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

January 24, 2011 updated by: Sanofi

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

313

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Drug: Insulin Glargine
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

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Rui Yan Ding, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

June 5, 2008

First Submitted That Met QC Criteria

June 6, 2008

First Posted (Estimate)

June 9, 2008

Study Record Updates

Last Update Posted (Estimate)

January 25, 2011

Last Update Submitted That Met QC Criteria

January 24, 2011

Last Verified

January 1, 2011

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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