Insulin Analogue With Continuous Glucose Monitoring System (CGMS) Measurement

Diabetes Mellitus Type 2 Clinical Trial

— SAFIR  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00354939
• Other study ID #: HOE901_4049
• Status: Completed
• Phase: Phase 4
• First received: July 19, 2006
• Last updated: August 30, 2010
• Start date: October 2003
• Est. completion date: March 2004

Study information

• Verified date: August 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin glargine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

References & Publications (1)

Zick R, Petersen B, Richter M, Haug C; SAFIR Study Group. Comparison of continuous blood glucose measurement with conventional documentation of hypoglycemia in patients with Type 2 diabetes on multiple daily insulin injection therapy. Diabetes Technol The — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of subjects with conventionally detected hypoglycemia