Insulin Glulisine in Type 2 Diabetic Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-08-31

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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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insulin glulisine+insulin glargine+metformin+glimepiride

Bolus arm

Group Type OTHER

Insulin Glargine

Intervention Type DRUG

One daily injection at bedtime

Glimepiride

Intervention Type DRUG

At same dosage as during the run-in period

Insulin Glulisine

Intervention Type DRUG

One bolus given before the main meal

Metformin

Intervention Type DRUG

At same dosage as during the run-in period

insulin glargine+metformin+glimepiride

Control arm

Group Type OTHER

Insulin Glargine

Intervention Type DRUG

One daily injection at bedtime

Glimepiride

Intervention Type DRUG

At same dosage as during the run-in period

Metformin

Intervention Type DRUG

At same dosage as during the run-in period

Interventions

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Insulin Glargine

One daily injection at bedtime

Intervention Type DRUG

Glimepiride

At same dosage as during the run-in period

Intervention Type DRUG

Insulin Glulisine

One bolus given before the main meal

Intervention Type DRUG

Metformin

At same dosage as during the run-in period

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No