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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Insulin, Globin Zinc
Glargine
Insulin glulisine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2014