Metformin Versus Insulin in Gestational Diabetes

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01240785
• Other study ID #: 246/2005
• Status: Completed
• Phase: Phase 4
• First received: November 3, 2010
• Last updated: November 21, 2014
• Start date: June 2006
• Est. completion date: December 2012

Study information

• Verified date: November 2014
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: December 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
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	delivery	Yes
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	up to on the average 40 weeks of gestation	Yes
Secondary	Maternal Weight Gain Per Arm		up to on the average 40 weeks of gestation	No
Secondary	Pre-eclampsia Per Arm		up to on the average 40 weeks of gestation	Yes
Secondary	Mode of Delivery Per Arm		delivery	No
Secondary	Gestational Weeks at Delivery Per Arm		delivery	Yes
Secondary	Induction of Delivery Per Arm		delivery	No
Secondary	Shoulder Dystocia Per Arm		delivery	Yes
Secondary	Neonatal Hypoglycemia Per Arm		0-24 h after delivery	Yes
Secondary	Neonatal Hyperbilirubinemia Per Arm		0-3 days after delivery	Yes
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	5 minutes after delivery	Yes
Secondary	Neonate Transfer to Intensive Care Unit Per Arm		0-5 days after delivery	Yes
Secondary	Child Outcome at 2 Years Per Arm	neuropsychological and motor skills testing	2 years after birth	Yes