Efficacy and Safety of Insulin Glulisine in Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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To evaluate the superiority in the efficacy of HMR1964 and OHA combination therapy as compared with OHA therapy. To evaluate the superiority in the efficacy of HMR1964 mono-therapy as compared with OHA therapy. To evaluate the safety of HMR1964.

Official Title
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Evaluation of Efficacy and Safety of HMR1964 Intensive Therapy in Subjects With Type 2 Diabetes Mellitus Not Optimally Controlled With Oral Hypoglycemic Agents (OHA); OHA Therapy Controlled, Open, Randomized, Parallel Group, Comparative (Superiority), 16-week, Multinational, Multicenter Study

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: insulin glulisine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women with type 2 diabetes mellitus diagnosed at least one year prior to the study with a BMI < 30 kg/m2 , a HbA1C of > 8.0 - < 11.0% at screening Fasting serum C-peptide at screening > 0.7 ng/mL Subjects who have been on a stable regimen and at the following doses of SU for at least 8 weeks prior to signing informed consent Glibenclamide > 5 mg/day Glimepiride > 3 mg/day Gliclazide > 80 mg/day In addition to receiving the above mentioned SU agents, subjects may have been treated with a biguanide at a stable dose for at least 8 weeks prior to signing informed consent. Subjects willing to administer three HMR1964 injections per day immediately prior to meals for a 16 week Exclusion Criteria: Subjects unwilling or incapable of receiving a starting dose of ≥ 0.2 IU/kg/day of HMR1964 Subjects with the likelihood of requiring concomitant treatment during the study period with the following classes of drugs: additional OHA (including thiazolidinediones, α-glucosidase inhibitors, D-phenylalanine derivative) other than those specified in the study protocol, insulin preparations other than HMR1964, systemic corticosteroids, other investigational products Subjects with clinically relevant cardiovascular, hepatic, neurologic, endocrine diseases; and active cancer; or other major systemic disease making implementation of the protocol or interpretation of the study results difficult Subjects who are pregnant, breast feeding or wish to become pregnant during the study period Subjects with diabetic retinopathy who received surgical treatments (laser photocoagulation or vitrectomy) within 12 weeks prior to informed consent, who are expected to have these surgical treatments during the study period, or who were diagnosed newly proliferative diabetic retinopathy within 12 weeks prior to informed consent

Ages Eligible for Study
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Minimum Age: 20 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

| Intervention/Treatment |
| --- |
|Drug: insulin glulisine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: change in HbA1C from baseline to endpoint (superiority of HMR1964 and OHA combination therapy as compared to OHA therapy, superiority of HMR1964 mono-therapy as compared to OHA therapy) |  |  | 
| Safety of HMR1964 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in HbA1C from baseline to week 16,consecutive change in HbA1C every 4 wks,plasma glucose parameters, symptomatic hypoglycemia (comparison of HMR1964 intensive therapy, mono-or OHA combination therapy, with OHA therapy). |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HMR1964, insulin glulisine, Diabetes Mellitus, Type 2