Lantus Effect on Myocardial Glucose Metabolism in T2

Diabetes Mellitus, Type 2 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00335465
• Other study ID #: HOE901_4053
• Secondary ID: EUDRACT # : 2004
• Status: Completed
• Phase: Phase 4
• First received: June 8, 2006
• Last updated: December 4, 2009
• Start date: September 2005
• Est. completion date: June 2008

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin glargine
once a daily, sc injection, 100IU/ml

Locations

Country	Name	City	State
Italy	Sanofi-Aventis Administrative Office	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect of insulin treatment on myocardial function, perfusion and glucose metabolism.		assessed before and after treatment	No
Primary	adverse events		throughout the study	Yes
Secondary	changes of myocardial structure and left ventricular systolic and diastolic function		at baseline and at the end of the study	No