Type 2 Diabetes MellitusPhase 3NCT01076088

Safety and Efficacy of Co-Administration of Sitagliptin and Metformin in China (MK-0431-121)

A Phase 3 study testing Sitagliptin 50 mg, Metformin 500 mg and Sitagliptin 100 mg 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

Search all trials

Trial summary

This study will assess the efficacy and safety of initial treatment with sitagliptin and metformin in patients with type 2 diabetes mellitus in China. The primary hypothesis is that after 24 weeks, initial co-administration treatment with sitagliptin and metformin provided greater reduction in hemoglobin A1C (A1C)… Read more about this study

Who is it for?: Ages 18 to 78 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Sitagliptin 50 mg, Metformin 500 mg and Sitagliptin 100 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 744 participants
Where: No sites listed yet
Study dates: 15 Nov 2010to 24 Dec 2012
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 to 78 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

has type 2 diabetes mellitus
is male, a female who cannot have children, or a female who agrees to use birth control during the study
is not on an antihyperglycemic agent (AHA) (hemoglobin A1c [A1C] 7.5-11.0%) or on oral single AHA (A1C 7.0-10.5%) or low-dose AHA combination therapy (A1C 7.0-10.0%)

Who cannot join

Patient has type 1 diabetes mellitus or ketoacidosis
Patient is taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin)
Patient is on a weight loss program not in the maintenance phase or on a weight loss medication
Patient has a history of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer
Patient is HIV positive
Patient is pregnant

About this study

Official title: A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial in China to Study the Safety and Efficacy of Co-administration of Sitagliptin and Metformin in Patients With Type 2 Diabetes Mellitus

Conditions: Type 2 Diabetes Mellitus
Being tested: Sitagliptin 50 mg, Metformin 500 mg, Sitagliptin 100 mg, Placebo, Metformin 850 mg
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 50 mgDrug
Also called Januvia®, Tesavel®, Xelevia®, Ristaben®
Sitagliptin 50 mg tablet twice a day, prior to the morning and evening meal, for 24 weeks.
Metformin 500 mgDrug
Also called Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Metformin 500 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.
Sitagliptin 100 mgDrug
Also called Januvia®, Tesavel®, Xelevia®, Ristaben®
Sitagliptin 100 mg once daily for 24 weeks.
PlaceboDrug
Matching placebo tablets to sitagliptin or metformin for 24 weeks.
Metformin 850 mgDrug
Also called Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Metformin 850 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.

Study groups in NCT01076088
Study group	Role	What they receive
Sitagliptin 50 mg + metformin 500 mg	Experimental	Sitagliptin 50 mg and metformin 500 mg twice a day for 24 weeks. Receives: Drug: Sitagliptin 50 mg; Drug: Metformin 500 mg
Sitagliptin 50 mg + metformin 850 mg	Experimental	Sitagliptin 50 mg and metformin 850 mg twice a day for 24 weeks. Receives: Drug: Sitagliptin 50 mg; Drug: Metformin 850 mg
Metformin 500 mg	Active comparator	Metformin 500 mg twice daily for 24 weeks. Receives: Drug: Metformin 500 mg
Metformin 850 mg	Active comparator	Metformin 850 mg twice daily for 24 weeks. Receives: Drug: Metformin 850 mg
Sitagliptin 100 mg	Experimental	Sitagliptin 100 mg once daily for 24 weeks. Receives: Drug: Sitagliptin 100 mg
Placebo	Placebo comparator	Matching placebo tablets for 24 weeks. Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Hemoglobin A1C (A1C) at Week 24
A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
Measured: Baseline and Week 24

Secondary outcomes (2)

Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24
Change from baseline in 2-h PMG at Week 24 is defined as Week 24 2-h PMG minus Week 0 2-h PMG.
Measured: Baseline and Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Change from baseline in FPG at Week 24 is defined as Week 24 FPG minus Week 0 FPG.
Measured: Baseline and Week 24

Timeline

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

15 Nov 201024 Dec 2012

First posted25 Feb 2010 (estimated)
Study start15 Nov 2010
Primary completion24 Dec 2012
Study completion24 Dec 2012

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 744 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01076088
Sponsor's protocol ID: 0431-121
Other IDs: 2010_514
Status last verified: Apr 2017
First submitted: 24 Feb 2010
Last updated: 23 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

Ji L, Han P, Wang X, Liu J, Zheng S, Jou YM, O'Neill EA, Golm GT, Engel SS, Kaufman KD, Shankar RR. Randomized clinical trial of the safety and efficacy of sitagliptin and metformin co-administered to Chinese patients with type 2 diabetes mellitus. J Diabetes Investig. 2016 Sep;7(5):727-36. doi: 10.1111/jdi.12511. Epub 2016 May 19.
PubMed 27181998

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 Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial in China to Study the Safety and Efficacy of Co-administration of Sitagliptin and Metformin in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01076088
Acronym / sponsor ID: 0431-121
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 744 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 15 Nov 2010 (actual)
Primary completion: 24 Dec 2012 (actual)
Study completion: 24 Dec 2012 (actual)
First posted: 25 Feb 2010 (estimated)
Results: Posted 6 Feb 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: 6

Arm	Type	Receives
Sitagliptin 50 mg + metformin 500 mg	Experimental	Drug: Sitagliptin 50 mg, Drug: Metformin 500 mgSitagliptin 50 mg and metformin 500 mg twice a day for 24 weeks.
Sitagliptin 50 mg + metformin 850 mg	Experimental	Drug: Sitagliptin 50 mg, Drug: Metformin 850 mgSitagliptin 50 mg and metformin 850 mg twice a day for 24 weeks.
Metformin 500 mg	Active comparator	Drug: Metformin 500 mgMetformin 500 mg twice daily for 24 weeks.
Metformin 850 mg	Active comparator	Drug: Metformin 850 mgMetformin 850 mg twice daily for 24 weeks.
Sitagliptin 100 mg	Experimental	Drug: Sitagliptin 100 mgSitagliptin 100 mg once daily for 24 weeks.
Placebo	Placebo comparator	Drug: PlaceboMatching placebo tablets for 24 weeks.

Who may qualify

Ages: 18 to 78 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

has type 2 diabetes mellitus
is male, a female who cannot have children, or a female who agrees to use birth control during the study
is not on an antihyperglycemic agent (AHA) (hemoglobin A1c [A1C] 7.5-11.0%) or on oral single AHA (A1C 7.0-10.5%) or low-dose AHA combination therapy (A1C 7.0-10.0%)

Key exclusion criteria (6 listed)

Patient has type 1 diabetes mellitus or ketoacidosis
Patient is taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin)
Patient is on a weight loss program not in the maintenance phase or on a weight loss medication
Patient has a history of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer
Patient is HIV positive

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 50 mgAlso: Januvia®, Tesavel®, Xelevia®, Ristaben®Sitagliptin 50 mg tablet twice a day, prior to the morning and evening meal, for 24 weeks.	Drug	Sitagliptin 50 mg + metformin 500 mg, Sitagliptin 50 mg + metformin 850 mg
Metformin 500 mgAlso: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®Metformin 500 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.	Drug	Metformin 500 mg, Sitagliptin 50 mg + metformin 500 mg
Sitagliptin 100 mgAlso: Januvia®, Tesavel®, Xelevia®, Ristaben®Sitagliptin 100 mg once daily for 24 weeks.	Drug	Sitagliptin 100 mg
PlaceboMatching placebo tablets to sitagliptin or metformin for 24 weeks.	Drug	Placebo
Metformin 850 mgAlso: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®Metformin 850 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.	Drug	Metformin 850 mg, Sitagliptin 50 mg + metformin 850 mg

Primary outcome

Change From Baseline in Hemoglobin A1C (A1C) at Week 24
Time frame: Baseline and Week 24
A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.

2 secondary outcomes

Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24
Time frame: Baseline and Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Time frame: Baseline and Week 24

Results and safety

Results posted to the registry on 6 Feb 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 50 mg + Metformin 500 mg	122	111
Sitagliptin 50 mg + Metformin 850 mg	125	107
Metformin 500 mg	126	109
Metformin 850	124	109
Sitagliptin 100 mg	120	104
Placebo	127	104

Primary outcome: Change From Baseline in Hemoglobin A1C (A1C) at Week 24

Time frame: Baseline and Week 24. Least squares mean (95% Confidence Interval). Unit: Percent of glycosylated hemoglobin

Measure	Sitagliptin 50 mg + Metformin 500 mg n = 118	Sitagliptin 50 mg + Metformin 850 mg n = 114	Metformin 500 mg n = 116	Metformin 850 mg n = 117	Sitagliptin 100 mg n = 113	Placebo n = 117
Value	-1.67 (-1.92 to -1.43)	-1.83 (-2.07 to -1.58)	-1.29 (-1.54 to -1.04)	-1.56 (-1.80 to -1.32)	-0.99 (-1.24 to -0.75)	-0.59 (-0.84 to -0.34)

Sitagliptin 50 mg + Metformin 850 mg vs Metformin 850 mg: Difference in Least Squares Mean: -0.27 (95% CI -0.58 to 0.04), p = 0.087, ANCOVA
Sitagliptin 50 mg + Metformin 850 mg vs Sitagliptin 100 mg: Difference in Least Squares Mean: -0.84 (95% CI -1.15 to -0.52), p <0.001, ANCOVA
Sitagliptin 50 mg + Metformin 500 mg vs Metformin 500 mg: Difference in Least Squares Mean: -0.39 (95% CI -0.69 to -0.08), p = 0.014, ANCOVA

Population analysed: Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for the A1C subsequent to at least 1 dose of study treatment, or lacked baseline data for the A1C. Last observation carried forward (missing data approach).

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 50 mg + Metformin 500 mg	0 of 122 (0%)	9 of 122 (7.4%)	Not reported
Sitagliptin 50 mg + Metformin 850 mg	0 of 125 (0%)	14 of 125 (11.2%)	Not reported
Metformin 500 mg	1 of 126 (0.8%)	8 of 126 (6.3%)	Not reported
Metformin 850	1 of 124 (0.8%)	13 of 124 (10.5%)	Not reported
Sitagliptin 100 mg	3 of 120 (2.5%)	6 of 120 (5%)	Not reported
Placebo	1 of 126 (0.8%)	4 of 126 (3.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27181998Ji L, Han P, Wang X, Liu J, Zheng S, Jou YM, O'Neill EA, Golm GT, Engel SS, Kaufman KD, Shankar RR. Randomized clinical trial of the safety and efficacy of sitagliptin and metformin co-administered to Chinese patients with type 2 diabetes mellitus. J Diabetes Investig. 2016 Sep;7(5):727-36. doi: 10.1111/jdi.12511. Epub 2016 May 19.
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

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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sitagliptin 50 mg, Metformin 500 mg and Sitagliptin 100 mg 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 3 inclusion and 6 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 23 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. Some participants in this study may receive a placebo. 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 6 Feb 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 (A1C) at Week 24 (time frame: Baseline and Week 24). 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 NCT01076088, 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 23 May 2017.