| Trial ID: | L4440 |
| Source ID: | NCT00858013
|
| Associated Drug: |
Nateglinide
|
| Title: |
Study of the Durability of Glycemic Control With Nateglinide
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00858013/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Nateglinide|DRUG: Glimepiride
|
| Outcome Measures: |
Primary: The Durability of Nateglinide in Comparison With Those of Glimepiride Based on the Withdrawal Rate, % monotherapy failure, that means % number of participants who withdrew from the study due to high HbA1c (\>8.0%), every 3 months following randomization, for 24 months | Secondary: HbA1c, HbA1c (%) at 24 months, at 24 months|Fasting Glucose, fasting glucose (mg/dL) at 24 months, at 24 months|C-peptide, c-peptide(uU/mL) at 24 months, at 24 months|HOMA-IR, insulin resistance marker HOMA-IR at 24 months, at 24 months
|
| Sponsor/Collaborators: |
Sponsor: Ajou University School of Medicine | Collaborators: Korea University Guro Hospital|Hanyang University|Inha University Hospital|Kyunghee University Medical Center|Myongji Hospital|Bundang CHA Hospital|Wonju Severance Christian Hospital|Hallym University Medical Center
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
88
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-04-24
|
| Completion Date: |
2014-06-25
|
| Results First Posted: |
2017-03-31
|
| Last Update Posted: |
2017-05-16
|
| Locations: |
Myongji Hospital, Ilsan, Kyounggi, Korea, Republic of|Hanyang University Medical Center, Guri-si, Kyunggi-do, Korea, Republic of|Inha University Hospital, Incheon, Korea, Republic of|Hallym University Medical Center, Seoul, Korea, Republic of|Korea University Guro Hospital, Seoul, Korea, Republic of|Kyung hee University Medical Center, Seoul, Korea, Republic of|Ajou University Hospital, Suwon-si, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT00858013
|