insulin analogue with continuous glucose monitoring system (cgms) measurement

Conditions: Diabetes Mellitus Type 2

Summary: 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.


Eligibility criteria:
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.