Diabetes Mellitus, Type 2Phase 3NCT00509262

Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1)

A Phase 3 study testing Sitagliptin and Glipizide in people with Diabetes Mellitus, Type 2 and Renal Insufficiency, Chronic, 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

Search all trials

Trial summary

The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in participants with moderate or severe renal insufficiency. Read more about this study

Who is it for?: Ages 30 years and older
Conditions the study is for: Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What is being tested?: Sitagliptin and Glipizide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 426 participants
Where: No sites listed yet
Study dates: 9 Oct 2007to 16 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

Has type 2 diabetes mellitus
Has moderate or severe renal insufficiency

Who cannot join

Has type 1 diabetes mellitus or a history of ketoacidosis
Is on a new weight loss program
Has active liver disease
Is on dialysis or is likely to need dialysis during the study

About this study

Official title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency Who Have Inadequate Glycemic Control

The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in participants with moderate or severe renal insufficiency.

Conditions: Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
Being tested: Sitagliptin, Glipizide, Placebo for Sitagliptin, Placebo for Glipizide
Medical subject headings: Diabetes Mellitus, Type 2, Renal Insufficiency, 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, Januvia
Participants with moderate renal insufficiency will receive two sitagliptin 25 mg tablets orally daily; participants with severe renal insufficiency will receive one sitagliptin 25 mg tablet orally daily
GlipizideDrug
Also called Glucotrol
Participants will receive glipizide 2.5 mg (1/2 tablet) orally once daily up to 20 mg orally daily (10 mg twice daily)
Placebo for SitagliptinDrug
Participants with moderate renal insufficiency will receive 2 placebo for sitagliptin tablets orally daily; participants with severe renal insufficiency will receive 1 placebo for sitagliptin tablet orally daily
Placebo for GlipizideDrug
Participants will receive 1/2 tablet of placebo for glipizide orally once daily up to 2 tablets orally twice daily

Study groups in NCT00509262
Study group	Role	What they receive
Sitagliptin	Experimental	Sitagliptin + Placebo for Glipizide Receives: Drug: Sitagliptin; Drug: Placebo for Glipizide
Glipizide	Active comparator	Glipizide + Placebo for Sitagliptin Receives: Drug: Glipizide; Drug: Placebo for Sitagliptin

What is being measured

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

Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54
A1C represents percentage of glycosylated hemoglobin.
Measured: Baseline to Week 54
Percentage of Participants With Hypoglycemic Events
Percentage of participants with at least one symptomatic hypoglycemic adverse event, excluding data after initiation of glycemic rescue therapy.
Measured: Baseline up to 28 days following the last dose of study therapy

Secondary outcomes (2)

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54
Measured: Baseline to Week 54
Change From Baseline in Body Weight at Week 54
Measured: Baseline to Week 54

Timeline

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

9 Oct 200716 Mar 2011

First posted31 Jul 2007 (estimated)
Study start9 Oct 2007
Primary completion16 Mar 2011
Study completion16 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 426 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00509262
Sponsor's protocol ID: 0431-063
Other IDs: 2007_549
Status last verified: Apr 2017
First submitted: 27 Jul 2007
Last updated: 12 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
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, Marre M, Barzilai N, Guo H, Golm GT, Sisk CM, Kaufman KD, Goldstein BJ. Efficacy and safety of sitagliptin versus glipizide in patients with type 2 diabetes and moderate-to-severe chronic renal insufficiency. Diabetes Care. 2013 May;36(5):1067-73. doi: 10.2337/dc12-1365. Epub 2012 Dec 17.
PubMed 23248197

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

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Diabetes Mellitus, Type 2 trials

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 Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency Who Have Inadequate Glycemic Control
ClinicalTrials.gov ID: NCT00509262
Acronym / sponsor ID: 0431-063
Conditions: Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 426 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 9 Oct 2007 (actual)
Primary completion: 16 Mar 2011 (actual)
Study completion: 16 Mar 2011 (actual)
First posted: 31 Jul 2007 (estimated)
Results: Posted 28 Mar 2012

Clinical summary

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

The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in participants with moderate or severe renal insufficiency.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sitagliptin	Experimental	Drug: Sitagliptin, Drug: Placebo for GlipizideSitagliptin + Placebo for Glipizide
Glipizide	Active comparator	Drug: Glipizide, Drug: Placebo for SitagliptinGlipizide + Placebo for Sitagliptin

Who may qualify

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

Key inclusion criteria (2 listed)

Has type 2 diabetes mellitus
Has moderate or severe renal insufficiency

Key exclusion criteria (4 listed)

Has type 1 diabetes mellitus or a history of ketoacidosis
Is on a new weight loss program
Has active liver disease
Is on dialysis or is likely to need dialysis during the study

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-0431, JanuviaParticipants with moderate renal insufficiency will receive two sitagliptin 25 mg tablets orally daily; participants with severe renal insufficiency will receive one sitagliptin 25 mg tablet orally daily	Drug	Sitagliptin
GlipizideAlso: GlucotrolParticipants will receive glipizide 2.5 mg (1/2 tablet) orally once daily up to 20 mg orally daily (10 mg twice daily)	Drug	Glipizide
Placebo for SitagliptinParticipants with moderate renal insufficiency will receive 2 placebo for sitagliptin tablets orally daily; participants with severe renal insufficiency will receive 1 placebo for sitagliptin tablet orally daily	Drug	Glipizide
Placebo for GlipizideParticipants will receive 1/2 tablet of placebo for glipizide orally once daily up to 2 tablets orally twice daily	Drug	Sitagliptin

Primary outcome

Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54
Time frame: Baseline to Week 54
A1C represents percentage of glycosylated hemoglobin.
Percentage of Participants With Hypoglycemic Events
Time frame: Baseline up to 28 days following the last dose of study therapy
Percentage of participants with at least one symptomatic hypoglycemic adverse event, excluding data after initiation of glycemic rescue therapy.

2 secondary outcomes

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54
Time frame: Baseline to Week 54
Change From Baseline in Body Weight at Week 54
Time frame: Baseline to Week 54

Results and safety

Results posted to the registry on 28 Mar 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	211	164
Glipizide	212	170

Primary outcome: Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54

Time frame: Baseline to Week 54. Mean (Standard Deviation). Unit: Percent of glycosylated hemoglobin

Measure	Sitagliptin n = 135	Glipizide n = 142
Baseline	7.76 (0.65)	7.79 (0.70)
Change from Baseline at Week 54	-0.70 (0.80)	-0.62 (0.91)

Sitagliptin vs Glipizide: Difference in least squares mean: -0.11 (95% CI -0.29 to 0.06), ANCOVA

Population analysed: The per protocol population required that a participant had measurements both at baseline and at Week 54, and did not have any major protocol violations (e.g. drug compliance \<75%, addition of prohibited antihyperglycemic agent, or incorrect double-blind study medication). No missing data were imputed.

Primary outcome: Percentage of Participants With Hypoglycemic Events

Time frame: Baseline up to 28 days following the last dose of study therapy. Number. Unit: percentage of participants

Measure	Sitagliptin n = 210	Glipizide n = 212
Value	6.2	17.0

Sitagliptin vs Glipizide: Mean Difference (Final Values): -10.8 (95% CI -17.1 to -4.8), p = 0.001, Miettirnen& Nurminen method

Population analysed: All participants as treated (APaT) population included all randomized participants who took at least one dose of study therapy.

2 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	36 of 210 (17.1%)	69 of 210 (32.9%)	Not reported
Glipizide	38 of 212 (17.9%)	89 of 212 (42%)	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 23248197Arjona Ferreira JC, Marre M, Barzilai N, Guo H, Golm GT, Sisk CM, Kaufman KD, Goldstein BJ. Efficacy and safety of sitagliptin versus glipizide in patients with type 2 diabetes and moderate-to-severe chronic renal insufficiency. Diabetes Care. 2013 May;36(5):1067-73. doi: 10.2337/dc12-1365. Epub 2012 Dec 17.
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

Related trials for Diabetes Mellitus, Type 2

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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 Renal Insufficiency, Chronic, 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 2 inclusion and 4 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 28 Mar 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 (A1C) Levels at Week 54 (time frame: Baseline to 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 NCT00509262, 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.