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Metformin Versus Insulin in Gestational Diabetes

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ClinicalTrials.gov Identifier: NCT01240785
Recruitment Status : Completed
First Posted : November 15, 2010
Results First Posted : November 24, 2014
Last Update Posted : November 24, 2014
Sponsor:
Information provided by (Responsible Party):
Tapani Rönnemaa, Turku University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gestational Diabetes
Interventions Drug: metformin
Drug: insulin
Enrollment 221
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Metformin Arm Insulin
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 111 110
Completed 110 [1] 107
Not Completed 1 3
Reason Not Completed
Lost to Follow-up             1             0
Protocol Violation             0             3
[1]
110 women completed in the metformin arm and 107 women completed in the insulin arm.
Arm/Group Title Metformin Insulin Total
Hide Arm/Group Description 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 Total of all reporting groups
Overall Number of Baseline Participants 110 107 217
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 110 participants 107 participants 217 participants
31.9  (5.0) 32.1  (5.4) 32.0  (4.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 107 participants 217 participants
Female
110
 100.0%
107
 100.0%
217
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Finland Number Analyzed 110 participants 107 participants 217 participants
110 107 217
1.Primary Outcome
Title Birth Weight Per Arm
Hide Description birth weight adjusted for gestational weeks expressed as standard deviation units using data from Finnish fetal growth charts in normal pregnancies
Time Frame delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Insulin
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 110 107
Mean (Standard Deviation)
Unit of Measure: g
3604  (488) 3589  (448)
2.Secondary Outcome
Title Pregnancy Induced Hypertension Per Arm
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Insulin
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 110 107
Measure Type: Number
Unit of Measure: participants
2 4
3.Secondary Outcome
Title Maternal Weight Gain Per Arm
Hide Description [Not Specified]
Time Frame up to on the average 40 weeks of gestation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Insulin
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 110 107
Mean (Standard Deviation)
Unit of Measure: kg
8.0  (5.3) 7.9  (5.3)
4.Secondary Outcome
Title Pre-eclampsia Per Arm
Hide Description [Not Specified]
Time Frame up to on the average 40 weeks of gestation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Insulin
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 110 107
Measure Type: Number
Unit of Measure: participants
5 10
5.Secondary Outcome
Title Mode of Delivery Per Arm
Hide Description [Not Specified]
Time Frame delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Insulin
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 110 107
Measure Type: Number
Unit of Measure: no of cesarean section
15 18
6.Secondary Outcome
Title Gestational Weeks at Delivery Per Arm
Hide Description [Not Specified]
Time Frame delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Insulin
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 110 107
Mean (Standard Deviation)
Unit of Measure: weeks
39.2  (1.4) 39.3  (1.6)
7.Secondary Outcome
Title Induction of Delivery Per Arm
Hide Description [Not Specified]
Time Frame delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Insulin
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 110 107
Measure Type: Number
Unit of Measure: participants
42 58
8.Secondary Outcome
Title Shoulder Dystocia Per Arm
Hide Description [Not Specified]
Time Frame delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Insulin
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 110 107
Measure Type: Number
Unit of Measure: participants
1 2
9.Secondary Outcome
Title Neonatal Hypoglycemia Per Arm
Hide Description [Not Specified]
Time Frame 0-24 h after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Insulin
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 109 107
Measure Type: Number
Unit of Measure: participants
18 18
10.Secondary Outcome
Title Neonatal Hyperbilirubinemia Per Arm
Hide Description [Not Specified]
Time Frame 0-3 days after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Insulin
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 109 107
Measure Type: Number
Unit of Measure: participants
9 10
11.Secondary Outcome
Title Apgar Score at 5 Min After Delivery Per Arm
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Insulin
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 109 107
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.7  (1.3) 8.9  (1.0)
12.Secondary Outcome
Title Neonate Transfer to Intensive Care Unit Per Arm
Hide Description [Not Specified]
Time Frame 0-5 days after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Insulin
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 109 107
Measure Type: Number
Unit of Measure: participants
34 39
13.Secondary Outcome
Title Child Outcome at 2 Years Per Arm
Hide Description neuropsychological and motor skills testing
Time Frame 2 years after birth
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description Fetal cardiac function evaluated with ultrasound and cardiotokography
 
Arm/Group Title Metformin Insulin
Hide Arm/Group Description 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
All-Cause Mortality
Metformin Insulin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Metformin Insulin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/110 (0.91%)      0/107 (0.00%)    
Pregnancy, puerperium and perinatal conditions     
fetal death  [1]  1/110 (0.91%)  1 0/107 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Fetal death at 39 weeks due to umbilical cord complication
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Metformin Insulin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/110 (0.00%)      0/107 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Kristiina Tertti
Organization: Department of Obstetrics and Gynecology, Turku University Central Hospital
Phone: +358 2 3130000
EMail: kristiina.tertti@tyks.fi
Layout table for additonal information
Responsible Party: Tapani Rönnemaa, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01240785     History of Changes
Other Study ID Numbers: 246/2005
First Submitted: November 3, 2010
First Posted: November 15, 2010
Results First Submitted: December 4, 2013
Results First Posted: November 24, 2014
Last Update Posted: November 24, 2014