Trial · NCT00858013

Study of the Durability of Glycemic Control With Nateglinide

NCT00858013, Phase 4, Completed, Ajou University School of Medicine; results first posted 2017-03-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of the Durability of Glycemic Control With Nateglinide. Trials, record NCT00858013. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00858013

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of the Durability of Glycemic Control With Nateglinide
NCT number: NCT00858013
Status: Completed
Phases: Phase 4
Enrollment: 88 participants, actual
Lead sponsor: Ajou University School of Medicine
Conditions: Type 2 Diabetes Mellitus
Interventions: Nateglinide, Glimepiride
First posted: 2009-03-09
Last updated: 2017-05-16
Results first posted: 2017-03-31

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Durability of Nateglinide in Comparison With Those of Glimepiride Based on the Withdrawal Rate	every 3 months following randomization, for 24 months	% monotherapy failure, that means % number of participants who withdrew from the study due to high HbA1c (\>8.0%)
Secondary	HbA1c	at 24 months	HbA1c (%) at 24 months
Secondary	Fasting Glucose	at 24 months	fasting glucose (mg/dL) at 24 months
Secondary	C-peptide	at 24 months	c-peptide(uU/mL) at 24 months
Secondary	HOMA-IR	at 24 months	insulin resistance marker HOMA-IR at 24 months

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Durability of Nateglinide in Comparison With Those of Glimepiride Based on the Withdrawal Rate	every 3 months following randomization, for 24 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	HbA1c	at 24 months	data of participants who finished 24 months of follow-up	% HbA1c	MEAN
SECONDARY	Fasting Glucose	at 24 months	data of participants who finished 24 months of follow-up	mg/dL	MEAN
SECONDARY	C-peptide	at 24 months	data of participants who finished 24 months of follow-up	uU/mL	MEAN
SECONDARY	HOMA-IR	at 24 months	data of participants who finished 24 months of follow-up	mg/dL x mIU/L	MEAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
The Durability of Nateglinide in Comparison With Those of Glimepiride Based on the Withdrawal Rate	Nateglinide	10		Participants
The Durability of Nateglinide in Comparison With Those of Glimepiride Based on the Withdrawal Rate	Glimepiride	7		Participants
HbA1c	Nateglinide	6.9	Standard Deviation 0.6	% HbA1c
HbA1c	Glimepiride	6.5	Standard Deviation 0.5	% HbA1c
Fasting Glucose	Nateglinide	131.2	Standard Deviation 25.9	mg/dL
Fasting Glucose	Glimepiride	115.7	Standard Deviation 19.8	mg/dL
C-peptide	Nateglinide	1.29	Standard Deviation 0.41	uU/mL
C-peptide	Glimepiride	1.77	Standard Deviation 0.72	uU/mL
HOMA-IR	Nateglinide	2.40	Standard Deviation 1.36	mg/dL x mIU/L
HOMA-IR	Glimepiride	2.31	Standard Deviation 1.70	mg/dL x mIU/L

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Nateglinide	46
Overall Study	STARTED	Glimepiride	42
Overall Study	COMPLETED	Nateglinide	24
Overall Study	COMPLETED	Glimepiride	23
Overall Study	NOT COMPLETED	Nateglinide	22
Overall Study	NOT COMPLETED	Glimepiride	19

Source ClinicalTrials.gov

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	hypoglycemia	Endocrine disorders	Nateglinide	1	24
other	hypoglycemia	Endocrine disorders	Glimepiride	0	23
other	dyspepsia	Gastrointestinal disorders	Nateglinide	2	24
other	dyspepsia	Gastrointestinal disorders	Glimepiride	0	23
other	gall stone	Gastrointestinal disorders	Nateglinide	1	24
other	gall stone	Gastrointestinal disorders	Glimepiride	0	23
other	herpes zoster	Skin and subcutaneous tissue disorders	Nateglinide	1	24
other	herpes zoster	Skin and subcutaneous tissue disorders	Glimepiride	0	23
other	gastritis	Gastrointestinal disorders	Nateglinide	1	24
other	gastritis	Gastrointestinal disorders	Glimepiride	0	23

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nateglinide	0	24
Total, all-cause mortality	Glimepiride	0	23
Total, other adverse events	Nateglinide	6	24
Total, other adverse events	Glimepiride	1	23
Total, serious adverse events	Nateglinide	0	24
Total, serious adverse events	Glimepiride	0	23

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Nateglinide vs Glimepiride: The Durability of Nateglinide in Comparison With Those of Glimepiride Based on the Withdrawal Rate	Trial comparisons
Nateglinide vs Glimepiride: deaths from any cause	Trial comparisons
Nateglinide vs Glimepiride: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00858013

GET https://conductscience.org/api/trials/v1/NCT00858013/registered

API reference For AI assistants