Insulin Glargine (Lantus) vs Sulfonylurea (SU) for BETA Cell Function (BETA Study)

July 16, 2012 updated by: Sanofi

Lantus vs Sulfonylurea as add-on Therapy in Type 2 Diabetic Patients Failing Metformin Monotherapy: Comparison of Effects on Beta Cell Function and Metabolic Profile.

Primary objective:

To compare long-term glycemic control and preservation of beta cell function when basal insulin or sulfonylurea is added on metformin in the early Type 2 Diabetes Mellitus patients

Secondary objective:

To assess the change of insulin resistance, microvascular complication incidence, patient satisfaction with treatment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

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

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

List of Inclusion and Exclusion Criteria:

Inclusion Criteria:

  • Type 2 Diabetes Mellitus patients on metformin monotherapy
  • 7% ≤ HbA1c ≤ 12%
  • 20 kg/m² ≤BMI ≤ 35 kg/m²
  • Diabetes duration: at least 6 months

Exclusion Criteria:

  • Type 1 Diabetes Mellitus patients
  • Clinical evidence of active liver disease, or serum Alanine AminoTransferase 3 times the upper limit of the normal range
  • Serum creatinine: 1.5 mg/dl for males, 1.4 mg/dl for females
  • Acute and chronic metabolic acidosis, including diabetic ketoacidosis
  • History of alcohol or other substance abuse
  • Pregnancy or not using contraceptive in childbearing aged women
  • Known hypersensitivity to Lantus, SU or metformin
  • Any disease or condition that in the opinion of the investigator may interfere with completion of the study

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Insulin glargine
Once daily in the morning
Drug: Metformin
At least 1000 mg/day
Active Comparator: 2
Drug: Metformin
At least 1000 mg/day
Drug: Glimepiride
Once daily in the morning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ß-cell Function parameter
Time Frame: From the signature of the Informed Consent Form (ICF) up to the end of study
From the signature of the Informed Consent Form (ICF) up to the end of study
Glucose Homeostasis and glycemic control status
Time Frame: From the signature of the Informed Consent Form (ICF) up to the end of study
From the signature of the Informed Consent Form (ICF) up to the end of study

Secondary Outcome Measures

Outcome Measure
Time Frame
Insulin resistance parameter, Hypoglycemic episode, symptomatic, Weight change, Lipid profile, Inflammatory markers (CRP, Adiponectin, etcs), Patient satisfaction with diabetes treatment, Urine analysis, Creatinine
Time Frame: End of the study
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: Ji Young Ahn, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2007

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

November 15, 2007

First Submitted That Met QC Criteria

November 20, 2007

First Posted (Estimate)

November 21, 2007

Study Record Updates

Last Update Posted (Estimate)

July 17, 2012

Last Update Submitted That Met QC Criteria

July 16, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LANTU_L_02193

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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