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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00539448
First received: October 3, 2007
Last updated: September 24, 2009
Last verified: September 2009

October 3, 2007
September 24, 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 ] [ Designated as safety issue: No ]
Evaluating the Glycemic control of the regimen : Change in A1C levels [ Time Frame: from baseline to study end ]
Complete list of historical versions of study NCT00539448 on ClinicalTrials.gov Archive Site
Average daily dose : - For both insulin Glulisine & insulin Glargine. - FBG and PPBG if possible ? [ Time Frame: from baseline to study end ] [ Designated as safety issue: No ]
Average daily dose : - For both insulin Glulisine & insulin Glargine. - FBG and PPBG if possible ? [ Time Frame: from baseline to study end ]
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
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Interventions:
  • Drug: insulin glargine
  • Drug: insulin glulisine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
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

Both
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Bahrain,   Kuwait,   Qatar,   United Arab Emirates
 
NCT00539448
LANTU_L_01578
No
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Hisham - MAHMOUD, MD Sanofi
Sanofi
September 2009

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