Type 2 DiabetesSTART-JNCT01183104

START-J: SiTAgliptin in eldeRly Trial in Japan

A study testing Sitagliptin and Glimepiride in people with Type 2 Diabetes, run by Japan Association for Diabetes Education and Care at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 years and older
Conditions the study is for: Type 2 Diabetes
What is being tested?: Sitagliptin and Glimepiride
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 305 participants
Where: 1 siteJapan
Study dates: Aug 2010to Jan 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with type 2 diabetes who are oral hypoglycemic agent naive or, α-glucosidase inhibitor or biguanide monotherapy (to be washed out 4 weeks prior to randomization)
Signed informed consent obtained before any trial-related activities
Treatment with diet and exercise for 12 weeks and longer at screening
Age =>60 y.o.
Male and Female
HbA1c 6.9%=< <8.9%

Who cannot join

Active proliferative retinopathy or maculopathy requiring treatment
Liver dysfunction (>x2 of upper normal limit), moderate or severe renal dysfunction(serum Cr>1.5mg/dL in male, Cr>1.3mg/dL in female, eGFR<30), severe cardiac disease (NYHA III or IV), malignancy or uncontrolled hypertension (treated or untreated) as judged by the Investigator
Mental incapacity (including moderate or severe dementia) precluding adequate understanding and/or cooperation as judged by the Investigator
Recurrent hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
Previous history of severe allergy to pharmaceutical products
Systemic glucocorticoids users or potential users
Suspected type 1 diabetes (including slowly progressive insulin dependent diabetes mellitus) or positive anti-glutamic acid decarboxylase antibody
Any condition that the investigator considers a potential obstacle to trial participation and/or data analysis

Trial locations and contacts

1 site in 1 country.

Japan1 site

Japan Association for Diabetes Education and Care
Chiyoda-Ku, Tokyo, 102-0083

Other trials in Japan

About this study

Official title: Efficacy and Safety Comparison of Sitagliptin and Glimepiride in Elderly Japanese Patients With Type 2 Diabetes

The purpose of this study is to compare the efficacy and the safety of sitagliptin and glimepiride in drug naïve elderly patients with Type 2 diabetes as evaluated by HbA1c change from baseline at 52 W as efficacy and incidence of hypoglycemia from randomization to 52 W as safety. The clinical hypotheses are non-inferiority of sitagliptin to glimepiride in efficacy as judged by HbA1c change from baseline at 52 W and superiority of sitagliptin to glimepiride in safety as judged by incidence of hypoglycemia in drug naïve elderly patients with T2DM. In addition, comparison of efficacy is extended to 104 W.

Conditions: Type 2 Diabetes
Being tested: Sitagliptin, Glimepiride
Keywords: Type 2 Diabetes, Sitagliptin, Glimepiride, Elderly patients, Japanese
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SitagliptinDrug
Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; estimate glomerular filtration rate (eGFR) 30=< <50).
GlimepirideDrug
Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg

Study groups in NCT01183104
Study group	Role	What they receive
Sitagliptin	Experimental	Not described Receives: Drug: Sitagliptin
Glimepiride	Active comparator	Not described Receives: Drug: Glimepiride

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in HbA1c at 52 W
Measured: Baseline and 52 W
Number of Participants With Hypoglycaemia
Measured: From baseline to 52 W

Secondary outcomes (4)

The Number of Participants Achieving HbA1c < 6.9 %
Measured: 52 W
Change From Baseline in HOMA-β at 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]
Measured: Baseline and 52 W
Change From Baseline in Insulin/Proinsulin Ratio at 52 W
Measured: Baseline and 52 W
Change From Baseline in Body Weight at 52 W
Measured: Baseline and 52 W

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Jan 2015

First posted17 Aug 2010 (estimated)
Study startAug 2010
Primary completionJan 2015
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 305 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01183104
Sponsor's protocol ID: START-J
Other IDs: UMIN000004047
Acronym: START-J
Status last verified: Mar 2017
First submitted: 16 Aug 2010
Last updated: 14 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Terauchi Y, Yamada Y, Ishida H, Ohsugi M, Kitaoka M, Satoh J, Yabe D, Shihara N, Seino Y. Efficacy and safety of sitagliptin as compared with glimepiride in Japanese patients with type 2 diabetes mellitus aged >/= 60 years (START-J trial). Diabetes Obes Metab. 2017 Aug;19(8):1188-1192. doi: 10.1111/dom.12933. Epub 2017 Apr 12.
PubMed 28294488

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety Comparison of Sitagliptin and Glimepiride in Elderly Japanese Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT01183104
Acronym / sponsor ID: START-J / START-J
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes, Sitagliptin, Glimepiride, Elderly patients, Japanese
Study type: Interventional
Recruitment status: Completed
Enrolment: 305 participants (actual)
Lead sponsor: Japan Association for Diabetes Education and CareUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: Aug 2010
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 17 Aug 2010 (estimated)
Results: Posted 14 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sitagliptin	Experimental	Drug: Sitagliptin
Glimepiride	Active comparator	Drug: Glimepiride

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patients with type 2 diabetes who are oral hypoglycemic agent naive or, α-glucosidase inhibitor or biguanide monotherapy (to be washed out 4 weeks prior to randomization)
Signed informed consent obtained before any trial-related activities
Treatment with diet and exercise for 12 weeks and longer at screening
Age =>60 y.o.
Male and Female

Key exclusion criteria (8 listed)

Active proliferative retinopathy or maculopathy requiring treatment
Liver dysfunction (>x2 of upper normal limit), moderate or severe renal dysfunction(serum Cr>1.5mg/dL in male, Cr>1.3mg/dL in female, eGFR<30), severe cardiac disease (NYHA III or IV), malignancy or uncontrolled hypertension (treated or untreated) as judged by the Investigator
Mental incapacity (including moderate or severe dementia) precluding adequate understanding and/or cooperation as judged by the Investigator
Recurrent hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
Previous history of severe allergy to pharmaceutical products

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SitagliptinStarting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; estimate glomerular filtration rate (eGFR) 30=< <50).	Drug	Sitagliptin
GlimepirideStarting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg	Drug	Glimepiride

Primary outcome

Change From Baseline in HbA1c at 52 W
Time frame: Baseline and 52 W
Number of Participants With Hypoglycaemia
Time frame: From baseline to 52 W

4 secondary outcomes

The Number of Participants Achieving HbA1c < 6.9 %
Time frame: 52 W
Change From Baseline in HOMA-β at 52 W
Time frame: Baseline and 52 W
Change From Baseline in Insulin/Proinsulin Ratio at 52 W
Time frame: Baseline and 52 W
Change From Baseline in Body Weight at 52 W
Time frame: Baseline and 52 W

Results and safety

Results posted to the registry on 14 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sitagliptin	153	76
Glimepiride	152	60

Primary outcome: Change From Baseline in HbA1c at 52 W

Time frame: Baseline and 52 W. Least squares mean (95% Confidence Interval). Unit: percent

Measure	Sitagliptin n = 143	Glimepiride n = 129
Value	-0.66 (-0.77 to -0.54)	-0.77 (-0.88 to -0.66)

Sitagliptin vs Glimepiride: LS mean difference: 0.11 (95% CI -0.02 to 0.24), p = 0.087, ANCOVA

Population analysed: Analysis set of evaluation for efficacy; Per Protocol Set.

Primary outcome: Number of Participants With Hypoglycaemia

Time frame: From baseline to 52 W. Count of participants. Unit: Participants

Measure	Sitagliptin n = 148	Glimepiride n = 143
Value	7	23

Sitagliptin vs Glimepiride: p = 0.002, Fisher Exact

Population analysed: Analysis set of evaluation for safety.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitagliptin	13 of 148 (8.8%)	33 of 148 (22.3%)	Not reported
Glimepiride	3 of 143 (2.1%)	31 of 143 (21.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28294488Terauchi Y, Yamada Y, Ishida H, Ohsugi M, Kitaoka M, Satoh J, Yabe D, Shihara N, Seino Y. Efficacy and safety of sitagliptin as compared with glimepiride in Japanese patients with type 2 diabetes mellitus aged >/= 60 years (START-J trial). Diabetes Obes Metab. 2017 Aug;19(8):1188-1192. doi: 10.1111/dom.12933. Epub 2017 Apr 12.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yasuo Terauchi, M.D., Ph.D. principal investigator

Yokohama City University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sitagliptin and Glimepiride in people with Type 2 Diabetes, run by Japan Association for Diabetes Education and Care at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in HbA1c at 52 W (time frame: Baseline and 52 W). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01183104, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017.