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Type 2 Diabetes MellitusPhase 3NCT01702298

A Study to Assess the Safety and Tolerability of Sitagliptin/Simvastatin Fixed-dose Combination (FDC) in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-312)

A Phase 3 study testing Sitagliptin 100 mg/simvastatin 40 mg FDC and Metformin 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

The purpose of this study is to examine the safety and tolerability of sitagliptin 100 mg/simvastatin 40 mg FDC (MK-0431D) in Vietnamese participants with type 2 diabetes mellitus with inadequate glycemic control on metformin. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Sitagliptin 100 mg/simvastatin 40 mg FDC and Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
No sites listed yet
Study dates
7 Dec 2012to 29 May 2013
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 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has type 2 diabetes mellitus
  • Male, or female who is not of reproductive potential or if of reproductive potential agrees to abstain or use (or have their partner use) two acceptable methods of birth control during the study and for 14 days after the last dose of study drug
  • Currently on metformin monotherapy (>=1000 mg per day) for at least 4 weeks prior to study participation
  • Not on statin therapy or other lipid-lowering agent for at least 6 weeks prior to study participation

Who cannot join

  • History of type 1 diabetes mellitus or a history of ketoacidosis
  • History of 2 or more episodes of hypoglycemia resulting in seizure, coma or loss of consciousness over the past 3 months
  • On a thiazolidinedione (TZD) within the past 12 weeks
  • Has been treated with a statin or other lipid-lowering agent within 6 weeks prior to study participation
  • Is on or likely to require treatment with a prohibited medication (itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, gemfibrozil, cyclosporine, danazol, amiodarone, verapamil, diltiazem, amlodipine, ranolazine, niacin)
  • Intends to consume >1.2 liters of grapefruit juice per day during the study
Show all 22Show fewer
  • Is on or likely to require treatment for >=2 consecutive weeks or repeated courses of corticosteroids (inhaled, nasal and topical corticosteroids are permitted)
  • Is on a weight loss program and not in the maintenance phase or has started a weight loss medication or has undergone bariatric surgery within 12 months prior to study participation
  • Has undergone a surgical procedure within 4 weeks of study participation or has planned major surgery during the study
  • History of myopathy or rhabdomyolysis with any statin
  • History of myocardial infarction, unstable or stable angina, angioplasty, bypass surgery, myocardial ischemia, peripheral artery disease, abdominal aortic aneurysm, transient ischemic attacks, stroke of carotid origin or >50% obstruction of a carotid artery
  • Diagnosis of congestive heart failure with New York Heart Association (NYHA) Class III or IV cardiac status
  • History of active liver disease (other than non-alcoholic steatosis) including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
  • Chronic progressive neuromuscular disorder
  • Human immunodeficiency virus (HIV)
  • Hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
  • Currently being treated for hyperthyroidism or is on thyroid hormone replacement therapy and has not been on a stable dose for at least 6 weeks
  • History of malignancy <=5 years prior to study participation, except for basal cell or squamous cell skin cancer or in situ cervical cancer
  • Positive urine pregnancy test
  • Pregnant or breastfeeding, or is expecting to conceive or donate eggs during the study, including 14 days following the last dose of study drug
  • User of recreational or illicit drugs or has had a recent history of drug abuse
  • Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking

About this study

Official title: An Open-label Study to Assess the Safety and Tolerability of MK-0431D for the Treatment of Patients With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy

The purpose of this study is to examine the safety and tolerability of sitagliptin 100 mg/simvastatin 40 mg FDC (MK-0431D) in Vietnamese participants with type 2 diabetes mellitus with inadequate glycemic control on metformin.

Being tested
Sitagliptin 100 mg/simvastatin 40 mg FDC, Metformin
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 100 mg/simvastatin 40 mg FDCDrug

    Also called MK-0431D

    Sitagliptin 100 mg/simvastatin 40 mg FDC tablet administered once daily in the evening for 6 weeks

  • MetforminDrug

    Also called Fortamet®, Glucophage®, Glucophage® XR, Glumetza®

    Participants will continue pre-study dose of metformin tablet(s) >=1000 per day

Study groups in NCT01702298
Study groupRoleWhat they receive
Sitagliptin 100 mg/simvastatin 40 mg FDCExperimentalSitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants will continue pre-study dose of metformin >=1000 mg per day.
Receives: Drug: Sitagliptin 100 mg/simvastatin 40 mg FDC; Drug: Metformin

What is being measured

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

  1. Change From Baseline in Fasting Plasma Glucose (FPG)

    Change from baseline in FPG at Week 6 based on longitudinal data analysis (LDA) model including both baseline and post-baseline measurements as response variable and term time.

    Measured: Baseline and Week 6

  2. Percentage of Participants Who Experienced at Least One Adverse Event

    An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.

    Measured: Up to 8 weeks (including 14 days after final dose of study drug)

  3. Number of Participants Who Discontinued Study Drug Due to an Adverse Event

    Participants who were discontinued from study drug due to an adverse event during the 6 weeks of treatment.

    Measured: Up to 6 weeks

Secondary outcomes (5)

  1. Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)

    Change from baseline in LDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.

    Measured: Baseline and Week 6

  2. Change From Baseline in Total Cholesterol (TC)

    Change from baseline in TC was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.

    Measured: Baseline and Week 6

  3. Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C)

    Change from baseline in non-HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.

    Measured: Baseline and Week 6

  4. Change From Baseline in Triglycerides (TG)

    Change from baseline in TG was measured as a percent change from baseline at Week 6 (median and distribution free 95% confidence interval).

    Measured: Baseline and Week 6

  5. Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)

    Change from baseline in HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.

    Measured: Baseline and Week 6

Timeline

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

  1. First posted8 Oct 2012 (estimated)
  2. Study start7 Dec 2012
  3. Primary completion29 May 2013
  4. Study completion29 May 2013

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01702298
Sponsor's protocol ID
0431D-312
Status last verified
Jul 2018
First submitted
4 Oct 2012
Last updated
24 Aug 2018
Data monitoring committee
No
Individual data sharing
Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sitagliptin 100 mg/simvastatin 40 mg FDC and Metformin 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 4 inclusion and 22 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 24 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 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 30 May 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 Fasting Plasma Glucose (FPG) (time frame: Baseline and Week 6). 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 NCT01702298.

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 24 Aug 2018.

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