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Insulin Analogue With Continuous Glucose Monitoring System (CGMS) Measurement (SAFIR)

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ClinicalTrials.gov Identifier: NCT00354939
Recruitment Status : Completed
First Posted : July 20, 2006
Last Update Posted : August 31, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Insulin glargine Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : October 2003
Actual Primary Completion Date : March 2004
Actual Study Completion Date : March 2004

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Frequency of subjects with conventionally detected hypoglycemia


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354939


Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Wolfgang Landgraf, Dr. Sanofi

Publications of Results:
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Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00354939     History of Changes
Other Study ID Numbers: HOE901_4049
First Posted: July 20, 2006    Key Record Dates
Last Update Posted: August 31, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs