Test of the Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: INSULIN GLULISINE (HMR1964); Drug: INSULIN GLARGINE

• Registration Number: NCT00964574
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To evaluate the efficacy and the safety of insulin glulisine in type I Diabetes Melittus (DM) patients

Secondary Objective:

To evaluate the insulin glulisine doses To assess the patient satisfaction

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-24
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-16
• Last Update Posted: 2012-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Patients with type 1 diabetes mellitus who need insulin basal+ bolus regimen
• 6.5 <=HbA1c <= 11% at visit 1
• BMI <35 kg/m²
• Provision of signed and dated informed consent prior to any study procedures
• Ability and willingness to complete study diaries and questionnaires
• Demonstrated ability to use the self-glucose-monitoring device, and to self-inject insulin
• A negative pregnancy test for all females of childbearing potential.

Exclusion criteria:

• Hypersensitivity to insulin Glulisine, insulin Glargine or one of their excipients
• Pregnant women
• Active proliferative diabetic retinopathy
• Impaired hepatic or renal function

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
APIDRA + LANTUS basal	INSULIN GLULISINE (HMR1964)	The 2 first weeks, patients will receive subcutaneous injection of Insulin Glulisine and Insulin Glargine once daily in hospital. The rest of the treatement is to be take at home until week 12
APIDRA + LANTUS basal	INSULIN GLARGINE	The 2 first weeks, patients will receive subcutaneous injection of Insulin Glulisine and Insulin Glargine once daily in hospital. The rest of the treatement is to be take at home until week 12

Primary Outcome Measures

Name	Time	Method
Mean change in Glycosylated haemoglobin (HbA1c)	Week 12

Secondary Outcome Measures

Name	Time	Method
Mean Glycosylated haemoglobin (HbA1c)	Week 12
Mean Fasting Blood Glucose and mean Post Prandial Glycemia	Week 12
Number of documented symptomatic hypoglycaemic episodes	From week 0 to week 12
Mean dose and mean dose change of insulin glulisine, basal glulisine and total insulin from baseline	week 12
Mean change of Fasting Blood Glucose and Post Prandial Glycemia	From week 0 to week 12

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇧🇾 Minsk, Belarus