Trial Outcomes & Findings for Metformin Versus Insulin in Gestational Diabetes (NCT NCT01240785)

NCT ID: NCT01240785

Last Updated: 2014-11-24

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 221 participants
• Primary outcome timeframe: delivery
• Results posted on: 2014-11-24

Participant Flow

Participant milestones

Measure	Metformin Arm	Insulin
Overall Study STARTED	111	110
Overall Study COMPLETED	110	107
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	Metformin Arm	Insulin
Overall Study Lost to Follow-up	1	0
Overall Study Protocol Violation	0	3

Baseline Characteristics

Metformin Versus Insulin in Gestational Diabetes

Baseline characteristics by cohort

Measure	Metformin n=110 Participants metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily	Insulin n=107 Participants insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery	Total n=217 Participants Total of all reporting groups
Age, Continuous	31.9 years STANDARD_DEVIATION 5.0 • n=5 Participants	32.1 years STANDARD_DEVIATION 5.4 • n=7 Participants	32.0 years STANDARD_DEVIATION 4.6 • n=5 Participants
Sex: Female, Male Female	110 Participants n=5 Participants	107 Participants n=7 Participants	217 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Finland	110 participants n=5 Participants	107 participants n=7 Participants	217 participants n=5 Participants

PRIMARY outcome

Timeframe: delivery

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

Outcome measures

Measure	Metformin n=110 Participants metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily	Insulin n=107 Participants insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
Birth Weight Per Arm	3604 g Standard Deviation 488	3589 g Standard Deviation 448

SECONDARY outcome

Timeframe: up to on the average 40 weeks of gestation

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

Outcome measures

Measure	Metformin n=110 Participants metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily	Insulin n=107 Participants insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
Pregnancy Induced Hypertension Per Arm	2 participants	4 participants

SECONDARY outcome

Timeframe: up to on the average 40 weeks of gestation

Outcome measures

Measure	Metformin n=110 Participants metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily	Insulin n=107 Participants insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
Maternal Weight Gain Per Arm	8.0 kg Standard Deviation 5.3	7.9 kg Standard Deviation 5.3

SECONDARY outcome

Timeframe: up to on the average 40 weeks of gestation

Outcome measures

Measure	Metformin n=110 Participants metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily	Insulin n=107 Participants insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
Pre-eclampsia Per Arm	5 participants	10 participants

SECONDARY outcome

Timeframe: delivery

Outcome measures

Measure	Metformin n=110 Participants metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily	Insulin n=107 Participants insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
Mode of Delivery Per Arm	15 no of cesarean section	18 no of cesarean section

SECONDARY outcome

Timeframe: delivery

Outcome measures

Measure	Metformin n=110 Participants metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily	Insulin n=107 Participants insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
Gestational Weeks at Delivery Per Arm	39.2 weeks Standard Deviation 1.4	39.3 weeks Standard Deviation 1.6

SECONDARY outcome

Timeframe: delivery

Outcome measures

Measure	Metformin n=110 Participants metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily	Insulin n=107 Participants insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
Induction of Delivery Per Arm	42 participants	58 participants

SECONDARY outcome

Timeframe: delivery

Outcome measures

Measure	Metformin n=110 Participants metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily	Insulin n=107 Participants insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
Shoulder Dystocia Per Arm	1 participants	2 participants

SECONDARY outcome

Timeframe: 0-24 h after delivery

Outcome measures

Measure	Metformin n=109 Participants metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily	Insulin n=107 Participants insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
Neonatal Hypoglycemia Per Arm	18 participants	18 participants

SECONDARY outcome

Timeframe: 0-3 days after delivery

Outcome measures

Measure	Metformin n=109 Participants metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily	Insulin n=107 Participants insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
Neonatal Hyperbilirubinemia Per Arm	9 participants	10 participants

SECONDARY outcome

Timeframe: 5 minutes after delivery

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

Outcome measures

Measure	Metformin n=109 Participants metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily	Insulin n=107 Participants insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
Apgar Score at 5 Min After Delivery Per Arm	8.7 units on a scale Standard Deviation 1.3	8.9 units on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: 0-5 days after delivery

Outcome measures

Measure	Metformin n=109 Participants metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily	Insulin n=107 Participants insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
Neonate Transfer to Intensive Care Unit Per Arm	34 participants	39 participants

SECONDARY outcome

Timeframe: 2 years after birth

neuropsychological and motor skills testing

Outcome measures

Outcome data not reported

Adverse Events

Metformin

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Insulin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Metformin n=110 participants at risk metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily	Insulin n=107 participants at risk insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
Pregnancy, puerperium and perinatal conditions fetal death	0.91% 1/110 • Number of events 1 Fetal cardiac function evaluated with ultrasound and cardiotokography	0.00% 0/107 Fetal cardiac function evaluated with ultrasound and cardiotokography

Other adverse events

Adverse event data not reported

Additional Information

Dr Kristiina Tertti

Department of Obstetrics and Gynecology, Turku University Central Hospital

Phone: +358 2 3130000

Email: kristiina.tertti@tyks.fi

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place