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TerminatedNCT01678820Updated Aug 24, 2018Results posted

A Study of the Efficacy and Safety of MK-0431D (a Fixed-dose Combination of Sitagliptin and Simvastatin) for the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-266)

A Phase 3 interventional study of Sitagliptin/Simvastatin FDC and Sitagliptin in Type 2 Diabetes Mellitus, sponsored by Merck Sharp & Dohme LLC. Terminated. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2018-08-24.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment

Why this study was terminated
Merck terminated the study for business reasons in November 2013.
Phase
Phase 3
Study type
Interventional
Enrollment
299
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study summary

The purpose of this study is to assess the efficacy and safety of sitagliptin/simvastatin fixed-dose combination (FDC) in participants with T2DM who have inadequate glycemic control while on metformin monotherapy. The primary hypothesis of this study is that after 16 weeks of therapy, the mean change from baseline in hemoglobin A1C (A1C) in participants treated with sitagliptin/simvastatin FDC is non-inferior compared to sitagliptin alone.

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 299 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • has T2DM
  • (1) Male; (2) female not of reproductive potential; or (3) female of reproductive potential who agrees to remain abstinent or use alone or in conjunction with their partner 2 methods of contraception to prevent pregnancy during the study and for 14 days after the last dose of study drug
  • is currently on metformin monotherapy at a daily dose of at least 1500 mg for at least 10 weeks
  • is not on a lipid-lowering agent for at least 6 weeks prior to entering the study

Exclusion criteria

Exclusion Criteria:

  • has history of type 1 diabetes mellitus (T1DM), or a history of ketoacidosis or possibly has T1DM
  • has been on a thiazolidinedione (TZD) within the previous 16 weeks
  • has been treated with a statin or other lipid-lowering agent (including over-the-counter [OTC] supplements) within the previous 6 weeks
  • currently participating in or has participated in another clinical study within the past 12 weeks
  • intends to consume >1.2 liters of grapefruit juice daily during the study
  • is on or likely to require treatment for at least 2 consecutive weeks or repeated courses of corticosteroids (inhaled, nasal and topical corticosteroids are permitted)
  • intolerance or hypersensitivity to sitagliptin, simvastatin, metformin or glimepiride
  • is on a weight loss program and not in the maintenance phase or has started a weight loss medication or has undergone bariatric surgery in the previous 12 months
  • has undergone a surgical procedure in the past 4 weeks or planned major surgery during the study
  • has symptomatic hyperglycemia that requires immediate initiation, adjustment, or addition of antihyperglycemic therapy
  • has a history of myopathy or rhabdomyolysis with any statin
  • has cardiovascular disease, a diagnosis of congestive heart failure, or uncontrolled high blood pressure
  • has a history of active liver disease
  • has chronic progressive neuromuscular disorder, human immunodeficiency virus (HIV), hematological disorder, or uncontrolled endocrine or metabolic disease
  • is currently being treated for hyperthyroidism or is on thyroid hormone therapy and has not been on a stable dose for at least 6 weeks
  • has a history of malignancy in the previous 5 years (excluding adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer)
  • is pregnant or breast feeding, or is expecting to conceive or donate eggs during the course of the study, including 14 days after the last dose of study drug
  • is a user of recreational or illicit drugs or has had a recent history of drug abuse
  • consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
299 participants (actual)

Study arms

  • Experimental
    Sitagliptin/Simvastatin FDC

    Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.

    Drug: Sitagliptin/Simvastatin FDC · Drug: Placebo to sitagliptin · Drug: Placebo to simvastatin · Drug: Metformin · Drug: Glimepiride

  • Active comparator
    Sitagliptin

    Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.

    Drug: Sitagliptin · Drug: Placebo to simvastatin · Drug: Placebo to Sitagliptin/Simvastatin FDC · Drug: Metformin · Drug: Glimepiride

  • Active comparator
    Simvastatin

    Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.

    Drug: Simvastatin · Drug: Placebo to sitagliptin · Drug: Placebo to Sitagliptin/Simvastatin FDC · Drug: Metformin · Drug: Glimepiride

Interventions

  • DrugSitagliptin/Simvastatin FDC

    Sitagliptin 100 mg/Simvastatin 40 mg fixed-dose combination tablet

    Also known as: MK-0431D, Juvisync™, Juvicor®

  • DrugSitagliptin

    Sitagliptin 100 mg tablet

    Also known as: MK-0431, Januvia®, Tesavel®, Xelevia®, Ristaben®

  • DrugSimvastatin

    Simvastatin 40 mg tablet

    Also known as: MK-0733, Zocor®

  • DrugPlacebo to sitagliptin

    Matching placebo to sitagliptin 100 mg tablet

  • DrugPlacebo to simvastatin

    Matching placebo to simvastatin 40 mg tablet

  • DrugPlacebo to Sitagliptin/Simvastatin FDC

    Matching placebo to sitagliptin 100 mg/simvastatin 40 mg FDC tablet

  • DrugMetformin

    Participants will continue on their stable, pre-screening metformin daily dose of \>= 1500 mg for at least 12 weeks prior to randomization and during the study

    Also known as: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®

  • DrugGlimepiride

    Following randomization, participants requiring glycemic rescue may receive open-label glimepiride initiated at a dose of 1 mg/day or 2 mg/day which may be up-titrated to 6 mg/day taken once daily with breakfast or the first main meal of the day.

    Also known as: Amaryl®, Glimy

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Hemoglobin A1C (A1C) at Week 16 (Sitagliptin/Simvastatin FDC vs. Sitagliptin)

    A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. sitagliptin. Results for simvastatin are presented below under secondary outcome measures.

    Time frame: Baseline and Week 16

  2. Number of Participants Who Experienced at Least One Adverse Event (AE)

    Excludes data after rescue therapy. 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.

    Time frame: Up to 16 weeks for non-serious AEs, up to 18 weeks for serious AEs

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

    Excludes data after rescue therapy. 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.

    Time frame: Up to 16 weeks

Secondary outcomes

  1. Change From Baseline in A1C at Week 16 (Sitagliptin/Simvastatin FDC vs. Simvastatin)

    A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. simvastatin. Results for sitagliptin are presented above under primary outcome measures.

    Time frame: Baseline and Week 16

  2. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16

    Change from baseline reflects the Week 16 value minus the Week 0 value.

    Time frame: Baseline and Week 16

  3. Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 16

    Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.

    Time frame: Baseline and Week 16

  4. Percent Change From Baseline in Total Cholesterol (TC) at Week 16

    Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.

    Time frame: Baseline and Week 16

  5. Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16

    Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.

    Time frame: Baseline and Week 16

  6. Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16

    Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.

    Time frame: Baseline and Week 16

  7. Percent Change From Baseline in Triglycerides (TG) at Week 16

    Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.

    Time frame: Baseline and Week 16

  8. Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 16

    Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.

    Time frame: Baseline and Week 16

  9. Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16

    Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.

    Time frame: Baseline and Week 16

  10. Percentage of Participants With A1C Level <7% at Week 16

    Percentage of participants achieving glycemic goal (A1C \<7%) after 16 weeks of treatment. Data as observed.

    Time frame: Week 16

07

Results

Posted Oct 22, 2014
Limitations and caveats
Study was terminated for business reasons in November 2013.

Participant flow

Participant flow — Overall Study
MilestoneSitagliptin/Simvastatin FDCSitagliptinSimvastatin
Started10099100
Treated with double-blind study drug1009798
Completed383643
Not completed626357
Withdrew: Study terminated by sponsor454343
Withdrew: Withdrawal by subject252
Withdrew: Protocol specified criteria231
Withdrew: Adverse event222
Withdrew: Lost to follow-up722
Withdrew: Non-compliance with study drug010
Withdrew: Physician decision001
Withdrew: Protocol violation454
Withdrew: Not treated with double-blind study drug022

Outcome measures

PrimaryChange From Baseline in Hemoglobin A1C (A1C) at Week 16 (Sitagliptin/Simvastatin FDC vs. Sitagliptin)

A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. sitagliptin. Results for simvastatin are presented below under secondary outcome measures.

Time frame:
Baseline and Week 16
Reported as:
Least squares mean · Percent
Change From Baseline in Hemoglobin A1C (A1C) at Week 16 (Sitagliptin/Simvastatin FDC vs. Sitagliptin)
PercentSitagliptin/Simvastatin FDCSitagliptin
Change From Baseline in Hemoglobin A1C (A1C) at Week 16 (Sitagliptin/Simvastatin FDC vs. Sitagliptin)-0.41 (-0.64 to -0.17)-0.59 (-0.83 to -0.36)
Statistical analysis
  • Sitagliptin/Simvastatin FDC vs Sitagliptin · Longitudinal Data Analysis Model · p = 0.267 · Difference in least squares means: 0.19 · 95% CI -0.14 to 0.52Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment
PrimaryNumber of Participants Who Experienced at Least One Adverse Event (AE)

Excludes data after rescue therapy. 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.

Time frame:
Up to 16 weeks for non-serious AEs, up to 18 weeks for serious AEs
Reported as:
Number · Participants
Number of Participants Who Experienced at Least One Adverse Event (AE)
ParticipantsSitagliptin/Simvastatin FDCSitagliptinSimvastatin
Number of Participants Who Experienced at Least One Adverse Event (AE)131317
Statistical analysis
  • Sitagliptin/Simvastatin FDC vs Sitagliptin · Difference in percents: -0.4 · 95% CI -10.2 to 9.3Based on Miettinen \& Nurminen method
  • Sitagliptin/Simvastatin FDC vs Simvastatin · Difference in percents: -4.3 · 95% CI -14.7 to 5.8Based on Miettinen \& Nurminen method
PrimaryNumber of Participants Who Discontinued Study Drug Due to an Adverse Event

Excludes data after rescue therapy. 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.

Time frame:
Up to 16 weeks
Reported as:
Number · Participants
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
ParticipantsSitagliptin/Simvastatin FDCSitagliptinSimvastatin
Number of Participants Who Discontinued Study Drug Due to an Adverse Event212
SecondaryChange From Baseline in A1C at Week 16 (Sitagliptin/Simvastatin FDC vs. Simvastatin)

A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. simvastatin. Results for sitagliptin are presented above under primary outcome measures.

Time frame:
Baseline and Week 16
Reported as:
Least squares mean · Percent
Change From Baseline in A1C at Week 16 (Sitagliptin/Simvastatin FDC vs. Simvastatin)
PercentSitagliptin/Simvastatin FDCSimvastatin
Change From Baseline in A1C at Week 16 (Sitagliptin/Simvastatin FDC vs. Simvastatin)-0.41 (-0.64 to -0.17)0.21 (-0.02 to 0.45)
Statistical analysis
  • Sitagliptin/Simvastatin FDC vs Simvastatin · Longitudinal Data Analysis Model · p = <0.001 · Difference in least squares means: -0.62 · 95% CI -0.95 to -0.28Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.
SecondaryChange From Baseline in Fasting Plasma Glucose (FPG) at Week 16

Change from baseline reflects the Week 16 value minus the Week 0 value.

Time frame:
Baseline and Week 16
Reported as:
Least squares mean · mg/dL
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16
mg/dLSitagliptin/Simvastatin FDCSitagliptinSimvastatin
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16-7.9 (-21.0 to 5.2)-9.6 (-23.4 to 4.1)21.3 (7.9 to 34.7)
Statistical analysis
  • Sitagliptin/Simvastatin FDC vs Sitagliptin · Longitudinal Data Analysis Model · p = 0.856 · Difference in least squares means: 1.7 · 95% CI -17.1 to 20.6Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.
  • Sitagliptin/Simvastatin FDC vs Simvastatin · Longitudinal Data Analysis Model · p = 0.002 · Difference in least squares means: -29.2 · 95% CI -47.9 to -10.6Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.
SecondaryPercent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 16

Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.

Time frame:
Baseline and Week 16
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 16
Percent changeSitagliptin/Simvastatin FDCSitagliptinSimvastatin
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 16-21.6 (-32.3 to -10.8)4.0 (-6.9 to 14.9)-26.9 (-37.5 to -16.3)
Statistical analysis
  • Sitagliptin/Simvastatin FDC vs Sitagliptin · Longitudinal Data Analysis Model · p = <0.001 · Difference in least squares means: -25.6 · 95% CI -35.6 to -15.6Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.
  • Sitagliptin/Simvastatin FDC vs Simvastatin · Longitudinal Data Analysis Model · p = 0.286 · Difference in least squares means: 5.3 · 95% CI -4.5 to 15.2Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.
SecondaryPercent Change From Baseline in Total Cholesterol (TC) at Week 16

Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.

Time frame:
Baseline and Week 16
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Total Cholesterol (TC) at Week 16
Percent changeSitagliptin/Simvastatin FDCSitagliptinSimvastatin
Percent Change From Baseline in Total Cholesterol (TC) at Week 16-18.4 (-26.6 to -10.2)-0.4 (-8.6 to 7.9)-18.4 (-26.4 to -10.4)
Statistical analysis
  • Sitagliptin/Simvastatin FDC vs Sitagliptin · Longitudinal Data Analysis Model · p = <0.001 · Difference in least squares means: -18.1 · 95% CI -24.2 to -12.0Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.
  • Sitagliptin/Simvastatin FDC vs Simvastatin · Longitudinal Data Analysis Model · p = 0.990 · Difference in least squares means: -0.0 · 95% CI -6.0 to 6.0Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.
SecondaryPercent Change From Baseline in Apolipoprotein B (Apo B) at Week 16

Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.

Time frame:
Baseline and Week 16
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16
Percent changeSitagliptin/Simvastatin FDCSitagliptinSimvastatin
Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16-16.9 (-27.0 to -6.8)3.3 (-7.1 to 13.7)-19.8 (-30.0 to -9.6)
Statistical analysis
  • Sitagliptin/Simvastatin FDC vs Sitagliptin · Longitudinal Data Analysis Model · p = <0.001 · Difference in least squares means: -20.2 · 95% CI -28.3 to -12.2Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.
  • Sitagliptin/Simvastatin FDC vs Simvastatin · Longitudinal Data Analysis Model · p = 0.469 · Difference in least squares means: 2.9 · 95% CI -5.0 to 10.7Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.
SecondaryPercent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16

Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.

Time frame:
Baseline and Week 16
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16
Percent changeSitagliptin/Simvastatin FDCSitagliptinSimvastatin
Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16-23.9 (-33.9 to -13.9)0.6 (-9.5 to 10.7)-24.2 (-34.0 to -14.4)
Statistical analysis
  • Sitagliptin/Simvastatin FDC vs Sitagliptin · Longitudinal Data Analysis Model · p = <0.001 · Difference in least squares means: -24.4 · 95% CI -32.6 to -16.3Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.
  • Sitagliptin/Simvastatin FDC vs Simvastatin · Longitudinal Data Analysis Model · p = 0.937 · Difference in least squares means: 0.3 · 95% CI -7.7 to 8.3Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.
SecondaryPercent Change From Baseline in Triglycerides (TG) at Week 16

Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.

Time frame:
Baseline and Week 16
Reported as:
Mean · Percent change
Percent Change From Baseline in Triglycerides (TG) at Week 16
Percent changeSitagliptin/Simvastatin FDCSitagliptinSimvastatin
Percent Change From Baseline in Triglycerides (TG) at Week 16-20.4 (-51.9 to 11.1)-4.9 (-39.5 to 29.7)-10.1 (-52.1 to 31.9)
Statistical analysis
  • Sitagliptin/Simvastatin FDC vs Sitagliptin · Robust regression · p = 0.068 · Difference in estimated means: -15.5 · 95% CI -32.2 to 1.2Using M-estimation with treatment, region, and a covariate for baseline triglycerides (mg/dL). Missing data were imputed by multiple imputations.
  • Sitagliptin/Simvastatin FDC vs Simvastatin · Robust regression · p = 0.365 · Difference in estimated means: -10.3 · 95% CI -33.6 to 13.0Using M-estimation with treatment, region, and a covariate for baseline triglycerides (mg/dL). Missing data were imputed by multiple imputations.
SecondaryPercent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 16

Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.

Time frame:
Baseline and Week 16
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 16
Percent changeSitagliptin/Simvastatin FDCSitagliptinSimvastatin
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 162.5 (-2.7 to 7.8)2.0 (-3.3 to 7.4)2.1 (-3.0 to 7.3)
Statistical analysis
  • Sitagliptin/Simvastatin FDC vs Sitagliptin · Longitudinal Data Analysis Model · p = 0.857 · Difference in least squares means: 0.5 · 95% CI -4.8 to 5.8Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.
  • Sitagliptin/Simvastatin FDC vs Simvastatin · Longitudinal Data Analysis Model · p = 0.879 · Difference in least squares means: 0.4 · 95% CI -4.8 to 5.6Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.
SecondaryPercent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16

Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.

Time frame:
Baseline and Week 16
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16
Percent changeSitagliptin/Simvastatin FDCSitagliptinSimvastatin
Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16-17.5 (-33.8 to -1.2)12.9 (-4.2 to 29.9)-2.2 (-18.9 to 14.5)
Statistical analysis
  • Sitagliptin/Simvastatin FDC vs Sitagliptin · Longitudinal Data Analysis Model · p = 0.004 · Difference in least squares means: -30.4 · 95% CI -51.0 to -9.7Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.
  • Sitagliptin/Simvastatin FDC vs Simvastatin · Longitudinal Data Analysis Model · p = 0.141 · Difference in least squares means: -15.3 · 95% CI -35.8 to 5.1Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.
SecondaryPercentage of Participants With A1C Level <7% at Week 16

Percentage of participants achieving glycemic goal (A1C \<7%) after 16 weeks of treatment. Data as observed.

Time frame:
Week 16
Reported as:
Number · Percentage of participants
Percentage of Participants With A1C Level <7% at Week 16
Percentage of participantsSitagliptin/Simvastatin FDCSitagliptinSimvastatin
Percentage of Participants With A1C Level <7% at Week 1629.929.617.6
Statistical analysis
  • Sitagliptin/Simvastatin FDC vs Sitagliptin · Difference in percents: 0.3 · 95% CI -12.2 to 12.9Based on Miettinen \& Nurminen method. Missing data were imputed by multiple impuattions.
  • Sitagliptin/Simvastatin FDC vs Simvastatin · Difference in percents: 12.3 · 95% CI 0.7 to 24.0Based on Miettinen \& Nurminen method. Missing data were imputed by multiple imputations.

Adverse events

Collected over Up to 18 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sitagliptin/Simvastatin FDC—1/100 (1%)0/100 (0%)
Sitagliptin—0/97 (0%)0/97 (0%)
Simvastatin—1/98 (1%)0/98 (0%)
Most frequent serious events
Most frequent serious events
EventSitagliptin/Simvastatin FDCSitagliptinSimvastatin
Musculoskeletal chest painMusculoskeletal and connective tissue disorders0/1000/971/98
Abdominal painGastrointestinal disorders1/1000/970/98
Intestinal obstructionGastrointestinal disorders1/1000/970/98

Baseline characteristics

All participants randomized population. Study specific baseline characteristics include all randomized participants with data.

Age, Continuous
Age, Continuous(Years)Sitagliptin/Simvastatin FDCSitagliptinSimvastatinTotal
Mean54.9 ± 10.254.2 ± 10.354.9 ± 10.054.7 ± 10.1
Sex: Female, Male
Sex: Female, Male(Participants)Sitagliptin/Simvastatin FDCSitagliptinSimvastatinTotal
Female455249146
Male554751153
Hemoglobin A1c (A1C)
Hemoglobin A1c (A1C)(Percent)Sitagliptin/Simvastatin FDCSitagliptinSimvastatinTotal
Mean8.16 ± 0.948.15 ± 1.098.22 ± 1.198.18 ± 1.08
Fasting plasma glucose (FPG)
Fasting plasma glucose (FPG)(mg/dL)Sitagliptin/Simvastatin FDCSitagliptinSimvastatinTotal
Mean169.9 ± 42.3175.9 ± 48.6175.7 ± 49.3173.8 ± 46.8
Low-density lipoprotein cholesterol (LDL-C)
Low-density lipoprotein cholesterol (LDL-C)(mg/dL)Sitagliptin/Simvastatin FDCSitagliptinSimvastatinTotal
Mean106.5 ± 26.7103.9 ± 24.2100.9 ± 22.0103.7 ± 24.4
Total cholesterol (TC)
Total cholesterol (TC)(mg/dL)Sitagliptin/Simvastatin FDCSitagliptinSimvastatinTotal
Mean189.3 ± 30.9187.7 ± 29.6183.5 ± 28.4186.8 ± 29.6
Apolipoprotein B (Apo B)
Apolipoprotein B (Apo B)(mg/dL)Sitagliptin/Simvastatin FDCSitagliptinSimvastatinTotal
Mean97.8 ± 19.095.4 ± 19.094.1 ± 17.295.8 ± 18.4
Non high-density lipoprotein cholesterol (non-HDL-C)
Non high-density lipoprotein cholesterol (non-HDL-C)(mg/dL)Sitagliptin/Simvastatin FDCSitagliptinSimvastatinTotal
Mean141.7 ± 30.9139.5 ± 29.9136.5 ± 27.1139.2 ± 29.3

3 further baseline measures are reported on the registry.

08

Study locations

No study locations are listed for this record.

09

References and documents

Individual participant data

Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01678820
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Sep 5, 2012
Start date
Oct 10, 2012
Primary completion
Nov 1, 2013
Completion
Nov 1, 2013
Results posted
Oct 22, 2014
Last update
Aug 24, 2018

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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