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NCT01915550 Clinical Trial

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

Diabetes Mellitus Clinical Trial

Official title:
The Role of Adding Metformin in Insulin-Resistant Diabetic Pregnant Women - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01915550
Other study ID # 361979
Secondary ID
Status Completed
Phase Phase 3
First received August 2, 2013
Last updated August 2, 2013
Start date April 2012
Est. completion date February 2013

Study information
Verified date August 2013
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority Egypt: Ministry of Higher Education
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date February 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria:

- pregnant women with insulin-resistant diabetes mellitus

Exclusion Criteria:

- type-1 diabetes mellitus

- secondary diabetes mellitus

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Metformin

• Humulin Insulin Mixtard

Locations
Country Name City State
Egypt Ain Shams University Maternity Hospital Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proper Glycemic Control 2 weeks Yes
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