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Metformin Versus Insulin in Gestational Diabetes

Metformin Versus Insulin in Gestational Diabetes. A Randomized Controlled Single Center Trial.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01240785
Enrollment
221
Registered
2010-11-15
Start date
2006-06-30
Completion date
2012-12-31
Last updated
2014-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes

Keywords

gestational diabetes, metformin, insulin

Brief summary

Gestational diabetes is traditionally treated with insulin. Metformin is a peroral drug used worldwide in the treatment of type 2 diabetes and also in a few studies on patients with gestational diabetes. The investigators aim is to compare insulin and metformin in the treatment of gestational diabetes. The investigators hypothesis is that there is no difference between insulin and metformin treated mothers in the main outcome criteria (birth weight, neonatal complications).

Detailed description

Gestational diabetes is traditionally treated with insulin. Metformin is a peroral drug used worldwide in the treatment of type 2 diabetes and also in a few studies on patients with gestational diabetes. The investigators aim is to compare insulin and metformin in the treatment of gestational diabetes. The investigators hypothesis is that there is no difference between insulin and metformin treated mothers in the main outcome criteria (birth weight, neonatal complications). The study was performed as a randomized controlled trial in one center, Turku University hospital using the non-inferiority design in June 2006 - December 2010. The final study population consisted of altogether 217 women, of whom 110 received metformin and 107 insulin.

Interventions

DRUGmetformin

metformin 1 g twice daily or maximum tolerated dose less than 2 g daily

DRUGinsulin

subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery

Sponsors

Turku University Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* Mothers with gestational diabetes who had at least twice plasma glucose at fasting \> 5.4 mmol/L and/or 1 hour postprandial value \> 7.7 mmol/L at 24 to 32 gestational weeks

Exclusion criteria

1. Fasting glucose \> 7.0 mmol/L or 1 hour postprandial plasma glucose \> 11.0 mmol/L or Glycosylated hemoglobin A1c (HbA1c) \> 7.0% 2. Renal, hepatic or cardiac failure 3. Pregestational use of metformin 4. Pregnancy with multiple fetuses

Design outcomes

Primary

MeasureTime frameDescription
Birth Weight Per Armdeliverybirth weight adjusted for gestational weeks expressed as standard deviation units using data from Finnish fetal growth charts in normal pregnancies

Secondary

MeasureTime frameDescription
Maternal Weight Gain Per Armup to on the average 40 weeks of gestation—
Pre-eclampsia Per Armup to on the average 40 weeks of gestation—
Mode of Delivery Per Armdelivery—
Gestational Weeks at Delivery Per Armdelivery—
Induction of Delivery Per Armdelivery—
Pregnancy Induced Hypertension Per Armup to on the average 40 weeks of gestationParticipants with pregnancy induced hypertension defined as blood pressure over 140/90 mmHg or increase in systolic blood pressure \> 30 mmHg or diastolic blood pressure \> 15 mmHg
Neonatal Hypoglycemia Per Arm0-24 h after delivery—
Neonatal Hyperbilirubinemia Per Arm0-3 days after delivery—
Apgar Score at 5 Min After Delivery Per Arm5 minutes after deliveryApgar score 0-10. 0-2 points from heart rate; 0-2 points for respiratory effort; 0-2 points for skin colour; 0-2 points for muscle tone; 0-2 points for reflex response. For all items the higher the value, the better the outcome
Neonate Transfer to Intensive Care Unit Per Arm0-5 days after delivery—
Child Outcome at 2 Years Per Arm2 years after birthneuropsychological and motor skills testing
Shoulder Dystocia Per Armdelivery—

Participant flow

Participants by arm

ArmCount
Metformin
metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
110
Insulin
insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
107
Total217

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up10
Overall StudyProtocol Violation03

Baseline characteristics

CharacteristicMetforminInsulinTotal
Age, Continuous31.9 years
STANDARD_DEVIATION 5
32.1 years
STANDARD_DEVIATION 5.4
32.0 years
STANDARD_DEVIATION 4.6
Region of Enrollment
Finland
110 participants107 participants217 participants
Sex: Female, Male
Female
110 Participants107 Participants217 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1100 / 107
serious
Total, serious adverse events
1 / 1100 / 107

Outcome results

Primary

Birth Weight Per Arm

birth weight adjusted for gestational weeks expressed as standard deviation units using data from Finnish fetal growth charts in normal pregnancies

Time frame: delivery

ArmMeasureValue (MEAN)Dispersion
MetforminBirth Weight Per Arm3604 gStandard Deviation 488
InsulinBirth Weight Per Arm3589 gStandard Deviation 448
Secondary

Apgar Score at 5 Min After Delivery Per Arm

Apgar score 0-10. 0-2 points from heart rate; 0-2 points for respiratory effort; 0-2 points for skin colour; 0-2 points for muscle tone; 0-2 points for reflex response. For all items the higher the value, the better the outcome

Time frame: 5 minutes after delivery

ArmMeasureValue (MEAN)Dispersion
MetforminApgar Score at 5 Min After Delivery Per Arm8.7 units on a scaleStandard Deviation 1.3
InsulinApgar Score at 5 Min After Delivery Per Arm8.9 units on a scaleStandard Deviation 1
Secondary

Child Outcome at 2 Years Per Arm

neuropsychological and motor skills testing

Time frame: 2 years after birth

Secondary

Gestational Weeks at Delivery Per Arm

Time frame: delivery

ArmMeasureValue (MEAN)Dispersion
MetforminGestational Weeks at Delivery Per Arm39.2 weeksStandard Deviation 1.4
InsulinGestational Weeks at Delivery Per Arm39.3 weeksStandard Deviation 1.6
Secondary

Induction of Delivery Per Arm

Time frame: delivery

ArmMeasureValue (NUMBER)
MetforminInduction of Delivery Per Arm42 participants
InsulinInduction of Delivery Per Arm58 participants
Secondary

Maternal Weight Gain Per Arm

Time frame: up to on the average 40 weeks of gestation

ArmMeasureValue (MEAN)Dispersion
MetforminMaternal Weight Gain Per Arm8.0 kgStandard Deviation 5.3
InsulinMaternal Weight Gain Per Arm7.9 kgStandard Deviation 5.3
Secondary

Mode of Delivery Per Arm

Time frame: delivery

ArmMeasureValue (NUMBER)
MetforminMode of Delivery Per Arm15 no of cesarean section
InsulinMode of Delivery Per Arm18 no of cesarean section
Secondary

Neonatal Hyperbilirubinemia Per Arm

Time frame: 0-3 days after delivery

ArmMeasureValue (NUMBER)
MetforminNeonatal Hyperbilirubinemia Per Arm9 participants
InsulinNeonatal Hyperbilirubinemia Per Arm10 participants
Secondary

Neonatal Hypoglycemia Per Arm

Time frame: 0-24 h after delivery

ArmMeasureValue (NUMBER)
MetforminNeonatal Hypoglycemia Per Arm18 participants
InsulinNeonatal Hypoglycemia Per Arm18 participants
Secondary

Neonate Transfer to Intensive Care Unit Per Arm

Time frame: 0-5 days after delivery

ArmMeasureValue (NUMBER)
MetforminNeonate Transfer to Intensive Care Unit Per Arm34 participants
InsulinNeonate Transfer to Intensive Care Unit Per Arm39 participants
Secondary

Pre-eclampsia Per Arm

Time frame: up to on the average 40 weeks of gestation

ArmMeasureValue (NUMBER)
MetforminPre-eclampsia Per Arm5 participants
InsulinPre-eclampsia Per Arm10 participants
Secondary

Pregnancy Induced Hypertension Per Arm

Participants with pregnancy induced hypertension defined as blood pressure over 140/90 mmHg or increase in systolic blood pressure \> 30 mmHg or diastolic blood pressure \> 15 mmHg

Time frame: up to on the average 40 weeks of gestation

ArmMeasureValue (NUMBER)
MetforminPregnancy Induced Hypertension Per Arm2 participants
InsulinPregnancy Induced Hypertension Per Arm4 participants
Secondary

Shoulder Dystocia Per Arm

Time frame: delivery

ArmMeasureValue (NUMBER)
MetforminShoulder Dystocia Per Arm1 participants
InsulinShoulder Dystocia Per Arm2 participants

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026