Comparison Safety and Efficacy of Basal Insulin Lantus® (Insulin Glargine) vs NPH Insulin in Combination With Oral Antidiabetic Drugs (OADs) in Patients With Diabetes Mellitus, Type 2 (DMT2)

Study Overview
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Brief Summary
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Aim of the study is to compare two treatment regimens (insulin Lantus as basal insulin vs insulin NPH) plus oral antidiabetics in type 2 diabetic patients and confirm superiority of insulin glargine. Comparison is focused on: blood glucose (BG) variability of the two treatment regimens, quality of diabetes compensation (HbA1c, FBG/Fasting blood glucose), body weight development, dose of insulin and occurrence of symptomatic hypoglycaemia and other adverse events.

Official Title
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Comparison Safety and Efficacy of Basal Insulin Lantus® (Insulin Glargine) vs NPH Insulin in Combination With OADs in Patients With DMT2, Assessed by Continuous Glucose Monitoring System (CGMS). Multicentre, Prospective, Open- Label, Single Arm, Comparative Study in Patients Switched From NPH Insulin to Insulin Lantus®.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: insulin glargine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes type 2 Patients treated NPH insulin with stable dosage of OADs (Oral antidiabetic drugs) for at least 2 months prior to study start and OADs treatment with metformin at least 1,7 g /day in combination with sulfonylurea or glinides. Patients must have a HbA1c range of >= 4,5% ( 6,2% DCCT/Diabetes Control and Complication Trials) and <= 8% ( 9,4 % DCCT/Diabetes Control and Complication Trials) Ability and willingness to perform continuous glucose monitoring system / CGMS (examination within the study) Written informed consent obtained prior to enrollment in the study Women are either not of childbearing potential or women of childbearing potential must not be pregnant and must use a reliable contraceptive measure for the duration of the study Exclusion Criteria: Fasting value C peptide <= 400 pmol/l Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable rapidly progressing retinopathy that may require photocoagulation or surgery during the study. Pregnant women or women planning gravidity during clinical study protocol 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 and during study and other treatment, that can significantly have impression to glycaemia. 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 as shown by Alamine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal range at study entry Impaired renal function as shown by serum creatinine >/= 133 micromol/L in men and >/= 124 micromol/L in women at study entry History of drug or alcohol abuse in the last year Mental condition causing the patient unable to understand the nature, scope and possible consequences of the study Patient unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits and unlikelihood of completing the study Use of insulin glargine outside the scope of the current SPC (Summary of Product Characteristics) 16. Patients included in other clinical studies 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: 80 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm<br> | Drug: insulin glargine<br>* once daily<br>* Other names: Lantus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in blood glucose variability |  | before start with insulin glargine treatment and at the end of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events |  | From signing of informed consent to the end of study | 
| Development of diabetes compensation - fastig blood glucose and HbA1 |  | before starting therapy with Lantus and at the end of study | 
| Development of weight of patients |  | Before starting Lantus vs at the end of the study | 
| Comparison of dose of insulins NPH vs Lantus |  | Before starting Lantus and at the end of the study |