- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00526513
Study of Safety and Effectiveness of Apidra® in Combination With Basal Insulin in Patients With Type 1 & 2 Diabetes Mellitus (SCALE)
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
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Cairo, Egypt
- Sanofi-Aventis Administrative Office
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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Glycosylated Haemoglobin (HbA1c)
Time Frame: At 6 months after the treatment start
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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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APIDR_L_01913
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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