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

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

Overview[ - collapse ][ - ]

Purpose	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	Diabetes Mellitus
Intervention	Drug: Metformin Drug: Humulin Insulin Mixtard
Phase	Phase 3
Sponsor	Ain Shams University
Responsible Party	Ain Shams University
ClinicalTrials.gov Identifier	NCT01915550
First Received	August 2, 2013
Last Updated	August 2, 2013
Last verified	August 2013

Tracking Information[ + expand ][ + ]

First Received Date	August 2, 2013
Last Updated Date	August 2, 2013
Start Date	April 2012
Estimated Primary Completion Date	February 2013
Current Primary Outcome Measures	Proper Glycemic Control [Time Frame: 2 weeks] [Designated as safety issue: Yes]
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Metformin as Adjuvant to Insulin Therapy in Insulin-resistant Diabetes Mellitus With Pregnancy
Official Title	The Role of Adding Metformin in Insulin-Resistant Diabetic Pregnant Women - a Randomized Controlled Trial
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 Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Diabetes Mellitus
Intervention	Drug: Metformin Other Names: CidophageDrug: Humulin Insulin Mixtard
Study Arm (s)	Active Comparator: metformin metformin was added without raising the insulin dose Active Comparator: Raising Insulin insulin dose is raised

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	90
Estimated Completion Date	February 2013
Estimated Primary Completion Date	January 2013
Eligibility Criteria	Inclusion Criteria: - pregnant women with insulin-resistant diabetes mellitus Exclusion Criteria: - type-1 diabetes mellitus - secondary diabetes mellitus
Gender	Female
Ages	20 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Egypt

Administrative Information[ + expand ][ + ]

NCT Number	NCT01915550
Other Study ID Numbers	361979
Has Data Monitoring Committee	Not Provided
Information Provided By	Ain Shams University
Study Sponsor	Ain Shams University
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	August 2013

Locations[ + expand ][ + ]