Insulin Analogue With Continuous Glucose Monitoring System (CGMS) Measurement
- Conditions
- Diabetes Mellitus Type 2
- Registration Number
- NCT00354939
- Lead Sponsor
- Sanofi
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 480
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Frequency of subjects with conventionally detected hypoglycemia
- Secondary Outcome Measures
Name Time Method