Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study (GLANS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00539448
Recruitment Status : Completed
First Posted : October 4, 2007
Last Update Posted : September 25, 2009
Information provided by:

October 3, 2007
October 4, 2007
September 25, 2009
April 2007
December 2008   (Final data collection date for primary outcome measure)
Evaluating the Glycemic control of the regimen : Change in A1C levels [ Time Frame: from baseline to study end ]
Same as current
Complete list of historical versions of study NCT00539448 on Archive Site
Average daily dose : - For both insulin Glulisine & insulin Glargine. - FBG and PPBG if possible ? [ Time Frame: from baseline to study end ]
Same as current
Not Provided
Not Provided
Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study
Phase IV, Open Label, Non-comparative, Multi-center, Study of the Effects of Both Insulin Glargine & Insulin Glulisine in Type I Diabetes Mellitus Patients.

Primary objective :

To evaluate the efficacy (in terms of change in HbA1c readings starting from baseline then after 13 weeks & at the end of the study which will be after 26 weeks) in subjects with type I diabetes mellitus.

Secondary objective :

  • Recording the average daily dose of both insulin Glulisine & insulin Glargine in type I DM.
  • Recording adverse events.
Not Provided
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
  • Drug: insulin glargine
    in combination with insulin Glulisine as bolus regimen
  • Drug: insulin glulisine
    in combination with insulin Glargine as bolus regimen
Experimental: 1
combination of insulin Glargine & insulin Glulisine as basal bolus regimen
  • Drug: insulin glargine
  • Drug: insulin glulisine
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2008
December 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Newly diagnosed type I diabetic patients
  • Type I diabetes treated with basal-bolus regimen including 3 or more injections of Regular Human Insulin per day
  • BMI, 26-40 kg/m2
  • HbA1c, 7.5%-10%
  • Median 2Hrs post -prandial more than or equal to 140 mg/dl (more than or equal to 7.8 mmol/L)
  • FPG more than or equal to 120 mg/dl (more than or equal to 6.7 mmol/L)
  • Willingness to accept, and ability to inject insulin Glargine therapy

Exclusion Criteria:

  • Pregnancy : The use of LANTUS & APIDRA during pregnancy is not contraindicated. However, in the absence of supportive data, Sanofi- Aventis Pharmaceuticals cannot specifically recommend the use of Lantus in this patient population

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Bahrain,   Kuwait,   Qatar,   United Arab Emirates
Not Provided
Not Provided
Medical Affairs Study Director, sanofi-aventis
Not Provided
Study Director: Hisham - MAHMOUD, MD Sanofi
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP