Diabetes Mellitus Type 2
Conditions
Brief 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.
Interventions
DRUGInsulin glargine
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of subjects with conventionally detected hypoglycemia | — |
Outcome results
None listed