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

Phase 3

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Metformin; Drug: Humulin Insulin Mixtard

• Registration Number: NCT01915550
• Lead Sponsor: Ain Shams University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2013-01
• Study Completion: 2013-02
• Status Verified: 2013-08
• Study First Submitted: 2013-08-02
• Study First Submitted QC: 2013-08-02
• Last Update Submitted: 2013-08-02
• Study First Posted: 2013-08-05
• Last Update Posted: 2013-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• pregnant women with insulin-resistant diabetes mellitus

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Exclusion Criteria

• type-1 diabetes mellitus
• secondary diabetes mellitus

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metformin	Metformin	metformin was added without raising the insulin dose
Raising Insulin	Humulin Insulin Mixtard	insulin dose is raised

Primary Outcome Measures

Name	Time	Method
Proper Glycemic Control	2 weeks

Trial Locations

Locations (1)

Ain Shams University Maternity Hospital; 🇪🇬 Cairo, Egypt