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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)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00526513
First received: September 6, 2007
Last updated: September 10, 2010
Last verified: September 2010
History of Changes
  Purpose

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 Intervention Phase
Diabetes Mellitus
 Drug: Insulin Glulisine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Glycosylated Haemoglobin (HbA1c) [ Time Frame: At 3 months after the treatment start ] [ Designated as safety issue: No ]
  • Glycosylated Haemoglobin (HbA1c) [ Time Frame: At 6 months after the treatment start ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Control of Fasting Blood Glucose (FBG) [ Time Frame: At 3 months after the treatment start ] [ Designated as safety issue: No ]
  • Control of Post-Prandial Glycemia (PPBG) [ Time Frame: At 3 months after the treatment start ] [ Designated as safety issue: No ]
  • Control of Post-Prandial Glycemia (PPBG) [ Time Frame: At 6 months after the treatment start ] [ Designated as safety issue: No ]

Enrollment: 188
Study Start Date: July 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00526513

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

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00526513     History of Changes
Other Study ID Numbers: APIDR_L_01913
Study First Received: September 6, 2007
Last Updated: September 10, 2010
Health Authority: Egypt: Ministry of Health

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

ClinicalTrials.gov processed this record on May 16, 2013