Efficacy Study on the Control of Blood Glucose Concentration in Type 1 Diabetic Patients (VARIABILITE)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00271284
First received: December 29, 2005
Last updated: December 4, 2009
Last verified: December 2009
  Purpose

·Main objective: To compare the variability of fasting capillary blood glucose concentration, observed with insulin glargine combined with insulin glulisine and with insulin detemir combined with insulin glulisine, in type 1 diabetics. It is a non-inferiority study.

·Secondary objectives:

Efficacy:

  • To compare the variability of blood glucose concentration before the evening meal, observed with insulin glargine combined with insulin glulisine and with insulin detemir combined with insulin glulisine, in type 1 diabetics.
  • To record the intra- and inter-daily variability using the MAGE and MODD indices [1,2,3,4]
  • To compare the glycaemic profiles (7 points)
  • To evaluate the HbA1c concentration, at the end of each period of treatment, weight change, the dose of insulin used and the number of daily injections.

Tolerance:

  • To record undesirable events
  • To evaluate the safety in use from the record of episodes of hypoglycaemia (symptomatic, diurnal, nocturnal, severe).

Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: insulin glulisine / insulin glargine
Drug: insulin glulisin / insulin detemir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Crossover, Multicentre, Randomised Trial Comparing the Effect on the Control of Blood Glucose Concentration of Insulin Glargine and Insulin Detemir, Combined With Insulin Glulisine, Used as a Bolus, in Type 1 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Efficacy data : fasting blood glucose concentration [ Time Frame: read daily during the last 2 months of each period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerance data : undesirable events including episodes of hypoglycaemia [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: October 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I Drug: insulin glulisine / insulin glargine
insulin glargine administered subcutaneously by the patient once a day, in the evening, between 18.30 and 24.00
Active Comparator: II Drug: insulin glulisin / insulin detemir
insulin detemir administered subcutaneously by the patient once a day, in the evening, between 18.30 and 24.00

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria :

  • Belonging to a social security scheme or covered by such a scheme
  • With type 1 diabetes (defined as a concentration of C-peptide < 0.1 nmol//l and a fasting blood glucose of >= 1.26 g/l), diagnosed not less than 5 years previously
  • Treated for at least 6 months by intensive insulin treatment, following a basal-bolus system, using insulin glargine (Lantus®) as basal insulin. During the study, this insulin will administered in the evening
  • Trained in the titration of prandial insulin (the dose of rapid insulin decided at each mealtime depending on the composition of the meal)
  • With an HbA1c level of <= 8.5% at the inclusion visit
  • Capable of checking their blood glucose concentration using the material supplied by the sponsor: blood glucose meter and patient notebook
  • Able to eat 3 regular daily meals on the days for recording the blood glucose cycle and similarly as much as possible on other days throughout the length of the study
  • Able to continue their usual daily activities during the study
  • Women of child-bearing potential should be using an effective method of contraception
  • Fundal examination result less than a year old available

Exclusion Criteria:

  • Recent history of severe hypoglycaemia (at least 2 events in the 6 months prior to inclusion)
  • An episode of acidocetosis in the 3 months prior to inclusion
  • Proliferating retinopathy, defined as having required treatment by surgery or photocoagulation, in the 6 months prior to visit 1, or non-stabilised (rapidly developing) retinopathy which may require photocoagulation or surgery
  • Pancreatectomy
  • Altered hepatic function (AST or ALT >= 2.5 x normal, in the initial measurements)
  • Altered renal function (plasma creatinine > 1.5 mg/dl)
  • Acute infection
  • Acute or chronic metabolic acidosis
  • Gastroparesis
  • History of cancer in the last 5 years
  • Medically significant cardiovascular, hepatic, neurological or endocrine disease or any other significant disease making carrying out the protocol or interpreting the trial results difficult
  • History of drug or alcohol abuse
  • Subject likely to receive treatment during the trial which is not authorised in the protocol (see Section 6.2), in particular, treatment by corticosteroids whatever the route of administration or dose.
  • Antidiabetic treatment by products other than those supplied within the framework of this study
  • Treatment by another product undergoing development during the 3 months prior to inclusion in the trial
  • Hypersensitivity to one of the study products (insulin glargine, insulin detemir, insulin glulisine) or to one of the excipients present in the insulin preparations, used in the study
  • Working at night
  • Pregnancy
  • Breast-feeding
  • Mental state making the subject incapable of understanding the objectives and possible consequences of the trial
  • Subject unable to submit to the restrictions of the protocol (e.g. uncooperative, incapable of attending monitoring visits and probably incapable of finishing the trial)
  • Subject deprived of his liberty because of an administrative or legal decision
  • The investigator or any member of the team or close to the investigator directly implicated in the trial particularly assistant doctors, pharmacists, nurses, trial coordinator, etc.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271284

Locations
France
Sanofi-Aventis Administrative Office
Paris, France
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Marie SEBILLE, Dr Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00271284     History of Changes
Other Study ID Numbers: HMR1964A_3516, EudraCT #: 2005-002771-32
Study First Received: December 29, 2005
Last Updated: December 4, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glargine
Insulin glulisine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014