OPAL - Insulin Glulisine, Diabetes Mellitus

Study Overview
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Brief Summary
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Primary objective: The primary study objective is to compare efficacy of Insulin glulisine, once a day at breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin glargine + OAD in terms of change in HbA1c, from baseline to endpoint for the individual patient. The aim of the study is to demonstrate two-sided equivalence between the two therapy regimens receiving two different injection timing of Insulin glulisine. Secondary objective: Secondary study objectives are to compare efficacy and safety of Insulin glulisine, once a day at breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin glargine + OAD in terms of: Change of fasting-, pre-/2h-postprandial-, mean daily and nocturnal blood glucose (baseline to endpoint) Change of fasting plasma glucose (baseline to endpoint) Response rate: Responders will be those patients with HbA1c smaller than 7.0% at study endpoint Insulin dose (rapid-acting, basal and total daily doses) Weight, body-mass index Hypoglycemic events Adverse events

Official Title
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Efficacy and Safety of Insulin Glulisine Given as a Single Injection at Breakfast + Insulin Glargine+OAD (Oral Antidiabetic Drug) vs Insulin Glulisine Given as a Single Injection at Main Meal+Insulin Glargine+OAD in Type 2 Diabetic Patients for Which Glycemic Control is Suboptimal Using Insulin Glargine+ OAD Alone

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: Type 2 Diabetes mellitus, previously treated with combination therapy of insulin glargine + OAD (maximal tolerated dose / approved in combination with insulin according to local SPCs (Summary of Product Characteristics), not including use of a-glucosidase inhibitors) for at least 3 months Pre-screening HbA1c value greater/equal 7% - smaller/equal 9% FBG (Fasting Blood Glucose) smaller/equal 120 mg/dl (6.6 mmol/l) Women are either not of childbearing potential (surgically sterile, or postmenopausal for more than 2 years) or are not pregnant and agree to use a reliable contraceptive measure for the duration of the study. Reliable contraceptive measures include the following: systemic contraceptive (oral, implant, injections), diaphragm with intravaginal spermicide, cervical cap, intrauterine device, or condom with spermicide. Ability and willingness to perform blood glucose monitoring using the sponsor-provided blood glucose meter and subject diary at home Exclusion criteria: More than two FBG greater 120 mg/dl (6.6 mmol/l) as measured on 5 consecutive days before visit II Active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation) Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult Known impaired hepatic and renal function History of drug or alcohol abuse History of hypersensitivity to insulin or insulin analogues or any of the excipients in the Insulin glulisine formulation Treatment with any investigational drug in the last month before visit I Pregnant or breast-feeding women, or women planning to become pregnant during the study Treatment or likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol Night shift workers if they are unable to comply with the treatment regimen

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- | --- |
| Change in HbA1c. |  | from baseline to study endpoint. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pre-, 2 h postprandial and nocturnal blood glucose values |  | 8-point profile | 
| Fasting blood glucose |  | 8-point blood glucose profile values | 
| Responder rate HbA1c smaller 7 % |  | at study endpoint | 
| Insulin dose |  | rapid-acting, basal and total daily doses | 
| Weight, BMI |  | study follow-up | 
| Hypoglycemic events |  | study follow-up | 
| Adverse events. |  | study follow-up |