Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus

NCT03106870 | Completed Results DMC

• 1 other identifier: Metformin
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study to prove benefits of adding metformin to insulin for controlling presentational and gestational diabetes mellitus and improving neonatal outcome.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Glycemic Control Over Period 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

  from 20 weeks to 36 weeks gestation

Secondary Outcomes (2)

• Number of Participants With a Macrosomic Baby

  24 hours after delivery

• Number of Participants With Neonates Who Were Hypoglycemic

  24 hours after delivery

Study Arms (2)

oral metformin and insulin

ACTIVE COMPARATOR

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

Drug: Insulin Mixtard; Drug: Metformin

insulin therapy only

ACTIVE COMPARATOR

Intervention 'Insulin Mixtard' had included

Drug: Insulin Mixtard

Interventions

Insulin Mixtard DRUG

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.

Also known as: insulin mixtures

insulin therapy only; oral metformin and insulin

Metformin DRUG

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.

Also known as: Metformin Hydrocloride

oral metformin and insulin

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 20 - 35 years.
• Gestational age: 20- 36 weeks gestation.
• Singleton pregnancy.
• Women with pregestational or gestational diabetes mellitus

You may not qualify if:

• Pregnant women with secondary diabetes (e.g. those on chronic steroid therapy).
• Hypertensive patients.
• Women with impaired liver or renal function
• Non-compliant patients.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Interventions

insulin, pork; isophane insulin, pork drug combination 30:70; Biphasic Insulins; Metformin

Intervention Hierarchy (Ancestors)

Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Drug Combinations; Pharmaceutical Preparations; Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Dr.Rehab Mohamed Abdelrahman
• Organization: Ain Shams University

rehababdulrahman.rm@gmail.com

+201004992772

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Sixty-two opaque envelopes were numbered serially and in each envelope the corresponding letter which detect allocated group were put according to randomization then all envelops were closed and put in one box .When the first patient arrives , the first envelope were opened and the patient were allocated according to the letter inside .
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynaecology Faculty of Medicine, Ain Shams University

Model Details: Group I: pregnant women who received oral metformin in addition to insulin therapy. Group II: pregnant women who received insulin therapy only.

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 11, 2017
• Study Start: June 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 14, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share