Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:

12-week, Multicenter, Controlled, Open, 3:1 Randomized, Parallel Clinical Trial Comparing Insulin Glulisine With Regular Human Insulin (Insulin Lispro) Injected Subcutaneously in Subjects With Type 1 or 2 Diabetes Mellitus Also Using Lantus (Insulin Glargine)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00467376
• Other study ID #: APIDR_L_00348
• Status: Completed
• Phase: Phase 3
• First received: April 27, 2007
• Last updated: September 14, 2009
• Start date: January 2007

Study information

• Verified date: September 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Primary:

• To compare the efficacy and safety of Insulin Glulisine to Insulin Lispro in subjects with type 1 or type 2 diabetes mellitus.

• To compare the frequency of hypoglycemia of Insulin Glulisine to Insulin Lispro.

Secondary:

• To compare Insulin Glulisine to Insulin Lispro in terms of the change in HbA1c at weeks 12, blood glucose parameters, insulin doses and treatment satisfaction in subjects with type 1 or type 2 diabetes mellitus

Recruitment information / eligibility

• Status: Completed
• Enrollment: 485
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Type 1 or type 2 diabetic patients

• Measure HbA1c 6.5% to 11.0% at visit 1

• More than 3 months of continuous insulin treatment immediately prior to study entry

Exclusion Criteria:

• Pregnant women

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Insulin Glulisine
3 times a day before each meal
• Lispro
3 times a day before each meal
• Insulin Glargine
once daily

Locations

Country	Name	City	State
China	Sanofi-Aventis	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoglycemic episodes		From the beginning to end of the study	No
Primary	Change in HbA1c		From baseline to endpoint	No
Primary	Adverse events		From the beginning to the end of study	Yes
Secondary	Change in HbA1c		From baseline to weeks 12	No
Secondary	blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and Lantus.		from baseline to week 12	No