Gene Expression Profiles and Metformin Efficacy in Type 2 Diabetes

Casa Sollievo della Sofferenza IRCCS

Status: Unknown

Conditions: Type 2 Diabetes

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT01334684

GExpProMet

Details and patient eligibility

About

Our general aim is to investigate whether messenger RNA (mRNA) and/or microRNA (miRNA) expression profiles in white blood cells, predict metformin monotherapy efficacy in patients with type 2 diabetes.

Enrollment: 100 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes (duration of diabetes of at least 2 years)
• age 40-70 yrs
• HbA1c > 6.4 < 9.0

Exclusion criteria

• insulin therapy
• contraindications to metformin use

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Metformin

Other group

Description:

At study entry, all oral hypoglycemic agents will be discontinued for 5 days and then metformin (2,550 mg/daily) will be given for 3 months. Fasting plasma glucose will be measured at baseline and 3 months after metformin treatment. Patients will be stratified according to the median value of metformin efficacy as indicated by fasting glucose change after metformin treatment (i.e. baseline fasting glucose minus 3-month fasting glucose). So, two subgroups of patients will be obtained, defined as relatively "high responders" (individual fasting glucose change \> median value) or relatively "low responders" (individual fasting glucose change \< median value) to metformin monotherapy.

Treatment:

Drug: Metformin