Type 2 Diabetes MellitusPhase 3NCT02791490

A Study of the Safety and Efficacy of Sitagliptin Addition During Metformin Up-titration (MK-0431-848)

A Phase 3 study testing Sitagliptin and Metformin IR 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Sitagliptin and Metformin IR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 458 participants
Where: No sites listed yet
Study dates: 16 Jun 2016to 1 Feb 2018
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

Male or female participants with T2DM in accordance with American Diabetes Association (ADA) guidelines
Meet one of the following criteria:
Be on stable Met-IR monotherapy 1000 mg/day for ≥8 weeks with a Screening A1C ≥7.5% and ≤11.0%.
OR
Be on stable Met-XR monotherapy 1000 mg/day for ≥8 weeks with a Screening A1C ≥7.5% and ≤11.0%.
OR

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Not on any anti-hyperglycemic agent (AHA) for ≥8 weeks (≥12 weeks if previously taking thiazolidinediones) with a Screening A1C ≥8.5% and ≤12.0%.
OR
Be on stable monotherapy with a sulfonylurea, a glinide, or an α-glucosidase inhibitor for ≥8 weeks with a Screening A1C ≥7.5% and ≤11.0%.
A body mass index (BMI) ≥18.0 kg/m2.
Is a male or a female not of reproductive potential (defined as one who is postmenopausal or has had a hysterectomy and/or bilateral oophorectomy, or had bilateral tubal ligation or occlusion at least 6 weeks prior to Screening visit). If participant is a female of reproductive potential, must agree to remain abstinent from heterosexual activity or agrees to use (or have her partner use) acceptable contraception to prevent pregnancy while receiving blinded study drug and for 14 days after the last dose of blinded study drug

Who cannot join

Has a history of type 1 diabetes mellitus or a history of ketoacidosis or has a history of secondary causes of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant).
A known hypersensitivity or intolerance to any DPP-4 inhibitor. A known hypersensitivity or intolerance to metformin, including participants who were previously unable to tolerate metformin at a dose >1000 mg/day or who have evidence of intolerance to the dose of metformin they are currently taking.
Has been treated with any of the following agents within 8 weeks (12 weeks for thiazolidinediones) of study participation:
Insulin of any type (except for short-term use [i.e., ≤7 days] during concomitant illness or other stress)
DPP-4 inhibitor
Pioglitazone or rosiglitazone (thiazolidinediones)

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Glucagon-like peptide-1 receptor (GLP-1R) agonists
Sodium glucose co-transporter 2 (SGLT2) inhibitors
Bromocriptine (Cycloset™)
Colesevelam (Welchol™)
Any other AHA with the exception of protocol-approved agents
Intends to initiate weight loss medication during the study period
Has undergone bariatric surgery within 12 months of Screening visit
Has started a weight loss medication or a medication associated with weight changes within the prior 12 weeks
A history of myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack, NYHA functional class III-IV heart failure, or severe peripheral vascular disease (e.g., claudication with minimal activity, a nonhealing ischemic ulcer, or disease which is likely to require surgery or angioplasty) within 3 months of study participation
A history of malignancy ≤5 years prior to study participation (i.e., the diagnosis occurred, or any evidence of residual or recurrent disease occurred, within the past 5 years), except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer. Note: A patient with any history of melanoma, leukemia, lymphoma, or renal cell carcinoma is excluded.
Has human immunodeficiency virus (HIV)
with AIDS related complications, or
has not been on a stable anti-retroviral regimen for >6 months, or
has progressive disease, or
using agents associated with glucose intolerance such as nucleoside reverse transcriptase inhibitors (NRTIs) such as azidothymidine (AZT), didanosine (ddI), and stavudine (d4T).
Is on or likely to require treatment for ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.
Has undergone a major surgical procedure within 12 weeks prior to signing the informed consent form (ICF) or has major surgery planned during the trial.
Currently participating, or has participated, in a study in which the participant received an investigational compound or used an investigational device within the prior 12 weeks of signing informed consent or is not willing to refrain from participating in another study.
Is pregnant or breast-feeding, has a positive urine pregnancy test, or is planning to conceive or donate eggs during the study, including 14 days following the last dose of blinded investigational product.
A recent history of alcohol or drug abuse (within 3 years) or is a user of recreational or illicit drugs at the time of screening.

About this study

Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Sitagliptin During Metformin Up-titration Compared With Metformin Up-titration Alone in Subjects With Type 2 Diabetes Mellitus

This trial is designed to evaluate, in adult participants with Type 2 diabetes mellitus (T2DM) and inadequate glycemic control on sub-maximal metformin mono-therapy (1000 mg/day), the effect of up-titration of metformin plus the addition of sitagliptin compared to up-titration of metformin alone on glycemic control. The primary hypothesis of this study is that up-titration of metformin to 2000 mg/day (1000 mg/twice a day) plus the addition of sitagliptin 100 mg/day provides greater reduction in hemoglobin A1C (A1C) compared to metformin up-titration alone. Another primary objective of this study is to evaluate the safety and tolerability of this treatment.

Conditions: Type 2 Diabetes Mellitus
Being tested: Sitagliptin, Placebo, Metformin IR
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®, TESAVEL®, XELEVIA®, RISTABEN®
Oral tablet, 100 mg, once daily at approximately the same time each day
PlaceboDrug
Oral tablet, once daily at approximately the same time each day
Metformin IRDrug
All participants will take Met-IR as background medication. Initially, they will take 1 x 500 mg tablet Met-IR b.i.d. (1000 mg/day). After randomization, all participants will be titrated to 2 x 500 mg tablets of Met-IR b.i.d. (2000 mg/day).

Study groups in NCT02791490
Study group	Role	What they receive
Sitagliptin	Experimental	Participants will receive sitagliptin 100 mg once daily for 20 weeks. They will also receive immediate-release metformin (Met-IR), which will be titrated from a baseline dose of 1000 mg/day (500 mg/twice a day [b.i.d.]) up to 2000 mg/day (1000 mg/b.i.d.) by Day 15. Participants will also receive glycemic rescue therapy as needed. Receives: Drug: Sitagliptin; Drug: Metformin IR
Placebo	Placebo comparator	Participants will receive placebo matching sitagliptin once daily for 20 weeks. They will also receive Met-IR, which will be titrated from baseline dose of 1000 mg/day (500 mg/b.i.d.) up to 2000 mg/day (1000 mg/b.i.d.) by Day 15. Participants will also receive glycemic rescue therapy as needed. Receives: Drug: Placebo; Drug: Metformin IR

What is being measured

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

Change From Baseline in Hemoglobin A1C at Week 20
Hemoglobin A1C is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. The change from baseline represents the Week 20 A1C value minus the Week 0 (baseline) A1C value.
Measured: Baseline and Week 20
Percentage of Participants Who Experienced at Least One Adverse Event (AE)
An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Measured: Up to 22 weeks
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Measured: Up to 20 weeks

Secondary outcomes (4)

Percentage of Participants With Hemoglobin A1C <7% at Week 20
Hemoglobin A1C is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100.
Measured: Week 20
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 20
Plasma glucose was measured on a fasting basis and is expressed as mg/dL. Blood was drawn predose on Day 1 and after 20 weeks of treatment to determine change in FPG levels. The change from baseline represents the Week 20 FPG value minus the Week 0 (baseline) FPG value.
Measured: Baseline and Week 20
Percentage of Participants With Hemoglobin A1C ≥8.5% at Baseline That Attained A1C Goal of <7% at Week 20
Hemoglobin A1C is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100.
Measured: Baseline and Week 20
Percentage of Participants Receiving Glycemic Rescue Therapy
Participants who met pre-specified criteria for glycemic rescue received appropriate rescue therapy. The choice of anti-hyperglycemic rescue agent, dose, and regimen was directed by the investigator, as clinically appropriate.
Measured: Up to 20 weeks

Timeline

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

16 Jun 20161 Feb 2018

First posted6 Jun 2016 (estimated)
Study start16 Jun 2016
Primary completion1 Feb 2018
Study completion1 Feb 2018

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: 458 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02791490
Sponsor's protocol ID: 0431-848
Other IDs: MK-0431-848, 2015-004224-59, 2015
Status last verified: Jan 2019
First submitted: 1 Jun 2016
Last updated: 28 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Frias JP, Zimmer Z, Lam RLH, Amorin G, Ntabadde C, Iredale C, O'Neill EA, Engel SS, Kaufman KD, Makimura H, Crutchlow MF. Double-blind, randomized clinical trial assessing the efficacy and safety of early initiation of sitagliptin during metformin uptitration in the treatment of patients with type 2 diabetes: The CompoSIT-M study. Diabetes Obes Metab. 2019 May;21(5):1128-1135. doi: 10.1111/dom.13626. Epub 2019 Feb 17.
PubMed 30609212

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 trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Sitagliptin During Metformin Up-titration Compared With Metformin Up-titration Alone in Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT02791490
Acronym / sponsor ID: 0431-848
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 458 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 16 Jun 2016 (actual)
Primary completion: 1 Feb 2018 (actual)
Study completion: 1 Feb 2018 (actual)
First posted: 6 Jun 2016 (estimated)
Results: Posted 28 Feb 2019

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	Experimental	Drug: Sitagliptin, Drug: Metformin IRParticipants will receive sitagliptin 100 mg once daily for 20 weeks. They will also receive immediate-release metformin (Met-IR), which will be titrated from a baseline dose of 1000 mg/day (500 mg/twice a day [b.i.d.]) up to 2000 mg/day (1000 mg/b.i.d.) by Day 15. Participants will also receive glycemic rescue therapy as needed.
Placebo	Placebo comparator	Drug: Placebo, Drug: Metformin IRParticipants will receive placebo matching sitagliptin once daily for 20 weeks. They will also receive Met-IR, which will be titrated from baseline dose of 1000 mg/day (500 mg/b.i.d.) up to 2000 mg/day (1000 mg/b.i.d.) by Day 15. Participants will also receive glycemic rescue therapy as needed.

Who may qualify

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

Key inclusion criteria (11 listed)

Male or female participants with T2DM in accordance with American Diabetes Association (ADA) guidelines
Meet one of the following criteria:
OR
OR
OR

Key exclusion criteria (26 listed)

Has a history of type 1 diabetes mellitus or a history of ketoacidosis or has a history of secondary causes of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant).
A known hypersensitivity or intolerance to any DPP-4 inhibitor. A known hypersensitivity or intolerance to metformin, including participants who were previously unable to tolerate metformin at a dose >1000 mg/day or who have evidence of intolerance to the dose of metformin they are currently taking.
Has been treated with any of the following agents within 8 weeks (12 weeks for thiazolidinediones) of study participation:
Intends to initiate weight loss medication during the study period
Has undergone bariatric surgery within 12 months of Screening visit

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: JANUVIA®, TESAVEL®, XELEVIA®, RISTABEN®Oral tablet, 100 mg, once daily at approximately the same time each day	Drug	Sitagliptin
PlaceboOral tablet, once daily at approximately the same time each day	Drug	Placebo
Metformin IRAll participants will take Met-IR as background medication. Initially, they will take 1 x 500 mg tablet Met-IR b.i.d. (1000 mg/day). After randomization, all participants will be titrated to 2 x 500 mg tablets of Met-IR b.i.d. (2000 mg/day).	Drug	Placebo, Sitagliptin

Primary outcome

Change From Baseline in Hemoglobin A1C at Week 20
Time frame: Baseline and Week 20
Hemoglobin A1C is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. The change from baseline represents the Week 20 A1C value minus the Week 0 (baseline) A1C value.
Percentage of Participants Who Experienced at Least One Adverse Event (AE)
Time frame: Up to 22 weeks
An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
Time frame: Up to 20 weeks
An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

4 secondary outcomes

Percentage of Participants With Hemoglobin A1C <7% at Week 20
Time frame: Week 20
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 20
Time frame: Baseline and Week 20
Percentage of Participants With Hemoglobin A1C ≥8.5% at Baseline That Attained A1C Goal of <7% at Week 20
Time frame: Baseline and Week 20
Percentage of Participants Receiving Glycemic Rescue Therapy
Time frame: Up to 20 weeks

Results and safety

Results posted to the registry on 28 Feb 2019, 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	229	226
Placebo	229	221

Primary outcome: Change From Baseline in Hemoglobin A1C at Week 20

Time frame: Baseline and Week 20. Least squares mean (95% Confidence Interval). Unit: A1C (%)

Measure	Sitagliptin n = 229	Placebo n = 229
Value	-1.10 (-1.28 to -0.93)	-0.69 (-0.88 to -0.51)

Sitagliptin vs Placebo: Difference in Least Squares Means: -0.41 (95% CI -0.59 to -0.23), p <0.001, Longitudinal Data Analysis

Population analysed: All randomized participants who received at least 1 dose of study medication and had at least 1 observation for the analysis endpoint

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

Time frame: Up to 22 weeks. Number. Unit: Percentage of participants

Measure	Sitagliptin n = 229	Placebo n = 229
Value	44.1	45.9

Sitagliptin vs Placebo: Difference in % vs Placebo: -1.7 (95% CI -10.8 to 7.4), Miettinen and Nurminen method

Population analysed: All randomized participants who received at least 1 dose of study medication

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

Time frame: Up to 20 weeks. Number. Unit: Percentage of participants

Measure	Sitagliptin n = 229	Placebo n = 229
Value	0.9	0.0

Population analysed: 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 22 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitagliptin	3 of 229 (1.3%)	18 of 229 (7.9%)	0 of 229
Placebo	4 of 229 (1.7%)	11 of 229 (4.8%)	0 of 229

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30609212Frias JP, Zimmer Z, Lam RLH, Amorin G, Ntabadde C, Iredale C, O'Neill EA, Engel SS, Kaufman KD, Makimura H, Crutchlow MF. Double-blind, randomized clinical trial assessing the efficacy and safety of early initiation of sitagliptin during metformin uptitration in the treatment of patients with type 2 diabetes: The CompoSIT-M study. Diabetes Obes Metab. 2019 May;21(5):1128-1135. doi: 10.1111/dom.13626. Epub 2019 Feb 17.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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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 Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sitagliptin and Metformin IR 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 11 inclusion and 26 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 28 Feb 2019. 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 28 Feb 2019). 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 at Week 20 (time frame: Baseline and Week 20). 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 NCT02791490, 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 28 Feb 2019.