Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study

NCT00539448 | Completed Phase 4

• 1 other identifier: LANTU_L_01578
• Study Type: interventional
• Target: 98
• Locations: 4 countries
• Sites: 4

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

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

  from baseline to study end

Secondary Outcomes (1)

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

  from baseline to study end

Study Arms (1)

1

EXPERIMENTAL

combination of insulin Glargine \& insulin Glulisine as basal bolus regimen

Drug: insulin glargine; Drug: insulin glulisine

Interventions

insulin glargine DRUG

in combination with insulin Glulisine as bolus regimen

1

insulin glulisine DRUG

in combination with insulin Glargine as bolus regimen

1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (4)

Sanofi-aventis administrative office

Manama, Bahrain

Location

Sanofi-aventis administrative office

Kuwait City, Kuwait

Location

Sanofi-Aventis Administrative Office

Doha, Qatar

Location

Sanofi-aventis administrative office

Dubai, United Arab Emirates

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine; insulin glulisine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Hisham - MAHMOUD, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 3, 2007
• First Posted: October 4, 2007
• Study Start: April 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 25, 2009

Record last verified: 2009-09

Locations

BA (1); AE (1); QA (1); KU (1)