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

NCT00964574 | Completed Phase 4

• 1 other identifier: APIDR_L_02483
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Mean change in Glycosylated haemoglobin (HbA1c)

  Week 12

Secondary Outcomes (5)

• 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

Study Arms (1)

APIDRA + LANTUS basal

EXPERIMENTAL

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

Drug: INSULIN GLULISINE (HMR1964); Drug: INSULIN GLARGINE

Interventions

INSULIN GLULISINE (HMR1964) DRUG

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

APIDRA + LANTUS basal

INSULIN GLARGINE DRUG

Pharmaceutical form: LANTUS 100U/ml solution for injection in cartridge Route of administration: Once daily subcutaneous injection in the evening

APIDRA + LANTUS basal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with type 1 diabetes mellitus who need insulin basal+ bolus regimen
• \<=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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Minsk, Belarus

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

insulin glulisine; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Natallia Zhyhaila

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2009
• First Posted: August 25, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 17, 2012

Record last verified: 2012-07

Locations

BE (1)