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OpenTrials
Completed

NCT Number: NCT00562172

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-aventis

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insulin glargine

Drug

Once daily in the morning

Glimepiride

Drug

Once daily in the morning

metformin

Drug

At least 1000 mg/day

Primary outcomes

  1. ß-cell Function parameter

    Time frame: From the signature of the Informed Consent Form (ICF) up to the end of study

  2. Glucose Homeostasis and glycemic control status

    Time frame: From the signature of the Informed Consent Form (ICF) up to the end of study

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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.

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Nov 21, 2007
Registry last updated
Jul 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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