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Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT03106870
Recruitment Status : Completed
First Posted : April 11, 2017
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Gestational Diabetes Mellitus in Pregnancy
Interventions: Drug: Insulin Mixtard
Drug: Metformin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

The current study was conducted at Ain Shams university maternity hospital during the period between June 2016 to December 2016.

Sixty two pregnant women were recruited from Ain Shams university maternity hospital who fulfilled the inclusion criteria. They were counseled and after consenting were included into the study.


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
Oral Metformin and Insulin

Intervention 'Insulin Mixtard' and Intervention 'metformin' had included

Insulin Mixtard: Insulin dose:

  • 0.7 IU/Kg (at the second trimester of pregnancy).
  • 0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.

Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.

If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day.

Insulin Therapy Only

Intervention 'Insulin Mixtard' had included

Insulin Mixtard: Insulin dose:

  • 0.7 IU/Kg (at the second trimester of pregnancy).
  • 0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.

Participant Flow:   Overall Study
    Oral Metformin and Insulin   Insulin Therapy Only
STARTED   31   31 
COMPLETED   31   31 
NOT COMPLETED   0   0 



  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
Oral Metformin and Insulin

Intervention 'Insulin Mixtard' and Intervention 'metformin' had included

Insulin Mixtard: Insulin dose:

  • 0.7 IU/Kg (at the second trimester of pregnancy).
  • 0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.

Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.

If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day.

Insulin Therapy Only

Intervention 'Insulin Mixtard' had included

Insulin Mixtard: Insulin dose:

  • 0.7 IU/Kg (at the second trimester of pregnancy).
  • 0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.
Total Total of all reporting groups

Baseline Measures
   Oral Metformin and Insulin   Insulin Therapy Only   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   31   62 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      31 100.0%      31 100.0%      62 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 28.9  (3.9)   29.7  (3.5)   29.3  (3.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      31 100.0%      31 100.0%      62 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
Egypt   31   31   62 


  Outcome Measures

1.  Primary:   Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation   [ Time Frame: from 20 weeks to 36 weeks gestation ]

2.  Secondary:   Number of Participants With a Macrosomic Baby   [ Time Frame: 24 hours after delivery ]

3.  Secondary:   Number of Participants With Neonates Who Were Hypoglycemic   [ Time Frame: 24 hours after delivery ]


  Serious Adverse Events


  Other Adverse Events


  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

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.Rehab Mohamed Abdelrahman
Organization: Ain Shams University
phone: +201004992772
e-mail: rehababdulrahman.rm@gmail.com



Responsible Party: Rehab Mohamed Abdelrahman, Ain Shams University
ClinicalTrials.gov Identifier: NCT03106870     History of Changes
Other Study ID Numbers: Metformin
First Submitted: March 28, 2017
First Posted: April 11, 2017
Results First Submitted: April 14, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017