Trial Outcomes & Findings for Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus (NCT NCT03106870)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

62 participants

Primary outcome timeframe

from 20 weeks to 36 weeks gestation

Results posted on

2017-06-14

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	31	31
Overall Study COMPLETED	31	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral Metformin and Insulin n=31 Participants 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 n=31 Participants 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 n=62 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants	31 Participants n=7 Participants	62 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	28.9 years STANDARD_DEVIATION 3.9 • n=5 Participants	29.7 years STANDARD_DEVIATION 3.5 • n=7 Participants	29.3 years STANDARD_DEVIATION 3.7 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	31 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Egypt	31 Participants n=5 Participants	31 Participants n=7 Participants	62 Participants n=5 Participants

PRIMARY outcome

Timeframe: from 20 weeks to 36 weeks gestation

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

Outcome measures

Outcome measures
Measure	Oral Metformin and Insulin n=31 Participants 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 n=31 Participants 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.
Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation	24 Participants	27 Participants

SECONDARY outcome

Timeframe: 24 hours after delivery

Fetal macrosomia has been defined birth weight greater than 4500 gm

Outcome measures

Outcome measures
Measure	Oral Metformin and Insulin n=31 Participants 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 n=31 Participants 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.
Number of Participants With a Macrosomic Baby	5 Participants	12 Participants

SECONDARY outcome

Timeframe: 24 hours after delivery

Neonatal hypoglycemia defined as a plasma glucose level of less than 30 mg/dL in the first 24 hours after delivery

Outcome measures

Outcome measures
Measure	Oral Metformin and Insulin n=31 Participants 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 n=31 Participants 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.
Number of Participants With Neonates Who Were Hypoglycemic	5 Participants	6 Participants

Adverse Events

Oral Metformin and Insulin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Insulin Therapy Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Rehab Mohamed Abdelrahman

Ain Shams University

Phone: +201004992772

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place