Study of Safety and Effectiveness of Apidra® in Combination With Basal Insulin in Patients With Type 1 & 2 Diabetes Mellitus

Diabetes Mellitus Clinical Trial

— SCALE  

Official title:

Study of Safety and Effectiveness of Apidra® in Combination With Basal Insulin in Patients With Type 1 & 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00526513
• Other study ID #: APIDR_L_01913
• Status: Completed
• Phase: Phase 4
• First received: September 6, 2007
• Last updated: September 10, 2010
• Start date: July 2007
• Est. completion date: May 2008

Study information

• Verified date: September 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Primary Objectives:

To determine the effect of insulin glulisine on glycemic control (HbA1c, FBG & PPBG) from baseline to the end of the study.

Secondary Objectives:

To evaluate the safety of insulin glulisine in basal/bolus regimen by monitoring the incidence of hypoglycemia and other adverse events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with type 1 or type 2 diabetes mellitus previously treated for 6 months with prandial insulin + Basal insulin or Premix (Type I) or by either a basal insulin + OAD or basal + RHI/other short acting analogue insulin or Premix (Type II) with HbA1c >7%.

• Adequate hepatic and renal functions

• Ability and willingness of a tight antidiabetic therapy and to perform blood glucose self-monitoring and especially blood glucose profiles, using a blood glucometer at home.

Exclusion Criteria:

• Pregnant or lactating women or women of childbearing potential not using adequate contraception.

• Patients with hypersensitivity to insulin glulisine or to any of the excipients.

• History of diabetic ketoacidosis.

• Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in the 3 months prior to study entry or which may require surgical treatment within 3 months of study entry.

• Alcohol abuse or drug abuse.

• Clinically relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, hematological or psychiatric illness, other serious illnesses, uncontrolled medical conditions or active infections making implementation of the protocol difficult.

• Medical, psychiatric, or neurologic condition that renders the patient unable to understand the nature and scope of the study. Mental retardation or language barrier such that the patient is unable to give informed consent.

• Participation in an investigational trial within 30 days of study entry.

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Insulin Glulisine
subcutaneous injection of insulin glulisine at meal, 1 to 3 injections a day based on the condition of the patient in addition to a basal SC insulin injection at bedtime

Locations

Country	Name	City	State
Egypt	Sanofi-Aventis Administrative Office	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated Haemoglobin (HbA1c)		At 3 months after the treatment start	No
Primary	Glycosylated Haemoglobin (HbA1c)		At 6 months after the treatment start	No
Secondary	Control of Fasting Blood Glucose (FBG)		At 3 months after the treatment start	No
Secondary	Control of Post-Prandial Glycemia (PPBG)		At 3 months after the treatment start	No
Secondary	Control of Post-Prandial Glycemia (PPBG)		At 6 months after the treatment start	No