Trial · NCT01183104

START-J: SiTAgliptin in eldeRly Trial in Japan

NCT01183104, Not applicable, Completed, Japan Association for Diabetes Education and Care; results first posted 2017-04-14

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. START-J: SiTAgliptin in eldeRly Trial in Japan. Trials, record NCT01183104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01183104

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Trial

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

Title: START-J: SiTAgliptin in eldeRly Trial in Japan
NCT number: NCT01183104
Status: Completed
Phases: Not applicable
Enrollment: 305 participants, actual
Lead sponsor: Japan Association for Diabetes Education and Care
Conditions: Type 2 Diabetes
Interventions: Sitagliptin, Glimepiride
First posted: 2010-08-17
Last updated: 2017-04-14
Results first posted: 2017-04-14

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in HbA1c at 52 W	Baseline and 52 W
Primary	Number of Participants With Hypoglycaemia	From baseline to 52 W
Secondary	The Number of Participants Achieving HbA1c < 6.9 %	52 W
Secondary	Change From Baseline in HOMA-β at 52 W	Baseline and 52 W	β cell function is measured by the Homeostatic Model Assessment(HOMA-β). HOMA β = \[20 x fasting insulin (μU/mL)\] / \[fasting plasma glucose (mmol/L) - 3.5\]
Secondary	Change From Baseline in Insulin/Proinsulin Ratio at 52 W	Baseline and 52 W
Secondary	Change From Baseline in Body Weight at 52 W	Baseline and 52 W

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in HbA1c at 52 W	Baseline and 52 W	Analysis set of evaluation for efficacy; Per Protocol Set.	percent	LEAST_SQUARES_MEAN
PRIMARY	Number of Participants With Hypoglycaemia	From baseline to 52 W	Analysis set of evaluation for safety.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	The Number of Participants Achieving HbA1c < 6.9 %	52 W	Analysis set of evaluation for efficacy; Per Protocol Set Some participants were not completed to 52 W.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in HOMA-β at 52 W	Baseline and 52 W	Analysis set of evaluation for efficacy; Per Protocol Set. Some participants had loss of the measurement.	percent	MEAN
SECONDARY	Change From Baseline in Insulin/Proinsulin Ratio at 52 W	Baseline and 52 W	Analysis set of evaluation for efficacy; Per Protocol Set. Some participants had loss of the measurement.	ratio	MEAN
SECONDARY	Change From Baseline in Body Weight at 52 W	Baseline and 52 W	Analysis set of evaluation for efficacy; Per Protocol Set. Some participants had loss of the measurement.	kg	MEAN

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Value	Spread	Units
Change From Baseline in HbA1c at 52 W	Sitagliptin	-0.66	95% Confidence Interval -0.77 to -0.54	percent
Change From Baseline in HbA1c at 52 W	Glimepiride	-0.77	95% Confidence Interval -0.88 to -0.66	percent
Number of Participants With Hypoglycaemia	Sitagliptin	7		Participants
Number of Participants With Hypoglycaemia	Glimepiride	23		Participants
The Number of Participants Achieving HbA1c < 6.9 %	Sitagliptin	89		Participants
The Number of Participants Achieving HbA1c < 6.9 %	Glimepiride	86		Participants
Change From Baseline in HOMA-β at 52 W	Sitagliptin	10.2	Standard Deviation 35.7	percent
Change From Baseline in HOMA-β at 52 W	Glimepiride	23.7	Standard Deviation 56.1	percent
Change From Baseline in Insulin/Proinsulin Ratio at 52 W	Sitagliptin	-0.049	Standard Deviation 0.111	ratio
Change From Baseline in Insulin/Proinsulin Ratio at 52 W	Glimepiride	-0.002	Standard Deviation 0.095	ratio

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow14

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Sitagliptin	153
Overall Study	STARTED	Glimepiride	152
Overall Study	Received Study Drug	Sitagliptin	148
Overall Study	Received Study Drug	Glimepiride	143
Overall Study	Continued Treatment for 12 Weeks	Sitagliptin	143
Overall Study	Continued Treatment for 12 Weeks	Glimepiride	129
Overall Study	Completed 52-week Treatment	Sitagliptin	119
Overall Study	Completed 52-week Treatment	Glimepiride	111
Overall Study	Enrolled in Extension Study	Sitagliptin	80
Overall Study	Enrolled in Extension Study	Glimepiride	61

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events182

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	Intestinal abscess	Infections and infestations	Sitagliptin	1	148
other	Intestinal abscess	Infections and infestations	Glimepiride	0	143
other	Appendicitis	Infections and infestations	Sitagliptin	1	148
other	Appendicitis	Infections and infestations	Glimepiride	0	143
other	Bronchitis	Infections and infestations	Sitagliptin	2	148
other	Bronchitis	Infections and infestations	Glimepiride	0	143
other	Cystitis	Infections and infestations	Sitagliptin	3	148
other	Cystitis	Infections and infestations	Glimepiride	0	143
other	Herpes zoster	Infections and infestations	Sitagliptin	1	148
other	Herpes zoster	Infections and infestations	Glimepiride	0	143

1 to 10 of 182Source ClinicalTrials.gov

See all 182 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sitagliptin
Total, all-cause mortality	Glimepiride
Total, other adverse events	Sitagliptin	33	148
Total, other adverse events	Glimepiride	31	143
Total, serious adverse events	Sitagliptin	13	148
Total, serious adverse events	Glimepiride	3	143

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28294488	DERIVED

Source PubMed

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
Sitagliptin vs Glimepiride: The Number of Participants Achieving HbA1c < 6.9 %	Trial comparisons
Sitagliptin vs Glimepiride: Number of Participants With Hypoglycaemia	Trial comparisons
Sitagliptin 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/NCT01183104

GET https://conductscience.org/api/trials/v1/NCT01183104/events?page=2

API reference For AI assistants