NCT01915550

Brief Summary

Adding metformin to insulin therapy in pregnant women with diabetes mellitus who show insulin resistance may be equivalently effective to further raising the insulin dose

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at below P25 for phase_3 diabetes-mellitus

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_3 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
Last Updated

August 5, 2013

Status Verified

August 1, 2013

Enrollment Period

9 months

First QC Date

August 2, 2013

Last Update Submit

August 2, 2013

Conditions

Diabetes Mellitus

Keywords

Diabetes mellitusPregnancyInsulinMetformin

Outcome Measures

Primary Outcomes (1)

  • Proper Glycemic Control

    2 weeks

Study Arms (2)

metformin

ACTIVE COMPARATOR

metformin was added without raising the insulin dose

Drug: Metformin

Raising Insulin

ACTIVE COMPARATOR

insulin dose is raised

Drug: Humulin Insulin Mixtard

Interventions

MetforminDRUG
Also known as: Cidophage
metformin
Humulin Insulin MixtardDRUG
Raising Insulin

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant women with insulin-resistant diabetes mellitus

You may not qualify if:

  • type-1 diabetes mellitus
  • secondary diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Cairo Governorate, 19931, Egypt

Location

MeSH Terms

Conditions

Diabetes MellitusInsulin Resistance

Interventions

Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Obstetrics and Gynecology

Study Record Dates

First Submitted

August 2, 2013

First Posted

August 5, 2013

Study Start

April 1, 2012

Primary Completion

January 1, 2013

Study Completion

February 1, 2013

Last Updated

August 5, 2013

Record last verified: 2013-08

Locations

EG(1)