Type 2 Diabetes MellitusPhase 4NCT00993187

Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (FDC) Compared to Glimepiride in Participants With Type 2 Diabetes Mellitus (MK-0431A-202)

A Phase 4 study testing Sitagliptin/Metformin FDC and Comparator: Glimepiride in people with Type 2 Diabetes Mellitus, 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

This study will assess the effect of sitagliptin/metformin FDC 50/1000 mg (Janumet®), MK-0431A) compared with the effect of glimepiride on hemoglobin A1c (HbA1c). The primary hypothesis is that after 30 weeks, sitagliptin/metformin FDC 50/1000 mg provides superior reduction in HbA1c (mean change from baseline)… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Sitagliptin/Metformin FDC and Comparator: Glimepiride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 292 participants
Where: No sites listed yet
Study dates: 4 May 2010to 29 Oct 2013
Phase: Phase 4
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

Has type 2 diabetes mellitus
Is currently not on an anti-hypoglycemic agent (AHA) (off for at least 12 weeks) and has a Visit 1/Screening Visit HbA1c greater than or equal to 7.0% and less than or equal to 9.5%; or is currently on AHA monotherapy or low-dose oral combination therapy (i.e., less than or equal to 50% maximum labeled dose of each agent) and has a Visit 1/Screening Visit HbA1c greater than or equal to 6.5% and less than or equal to 9.0%

Who cannot join

Has a history of type 1 diabetes mellitus or a history of ketoacidosis
Has been on any investigational or approved glucagon-like peptide-1 (GLP-1) analogue (such as exenatide, liraglutide, etc.), any investigational or approved dipeptidyl peptidase IV (DPP-4) inhibitor (such as sitagliptin, vildagliptin, alogliptin, etc.) or a peroxisome proliferator-activated receptor (PPAR) gamma agonist agent (such as rosiglitazone, pioglitazone, etc.) within 12 weeks of Visit 1
Required insulin within the prior 12 weeks
Has a hypersensitivity or contraindication to any sulfonylurea medication (such as glimepiride, glipizide, etc.), DPP-4 inhibitor (such as sitagliptin, vildagliptin, alogliptin, etc.), or biguanide medication (such as metformin, etc.)
Has inadequately controlled hypertension
Has cirrhosis or active liver disease

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Has severe cardiac conditions
Is obese
Has human immunodeficiency virus (HIV)

About this study

Official title: A Multicenter, Randomized, Double Blind Study to Compare the Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (Janumet®) Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus

Conditions: Type 2 Diabetes Mellitus
Being tested: Sitagliptin/Metformin FDC, Comparator: Glimepiride, Matching placebo to Sitagliptin/Metformin FDC, Matching placebo to glimepiride
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.

Sitagliptin/Metformin FDCDrug
Also called Janumet®
Sitagliptin phosphate plus metformin hydrochloride combination tablet (MK-0431A) orally up to 50/1000 mg BID for 30 weeks
Comparator: GlimepirideDrug
Also called Amaryl®
Glimepiride tablet orally up to 6 mg daily for 30 Weeks
Matching placebo to Sitagliptin/Metformin FDCDrug
Matching placebo to Sitagliptin/Metformin FDC 50/1000 mg orally BID for 30 weeks
Matching placebo to glimepirideDrug
Matching placebo to glimepiride tablet orally daily for 30 weeks

Study groups in NCT00993187
Study group	Role	What they receive
Sitagliptin/Metformin FDC	Experimental	Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks. Receives: Drug: Sitagliptin/Metformin FDC; Drug: Matching placebo to glimepiride
Glimepiride	Active comparator	Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day. Receives: Drug: Comparator: Glimepiride; Drug: Matching placebo to Sitagliptin/Metformin FDC

What is being measured

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

Change From Baseline in Hemoglobin A1C (HbA1C) at Week 30
HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Change in A1C following 30 weeks of therapy (i.e., A1C at Week 30 minus A1C at baseline).
Measured: Baseline and Week 30
Number of Participants Who Experienced at Least One Adverse Event (AE)
An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Measured: Up to 32 weeks
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Measured: Up to 30 weeks

Secondary outcomes (4)

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30
Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 30 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 30 minus FPG at baseline).
Measured: Baseline and Week 30
Percentage of Participants With One or More Episodes of Hypoglycemia
Symptomatic episodes assessed as likely to be due to hypoglycemia were reported by investigators as adverse experiences of hypoglycemia. Adverse experiences of hypoglycemia were based on all reports of hypoglycemia; a concurrent glucose measurement was not required.
Measured: Up to Week 30
Change From Baseline in Body Weight at Week 30
Change in body weight following 30 weeks of therapy (i.e., body weight at Week 30 minus body weight at baseline)
Measured: Baseline and Week 30
Percentage of Participants With HbA1C < 7.0% at Week 30
HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%).
Measured: Week 30

Timeline

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

4 May 201029 Oct 2013

First posted12 Oct 2009 (estimated)
Study start4 May 2010
Primary completion29 Oct 2013
Study completion29 Oct 2013

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 Diabetes MellitusStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 292 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00993187
Sponsor's protocol ID: 0431A-202
Other IDs: 2009_672
Status last verified: Jul 2018
First submitted: 9 Oct 2009
Last updated: 22 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Kim SS, Kim IJ, Lee KJ, Park JH, Kim YI, Lee YS, Chung SC, Lee SJ. Efficacy and safety of sitagliptin/metformin fixed-dose combination compared with glimepiride in patients with type 2 diabetes: A multicenter randomized double-blind study. J Diabetes. 2017 Apr;9(4):412-422. doi: 10.1111/1753-0407.12432. Epub 2016 Aug 8.
PubMed 27229178

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 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double Blind Study to Compare the Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (Janumet®) Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT00993187
Acronym / sponsor ID: 0431A-202
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 292 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 4 May 2010 (actual)
Primary completion: 29 Oct 2013 (actual)
Study completion: 29 Oct 2013 (actual)
First posted: 12 Oct 2009 (estimated)
Results: Posted 15 Sep 2014

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/Metformin FDC	Experimental	Drug: Sitagliptin/Metformin FDC, Drug: Matching placebo to glimepirideParticipants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
Glimepiride	Active comparator	Drug: Comparator: Glimepiride, Drug: Matching placebo to Sitagliptin/Metformin FDCParticipants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.

Who may qualify

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

Key inclusion criteria (2 listed)

Has type 2 diabetes mellitus
Is currently not on an anti-hypoglycemic agent (AHA) (off for at least 12 weeks) and has a Visit 1/Screening Visit HbA1c greater than or equal to 7.0% and less than or equal to 9.5%; or is currently on AHA monotherapy or low-dose oral combination therapy (i.e., less than or equal to 50% maximum labeled dose of each agent) and has a Visit 1/Screening Visit HbA1c greater than or equal to 6.5% and less than or equal to 9.0%

Key exclusion criteria (9 listed)

Has a history of type 1 diabetes mellitus or a history of ketoacidosis
Has been on any investigational or approved glucagon-like peptide-1 (GLP-1) analogue (such as exenatide, liraglutide, etc.), any investigational or approved dipeptidyl peptidase IV (DPP-4) inhibitor (such as sitagliptin, vildagliptin, alogliptin, etc.) or a peroxisome proliferator-activated receptor (PPAR) gamma agonist agent (such as rosiglitazone, pioglitazone, etc.) within 12 weeks of Visit 1
Required insulin within the prior 12 weeks
Has a hypersensitivity or contraindication to any sulfonylurea medication (such as glimepiride, glipizide, etc.), DPP-4 inhibitor (such as sitagliptin, vildagliptin, alogliptin, etc.), or biguanide medication (such as metformin, etc.)
Has inadequately controlled hypertension

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
Sitagliptin/Metformin FDCAlso: Janumet®Sitagliptin phosphate plus metformin hydrochloride combination tablet (MK-0431A) orally up to 50/1000 mg BID for 30 weeks	Drug	Sitagliptin/Metformin FDC
Comparator: GlimepirideAlso: Amaryl®Glimepiride tablet orally up to 6 mg daily for 30 Weeks	Drug	Glimepiride
Matching placebo to Sitagliptin/Metformin FDCMatching placebo to Sitagliptin/Metformin FDC 50/1000 mg orally BID for 30 weeks	Drug	Glimepiride
Matching placebo to glimepirideMatching placebo to glimepiride tablet orally daily for 30 weeks	Drug	Sitagliptin/Metformin FDC

Primary outcome

Change From Baseline in Hemoglobin A1C (HbA1C) at Week 30
Time frame: Baseline and Week 30
HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Change in A1C following 30 weeks of therapy (i.e., A1C at Week 30 minus A1C at baseline).
Number of Participants Who Experienced at Least One Adverse Event (AE)
Time frame: Up to 32 weeks
An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Time frame: Up to 30 weeks
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.

4 secondary outcomes

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30
Time frame: Baseline and Week 30
Percentage of Participants With One or More Episodes of Hypoglycemia
Time frame: Up to Week 30
Change From Baseline in Body Weight at Week 30
Time frame: Baseline and Week 30
Percentage of Participants With HbA1C < 7.0% at Week 30
Time frame: Week 30

Results and safety

Results posted to the registry on 15 Sep 2014, 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/Metformin	147	121
Glimepiride	145	108

Primary outcome: Change From Baseline in Hemoglobin A1C (HbA1C) at Week 30

Time frame: Baseline and Week 30. Least squares mean (95% Confidence Interval). Unit: Percent of total hemoglobin

Measure	Sitagliptin/Metformin n = 138	Glimepiride n = 137
Value	-1.5 (-1.6 to -1.4)	-0.7 (-0.8 to -0.6)

Sitagliptin/Metformin vs Glimepiride: Difference in Least Squares Mean: -0.8 (95% CI -1.0 to -0.6), p <0.001, ANCOVA

Population analysed: Full-Analysis-Set (FAS) Population included all randomized participants who had a baseline measurement, consumed at least one dose of study medication, and had at least one post-randomization measurement.

Primary outcome: Number of Participants Who Experienced at Least One Adverse Event (AE)

Time frame: Up to 32 weeks. Number. Unit: Participants

Measure	Sitagliptin/Metformin n = 146	Glimepiride n = 144
Value	88	101

Population analysed: The All Patients as Treated (APaT) Population includes all randomized participants who received at least 1 dose of study medication.

Primary outcome: Number of Participants Who Discontinued Study Drug Due to an Adverse Event

Time frame: Up to 30 weeks. Number. Unit: Participants

Measure	Sitagliptin/Metformin n = 146	Glimepiride n = 144
Value	8	8

Population analysed: The APaT Population includes all randomized participants who received at least 1 dose of study medication.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 32 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitagliptin/Metformin	8 of 146 (5.5%)	62 of 146 (42.5%)	Not reported
Glimepiride	9 of 144 (6.3%)	54 of 144 (37.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27229178Kim SS, Kim IJ, Lee KJ, Park JH, Kim YI, Lee YS, Chung SC, Lee SJ. Efficacy and safety of sitagliptin/metformin fixed-dose combination compared with glimepiride in patients with type 2 diabetes: A multicenter randomized double-blind study. J Diabetes. 2017 Apr;9(4):412-422. doi: 10.1111/1753-0407.12432. Epub 2016 Aug 8.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Type 2 Diabetes Mellitus

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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?

A Phase 4 study testing Sitagliptin/Metformin FDC and Comparator: Glimepiride in people with Type 2 Diabetes Mellitus, 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 9 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 22 Aug 2018. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 15 Sep 2014). 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 (HbA1C) at Week 30 (time frame: Baseline and Week 30). The study lists 3 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 NCT00993187, 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 22 Aug 2018.