ELEONOR STUDY: Insulin Glulisine in Type 2 Diabetes Mellitus.

NCT00272064 | Completed Phase 3

• 2 other identifiers: HMR1964A_3514EudraCT # : 2004-002731-62
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief Summary

• The primary objective of the present study is to verify the superiority of Telecare program vs. standard SMBG program in terms of mean HbA1c value (- 0,5%) at end-point.
• The secondary objectives of the study are the assessment of: total daily dose of insulin, changes in glycaemic and lipid profile, frequency of hypoglycaemias, changes in weight, health-related quality of life, cost-effectiveness of Telecare program vs. common ambulatory program; general safety (adverse event profile, other routine laboratory parameters).

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Changes of glycosilated haemoglobin (HbA1c)

  At least 12 weeks from baseline (visit 3)

Secondary Outcomes (9)

• Changes in fasting plasma glucose

  At each visit

• Changes in plasma insulin levels

  At each visit

• Change of Self-monitoring of Blood Glucose (SMBG)

  for the total study duration

• Mean Amplitude Glucose Excursion (MAGE)

  for the total study duration

• Change in lipid profile

  V1 (screening) and V5 (end of treatment)

Study Arms (2)

1

OTHER

Telecare system

Drug: Insulin glulisine; Drug: Insulin glargine; Drug: Metformin

2

OTHER

Self Monitoring Blood Glucose (SMBG)system.

Drug: Insulin glulisine; Drug: Insulin glargine; Drug: Metformin

Interventions

Insulin glulisine DRUG

individualized, once daily, dose aiming at 2h post-prandial plasma glucose goal \< 140 mg/dl (7.8 mmol/l) in the optimized treatment phase, since visit 3, subcutaneous

1; 2

Insulin glargine DRUG

individualized, once daily, dose to reach mean fasting plasma glucose (FPG) \<= 126 mg/dl (7.0 mmol/l), since randomization, subcutaneous

1; 2

Metformin DRUG

1000 mg b.i.d, since the qualification phase, oral

1; 2

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of type 2 Diabetes Mellitus
• Patients treated with combined oral antidiabetic drugs(as fixed combination or simultaneous administration) or with metformin in monotherapy at maximal doses for at least 3 months
• Patients having BMI \> 25 Kg/m2;
• Patients having a HbA1c ≥ 7.5 % and ≤ 11 %
• Female patients must be menopausal, surgically sterile, or using effective contraceptive measures;
• Female of childbearing potential must use effective contraceptive measures for at least 1 month prior to the entry into the study and should continue to use the same contraceptive method during the overall study period.

You may not qualify if:

• Patients diagnosed with type 1 insulin dependent Diabetes Mellitus;
• History of two or more severe hypoglycaemic episodes within the past 3 months or history of unawareness hypoglycaemia;
• Active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation);
• Impaired renal function
• Impaired liver function
• History of hypersensitivity to insulin or insulin analogues or any of the excipients in the Insulin glulisine and Insulin glargine formulation
• History of hypersensitivity to metformin;
• Pregnant or breast-feeding women, or women planning to become pregnant during the study;
• Failure to use adequate contraception (women of current reproductive potential only);
• Any clinically significant major organ system disease such as relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, haematological or other major systemic diseases or infective diseases;
• History of drug or alcohol abuse within the last 2 years or current addiction to substances of abuse;
• Night shift workers;
• Receipt of an experimental drug or use of an experimental device within the 30 days prior to study entry;
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study;
• Treatment or likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol;

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Milan, Italy

Location

Related Publications (1)

• Del Prato S, Nicolucci A, Lovagnini-Scher AC, Turco S, Leotta S, Vespasiani G; ELEONOR Study Group. Telecare Provides comparable efficacy to conventional self-monitored blood glucose in patients with type 2 diabetes titrating one injection of insulin glulisine-the ELEONOR study. Diabetes Technol Ther. 2012 Feb;14(2):175-82. doi: 10.1089/dia.2011.0163. Epub 2011 Oct 20.

  PMID: 22013886 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin glulisine; Insulin Glargine; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• PAIZIS GEORGES, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 2, 2006
• First Posted: January 4, 2006
• Study Start: October 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: December 7, 2009

Record last verified: 2009-12

Locations

IT (1)