Lantus Effect on Myocardial Glucose Metabolism in T2

This study has been completed.
Sponsor:
Information provided by:
Sanofi-Aventis
ClinicalTrials.gov Identifier:
NCT00335465
First received: June 8, 2006
Last updated: December 4, 2009
Last verified: December 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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
Study Completion Date: June 2008
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 Administrative Office
Milan, Italy
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Georges Paizis, MD Sanofi-Aventis
  More Information

No publications provided by Sanofi-Aventis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00335465     History of Changes
Other Study ID Numbers: HOE901_4053, EUDRACT # : 2004-002729-34
Study First Received: June 8, 2006
Last Updated: December 4, 2009
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Ventricular Dysfunction, Left
Ventricular Dysfunction
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Glargine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2012