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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00526513
Recruitment Status : Completed
First Posted : September 10, 2007
Last Update Posted : September 13, 2010
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Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Insulin Glulisine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Safety and Effectiveness of Apidra® in Combination With Basal Insulin in Patients With Type 1 & 2 Diabetes Mellitus
Study Start Date : July 2007
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    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

Primary Outcome Measures :
  1. Glycosylated Haemoglobin (HbA1c) [ Time Frame: At 3 months after the treatment start ]
  2. Glycosylated Haemoglobin (HbA1c) [ Time Frame: At 6 months after the treatment start ]

Secondary Outcome Measures :
  1. Control of Fasting Blood Glucose (FBG) [ Time Frame: At 3 months after the treatment start ]
  2. Control of Post-Prandial Glycemia (PPBG) [ Time Frame: At 3 months after the treatment start ]
  3. Control of Post-Prandial Glycemia (PPBG) [ Time Frame: At 6 months after the treatment start ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00526513

Sanofi-Aventis Administrative Office
Cairo, Egypt
Sponsors and Collaborators
Study Director: Mosaad I Morsi, MBBCH, MSC Sanofi

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00526513     History of Changes
Other Study ID Numbers: APIDR_L_01913
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: September 13, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin glulisine
Hypoglycemic Agents
Physiological Effects of Drugs