). In the 2nd trimester, we will start with half of the previous dose and if post dinner glucose level remain elevated additional injection of rapid acting insulin will be given just prior to dinner. If fasting glucose is elevated, intermediate acting insulin can be given along with the dinner dose of rapid acting insulin.
MetforminDrug
Also called Cidophage
Women with GDM will receive metformin and tailored according to their blood glucose levels to achieve glycemic control. They will receive an initial metformin dose of 500 mg once or twice daily (according to initial blood glucose level) with food and increased 500 mg every one or two weeks toward targets or up to a maximum daily dose of 2500 mg divided doses with each meal.
Assessment of weight gainOther
Body weight will be measured monthly from the start of treatment till delivery.
| Study group | Role | What they receive |
|---|---|---|
| Insulin Group | Active comparator | This includes women with GDM allocated to receive insulin treatment. Starting dose will be 30unit (20 unit intermediate dose + 10 unit rapid acting insulin) in the morning and before breakfast). In the 2nd trimester, we will start with half of the previous dose and if post dinner glucose level remain elevated additional injection of rapid acting insulin will be given just prior to dinner. If fasting glucose is elevated, intermediate acting insulin can be given along with the dinner dose of rapid acting insulin. Receives: Drug: Insulin; Other: Assessment of weight gain |
| Metformin Group | Active comparator | This includes women with GDM allocated to receive metformin treatment. They will receive an initial metformin dose of 500 mg once or twice daily (according to initial blood glucose level) with food and increased 500 mg every one or two weeks toward targets or up to a maximum daily dose of 2500 mg divided doses with each meal. Receives: Drug: Metformin; Other: Assessment of weight gain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of maternal weight gain per week
Maternal weight (in grams) will be measured monthly. Difference in measured weight between starting treatment and delivery will be divided by the number of weeks.
Measured: 4 months
Secondary outcomes (5)
1-min APGAR score
APGAR score at minute 1 after delivery
Measured: 1 minute
5-min APGAR score
APGAR score at minute 5 after delivery
Measured: 5 minutes
Incidence of neonatal hypoglycemia
Number of neonates with two or more neonatal glucose value <2.6 mmol per liter during the first day after delivery.
Measured: 1 day
Incidence of neonatal respiratory distress
Number of neonates needing at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or intermittent positive-pressure ventilation during the first 24 hours after delivery.
Measured: 1 day
Incidence of macrosomia
Number of neonates with birth weight greater than 4000 g or greater than 90% for gestational age
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Feb 2018
- Primary completion25 Dec 2018
- Study completion15 Jan 2019
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 Ain Shams UniversityThe 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinaa Hamdy Abo ElWafa, Ain Shams University
- Investigators
- Sinaa Hamdy, MBBCh, Principal investigator, S Hamdy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841591
- Sponsor's protocol ID
- MatWt-GDM
- Status last verified
- Feb 2019
- First submitted
- 13 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03841591
- Acronym / sponsor ID
- MatWt-GDM
- Conditions
- Gestational Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 25 Dec 2018 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 15 Feb 2019 (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.
Insulin has many disadvantages for mothers with GDM including the need to give injections, frequent daily testing for monitoring, and risks of hypoglycemia, increase in appetite, weight gain and high cost. Metformin, an oral biguanide, may be a more logical alternative to insulin for women with GDM who are unable to cope with the increasing insulin resistance of pregnancy.
This study aim to compare maternal weight gain during pregnancy in women with gestational diabetes, treated by insulin versus metformin.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin Group | Active comparator | Drug: Insulin, Other: Assessment of weight gainThis includes women with GDM allocated to receive insulin treatment. Starting dose will be 30unit (20 unit intermediate dose + 10 unit rapid acting insulin) in the morning and before breakfast). In the 2nd trimester, we will start with half of the previous dose and if post dinner glucose level remain elevated additional injection of rapid acting insulin will be given just prior to dinner. If fasting glucose is elevated, intermediate acting insulin can be given along with the dinner dose of rapid acting insulin. |
| Metformin Group | Active comparator | Drug: Metformin, Other: Assessment of weight gainThis includes women with GDM allocated to receive metformin treatment. They will receive an initial metformin dose of 500 mg once or twice daily (according to initial blood glucose level) with food and increased 500 mg every one or two weeks toward targets or up to a maximum daily dose of 2500 mg divided doses with each meal. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients aged (19-35) years
- BMI 18-30 kg/m2
- Gestational age >24 weeks
- Singleton pregnancy
- Gestational diabetes mellitus with failure to achieve adequate glucose control on diet therapy alone (FBG > 105) OR patients with gestational diabetes who are controlled with either metformin alone or insulin alone.
Key exclusion criteria (5 listed)
- Pregnant women with preexisting diabetes mellitus
- Women who have contraindication to take metformin e.g.: impaired renal function, hepatic cirrhosis, hepatitis).
- Patients with other medical disorders that could affect perinatal outcome (e.g., hypertension, SLE etc).
- Fetal anomalies identified on ultrasound prior to initiation of therapy.
- Patients who refused to participate
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 |
|---|---|---|
| InsulinWomen with GDM will receive insulin and tailored according to their blood glucose levels to achieve glycemic control. Starting dose will be 30unit (20 unit intermediate dose + 10 unit rapid acting insulin) in the morning and before breakfast). In the 2nd trimester, we will start with half of the previous dose and if post dinner glucose level remain elevated additional injection of rapid acting insulin will be given just prior to dinner. If fasting glucose is elevated, intermediate acting insulin can be given along with the dinner dose of rapid acting insulin. | Drug | Insulin Group |
| MetforminAlso: CidophageWomen with GDM will receive metformin and tailored according to their blood glucose levels to achieve glycemic control. They will receive an initial metformin dose of 500 mg once or twice daily (according to initial blood glucose level) with food and increased 500 mg every one or two weeks toward targets or up to a maximum daily dose of 2500 mg divided doses with each meal. | Drug | Metformin Group |
| Assessment of weight gainBody weight will be measured monthly from the start of treatment till delivery. | Other | Insulin Group, Metformin Group |
Primary outcome
Rate of maternal weight gain per week
Time frame: 4 months
Maternal weight (in grams) will be measured monthly. Difference in measured weight between starting treatment and delivery will be divided by the number of weeks.
5 secondary outcomes
1-min APGAR score
Time frame: 1 minute
5-min APGAR score
Time frame: 5 minutes
Incidence of neonatal hypoglycemia
Time frame: 1 day
Incidence of neonatal respiratory distress
Time frame: 1 day
Incidence of macrosomia
Time frame: 1 hour
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 15 Feb 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.
Sinaa Hamdy, MBBCh principal investigator
S Hamdy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin, Metformin and Assessment of weight gain in people with Gestational Diabetes, run by Ain Shams University at 1 site in Egypt.
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 5 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 15 Feb 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 Egypt. 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 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?
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?
Rate of maternal weight gain per week (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 15 Feb 2019.