Test of the Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus (PORTAL 1)
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 4
Locations
Belarus
Study Type
Interventional
Intervention
INSULIN GLULISINE (HMR1964)
INSULIN GLARGINE
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
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.
Sites / Locations
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
APIDRA + LANTUS basal
Arm Description
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
Outcomes
Primary Outcome Measures
Mean change in Glycosylated haemoglobin (HbA1c)
Secondary Outcome Measures
Mean Glycosylated haemoglobin (HbA1c)
Mean Fasting Blood Glucose and mean Post Prandial Glycemia
Number of documented symptomatic hypoglycaemic episodes
Mean dose and mean dose change of insulin glulisine, basal glulisine and total insulin from baseline
Mean change of Fasting Blood Glucose and Post Prandial Glycemia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00964574
Brief Title
Test of the Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
APIDRA + LANTUS basal
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
INSULIN GLULISINE (HMR1964)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
INSULIN GLARGINE
Intervention Description
Pharmaceutical form:
LANTUS 100U/ml solution for injection in cartridge
Route of administration:
Once daily subcutaneous injection in the evening
Primary Outcome Measure Information:
Title
Mean change in Glycosylated haemoglobin (HbA1c)
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Mean Glycosylated haemoglobin (HbA1c)
Time Frame
Week 12
Title
Mean Fasting Blood Glucose and mean Post Prandial Glycemia
Time Frame
Week 12
Title
Number of documented symptomatic hypoglycaemic episodes
Time Frame
From week 0 to week 12
Title
Mean dose and mean dose change of insulin glulisine, basal glulisine and total insulin from baseline
Time Frame
week 12
Title
Mean change of Fasting Blood Glucose and Post Prandial Glycemia
Time Frame
From week 0 to week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natallia Zhyhaila
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Minsk
Country
Belarus
12. IPD Sharing Statement
Learn more about this trial
Test of the Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus
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