Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354939
Status:
COMPLETED
Last Update Posted:
2010-08-31
First Post:
2006-07-19
Brief Title:
Insulin Analogue With Continuous Glucose Monitoring System CGMS Measurement
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAFIR
Brief Summary:
Primary objective
Difference in frequency of subjects with conventionally detected hypoglycemia by the subject at least one measurement smallerequal 60mgdl documented in the 8-point profile in the case record form CRF or documentation of symptomatic hypoglycemia in the CRF through Visits 89 compared to CGMS detected blood glucose values smallerequal 60mgdl during CGMS measurements at least one measurement through Visits 89 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 measurementsCGMS datasmallerequal 60mgdl 33 mmoll
Percentage of nocturnal blood glucose measurementsCGMS datasmallerequal 60mgdl33 mmoll
Percentage of daytime blood glucose measurementsCGMS datasmallerequal 60mgdl33 mmoll
Area under the curve AUC smallerequal 60and timet smallerequal 60for blood glucose smallerequal 60mgdl33mmoll area under the curve AUC greaterequal 180and time t greaterequal 180 for blood glucose greaterequal 180mgdl100mmoll
Area under the curve AUC smallerequal 60and timet smallerequal 60for blood glucose smallerequal 60mgdl33mmollduring the day AUC 0600am - 1000pmand during the nightAUC 1000pm - 0600am
Area under the curve AUC greaterequal 180and timet greaterequal 180for blood glucose greaterequal 180mgdl100mmollduring the day AUC 0600am - 1000pmand during the nightAUC 1000pm - 0600am
Frequency of subjects with nocturnal blood glucose value smallerequal 60mgdl33 mmoll
Frequency of subjects with asymptomatic nocturnal blood glucose smallerequal 60mgdl33 mmoll
Frequency of subjects with symptomatic nocturnal blood glucose smallerequal 60mgdl 33 mmoll
Frequency of subjects with daytime blood glucose smallerequal 60mgdl 33 mmoll
Frequency of subjects with asymptomatic daytime blood glucose smallerequal 60mgdl33 mmoll
Frequency of subjects with symptomatic daytime blood glucose smallerequal 60mgdl33 mmoll
Frequency of subjects with hyperglycemic blood glucosegreaterequal 180mgdl100mmoll
Frequency of subjects with symptomatic hypoglycemiasmallerequal 60mgdl 33mmol
Frequency of subjects with severe hypoglycemiasmallerequal 36mgdl 20mmoll
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
Difference in frequency of subjects with conventionally detected hypoglycemia by the subject at least one measurement smallerequal 60mgdl documented in the 8-point profile in the case record form CRF or documentation of symptomatic hypoglycemia in the CRF through Visits 89 compared to CGMS detected blood glucose values smallerequal 60mgdl during CGMS measurements at least one measurement through Visits 89 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 measurementsCGMS datasmallerequal 60mgdl 33 mmoll
Percentage of nocturnal blood glucose measurementsCGMS datasmallerequal 60mgdl33 mmoll
Percentage of daytime blood glucose measurementsCGMS datasmallerequal 60mgdl33 mmoll
Area under the curve AUC smallerequal 60and timet smallerequal 60for blood glucose smallerequal 60mgdl33mmoll area under the curve AUC greaterequal 180and time t greaterequal 180 for blood glucose greaterequal 180mgdl100mmoll
Area under the curve AUC smallerequal 60and timet smallerequal 60for blood glucose smallerequal 60mgdl33mmollduring the day AUC 0600am - 1000pmand during the nightAUC 1000pm - 0600am
Area under the curve AUC greaterequal 180and timet greaterequal 180for blood glucose greaterequal 180mgdl100mmollduring the day AUC 0600am - 1000pmand during the nightAUC 1000pm - 0600am
Frequency of subjects with nocturnal blood glucose value smallerequal 60mgdl33 mmoll
Frequency of subjects with asymptomatic nocturnal blood glucose smallerequal 60mgdl33 mmoll
Frequency of subjects with symptomatic nocturnal blood glucose smallerequal 60mgdl 33 mmoll
Frequency of subjects with daytime blood glucose smallerequal 60mgdl 33 mmoll
Frequency of subjects with asymptomatic daytime blood glucose smallerequal 60mgdl33 mmoll
Frequency of subjects with symptomatic daytime blood glucose smallerequal 60mgdl33 mmoll
Frequency of subjects with hyperglycemic blood glucosegreaterequal 180mgdl100mmoll
Frequency of subjects with symptomatic hypoglycemiasmallerequal 60mgdl 33mmol
Frequency of subjects with severe hypoglycemiasmallerequal 36mgdl 20mmoll
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None