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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00964574
• Date of registration: 24/08/2009
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Test of the Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus PORTAL 1
• Scientific 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
• Date of first enrolment: July 2009
• Target sample size: 68
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00964574
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Belarus

Contacts

• Name: Natallia Zhyhaila
• Affiliation: Sanofi

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 1

Intervention(s)

Drug: INSULIN GLARGINE

Drug: INSULIN GLULISINE (HMR1964)

Primary Outcome(s)

Mean change in Glycosylated haemoglobin (HbA1c) [Time Frame: Week 12]

Secondary Outcome(s)

Mean Fasting Blood Glucose and mean Post Prandial Glycemia [Time Frame: Week 12]

Mean dose and mean dose change of insulin glulisine, basal glulisine and total insulin from baseline [Time Frame: week 12]

Mean Glycosylated haemoglobin (HbA1c) [Time Frame: Week 12]

Number of documented symptomatic hypoglycaemic episodes [Time Frame: From week 0 to week 12]

Mean change of Fasting Blood Glucose and Post Prandial Glycemia [Time Frame: From week 0 to week 12]

Secondary ID(s)

APIDR_L_02483

Source(s) of Monetary Support

Please refer to primary and secondary sponsors