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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
ClinicalTrials.gov Identifier:
NCT01349387
First received: May 3, 2011
Last updated: February 8, 2012
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention
Type 2 Diabetes
 Drug: Metformin

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète:

Primary Outcome Measures:
  • Comparison of expression of isoforms A and B of the insulin receptor using quantitative RT PCR [ Time Frame: inclusion (baseline), 30th days and 60th days ] [ Designated as safety issue: No ]
    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)


Enrollment: 25
Study Start Date: May 2011
Study Completion Date: January 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm1

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.

 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349387

Locations
France
Centre Hospitalier Sud Francilien
Corbeil Essonnes, France, 91106
Sponsors and Collaborators
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
Investigators
Principal Investigator: Guillaume CHARPENTIER, MD CHSF-CERITD
  More Information

No publications provided

Responsible Party: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
ClinicalTrials.gov Identifier: NCT01349387     History of Changes
Other Study ID Numbers: 2010-A01389-30, 2011-000128-13
Study First Received: May 3, 2011
Last Updated: February 8, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013