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

September 10, 2010 updated by: Sanofi

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.

Study Overview

Status

Completed

Conditions

Diabetes Mellitus

Intervention / Treatment

Drug: Insulin Glulisine

Study Type

Interventional

Enrollment (Actual)

188

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Egypt
- - Cairo, Egypt
    - Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Glycosylated Haemoglobin (HbA1c) Time Frame: At 3 months after the treatment start	At 3 months after the treatment start
Glycosylated Haemoglobin (HbA1c) Time Frame: At 6 months after the treatment start	At 6 months after the treatment start

Secondary Outcome Measures

Outcome Measure	Time Frame
Control of Fasting Blood Glucose (FBG) Time Frame: At 3 months after the treatment start	At 3 months after the treatment start
Control of Post-Prandial Glycemia (PPBG) Time Frame: At 3 months after the treatment start	At 3 months after the treatment start
Control of Post-Prandial Glycemia (PPBG) Time Frame: At 6 months after the treatment start	At 6 months after the treatment start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ACTUAL)

May 1, 2008

Study Completion (ACTUAL)

May 1, 2008

Study Registration Dates

First Submitted

September 6, 2007

First Submitted That Met QC Criteria