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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 1

Treatments

Drug: insulin glulisin / insulin detemir

Drug: insulin glulisine / insulin glargine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00271284

EudraCT #: 2005-002771-32

HMR1964A_3516

Details and patient eligibility

About

·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).

Enrollment

88 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.