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Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus

NCT ID: NCT03320694

Last Updated: 2017-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2017-06-30

Brief Summary

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Gestational diabetic mellitus (GDM) patients randomised to metformin or insulin group.Aim was to achieve blood sugar levels of Blood sugar fasting (BSF) \<5.3 mmol/l and 1 hour post meal\<7.8mmol/l. Both groups were followed till delivery and outcome studied.

Detailed Description

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75 gm Oral Glucose Tolerance Test (OGTT) was done in pregnant patients. Blood sugar fasting(BSF) \> 5.5 mmol/l \& 2 hours postprandial \>7.8 mmol/l was labelled as GDM. They were randomised to metformin or insulin group. Those assigned to metformin group were started metformin 500mg twice daily \& increased until 2500mg depending on the blood sugar levels. Aim was to achieve blood sugar levels of BSF \<5.3 mmol/l and 1 hour post meal\<7.8mmol/l. If blood sugar levels were not controlled, insulin was added. The insulin group was given 3 injections of regular insulin \& one intermediate acting insulin injection at night subcutaneously. Both groups were followed till delivery and outcome studied

Conditions

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Gestational Diabetes Mellitus in Pregnancy

Keywords

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Gestational Diabetes Mellitus, Metformin, Insulin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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metformin

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

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

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

Insulin

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

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

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

Interventions

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Metformin

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

Intervention Type DRUG

Insulin

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

Intervention Type DRUG

Other Intervention Names

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Glucophage Humulin R U 100 and Humulin N

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with Known diabetes mellitus
* Patients with multiple pregnancy
* With essential hypertension or pre eclampsia
* Patients having fetal malformation incompatible with life
* Patients with intrauterine death of fetus
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Services Institute of Medical Sciences, Pakistan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tayyiba Wasim

Professor Obs Gynae

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Services Institute of Medical Sciences

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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IRB/2015/211/SIMS

Identifier Type: -

Identifier Source: org_study_id