Trials Sponsors Conditions Drugs Pricing

Conditions

Gestational Diabetes Mellitus in Pregnancy

Keywords

Gestational Diabetes Mellitus, Metformin, Insulin

Outcome Measures

Primary Outcomes (1)

maternal glycemic control
Maternal glycemic control was measured by blood sugar levels
From time of randomisation till 40 weeks

Secondary Outcomes (6)

Fetal macrosomia
at birth
Apgar score
at birth
Neonatal intensive care unit (NICU) stay
>24 hours after birth
Perinatal death
7 days of delivery
mode of delivery
at delivery
+1 more secondary outcomes

Study Arms (2)

metformin

EXPERIMENTAL

Metformin will be given until 2500mg in divided doses till normoglycemia is achieved and will be continued till delivery

Drug: Metformin

Insulin

ACTIVE COMPARATOR

Insulin will be give as 3 regular injection and one intermediate acting injection at bedtime till normoglycemia is achieved and will be continued till delivery

Drug: Insulin

Interventions

MetforminDrug

metformin 500mg twice daily \& increased until 2500mg till normoglycemia was achieved and was continued till delivery

Also known as: Glucophage

metformin

InsulinDrug

The insulin group was given 3 S/C injections of regular insulin \& one intermediate acting injection at night till normoglycemia was achieved and was continued till delivery

Eligibility Criteria

Age18 Years - 45 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

All pregnant Diagnosed GDM in pregnancy by OGTT from 22 week to 34 week with singleton pregnancy

You may not qualify if:

Sponsors & Collaborators

Services Institute of Medical Sciences, Pakistan
Governmentlead

Study Sites (1)

Services Institute of Medical Sciences

Lahore, Punjab Province, Pakistan

MeSH Terms

Conditions

Diabetes, GestationalInsulin Resistance

Interventions

MetforminInsulinIsophane Insulin, Human

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Enrollment

278 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER GOV
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor Obs Gynae

Study Record Dates

First Submitted

September 30, 2017

First Posted

October 25, 2017

Study Start

February 1, 2016

Actual (reported)

Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

metformin

Insulin

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

metformin

Insulin

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations