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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: insulin glulisine / insulin glargine; Drug: insulin glulisin / insulin detemir

• Registration Number: NCT00271284
• Lead Sponsor: Sanofi

Brief Summary

·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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-12-29
• Study First Submitted QC: 2005-12-29
• Study First Posted: 2005-12-30
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-04
• Last Update Posted: 2009-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
I	insulin glulisine / insulin glargine	-
II	insulin glulisin / insulin detemir	-

Primary Outcome Measures

Name	Time	Method
Efficacy data : fasting blood glucose concentration	read daily during the last 2 months of each period

Secondary Outcome Measures

Name	Time	Method
Tolerance data : undesirable events including episodes of hypoglycaemia	throughout the study

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇫🇷 Paris, France