Diabetes Mellitus, Type 2Phase 3NCT00509236

Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease (MK-0431-073 AM1)

A Phase 3 study testing Sitagliptin and Glipizide in people with Diabetes Mellitus, Type 2 and End-Stage Kidney Disease, run by Merck Sharp & Dohme LLC.

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

The purpose of the study is to compare sitagliptin and glipizide in lowering blood sugar in participants with type-2 diabetes mellitus (T2DM) and end-stage renal disease on dialysis who do not have adequate glycemic control. Read more about this study

Who is it for?: Ages 30 years and older
Conditions the study is for: Diabetes Mellitus, Type 2, End-Stage Kidney Disease
What is being tested?: Sitagliptin and Glipizide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 129 participants
Where: No sites listed yet
Study dates: 19 Oct 2007to 14 Mar 2011
Phase: Phase 3
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 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant has T2DM.
Participant is on dialysis on day of signing informed consent.
Participant is unlikely to conceive or uses acceptable methods of birth control: hormonal contraceptive, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, or vasectomy.
Participant has hemoglobin A1c ≥7% and ≤9% measured at or within 2 weeks prior to Visit 4/Week -2.
Participant is ≥85% compliant with study medication during the single-blind placebo run-in (as determined by tablet/capsule count) and compliant with diet, exercise and other run-in treatments during the run-in period.

Who cannot join

Participant has a history of type 1 diabetes mellitus or a history of ketoacidosis.
Participant is losing weight in a weight loss program and is not in the maintenance phase (defined as <2 kg weight loss in 2 months), or intends to be involved in weight loss intervention outside that prescribed by the study.
Participant has a clinically significant hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia).
Participant has cirrhosis or active liver disease.
Participant has been on dialysis for < 6 months.
Participant has been diagnosed with a significant cardiovascular disorder and has new or worsening signs or symptoms of congestive heart failure within 3 months of signing informed consent.

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Participant has severe active peripheral vascular disease.
Participant has a history of malignancy ≤ 5 years prior to signing informed consent, or > 5 years without documentation of remission/cure.
Participant is under treatment for hyperthyroidism.
Participant has a hypersensitivity or contraindication to glipizide.

About this study

Official title: A Multicenter, Randomized Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease Who Are on Dialysis and Who Have Inadequate Glycemic Control

Conditions: Diabetes Mellitus, Type 2, End-Stage Kidney Disease
Being tested: Sitagliptin, Glipizide
Medical subject headings: Diabetes Mellitus, Type 2, Kidney Failure, Chronic

What participants receive

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

SitagliptinDrug
Also called MK-0431
25 mg (one 25-mg tablet) once daily
GlipizideDrug
Also called Glucotrol
2.5 mg (1/2 of a 5-mg tablet) once daily, up to 10 mg twice daily (four 5-mg tablets), for a maximum of 20 mg

Study groups in NCT00509236
Study group	Role	What they receive
Sitagliptin 25 mg	Experimental	Not described Receives: Drug: Sitagliptin
Glipizide 2.5 mg - 20 mg	Active comparator	Not described Receives: Drug: Glipizide

What is being measured

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

Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment
Change from baseline in mean hemoglobin A1c after treatment with sitagliptin for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated. Results for the glipizide arm are not reported in this table because the primary outcome measure is for the sitagliptin arm only.
Measured: Baseline / Week 54
Number of Participants With Clinical Adverse Events
Reported experiences assessed by investigators as adverse events, excluding data after initiation of glycemic rescue therapy.
Measured: 54 Week Treatment Period + 28 days

Secondary outcomes (3)

Number of Participants With Symptomatic Hypoglycemic Adverse Events
A symptomatic hypoglycemic adverse event is an episode with clinical symptoms attributed to hypoglycemia, without regard to fingerstick glucose level.
Measured: 54 Week Treatment Period + 28 days
Change From Baseline in Fasting Plasma Glucose (FPG)
Change from baseline in mean Fasting Plasma Glucose after treatment with sitagliptin versus glipizide for 54 weeks.
Measured: Baseline / Week 54
Change From Baseline in Hemoglobin A1c for Sitagliptin Versus Glipizide Treatment
Change from baseline in least square means hemoglobin A1c after treatment with sitagliptin versus glipizide for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated.
Measured: Baseline / Week 54

Timeline

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

19 Oct 200714 Mar 2011

First posted31 Jul 2007 (estimated)
Study start19 Oct 2007
Primary completion14 Mar 2011
Study completion14 Mar 2011

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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00509236
Sponsor's protocol ID: 0431-073
Other IDs: 2007_550
Status last verified: Apr 2017
First submitted: 27 Jul 2007
Last updated: 12 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

Arjona Ferreira JC, Corry D, Mogensen CE, Sloan L, Xu L, Golm GT, Gonzalez EJ, Davies MJ, Kaufman KD, Goldstein BJ. Efficacy and safety of sitagliptin in patients with type 2 diabetes and ESRD receiving dialysis: a 54-week randomized trial. Am J Kidney Dis. 2013 Apr;61(4):579-87. doi: 10.1053/j.ajkd.2012.11.043. Epub 2013 Jan 24.
PubMed 23352379

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease Who Are on Dialysis and Who Have Inadequate Glycemic Control
ClinicalTrials.gov ID: NCT00509236
Acronym / sponsor ID: 0431-073
Conditions: Diabetes Mellitus, Type 2, End-Stage Kidney Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 129 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 19 Oct 2007 (actual)
Primary completion: 14 Mar 2011 (actual)
Study completion: 14 Mar 2011 (actual)
First posted: 31 Jul 2007 (estimated)
Results: Posted 3 May 2012

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: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Sitagliptin 25 mg	Experimental	Drug: Sitagliptin
Glipizide 2.5 mg - 20 mg	Active comparator	Drug: Glipizide

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Participant has T2DM.
Participant is on dialysis on day of signing informed consent.
Participant is unlikely to conceive or uses acceptable methods of birth control: hormonal contraceptive, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, or vasectomy.
Participant has hemoglobin A1c ≥7% and ≤9% measured at or within 2 weeks prior to Visit 4/Week -2.
Participant is ≥85% compliant with study medication during the single-blind placebo run-in (as determined by tablet/capsule count) and compliant with diet, exercise and other run-in treatments during the run-in period.

Key exclusion criteria (10 listed)

Participant has a history of type 1 diabetes mellitus or a history of ketoacidosis.
Participant is losing weight in a weight loss program and is not in the maintenance phase (defined as <2 kg weight loss in 2 months), or intends to be involved in weight loss intervention outside that prescribed by the study.
Participant has a clinically significant hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia).
Participant has cirrhosis or active liver disease.
Participant has been on dialysis for < 6 months.

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
SitagliptinAlso: MK-043125 mg (one 25-mg tablet) once daily	Drug	Sitagliptin 25 mg
GlipizideAlso: Glucotrol2.5 mg (1/2 of a 5-mg tablet) once daily, up to 10 mg twice daily (four 5-mg tablets), for a maximum of 20 mg	Drug	Glipizide 2.5 mg - 20 mg

Primary outcome

Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment
Time frame: Baseline / Week 54
Change from baseline in mean hemoglobin A1c after treatment with sitagliptin for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated. Results for the glipizide arm are not reported in this table because the primary outcome measure is for the sitagliptin arm only.
Number of Participants With Clinical Adverse Events
Time frame: 54 Week Treatment Period + 28 days
Reported experiences assessed by investigators as adverse events, excluding data after initiation of glycemic rescue therapy.

3 secondary outcomes

Number of Participants With Symptomatic Hypoglycemic Adverse Events
Time frame: 54 Week Treatment Period + 28 days
Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame: Baseline / Week 54
Change From Baseline in Hemoglobin A1c for Sitagliptin Versus Glipizide Treatment
Time frame: Baseline / Week 54

Results and safety

Results posted to the registry on 3 May 2012, 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 25 mg	64	47
Glipizide 2.5 mg - 20 mg	65	45

Primary outcome: Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment

Time frame: Baseline / Week 54. Mean (Standard Deviation). Unit: Percent hemoglobin A1c

Measure	Sitagliptin 25 mg n = 62
Baseline	7.89 (0.74)
Week 54	7.15 (0.98)
Change from Baseline at Week 54	-0.74 (0.95)

Sitagliptin 25 mg: p <0.001, ANCOVA

Population analysed: Randomized participants. Numbers analyzed excluded participants with either no baseline or no post-baseline measurements. The last observation carried forward (LOCF) method was used to impute missing values.

Primary outcome: Number of Participants With Clinical Adverse Events

Time frame: 54 Week Treatment Period + 28 days. Number. Unit: Participants

Measure	Sitagliptin 25 mg n = 64	Glipizide 2.5 mg - 20 mg n = 65
Value	53	52

Sitagliptin 25 mg vs Glipizide 2.5 mg - 20 mg: Difference in % Affected: 2.8 (95% CI -10.9 to 16.5)

Population analysed: All randomized participants.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitagliptin 25 mg	23 of 64 (35.9%)	33 of 64 (51.6%)	Not reported
Glipizide 2.5 mg - 20 mg	22 of 65 (33.8%)	37 of 65 (56.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23352379Arjona Ferreira JC, Corry D, Mogensen CE, Sloan L, Xu L, Golm GT, Gonzalez EJ, Davies MJ, Kaufman KD, Goldstein BJ. Efficacy and safety of sitagliptin in patients with type 2 diabetes and ESRD receiving dialysis: a 54-week randomized trial. Am J Kidney Dis. 2013 Apr;61(4):579-87. doi: 10.1053/j.ajkd.2012.11.043. Epub 2013 Jan 24.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sitagliptin and Glipizide in people with Diabetes Mellitus, Type 2 and End-Stage Kidney Disease, run by Merck Sharp & Dohme LLC.

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 5 inclusion and 10 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 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2012). 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 Hemoglobin A1c After Sitagliptin Treatment (time frame: Baseline / Week 54). 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 NCT00509236, 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 12 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.