Effect of Treatment With Metformin in Type 2 Diabetes Patients on Alternative Genes Splicing (METFORGENE)

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT01349387

2010-A01389-30

2011-000128-13 (EudraCT Number)

Details and patient eligibility

About

Main objective : Show that treatment with metformin in patients with type 2 diabetes has an effect on alternative splicing of the insulin receptor.

Secondary objective : demonstrate that the effect on the ratio A/isoform B isoform with discontinuation of treatment with metformin can be réversé by the resumption of metformin treatment.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 Diabetic patients usually treated with metformin (≥ 1400 mg/day), associated or not to other oral anti-diabetic treatment or. injection treatment
• Patients major.
• Patients with a social security number
• Patients having signed a consent to participate in the study

Exclusion criteria

• Intolerance metformin
• Patients with type 1.
• Patients on pioglitazone or rosiglitazone
• Renal failure by an anomaly of the creatinine clearance (< 60 mL/min).
• Patients pregnant or likely to be.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Arm1

Experimental group

Description:

During their visit of consultation on the follow-up to the type 2 diabetes, les patients will be selected on the basis of active metformin treatment at a dose greater than or equal to 1400 mg/day. Patients will have to achieve a 10 ml blood sample. The blood will be processed by Ficoll gradient centrifugation to remove the red cells and isolate circulating leukocytes: this stage will be conducted in the CERITD. Analysis on circulating leukocytes and in particular the quantification of expressions of isoforms A and B of the INSR1 by quantitative RT - PCR gene will be conducted in the laboratory of the Professor Marc Peschanski (unit INSERM 861 I - STEM of Evry). After inclusion in the study to J0, metformin treatment will be interrupted between J1 and J30, replaced by Januvia 100 mg/day dose, then resumed at J31.

Treatment:

Drug: Metformin