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
  Purpose

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.

Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: insulin glargine
Drug: insulin glulisine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV, Open Label, Non-comparative, Multi-center, Study of the Effects of Both Insulin Glargine & Insulin Glulisine in Type I Diabetes Mellitus Patients.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Evaluating the Glycemic control of the regimen : Change in A1C levels [ Time Frame: from baseline to study end ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 98
Study Start Date: April 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
combination of insulin Glargine & insulin Glulisine as basal bolus regimen
Drug: insulin glargine
in combination with insulin Glulisine as bolus regimen
Drug: insulin glulisine
in combination with insulin Glargine as bolus regimen

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00539448

Locations
Bahrain
Sanofi-aventis administrative office
Manama, Bahrain
Kuwait
Sanofi-aventis administrative office
Kuwait City, Kuwait
Qatar
Sanofi-Aventis Administrative Office
Doha, Qatar
United Arab Emirates
Sanofi-aventis administrative office
Dubai, United Arab Emirates
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Hisham - MAHMOUD, MD Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00539448     History of Changes
Other Study ID Numbers: LANTU_L_01578
Study First Received: October 3, 2007
Last Updated: September 24, 2009
Health Authority: United Arab Emirates: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glargine
Insulin glulisine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014