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

A

Ain Shams University

Status and phase

Completed
Phase 3

Conditions

Diabetes Mellitus

Treatments

Drug: Humulin Insulin Mixtard
Drug: Metformin

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

90 patients

Sex

Female

Ages

20 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • pregnant women with insulin-resistant diabetes mellitus

Exclusion criteria

  • type-1 diabetes mellitus
  • secondary diabetes mellitus

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 2 patient groups

metformin
Active Comparator group
Description:
metformin was added without raising the insulin dose
Treatment:
Drug: Metformin
Raising Insulin
Active Comparator group
Description:
insulin dose is raised
Treatment:
Drug: Humulin Insulin Mixtard

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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