- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00693771
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Shanghai, China
- Sanofi-Aventis Administrative Office
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Once daily and up-titrate accordingly
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbA1c values
Time Frame: At baseline and 16 weeks
|
At baseline and 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events including hypoglycemia
Time Frame: From the beginning to the end of the study
|
From the beginning to the end of the study
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Rui Yan Ding, Sanofi
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LANTU_L_02756
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
AstraZenecaRecruiting
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
-
Zhongda HospitalRecruitingType 2 Diabetes Mellitus (T2DM)China
Clinical Trials on Insulin Glargine
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2United States, Poland, Puerto Rico, Canada, Hungary, Germany, Turkey, Greece
-
SanofiCompleted
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2Germany
-
SanofiCompletedDiabetes Mellitus Type 2Germany
-
University of AarhusCompletedDiabetes Mellitus, Type 1Denmark
-
IRCCS San RaffaeleTerminatedType 2 Diabetes Mellitus | Peripheral Vascular DiseaseItaly
-
Johns Hopkins UniversityTerminatedHypoglycemia | Type 1 DiabetesUnited States
-
SanofiCompleted
-
Medical University of GrazCompletedDiabetes Mellitus, Type 2Austria
-
SanofiCompletedType 1 Diabetes MellitusJapan