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

Type 2 Diabetes Clinical Trial

— METFORGENE  

Official title:

Effect of Treatment With Metformin in Type 2 Diabetes Patients on Alternative Genes Splicing Whose Maturation Depends on the Protein HuR, Including Gene Encoding Insulin Receptor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01349387
• Other study ID #: 2010-A01389-30
• Secondary ID: 2011-000128-13
• Status: Completed
• Phase: N/A
• First received: May 3, 2011
• Last updated: February 8, 2012
• Start date: May 2011
• Est. completion date: January 2012

Study information

• Verified date: May 2011
• Source: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Metformin
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.

Locations

Country	Name	City	State
France	Centre Hospitalier Sud Francilien	Corbeil Essonnes

Sponsors (1)

Lead Sponsor	Collaborator
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of expression of isoforms A and B of the insulin receptor using quantitative RT PCR	comparison of the A isoform (without inclusion of exon 11) and B isoform (with inclusion of exon 11) ratio of the receptor in insulin, during the first period (without metformin) and the second period (with metformin)	inclusion (baseline), 30th days and 60th days	No