Study to Optimize Insulin Treatment by Basal Regimen With Insulin Glargine in Type-2-Diabetic Patients Previously Uncontrolled on Premixed Insulin

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Insulin Glargine

• Registration Number: NCT00693771
• Lead Sponsor: Sanofi

Brief Summary

Primary objective:

To show an improvement in HbA1c control after 4 months of treatment with insulin glargine + Oral Anti Diabetic (OAD) in patients previously uncontrolled on premixed insulin (with OAD)

Secondary objective:

Improvement of Fasting blood glucose (FPG) after 4 months treatment (% of patients treated to target HbA1c ≤7.0% and/or FBG≤6.0mmol/L). Frequency of hypoglycemic episodes, quality of life with basal+ OAD regimen.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-06-05
• Study First Submitted QC: 2008-06-06
• Study First Posted: 2008-06-09
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-24
• Last Update Posted: 2011-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 313

Inclusion Criteria

• Patients with Type 2 Diabetes Mellitus inadequately controlled at least 3 months on premixed insulin with 1 or 2 OADs
• 7.5 ≤ HbA1c ≤ 9.5%
• FPG ≥6.7 mmol/L
• History of Diabetes mellitus ≤10 years
• Premix insulin daily dosage ≤ 50 IU/Day

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Exclusion Criteria

• Type 1 Diabetes Mellitus
• Former treated on TZD
• Pregnancy / Lactation
• Creatine ≥1.5 mg/dl
• Hepatic disease, jaundice,or ALT/AST≥ 2.5 times of normal range
• Hormone therapy,
• Acute status of Diabetes complications
• Severe concomitant disease or complications with high risk of unexpected fatal events, like Myocardial Infarct, stroke, heart failure.
• Allergic to insulin glargine or any ingredient
• Participation in another clinical trial within 3 months

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Insulin Glargine	-

Primary Outcome Measures

Name	Time	Method
HbA1c values	At baseline and 16 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse events including hypoglycemia	From the beginning to the end of the study

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇨🇳 Shanghai, China