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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Insulin Glulisine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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