Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study

Phase IV, Open Label, Non-comparative, Multi-center, Study of the Effects of Both Insulin Glargine & Insulin Glulisine in Type I Diabetes Mellitus Patients.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00539448

Acronym

GLANS

Enrollment

Registered

2007-10-04

Start date

2007-04-30

Completion date

2008-12-31

Last updated

2009-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

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.

Interventions

DRUGinsulin glargine

in combination with insulin Glulisine as bolus regimen

DRUGinsulin glulisine

in combination with insulin Glargine as bolus regimen

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
Evaluating the Glycemic control of the regimen : Change in A1C levels	from baseline to study end

Secondary

Measure	Time frame
Average daily dose : - For both insulin Glulisine & insulin Glargine. - FBG and PPBG if possible ?	from baseline to study end

Countries

Bahrain, Kuwait, Qatar, United Arab Emirates

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026