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Metformin as Adjuvant to Insulin Therapy in Insulin-resistant Diabetes Mellitus With Pregnancy

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT01915550
Collaborator
(none)
90
Enrollment
1
Location
2
Arms
10.1
Duration (Months)
9
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Role of Adding Metformin in Insulin-Resistant Diabetic Pregnant Women - a Randomized Controlled Trial
Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Feb 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: metformin

metformin was added without raising the insulin dose

Drug: Metformin
Other Names:
  • Cidophage

    		•
    Active Comparator: Raising Insulin

    insulin dose is raised

    Drug: Humulin Insulin Mixtard

    Outcome Measures

    Primary Outcome Measures

    1. Proper Glycemic Control [2 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • pregnant women with insulin-resistant diabetes mellitus
    Exclusion Criteria:

    • type-1 diabetes mellitus

    • secondary diabetes mellitus

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ain Shams University Maternity Hospital Cairo Egypt 19931

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohammed Faris, Assistant Lecturer of Obstetrics and Gynecology, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT01915550
    Other Study ID Numbers:
    • 361979
    First Posted:
    Aug 5, 2013
    Last Update Posted:
    Aug 5, 2013
    Last Verified:
    Aug 1, 2013
    Keywords provided by Mohammed Faris, Assistant Lecturer of Obstetrics and Gynecology, Ain Shams University
    Diabetes mellitus
    Pregnancy
    Insulin
    Metformin
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Insulin
    Metformin
    Insulin, Globin Zinc
    Insulin, pork; isophane insulin, pork drug combination 30:70

    Study Results

    No Results Posted as of Aug 5, 2013