Study to Optimize Insulin Treatment by Basal Regimen With Insulin Glargine in Type-2-Diabetic Patients Previously Uncontrolled on Premixed Insulin
OPTIMIZATION
A Prospective Study to Optimize Insulin Treatment by Basal Regimen With Insulin Glargine in Type-2-Diabetic Patients Previously Uncontrolled on Premixed Insulin
1 other identifier
interventional
313
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 diabetes-mellitus-type-2
Started Apr 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 5, 2008
CompletedFirst Posted
Study publicly available on registry
June 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedJanuary 25, 2011
January 1, 2011
1.2 years
June 5, 2008
January 24, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c values
At baseline and 16 weeks
Secondary Outcomes (1)
Adverse events including hypoglycemia
From the beginning to the end of the study
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients with Type 2 Diabetes Mellitus inadequately controlled at least 3 months on premixed insulin with 1 or 2 OADs
- ≤ HbA1c ≤ 9.5%
- FPG ≥6.7 mmol/L
- History of Diabetes mellitus ≤10 years
- Premix insulin daily dosage ≤ 50 IU/Day
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Sanofi-Aventis Administrative Office
Shanghai, China
Related Publications (1)
Yang W, Du J, Zhang M, Hou J, Zhang X, Cui N. Predictors of HbA1c reduction and hypoglycemia in type 2 diabetes mellitus individuals switching from premixed to basal insulin: an exploratory analysis of optimization study. Curr Med Res Opin. 2022 Nov;38(11):1807-1814. doi: 10.1080/03007995.2022.2105538. Epub 2022 Aug 9.
PMID: 35943899DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rui Yan Ding
Sanofi
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
June 5, 2008
First Posted
June 9, 2008
Study Start
April 1, 2008
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
January 25, 2011
Record last verified: 2011-01