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

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

insulin glargine

insulin glulisine

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sanofi-aventis administrative office
Sanofi-aventis administrative office
Sanofi-Aventis Administrative Office
Sanofi-aventis administrative office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

combination of insulin Glargine & insulin Glulisine as basal bolus regimen

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00539448

First Posted

October 3, 2007

Last Updated

September 24, 2009

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00539448

Brief Title

Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study

Acronym

GLANS

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

98 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

combination of insulin Glargine & insulin Glulisine as basal bolus regimen

Intervention Type

Drug

Intervention Name(s)

insulin glargine

Intervention Description

in combination with insulin Glulisine as bolus regimen

Intervention Type

Drug

Intervention Name(s)

insulin glulisine

Intervention Description

in combination with insulin Glargine as bolus regimen

Primary Outcome Measure Information:

Title

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

Time Frame

from baseline to study end

Secondary Outcome Measure Information:

Title

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

Time Frame

from baseline to study end

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hisham - MAHMOUD, MD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-aventis administrative office

City

Manama

Country

Bahrain

Facility Name

Sanofi-aventis administrative office

City

Kuwait City

Country

Kuwait

Facility Name

Sanofi-Aventis Administrative Office

City

Doha

Country

Qatar

Facility Name

Sanofi-aventis administrative office

City

Dubai

Country

United Arab Emirates

12. IPD Sharing Statement

Learn more about this trial

Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study

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