NCT00562172

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Sep 2007

Typical duration for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

July 17, 2012

Status Verified

July 1, 2012

Enrollment Period

3.1 years

First QC Date

November 15, 2007

Last Update Submit

July 16, 2012

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • ß-cell Function parameter

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

  • Glucose Homeostasis and glycemic control status

    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

    End of the study

Study Arms (2)

1

EXPERIMENTAL
Drug: Insulin glargineDrug: Metformin

2

ACTIVE COMPARATOR
Drug: GlimepirideDrug: Metformin

Interventions

Insulin glargineDRUG

Once daily in the morning

1
GlimepirideDRUG

Once daily in the morning

2
MetforminDRUG

At least 1000 mg/day

12

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-aventis

Seoul, South Korea

Location

Related Publications (1)

  • Moon JS, Ha KS, Yoon JS, Lee HW, Lee HC, Won KC; BETA study group. The effect of glargine versus glimepiride on pancreatic beta-cell function in patients with type 2 diabetes uncontrolled on metformin monotherapy: open-label, randomized, controlled study. Acta Diabetol. 2014 Apr;51(2):277-85. doi: 10.1007/s00592-013-0553-z. Epub 2014 Jan 21.

    PMID: 24445656DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin GlargineglimepirideMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsBiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Ji Young Ahn

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2007

First Posted

November 21, 2007

Study Start

September 1, 2007

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

July 17, 2012

Record last verified: 2012-07

Locations

KR(1)