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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):
Rehab Mohamed Abdelrahman, Ain Shams University

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
Enrollment 62
Recruitment Details

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  
Arm/Group Title Oral Metformin and Insulin Insulin Therapy Only
Hide Arm/Group Description

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.

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.
Period Title: Overall Study
Started 31 31
Completed 31 31
Not Completed 0 0
Arm/Group Title Oral Metformin and Insulin Insulin Therapy Only Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 31 31 62
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 62 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 31 participants 62 participants
28.9  (3.9) 29.7  (3.5) 29.3  (3.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 62 participants
Female
31
 100.0%
31
 100.0%
62
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Egypt Number Analyzed 31 participants 31 participants 62 participants
31
 100.0%
31
 100.0%
62
 100.0%
1.Primary Outcome
Title Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation
Hide Description

Fasting and two-hours postprandial blood glucose every 48 hours, till reaching the target blood glucose concentrations:

60 - 95 mg/dl and < 120 mg/dl (for fasting and two-hour postprandial status, respectively) If patient reached blood glucose concentrations, she considered as controlled Diabetes Mellitus If patient did not reach blood glucose concentrations, she considered as uncontrolled Diabetes Mellitus

Time Frame from 20 weeks to 36 weeks gestation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Metformin and Insulin Insulin Therapy Only
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 31 31
Measure Type: Count of Participants
Unit of Measure: Participants
24
  77.4%
27
  87.1%
2.Secondary Outcome
Title Number of Participants With a Macrosomic Baby
Hide Description Fetal macrosomia has been defined birth weight greater than 4500 gm
Time Frame 24 hours after delivery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Metformin and Insulin Insulin Therapy Only
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 31 31
Measure Type: Count of Participants
Unit of Measure: Participants
5
  16.1%
12
  38.7%
3.Secondary Outcome
Title Number of Participants With Neonates Who Were Hypoglycemic
Hide Description Neonatal hypoglycemia defined as a plasma glucose level of less than 30 mg/dL in the first 24 hours after delivery
Time Frame 24 hours after delivery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Metformin and Insulin Insulin Therapy Only
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 31 31
Measure Type: Count of Participants
Unit of Measure: Participants
5
  16.1%
6
  19.4%
Time Frame 7 months from June 2016 to December 2016
Adverse Event Reporting Description Adverse Events of oral metformin and insulin were assessed.
 
Arm/Group Title Oral Metformin and Insulin Insulin Therapy Only
Hide Arm/Group Description

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.

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.
All-Cause Mortality
Oral Metformin and Insulin Insulin Therapy Only
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Oral Metformin and Insulin Insulin Therapy Only
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/31 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oral Metformin and Insulin Insulin Therapy Only
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/31 (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
Name/Title: Dr.Rehab Mohamed Abdelrahman
Organization: Ain Shams University
Phone: +201004992772
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