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

Diabetes Mellitus, Type 1 Clinical Trial

— PORTAL 1  

Official title:

Multicentre, Open, Non-randomised Controlled Phase IV Clinical Trial of Efficacy and Safety for Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964574
• Other study ID #: APIDR_L_02483
• Status: Completed
• Phase: Phase 4
• First received: August 24, 2009
• Last updated: July 16, 2012
• Start date: July 2009
• Est. completion date: July 2010

Study information

• Verified date: July 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belarus: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• INSULIN GLULISINE (HMR1964)
Pharmaceutical form: APIDRA 100U/ml flacon for the titration period in the hospital APIDRA 100U/ml solution for injection in cartridge in OptiSet Route of administration: 3-4 subcutaneous injections per day
• INSULIN GLARGINE
Pharmaceutical form: LANTUS 100U/ml solution for injection in cartridge Route of administration: Once daily subcutaneous injection in the evening

Locations

Country	Name	City	State
Belarus	Sanofi-Aventis Administrative Office	Minsk

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Belarus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in Glycosylated haemoglobin (HbA1c)		Week 12	No
Secondary	Mean Glycosylated haemoglobin (HbA1c)		Week 12	No
Secondary	Mean Fasting Blood Glucose and mean Post Prandial Glycemia		Week 12	No
Secondary	Number of documented symptomatic hypoglycaemic episodes		From week 0 to week 12	No
Secondary	Mean dose and mean dose change of insulin glulisine, basal glulisine and total insulin from baseline		week 12	No
Secondary	Mean change of Fasting Blood Glucose and Post Prandial Glycemia		From week 0 to week 12	No