Insulin Glulisine in Type 2 Diabetic Patients

Study Overview
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Brief Summary
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To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.

Official Title
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Comparison of Two Therapeutic Strategies for Treating Type 2 Diabetic Patients Poorly Controlled With Basal Insulin Associated With Oral Antidiabetic Drugs : 6-month Proof of Concept Study.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Insulin Glargine
* Drug: Glimepiride
* Drug: Insulin Glulisine
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes Mellitus, Type 2 25 < BMI < 45 kg/m² 7,5% < HbA1c < 9% Treated with a basal insulin (NPH, Insulin Zinc, Insulin glargine or Insulin detemir), and at least 1g metformin daily, for more than 3 months Exclusion Criteria: Type 1 diabetes mellitus Treatment with OADs only Treatment with thiazolidinediones, with exenatide or with pramlintide Treatment with an insulin other than basal insulin (Premix, rapid insulin, fast-acting insulin analogue) Active proliferative diabetic retinopathy, Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and effective contraception) Breast-feeding History of hypersensitivity to the study drugs or to drugs with a similar chemical structure. Treatment with systemic corticosteroids in the 3 months prior to study entry Treatment with any investigational product in the 2 months prior to study entry Previous treatment with insulin glulisine Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult Impaired hepatic function Impaired renal function History of drug or alcohol abuse 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: 75 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: insulin glulisine+insulin glargine+metformin+glimepiride<br>Bolus arm | Drug: Insulin Glargine<br>* One daily injection at bedtime<br>Drug: Glimepiride<br>* At same dosage as during the run-in period<br>Drug: Insulin Glulisine<br>* One bolus given before the main meal<br>Drug: Metformin<br>* At same dosage as during the run-in period<br>|
| Other: insulin glargine+metformin+glimepiride<br>Control arm | Drug: Insulin Glargine<br>* One daily injection at bedtime<br>Drug: Glimepiride<br>* At same dosage as during the run-in period<br>Drug: Metformin<br>* At same dosage as during the run-in period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With Glycosylated Haemoglobin (HbA1c) Value < 7% | Glycosylated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow -up in diabetic patients. this parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c <7% | at the end of treatment (week 24) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated Haemoglobin (HbA1c) Value |  | at the end of treatment (week 24) | 
| Change in Glycosylated Haemoglobin (HbA1c) Value |  | from baseline to the end of treatment (week 24) | 
| Daily Mean Plasma Glucose |  | at the end of treatment (week 24) | 
| Change in Daily Mean Plasma Glucose |  | from baseline to the end of treatment (week 24) | 
| Change in Weight |  | from baseline to the end of treatment (week 24) | 
| Daily Dose of Insulin Glargine | Mean of 3 daily doses reported during the week prior to the final visit | at the end of treatment (week 24) | 
| Daily Dose of Insulin Glulisine | Mean of 3 daily doses reported during the week prior to the final visit | at the end of treatment (week 24) | 
| Rate of Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL |  | during treatment period (12 weeks) | 
| Rate of Nocturnal Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL |  | during treatment period (12 weeks) | 
| Rate of Severe Symptomatic Hypoglycemia |  | during treatment period (12 weeks) |