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Lantus Effect on Myocardial Glucose Metabolism in T2

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Insulin glargine
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office

Outcomes

Primary Outcome Measures

effect of insulin treatment on myocardial function, perfusion and glucose metabolism.
adverse events

Secondary Outcome Measures

changes of myocardial structure and left ventricular systolic and diastolic function

Full Information

First Posted
June 8, 2006
Last Updated
December 4, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00335465
Brief Title
Lantus Effect on Myocardial Glucose Metabolism in T2
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Insulin glargine
Intervention Description
once a daily, sc injection, 100IU/ml
Primary Outcome Measure Information:
Title
effect of insulin treatment on myocardial function, perfusion and glucose metabolism.
Time Frame
assessed before and after treatment
Title
adverse events
Time Frame
throughout the study
Secondary Outcome Measure Information:
Title
changes of myocardial structure and left ventricular systolic and diastolic function
Time Frame
at baseline and at the end of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georges Paizis, MD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Milan
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22752026
Citation
Masi S, Lautamaki R, Guiducci L, Di Cecco P, Porciello C, Pardini S, Morales MA, Chubuchny V, Salvadori PA, Emdin M, Sironi AM, Knuuti J, Neglia D, Nuutila P, Ferrannini E, Iozzo P. Similar patterns of myocardial metabolism and perfusion in patients with type 2 diabetes and heart disease of ischaemic and non-ischaemic origin. Diabetologia. 2012 Sep;55(9):2494-500. doi: 10.1007/s00125-012-2631-0. Epub 2012 Jul 1.
Results Reference
derived

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Lantus Effect on Myocardial Glucose Metabolism in T2

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