Insulin Analogue With Continuous Glucose Monitoring System (CGMS) Measurement

Study Overview
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Brief Summary
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Primary objective: Difference in frequency of subjects with conventionally detected hypoglycemia by the subject [at least one measurement smaller/equal 60mg/dl documented in the 8-point profile in the case record form (CRF) or documentation of symptomatic hypoglycemia in the CRF through Visits 8/9] compared to CGMS detected blood glucose values smaller/equal 60mg/dl during CGMS measurements (at least one measurement through Visits 8/9) after eight weeks of treatment with insulin glargine. Secondary objective: Secondary study objectives were to investigate the safety and efficacy of a treatment change to insulin glargine in ICT treated subjects in terms of: Percentage of blood glucose measurements(CGMS data)smaller/equal 60mg/dl [3.3 mmol/l]. Percentage of nocturnal blood glucose measurements(CGMS data)smaller/equal 60mg/dl[3.3 mmol/l]. Percentage of daytime blood glucose measurements(CGMS data)smaller/equal 60mg/dl[3.3 mmol/l]. Area under the curve (AUC smaller/equal 60)and time(t smaller/equal 60)for blood glucose smaller/equal 60mg/dl[3.3mmol/l], area under the curve (AUC greater/equal 180)and time (t greater/equal 180) for blood glucose greater/equal 180mg/dl[10.0mmol/l]. Area under the curve (AUC smaller/equal 60)and time(t smaller/equal 60)for blood glucose smaller/equal 60mg/dl[3.3mmol/l]during the day (AUC 06.00am - 10.00pm)and during the night(AUC 10.00pm - 06.00am). Area under the curve (AUC greater/equal 180)and time(t greater/equal 180)for blood glucose greater/equal 180mg/dl[10.0mmol/l]during the day (AUC 06.00am - 10.00pm)and during the night(AUC 10.00pm - 06.00am). Frequency of subjects with nocturnal blood glucose value smaller/equal 60mg/dl[3.3 mmol/l]. Frequency of subjects with asymptomatic nocturnal blood glucose smaller/equal 60mg/dl[3.3 mmol/l]. Frequency of subjects with symptomatic nocturnal blood glucose smaller/equal 60mg/dl [3.3 mmol/l]. Frequency of subjects with daytime blood glucose smaller/equal 60mg/dl [3.3 mmol/l]. Frequency of subjects with asymptomatic daytime blood glucose smaller/equal 60mg/dl[3.3 mmol/l]. Frequency of subjects with symptomatic daytime blood glucose smaller/equal 60mg/dl[3.3 mmol/l]. Frequency of subjects with hyperglycemic blood glucose(greater/equal 180mg/dl,[10.0mmol/l]). Frequency of subjects with symptomatic hypoglycemia(smaller/equal 60mg/dl [3.3mmol]). Frequency of subjects with severe hypoglycemia(smaller/equal 36mg/dl [2.0mmol/l]). Blood glucose values of 8-point profiles. Mean daytime & mean nocturnal blood glucose of 8-point-profiles. HbA1c. Fasting blood glucose (FBG). Dose of insulin. Adjustment of insulin. Body weight, body mass index.

Official Title
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10-week, Open, National, Multicenter Clinical Trial to Evaluate the Safety of Insulin Glargine in Type 2 Diabetes Mellitus Patients, on Intensified Conventional Therapy (ICT)

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: Subjects with type 2 diabetes mellitus (no history of ketoacidosis)and stable treatment with NPH insulin(once or twice daily)and mealtime insulin for at least 3 months. HbA1c values smaller/equal 8.0%(measured at screening visit, Visit 1). Ability and willingness to perform continuous and self monitoring blood glucose profiles, using a self monitoring blood glucose meter as well as carrying the continuous blood glucose meter at least two times for 72 hours throughout the study at home. Exclusion Criteria: All forms of diabetes other than type 2 diabetes mellitus. Oral antidiabetic drugs(OADs)and/or insulins other than NPH and mealtime insulins, except metformin(stable dose for a minimum of 3 months, no dose adjustments during the study). Pregnant(as determined by urine pregnancy test at Visit 1)or breast-feeding. Women of childbearing potential who did not take adequate contraceptive protection such as systemic hormones or who planned to become pregnant during the study. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (e.g. systemic corticosteroids). History of hypersensitivity to the study medication or to drugs with similar chemical structures. Treatment with any investigational drugs in the last month before study entry. History of drug or alcohol abuse. Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in the 3 months prior to study entry or which required surgical treatment within the study. Clinically relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, hematological or other major systemic diseases making implementation of the protocol or interpretation of the study results difficult. Known impaired hepatic or renal function. 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

| Intervention/Treatment |
| --- |
|Drug: Insulin glargine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of subjects with conventionally detected hypoglycemia |  |  |