Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: June 5, 2008
Last updated: January 24, 2011
Last verified: January 2011

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.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Insulin Glargine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Study to Optimize Insulin Treatment by Basal Regimen With Insulin Glargine in Type-2-Diabetic Patients Previously Uncontrolled on Premixed Insulin

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • HbA1c values [ Time Frame: At baseline and 16 weeks ]

Secondary Outcome Measures:
  • Adverse events including hypoglycemia [ Time Frame: From the beginning to the end of the study ]

Enrollment: 313
Study Start Date: April 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Insulin Glargine
Once daily and up-titrate accordingly


Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00693771

Sanofi-Aventis Administrative Office
Shanghai, China
Sponsors and Collaborators
Study Director: Rui Yan Ding Sanofi
  More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00693771     History of Changes
Other Study ID Numbers: LANTU_L_02756
Study First Received: June 5, 2008
Last Updated: January 24, 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 25, 2017