search
Back to results

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
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 24, 2009
Last Updated
July 16, 2012
Sponsor
Sanofi
search

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

We'll reach out to this number within 24 hrs