NCT00335465

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

December 7, 2009

Status Verified

December 1, 2009

Enrollment Period

2.8 years

First QC Date

June 8, 2006

Last Update Submit

December 4, 2009

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

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

    assessed before and after treatment

  • adverse events

    throughout the study

Secondary Outcomes (1)

  • changes of myocardial structure and left ventricular systolic and diastolic function

    at baseline and at the end of the study

Interventions

Insulin glargineDRUG

once a daily, sc injection, 100IU/ml

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Administrative Office

Milan, Italy

Location

Related Publications (1)

  • 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.

    PMID: 22752026DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Georges Paizis, MD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 8, 2006

First Posted

June 9, 2006

Study Start

September 1, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

December 7, 2009

Record last verified: 2009-12

Locations

IT(1)