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Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 1

Intervention: insulin glargine (Drug); insulin glulisine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Hisham - MAHMOUD, MD, Study Director, Affiliation: Sanofi

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.

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

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

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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

Locations and Contacts

Sanofi-aventis administrative office, Manama, Bahrain

Sanofi-aventis administrative office, Kuwait City, Kuwait

Sanofi-Aventis Administrative Office, Doha, Qatar

Sanofi-aventis administrative office, Dubai, United Arab Emirates

Additional Information

Starting date: April 2007
Last updated: September 24, 2009

Page last updated: August 23, 2015

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