Gestational Diabetes Mellitus in PregnancyPhase 3NCT03320694
Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus
A Phase 3 study testing Metformin and Insulin in people with Gestational Diabetes Mellitus in Pregnancy, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
Trial summary
Gestational diabetic mellitus (GDM) patients randomised to metformin or insulin group.Aim was to achieve blood sugar levels of Blood sugar fasting (BSF) <5.3 mmol/l and 1 hour post meal<7.8mmol/l. Both groups were followed till delivery and outcome studied. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- Metformin and Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2016to 30 Jun 2017
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- All pregnant Diagnosed GDM in pregnancy by OGTT from 22 week to 34 week with singleton pregnancy
Who cannot join
- Patients with Known diabetes mellitus
- Patients with multiple pregnancy
- With essential hypertension or pre eclampsia
- Patients having fetal malformation incompatible with life
- Patients with intrauterine death of fetus
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Services Institute of Medical Sciences
Lahore, Punjab Province
About this study
Gestational diabetic mellitus (GDM) patients randomised to metformin or insulin group.Aim was to achieve blood sugar levels of Blood sugar fasting (BSF) <5.3 mmol/l and 1 hour post meal<7.8mmol/l. Both groups were followed till delivery and outcome studied.
Read the detailed description
75 gm Oral Glucose Tolerance Test (OGTT) was done in pregnant patients. Blood sugar fasting(BSF) > 5.5 mmol/l \& 2 hours postprandial >7.8 mmol/l was labelled as GDM. They were randomised to metformin or insulin group. Those assigned to metformin group were started metformin 500mg twice daily \& increased until 2500mg depending on the blood sugar levels. Aim was to achieve blood sugar levels of BSF <5.3 mmol/l and 1 hour post meal<7.8mmol/l. If blood sugar levels were not controlled, insulin was added. The insulin group was given 3 injections of regular insulin \& one intermediate acting insulin injection at night subcutaneously. Both groups were followed till delivery and outcome studied
- Keywords
- Gestational Diabetes Mellitus, Metformin, Insulin
- Medical subject headings
- Diabetes, Gestational, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage
metformin 500mg twice daily \& increased until 2500mg till normoglycemia was achieved and was continued till delivery
InsulinDrug
Also called Humulin R U 100 and Humulin N
The insulin group was given 3 S/C injections of regular insulin \& one intermediate acting injection at night till normoglycemia was achieved and was continued till delivery
| Study group | Role | What they receive |
|---|---|---|
| metformin | Experimental | Metformin will be given until 2500mg in divided doses till normoglycemia is achieved and will be continued till delivery Receives: Drug: Metformin |
| Insulin | Active comparator | Insulin will be give as 3 regular injection and one intermediate acting injection at bedtime till normoglycemia is achieved and will be continued till delivery Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal glycemic control
Maternal glycemic control was measured by blood sugar levels
Measured: From time of randomisation till 40 weeks
Secondary outcomes (6)
Fetal macrosomia
Birth weight more than 4kg
Measured: at birth
Apgar score
<7 at 5min
Measured: at birth
Neonatal intensive care unit (NICU) stay
Admitted to NICU
Measured: >24 hours after birth
Perinatal death
Fetal or neonatal death within 7 days
Measured: 7 days of delivery
mode of delivery
Lower segment cesarean section , Spontaneous Vaginal Delivery, Instrumental delivery
Measured: at delivery
Neonatal hypoglycemia
Neonatal blood sugar was checked at birth and if <2.2mmol/l, was labelled
Measured: at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start1 Feb 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies 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
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Institute of Medical Sciences, Pakistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tayyiba Wasim, Services Institute of Medical Sciences, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320694
- Sponsor's protocol ID
- IRB/2015/211/SIMS
- Status last verified
- Oct 2017
- First submitted
- 30 Sep 2017
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03320694
- Acronym / sponsor ID
- IRB/2015/211/SIMS
- Keywords
- Gestational Diabetes Mellitus, Metformin, Insulin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Services Institute of Medical Sciences, PakistanOther government
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 25 Oct 2017 (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.
Gestational diabetic mellitus (GDM) patients randomised to metformin or insulin group.Aim was to achieve blood sugar levels of Blood sugar fasting (BSF) <5.3 mmol/l and 1 hour post meal<7.8mmol/l. Both groups were followed till delivery and outcome studied.
Detailed description
75 gm Oral Glucose Tolerance Test (OGTT) was done in pregnant patients. Blood sugar fasting(BSF) > 5.5 mmol/l \& 2 hours postprandial >7.8 mmol/l was labelled as GDM. They were randomised to metformin or insulin group. Those assigned to metformin group were started metformin 500mg twice daily \& increased until 2500mg depending on the blood sugar levels. Aim was to achieve blood sugar levels of BSF <5.3 mmol/l and 1 hour post meal<7.8mmol/l. If blood sugar levels were not controlled, insulin was added. The insulin group was given 3 injections of regular insulin \& one intermediate acting insulin injection at night subcutaneously. Both groups were followed till delivery and outcome studied
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metformin | Experimental | Drug: MetforminMetformin will be given until 2500mg in divided doses till normoglycemia is achieved and will be continued till delivery |
| Insulin | Active comparator | Drug: InsulinInsulin will be give as 3 regular injection and one intermediate acting injection at bedtime till normoglycemia is achieved and will be continued till delivery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All pregnant Diagnosed GDM in pregnancy by OGTT from 22 week to 34 week with singleton pregnancy
Key exclusion criteria (5 listed)
- Patients with Known diabetes mellitus
- Patients with multiple pregnancy
- With essential hypertension or pre eclampsia
- Patients having fetal malformation incompatible with life
- Patients with intrauterine death of fetus
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 |
|---|---|---|
| MetforminAlso: Glucophagemetformin 500mg twice daily \& increased until 2500mg till normoglycemia was achieved and was continued till delivery | Drug | metformin |
| InsulinAlso: Humulin R U 100 and Humulin NThe insulin group was given 3 S/C injections of regular insulin \& one intermediate acting injection at night till normoglycemia was achieved and was continued till delivery | Drug | Insulin |
Primary outcome
maternal glycemic control
Time frame: From time of randomisation till 40 weeks
Maternal glycemic control was measured by blood sugar levels
6 secondary outcomes
Fetal macrosomia
Time frame: at birth
Apgar score
Time frame: at birth
Neonatal intensive care unit (NICU) stay
Time frame: >24 hours after birth
Perinatal death
Time frame: 7 days of delivery
mode of delivery
Time frame: at delivery
Neonatal hypoglycemia
Time frame: at birth
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 Oct 2017.
Related trials for Gestational Diabetes Mellitus in Pregnancy
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
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.
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 Metformin and Insulin in people with Gestational Diabetes Mellitus in Pregnancy, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
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 1 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 27 Oct 2017. 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 Pakistan. 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?
maternal glycemic control (time frame: From time of randomisation till 40 weeks). 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 Oct 2017.