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

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ClinicalTrials.gov Identifier: NCT00693771
Recruitment Status : Completed
First Posted : June 9, 2008
Last Update Posted : January 25, 2011
Sponsor:
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Insulin Glargine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 313 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Insulin Glargine
Once daily and up-titrate accordingly



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

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


Information from the National Library of Medicine

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

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00693771


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

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00693771     History of Changes
Other Study ID Numbers: LANTU_L_02756
First Posted: June 9, 2008    Key Record Dates
Last Update Posted: January 25, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs