Gestational Diabetes Mellitus in PregnancyNCT03106870
Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus
A study testing Insulin Mixtard and Metformin in people with Gestational Diabetes Mellitus in Pregnancy, run by Ain Shams University.
Trial summary
The purpose of the study to prove benefits of adding metformin to insulin for controlling presentational and gestational diabetes mellitus and improving neonatal outcome. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- Insulin Mixtard and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20 - 35 years.
- Gestational age: 20- 36 weeks gestation.
- Singleton pregnancy.
- Women with pregestational or gestational diabetes mellitus
Who cannot join
- Pregnant women with secondary diabetes (e.g. those on chronic steroid therapy).
- Hypertensive patients.
- Women with impaired liver or renal function
- Non-compliant patients.
About this study
Official title: Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus and Improving Neonatal Outcome Regarding Birth Weight
The purpose of the study to prove benefits of adding metformin to insulin for controlling presentational and gestational diabetes mellitus and improving neonatal outcome.
Read the detailed description
The current study was conducted at Ain Shams university maternity hospital during the period between June 2016 to December 2016.
All patients were subjected to:
- History taking:
- General and Abdominal Examination: With particular emphasis on :
- Body mass index
- Blood pressure.
- Fundal height .
- Estimated fetal weight .
- Insulin and metformin doses : Insulin dose: 0.7 IU/Kg (at the second trimester of pregnancy). 0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration. Metformin dose : Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin. If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day.
- Investigations:
Fasting and two hours postprandial blood glucose levels were measured in two groups of pregnant women:
- Group I: pregnant women who received oral metformin in addition to insulin therapy.
- Group II: pregnant women who received insulin therapy only.
- Being tested
- Insulin Mixtard, Metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin MixtardDrug
Also called insulin mixtures
Insulin dose:
- 0.7 IU/Kg (at the second trimester of pregnancy).
- 0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.
MetforminDrug
Also called Metformin Hydrocloride
Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.
If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day.
| Study group | Role | What they receive |
|---|---|---|
| oral metformin and insulin | Active comparator | Intervention 'Insulin Mixtard' and Intervention 'metformin' had included Receives: Drug: Insulin Mixtard; Drug: Metformin |
| insulin therapy only | Active comparator | Intervention 'Insulin Mixtard' had included Receives: Drug: Insulin Mixtard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation
Fasting and two-hours postprandial blood glucose every 48 hours, till reaching the target blood glucose concentrations:
60 - 95 mg/dl and < 120 mg/dl (for fasting and two-hour postprandial status, respectively) If patient reached blood glucose concentrations, she considered as controlled Diabetes Mellitus If patient did not reach blood glucose concentrations, she considered as uncontrolled Diabetes Mellitus
Measured: from 20 weeks to 36 weeks gestation
Secondary outcomes (2)
Number of Participants With a Macrosomic Baby
Fetal macrosomia has been defined birth weight greater than 4500 gm
Measured: 24 hours after delivery
Number of Participants With Neonates Who Were Hypoglycemic
Neonatal hypoglycemia defined as a plasma glucose level of less than 30 mg/dL in the first 24 hours after delivery
Measured: 24 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 posted11 Apr 2017
- Study startJun 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group I: pregnant women who received oral metformin in addition to insulin therapy. Group II: pregnant women who received insulin therapy only.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Mohamed Abdelrahman, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106870
- Sponsor's protocol ID
- Metformin
- Status last verified
- May 2017
- First submitted
- 28 Mar 2017
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus and Improving Neonatal Outcome Regarding Birth Weight
- ClinicalTrials.gov ID
- NCT03106870
- Acronym / sponsor ID
- Metformin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study to prove benefits of adding metformin to insulin for controlling presentational and gestational diabetes mellitus and improving neonatal outcome.
Detailed description
The current study was conducted at Ain Shams university maternity hospital during the period between June 2016 to December 2016.
All patients were subjected to:
- History taking:
- General and Abdominal Examination: With particular emphasis on :
- Body mass index
- Blood pressure.
- Fundal height .
- Estimated fetal weight .
- Insulin and metformin doses : Insulin dose: 0.7 IU/Kg (at the second trimester of pregnancy). 0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration. Metformin dose : Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin. If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day.
- Investigations:
Fasting and two hours postprandial blood glucose levels were measured in two groups of pregnant women:
- Group I: pregnant women who received oral metformin in addition to insulin therapy.
- Group II: pregnant women who received insulin therapy only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Group I: pregnant women who received oral metformin in addition to insulin therapy. Group II: pregnant women who received insulin therapy only.
| Arm | Type | Receives |
|---|---|---|
| oral metformin and insulin | Active comparator | Drug: Insulin Mixtard, Drug: MetforminIntervention 'Insulin Mixtard' and Intervention 'metformin' had included |
| insulin therapy only | Active comparator | Drug: Insulin MixtardIntervention 'Insulin Mixtard' had included |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 20 - 35 years.
- Gestational age: 20- 36 weeks gestation.
- Singleton pregnancy.
- Women with pregestational or gestational diabetes mellitus
Key exclusion criteria (4 listed)
- Pregnant women with secondary diabetes (e.g. those on chronic steroid therapy).
- Hypertensive patients.
- Women with impaired liver or renal function
- Non-compliant patients.
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 |
|---|---|---|
| Insulin MixtardAlso: insulin mixturesInsulin dose: * 0.7 IU/Kg (at the second trimester of pregnancy). * 0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration. | Drug | insulin therapy only, oral metformin and insulin |
| MetforminAlso: Metformin HydroclorideOral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin. If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day. | Drug | oral metformin and insulin |
Primary outcome
Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation
Time frame: from 20 weeks to 36 weeks gestation
Fasting and two-hours postprandial blood glucose every 48 hours, till reaching the target blood glucose concentrations: 60 - 95 mg/dl and < 120 mg/dl (for fasting and two-hour postprandial status, respectively) If patient reached blood glucose concentrations, she considered as controlled Diabetes Mellitus If patient did not reach blood glucose concentrations, she considered as uncontrolled Diabetes Mellitus
2 secondary outcomes
Number of Participants With a Macrosomic Baby
Time frame: 24 hours after delivery
Number of Participants With Neonates Who Were Hypoglycemic
Time frame: 24 hours after delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 study testing Insulin Mixtard and Metformin in people with Gestational Diabetes Mellitus in Pregnancy, run by Ain Shams University.
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 4 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 14 Jun 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation (time frame: from 20 weeks to 36 weeks 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 14 Jun 2017.