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OpenTrials
Completed

NCT Number: NCT00539448

Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-aventis administrative office, Manama, Bahrain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin glargine

Drug

in combination with insulin Glulisine as bolus regimen

insulin glulisine

Drug

in combination with insulin Glargine as bolus regimen

Primary outcomes

  1. Evaluating the Glycemic control of the regimen : Change in A1C levels

    Time frame: from baseline to study end

Secondary outcomes

  1. Average daily dose : - For both insulin Glulisine & insulin Glargine. - FBG and PPBG if possible ?

    Time frame: from baseline to study end

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Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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.

Acronym: GLANS

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 4, 2007
Registry last updated
Sep 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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