ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Lantus Effect on Myocardial Glucose Metabolism in T2

This study has been completed.

Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00335465
  Purpose

The primary objective of the present study is to assess changes of myocardial glucose uptake (MGU) during clamp studies using positron emission tomography (PET) scanning in patients with type 2 diabetes and idiopathic left ventricular dysfunction (LVD).

The secondary objectives of the study are: assessment of changes of myocardial microcirculation at rest and during adenosine stimulation using PET; assessment of changes in myocardial structure and function evaluated by magnetic resonance imaging (MRI); assessment of glycaemic control by measurement of HbA1c, fasting blood glucose and insulin levels; assessment of safety (adverse event profile, laboratory data).


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Insulin glargine
Phase IV

MedlinePlus related topics:   Diabetes   

ChemIDplus related topics:   Insulin    Insulin glargine    Dextrose   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Pilot Study for the Evaluation of the Effects of Insulin Treatment on Myocardial Function, Perfusion, and Glucose Metabolism in Patients With Primary Left Ventricular Dysfunction and Type 2 Diabetes.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • effect of insulin treatment on myocardial function, perfusion and glucose metabolism. [ Time Frame: assessed before and after treatment ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • changes of myocardial structure and left ventricular systolic and diastolic function [ Time Frame: at baseline and at the end of the study ] [ Designated as safety issue: No ]

Enrollment:   15
Study Start Date:   September 2005
Primary Completion Date:   June 2008 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: Insulin glargine
    once a daily, sc injection, 100IU/ml
  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • LV systolic dysfunction (2D-Echo LVEF < 50%) with or without LV dilation (2D-Echo LV EDD > 56 mm) or left ventricular end-diastolic diameter (LVEDD) >55mm with or without LV dysfunction
  • angiographically normal coronary arteries (< 50% vessel narrowing);
  • newly diagnosed type 2 diabetes;
  • previously diagnosed: OAD treated type 2 diabetic patients able to take part in the study after a one-month wash-out period and insulin treated type 2 diabetic patients able to take part in the study after one week wash-out period.

Exclusion Criteria:

  • evidence of congenital or valvular cardiac diseases, hypertrophic cardiomyopathy, overt heart failure (NYHA class III-IV);
  • moderate to severe hypertension (diastolic aortic pressure > 100 mmHg);
  • hypotension (systolic aortic pressure < 100 mmHg);
  • nephropathy (serum creatinine > 3 mg/dL);
  • other systemic and/or infective diseases;
  • severe dyslipidemia;
  • peripheral vasculopathy;
  • necessity of vasoactive medical treatment in the last 48 hours;
  • atrial fibrillation;
  • Refusal or impossibility to give written informed consent;
  • patients diagnosed with type 1 insulin dependent diabetes;
  • clinically relevant cardiovascular, hepatic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult;
  • patients with medical history positive for cerebrovascular accidents, including Transient Ischaemic Attack (TIA);
  • women who are lactating, pregnant, or planning to become pregnant during the study;
  • history of hypersensitivity to the investigational products or to drugs with similar chemical structures;
  • likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol;
  • treatment with any investigational product in the last 30 days or 5 half-lives (whichever is longer) before study entry;
  • current use of investigational agents or participation in any other investigational studies during study period;
  • history of drug or alcohol abuse;
  • impaired hepatic function, as shown by Alamine AminoTransferase (ALT) > 2,5 times the upper limit of the normal laboratory range;
  • mental condition making the subject unable to understand the nature, scope, and possible consequences of the study;
  • patients unable to understand dosing directions;
  • subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study procedures;
  • receipt of an experimental drug or use of an experimental device within the 30 days prior to study entry;
  • previous enrollment in the present study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335465

Locations
Italy
Sanofi-aventis    
      Milan, Italy

Sponsors and Collaborators
Sanofi-Aventis

Investigators
Study Director:     Georges Paizis, MD     Sanofi-Aventis    
  More Information


Responsible Party:   sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:   HOE901_4053, EUDRACT # : 2004-002729-34
First Received:   June 8, 2006
Last Updated:   July 1, 2008
ClinicalTrials.gov Identifier:   NCT00335465
Health Authority:   Italy: Ministry of Health

Study placed in the following topic categories:
Ventricular Dysfunction
Heart Diseases
Metabolic Diseases
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus
Endocrine System Diseases
Ventricular Dysfunction, Left
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 14, 2008




Links to all studies - primarily for crawlers