Insulin Analogue With Continuous Glucose Monitoring System (CGMS) Measurement
Status:
Completed
Trial end date:
2004-03-01
Target enrollment:
Participant gender:
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.