Type 2 Diabetes Mellitus, Non Insulin DependentPhase 3NCT00701090

A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)

A Phase 3 study testing sitagliptin, Comparator: glimepiride and open-label metformin in people with Type 2 Diabetes Mellitus, Non Insulin Dependent and Diabetes Mellitus, Non-Insulin-Dependent, 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

A study to see if better control of type 2 diabetes can occur in patients taking a stable dose of metformin when they are also provided either sitagliptin or glimepiride. This study will also see if this treatment is safe and tolerable. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus, Non Insulin Dependent, Diabetes Mellitus, Non-Insulin-Dependent
What is being tested?: sitagliptin, Comparator: glimepiride and open-label metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,035 participants
Where: No sites listed yet
Study dates: May 2008to Oct 2009
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 years or older
Diagnosed with type 2 diabetes
On a stable dose of metformin of at least 1500 mg per day

Who cannot join

History of type 1 diabetes
Pregnant
HIV positive
On a weight loss program or medication
Has a history of blood disorder, certain cancers, heart, liver or kidney disease

About this study

Official title: A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin Compared With the Addition of Glimepiride in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin

Conditions: Type 2 Diabetes Mellitus, Non Insulin Dependent, Diabetes Mellitus, Non-Insulin-Dependent
Being tested: sitagliptin, Comparator: glimepiride, open-label metformin
Keywords: Type 2 Diabetes Mellitus, Non Insulin Dependent
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
Also called Januvia
Sitagliptin 100 mg q.d. (q.d. = once daily); Duration of Treatment: 30 weeks
Comparator: glimepirideDrug
glimepiride 1 mg per day to be up-titrated (up to week 18 of the double-blind treatment period) as considered appropriate by the investigator, based upon the results of patient's self blood glucose monitoring (SBGM). The maximum dose of glimepiride must not be higher than 6 mg/day.
open-label metforminDrug
Also called metformin
open-label metformin oral tablets (≥1500 mg/day) in addition to Glimepiride or Sitagliptin treatment.

Study groups in NCT00701090
Study group	Role	What they receive
1	Experimental	sitagliptin Receives: Drug: sitagliptin; Drug: open-label metformin
2	Active comparator	glimepiride Receives: Drug: Comparator: glimepiride; Drug: open-label metformin

What is being measured

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

Change From Baseline in HbA1c at Week 30
Patient-level HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the Week 0 HbA1c percent.
Measured: Week 0 to Week 30

Secondary outcomes (5)

Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30
Change from baseline at Week 30 was defined as Week 30 minus Week 0.
Measured: Week 0 to Week 30
Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30
Measured: Week 0 to Week 30
Change From Baseline in Body Weight at Week 30
Change from baseline at Week 30 was defined as Week 30 minus Week 0.
Measured: Week 0 to Week 30
Percent of Patients With A1C <7.0% at Week 30
Measured: Week 30
Percent of Patients With A1C <6.5% at Week 30
Measured: Week 30

Timeline

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

May 2008Oct 2009

First posted19 Jun 2008 (estimated)
Study startMay 2008
Primary completionOct 2009
Study completionOct 2009

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 (2)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes Mellitus, Non Insulin DependentStudies 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: 1,035 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00701090
Sponsor's protocol ID: 0431-803
Other IDs: 2008_503
Status last verified: Jan 2017
First submitted: 17 Jun 2008
Last updated: 10 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
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

Arechavaleta R, Seck T, Chen Y, Krobot KJ, O'Neill EA, Duran L, Kaufman KD, Williams-Herman D, Goldstein BJ. Efficacy and safety of treatment with sitagliptin or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2011 Feb;13(2):160-8. doi: 10.1111/j.1463-1326.2010.01334.x.
PubMed 21199268
Ommen ES, Xu L, O'Neill EA, Goldstein BJ, Kaufman KD, Engel SS. Comparison of treatment with sitagliptin or sulfonylurea in patients with type 2 diabetes mellitus and mild renal impairment: a post hoc analysis of clinical trials. Diabetes Ther. 2015 Mar;6(1):29-40. doi: 10.1007/s13300-015-0098-y. Epub 2015 Jan 30.
PubMed 25633134

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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All Type 2 Diabetes Mellitus, Non Insulin Dependent trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin Compared With the Addition of Glimepiride in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin
ClinicalTrials.gov ID: NCT00701090
Acronym / sponsor ID: 0431-803
Conditions: Type 2 Diabetes Mellitus, Non Insulin Dependent, Diabetes Mellitus, Non-Insulin-Dependent
Keywords: Type 2 Diabetes Mellitus, Non Insulin Dependent
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,035 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 19 Jun 2008 (estimated)
Results: Posted 5 Oct 2010

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
1	Experimental	Drug: sitagliptin, Drug: open-label metforminsitagliptin
2	Active comparator	Drug: Comparator: glimepiride, Drug: open-label metforminglimepiride

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

18 years or older
Diagnosed with type 2 diabetes
On a stable dose of metformin of at least 1500 mg per day

Key exclusion criteria (5 listed)

History of type 1 diabetes
Pregnant
HIV positive
On a weight loss program or medication
Has a history of blood disorder, certain cancers, heart, liver or kidney disease

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: JanuviaSitagliptin 100 mg q.d. (q.d. = once daily); Duration of Treatment: 30 weeks	Drug	1
Comparator: glimepirideglimepiride 1 mg per day to be up-titrated (up to week 18 of the double-blind treatment period) as considered appropriate by the investigator, based upon the results of patient's self blood glucose monitoring (SBGM). The maximum dose of glimepiride must not be higher than 6 mg/day.	Drug	2
open-label metforminAlso: metforminopen-label metformin oral tablets (≥1500 mg/day) in addition to Glimepiride or Sitagliptin treatment.	Drug	1, 2

Primary outcome

Change From Baseline in HbA1c at Week 30
Time frame: Week 0 to Week 30
Patient-level HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the Week 0 HbA1c percent.

5 secondary outcomes

Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30
Time frame: Week 0 to Week 30
Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30
Time frame: Week 0 to Week 30
Change From Baseline in Body Weight at Week 30
Time frame: Week 0 to Week 30
Percent of Patients With A1C <7.0% at Week 30
Time frame: Week 30
Percent of Patients With A1C <6.5% at Week 30
Time frame: Week 30

Results and safety

Results posted to the registry on 5 Oct 2010, 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	516	468
Glimepiride	519	468

Primary outcome: Change From Baseline in HbA1c at Week 30

Time frame: Week 0 to Week 30. Least squares mean (95% Confidence Interval). Unit: Percent

Measure	Sitagliptin n = 443	Glimepiride n = 436
Value	-0.47 (-0.55 to -0.39)	-0.54 (-0.62 to -0.45)

Sitagliptin vs Glimepiride: Mean Difference (Net): 0.07 (95% CI -0.03 to 0.16)

Population analysed: The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance \<85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication).

5 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	16 of 516 (3.1%)	58 of 519 (11.2%)	Not reported
Glimepiride	11 of 518 (2.1%)	134 of 518 (25.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21199268Arechavaleta R, Seck T, Chen Y, Krobot KJ, O'Neill EA, Duran L, Kaufman KD, Williams-Herman D, Goldstein BJ. Efficacy and safety of treatment with sitagliptin or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2011 Feb;13(2):160-8. doi: 10.1111/j.1463-1326.2010.01334.x.
Derived from this study: PubMed 25633134Ommen ES, Xu L, O'Neill EA, Goldstein BJ, Kaufman KD, Engel SS. Comparison of treatment with sitagliptin or sulfonylurea in patients with type 2 diabetes mellitus and mild renal impairment: a post hoc analysis of clinical trials. Diabetes Ther. 2015 Mar;6(1):29-40. doi: 10.1007/s13300-015-0098-y. Epub 2015 Jan 30.
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 Type 2 Diabetes Mellitus, Non Insulin Dependent

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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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 5 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 10 Mar 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 5 Oct 2010). 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 Week 30 (time frame: Week 0 to Week 30). 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 NCT00701090, which also lists 2 linked publications.

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 10 Mar 2017.