Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Metformin Versus Insulin in Gestational Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tapani Rönnemaa, Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01240785
First received: November 3, 2010
Last updated: November 21, 2014
Last verified: November 2014
Results First Received: December 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gestational Diabetes
Interventions: Drug: metformin
Drug: insulin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Metformin Arm No text entered.
Insulin No text entered.

Participant Flow:   Overall Study
    Metformin Arm     Insulin  
STARTED     111     110  
COMPLETED     110 [1]   107  
NOT COMPLETED     1     3  
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.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Metformin metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
Insulin insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
Total Total of all reporting groups

Baseline Measures
    Metformin     Insulin     Total  
Number of Participants  
[units: participants]
  110     107     217  
Age  
[units: years]
Mean ± Standard Deviation
  31.9  ± 5.0     32.1  ± 5.4     32.0  ± 4.6  
Gender  
[units: participants]
     
Female     110     107     217  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Finland     110     107     217  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Birth Weight Per Arm   [ Time Frame: delivery ]

2.  Secondary:   Pregnancy Induced Hypertension Per Arm   [ Time Frame: up to on the average 40 weeks of gestation ]

3.  Secondary:   Maternal Weight Gain Per Arm   [ Time Frame: up to on the average 40 weeks of gestation ]

4.  Secondary:   Pre-eclampsia Per Arm   [ Time Frame: up to on the average 40 weeks of gestation ]

5.  Secondary:   Mode of Delivery Per Arm   [ Time Frame: delivery ]

6.  Secondary:   Gestational Weeks at Delivery Per Arm   [ Time Frame: delivery ]

7.  Secondary:   Induction of Delivery Per Arm   [ Time Frame: delivery ]

8.  Secondary:   Shoulder Dystocia Per Arm   [ Time Frame: delivery ]

9.  Secondary:   Neonatal Hypoglycemia Per Arm   [ Time Frame: 0-24 h after delivery ]

10.  Secondary:   Neonatal Hyperbilirubinemia Per Arm   [ Time Frame: 0-3 days after delivery ]

11.  Secondary:   Apgar Score at 5 Min After Delivery Per Arm   [ Time Frame: 5 minutes after delivery ]

12.  Secondary:   Neonate Transfer to Intensive Care Unit Per Arm   [ Time Frame: 0-5 days after delivery ]

13.  Secondary:   Child Outcome at 2 Years Per Arm   [ Time Frame: 2 years after birth ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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:  
Name/Title: Dr Kristiina Tertti
Organization: Department of Obstetrics and Gynecology, Turku University Central Hospital
phone: +358 2 3130000
e-mail: kristiina.tertti@tyks.fi


No publications provided by Turku University Hospital

Publications automatically indexed to this study:

Responsible Party: Tapani Rönnemaa, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01240785     History of Changes
Other Study ID Numbers: 246/2005
Study First Received: November 3, 2010
Results First Received: December 4, 2013
Last Updated: November 21, 2014
Health Authority: Finland: Finnish Medicines Agency