NCT00474838

Brief Summary

This randomized controlled prospective study aims to evaluate the efficacy of intensive insulin therapy for long term glycemic control and improvement or preservation of beta cell function in newly diagnosed type 2 diabetes patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Apr 2007

Longer than P75 for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

8 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2007

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 26, 2013

Status Verified

September 1, 2013

Enrollment Period

5.3 years

First QC Date

May 16, 2007

Last Update Submit

September 25, 2013

Conditions

Type 2 Diabetes MellitusPancreatic Beta Cell FunctionGlucotoxicity

Keywords

type 2 diabetes mellitusintensive insulin therapy

Outcome Measures

Primary Outcomes (2)

  • Long-term glycemic control

    up to 2 years

  • Change of pancreatic beta cell function

    up to 2 years

Secondary Outcomes (2)

  • Inflammatory marker and insulin sensitivity

    up to 2 years

  • Time to reach target goal of blood glucose level

    up to 2 year

Study Arms (2)

Oral AntiDiabetic Drug

ACTIVE COMPARATOR

glimepiride and metformin and/or once daily glargine

Drug: Oral AntiDiabetic Drug (glimepiride and metformin)

intensive insulin group

EXPERIMENTAL

insulin glargine insulin glulisine

Drug: intensive insulin group

Interventions

intensive insulin groupDRUG

Once daily long acting insulin and preprandial rapid acting insulin injection

intensive insulin group
Oral AntiDiabetic Drug (glimepiride and metformin)DRUG

glimepiride and metformin combined therapy

Also known as: glimepiride(amaryl), metformin(diabex)
Oral AntiDiabetic Drug

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed drug naïve type 2 diabetic patient with typical diabetic symptom (polydipsia, polyuria, unexplained weight loss) within recent 1 year
  • Initial HbA1c : 8.0 % ≤ HbA1c \< 12.0%

You may not qualify if:

  • Known contraindication to insulin glargine, insulin glulisine, metformin, glimepiride
  • Patients with proliferative diabetic retinopathy
  • Severe liver disease or AST, ALT ≥ 2.5 x ULN
  • History of lactic acidosis
  • Unstable or severe angina
  • Congestive heart failure
  • Chronic disease treated with continuous corticosteroid therapy
  • Diagnosis of cancer
  • Positive urine pregnancy test or plan to become pregnant during the clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hanyang University Medical Center

Guri-si, Gyeonggi-do, 471-020, South Korea

Location

The Catholic University of Korea Bucheon St.Mary's Hospital

Bucheon-si, South Korea

Location

Inha University Hospital

Incheon, 400-711, South Korea

Location

Jeju National University Hospital

Jeju-do, South Korea

Location

Kyunghee University Medical Center

Seoul, 130-702, South Korea

Location

Korea University Guro Hospital

Seoul, 152-730, South Korea

Location

Kyung Hee University East Weast Neo Medicalcenter

Seoul, South Korea

Location

Ajou University Medical Center

Suwon, 443-721, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Hypoglycemic AgentsglimepirideMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Physiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesBiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Jeong-taek Woo, MD, PhD

    Kyunghee University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 16, 2007

First Posted

May 17, 2007

Study Start

April 1, 2007

Primary Completion

August 1, 2012

Study Completion

December 1, 2012

Last Updated

September 26, 2013

Record last verified: 2013-09

Locations

KR(8)