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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00539448
First Posted: October 4, 2007
Last Update Posted: September 25, 2009
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.
Information provided by:
Sanofi
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Average daily dose : - For both insulin Glulisine & insulin Glargine. - FBG and PPBG if possible ? [ Time Frame: from baseline to study end ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00539448     History of Changes
Other Study ID Numbers: LANTU_L_01578
First Submitted: October 3, 2007
First Posted: October 4, 2007
Last Update Posted: September 25, 2009
Last Verified: September 2009

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
Insulin glulisine
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs