Type 2 Diabetes Mellitus
Conditions
Brief 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.
Interventions
DRUGSitagliptin/Simvastatin FDC
Sitagliptin 100 mg/Simvastatin 40 mg fixed-dose combination tablet
DRUGSitagliptin
Sitagliptin 100 mg tablet
DRUGSimvastatin
Simvastatin 40 mg tablet
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
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.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin A1C (A1C) at Week 16 (Sitagliptin/Simvastatin FDC vs. Sitagliptin) | Baseline and Week 16 | 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. |
| Number of Participants Who Experienced at Least One Adverse Event (AE) | Up to 16 weeks for non-serious AEs, up to 18 weeks for serious AEs | 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. |
| Number of Participants Who Discontinued Study Drug Due to an Adverse Event | Up to 16 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Total Cholesterol (TC) at Week 16 | Baseline and 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%. |
| Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 | Baseline and 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%. |
| Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16 | Baseline and 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%. |
| Change From Baseline in A1C at Week 16 (Sitagliptin/Simvastatin FDC vs. Simvastatin) | Baseline and Week 16 | 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. |
| Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 16 | Baseline and 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%. |
| Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16 | Baseline and 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%. |
| Percentage of Participants With A1C Level <7% at Week 16 | Week 16 | Percentage of participants achieving glycemic goal (A1C \<7%) after 16 weeks of treatment. Data as observed. |
| Percent Change From Baseline in Triglycerides (TG) at Week 16 | Baseline and 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%. |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16 | Baseline and Week 16 | Change from baseline reflects the Week 16 value minus the Week 0 value. |
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 16 | Baseline and 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%. |
Participant flow
Pre-assignment details
All participants randomized population.
Participants by arm
| Arm | Count |
|---|---|
| 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. 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. | 100 |
| Sitagliptin Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. 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. | 99 |
| Simvastatin Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. 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. | 100 |
| Total | 299 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 | 2 |
| Overall Study | Lost to Follow-up | 7 | 2 | 2 |
| Overall Study | Non-compliance with study drug | 0 | 1 | 0 |
| Overall Study | Not treated with double-blind study drug | 0 | 2 | 2 |
| Overall Study | Physician Decision | 0 | 0 | 1 |
| Overall Study | Protocol Specified Criteria | 2 | 3 | 1 |
| Overall Study | Protocol Violation | 4 | 5 | 4 |
| Overall Study | Study Terminated by Sponsor | 45 | 43 | 43 |
| Overall Study | Withdrawal by Subject | 2 | 5 | 2 |
Baseline characteristics
| Characteristic | Sitagliptin/Simvastatin FDC | Sitagliptin | Simvastatin | Total |
|---|---|---|---|---|
| Age, Continuous | 54.9 Years STANDARD_DEVIATION 10.2 | 54.2 Years STANDARD_DEVIATION 10.3 | 54.9 Years STANDARD_DEVIATION 10 | 54.7 Years STANDARD_DEVIATION 10.1 |
| Apolipoprotein B (Apo B) | 97.8 mg/dL STANDARD_DEVIATION 19 | 95.4 mg/dL STANDARD_DEVIATION 19 | 94.1 mg/dL STANDARD_DEVIATION 17.2 | 95.8 mg/dL STANDARD_DEVIATION 18.4 |
| Fasting plasma glucose (FPG) | 169.9 mg/dL STANDARD_DEVIATION 42.3 | 175.9 mg/dL STANDARD_DEVIATION 48.6 | 175.7 mg/dL STANDARD_DEVIATION 49.3 | 173.8 mg/dL STANDARD_DEVIATION 46.8 |
| Hemoglobin A1c (A1C) | 8.16 Percent STANDARD_DEVIATION 0.94 | 8.15 Percent STANDARD_DEVIATION 1.09 | 8.22 Percent STANDARD_DEVIATION 1.19 | 8.18 Percent STANDARD_DEVIATION 1.08 |
| High-density lipoprotein cholesterol (HDL-C) | 47.6 mg/dL STANDARD_DEVIATION 11.3 | 48.2 mg/dL STANDARD_DEVIATION 12.1 | 47.0 mg/dL STANDARD_DEVIATION 11.2 | 47.6 mg/dL STANDARD_DEVIATION 11.5 |
| Low-density lipoprotein cholesterol (LDL-C) | 106.5 mg/dL STANDARD_DEVIATION 26.7 | 103.9 mg/dL STANDARD_DEVIATION 24.2 | 100.9 mg/dL STANDARD_DEVIATION 22 | 103.7 mg/dL STANDARD_DEVIATION 24.4 |
| Non high-density lipoprotein cholesterol (non-HDL-C) | 141.7 mg/dL STANDARD_DEVIATION 30.9 | 139.5 mg/dL STANDARD_DEVIATION 29.9 | 136.5 mg/dL STANDARD_DEVIATION 27.1 | 139.2 mg/dL STANDARD_DEVIATION 29.3 |
| Sex: Female, Male Female | 45 Participants | 52 Participants | 49 Participants | 146 Participants |
| Sex: Female, Male Male | 55 Participants | 47 Participants | 51 Participants | 153 Participants |
| Total cholesterol (TC) | 189.3 mg/dL STANDARD_DEVIATION 30.9 | 187.7 mg/dL STANDARD_DEVIATION 29.6 | 183.5 mg/dL STANDARD_DEVIATION 28.4 | 186.8 mg/dL STANDARD_DEVIATION 29.6 |
| Triglycerides (TG) | 177.4 mg/dL STANDARD_DEVIATION 101.2 | 180.8 mg/dL STANDARD_DEVIATION 119.1 | 184.2 mg/dL STANDARD_DEVIATION 118.6 | 180.8 mg/dL STANDARD_DEVIATION 112.9 |
| Very low-density lipoprotein cholesterol (VLDL-C) | 35.4 mg/dL STANDARD_DEVIATION 18.8 | 35.8 mg/dL STANDARD_DEVIATION 20.4 | 35.7 mg/dL STANDARD_DEVIATION 18.8 | 35.6 mg/dL STANDARD_DEVIATION 19.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 100 | 0 / 97 | 0 / 98 |
| serious Total, serious adverse events | 1 / 100 | 0 / 97 | 1 / 98 |
Outcome results
Primary
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
Population: Full analysis set (FAS) population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Sitagliptin/Simvastatin FDC | Change From Baseline in Hemoglobin A1C (A1C) at Week 16 (Sitagliptin/Simvastatin FDC vs. Sitagliptin) | -0.41 Percent |
| Sitagliptin | Change From Baseline in Hemoglobin A1C (A1C) at Week 16 (Sitagliptin/Simvastatin FDC vs. Sitagliptin) | -0.59 Percent |
p-value: 0.26795% CI: [-0.14, 0.52]Longitudinal Data Analysis Model
Primary
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
Population: All participants as treated population defined as all randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sitagliptin/Simvastatin FDC | Number of Participants Who Discontinued Study Drug Due to an Adverse Event | 2 Participants |
| Sitagliptin | Number of Participants Who Discontinued Study Drug Due to an Adverse Event | 1 Participants |
| Simvastatin | Number of Participants Who Discontinued Study Drug Due to an Adverse Event | 2 Participants |
Primary
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
Population: All participants as treated population defined as all randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sitagliptin/Simvastatin FDC | Number of Participants Who Experienced at Least One Adverse Event (AE) | 13 Participants |
| Sitagliptin | Number of Participants Who Experienced at Least One Adverse Event (AE) | 13 Participants |
| Simvastatin | Number of Participants Who Experienced at Least One Adverse Event (AE) | 17 Participants |
95% CI: [-10.2, 9.3]
95% CI: [-14.7, 5.8]
Secondary
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
Population: FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Sitagliptin/Simvastatin FDC | Change From Baseline in A1C at Week 16 (Sitagliptin/Simvastatin FDC vs. Simvastatin) | -0.41 Percent |
| Sitagliptin | Change From Baseline in A1C at Week 16 (Sitagliptin/Simvastatin FDC vs. Simvastatin) | 0.21 Percent |
p-value: <0.00195% CI: [-0.95, -0.28]Longitudinal Data Analysis Model
Secondary
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
Population: FAS population defined as all randomized participants who took at least one dose of study drug and who had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Sitagliptin/Simvastatin FDC | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16 | -7.9 mg/dL |
| Sitagliptin | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16 | -9.6 mg/dL |
| Simvastatin | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16 | 21.3 mg/dL |
p-value: 0.85695% CI: [-17.1, 20.6]Longitudinal Data Analysis Model
p-value: 0.00295% CI: [-47.9, -10.6]Longitudinal Data Analysis Model
Secondary
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
Population: FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sitagliptin/Simvastatin FDC | Percentage of Participants With A1C Level <7% at Week 16 | 29.9 Percentage of participants |
| Sitagliptin | Percentage of Participants With A1C Level <7% at Week 16 | 29.6 Percentage of participants |
| Simvastatin | Percentage of Participants With A1C Level <7% at Week 16 | 17.6 Percentage of participants |
95% CI: [-12.2, 12.9]
95% CI: [0.7, 24]
Secondary
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
Population: FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Sitagliptin/Simvastatin FDC | Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 | -16.9 Percent change |
| Sitagliptin | Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 | 3.3 Percent change |
| Simvastatin | Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 | -19.8 Percent change |
p-value: <0.00195% CI: [-28.3, -12.2]Longitudinal Data Analysis Model
p-value: 0.46995% CI: [-5, 10.7]Longitudinal Data Analysis Model
Secondary
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
Population: FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Sitagliptin/Simvastatin FDC | Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 16 | 2.5 Percent change |
| Sitagliptin | Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 16 | 2.0 Percent change |
| Simvastatin | Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 16 | 2.1 Percent change |
p-value: 0.85795% CI: [-4.8, 5.8]Longitudinal Data Analysis Model
p-value: 0.87995% CI: [-4.8, 5.6]Longitudinal Data Analysis Model
Secondary
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
Population: FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Sitagliptin/Simvastatin FDC | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 16 | -21.6 Percent change |
| Sitagliptin | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 16 | 4.0 Percent change |
| Simvastatin | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 16 | -26.9 Percent change |
p-value: <0.00195% CI: [-35.6, -15.6]Longitudinal Data Analysis Model
p-value: 0.28695% CI: [-4.5, 15.2]Longitudinal Data Analysis Model
Secondary
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
Population: FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Sitagliptin/Simvastatin FDC | Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16 | -23.9 Percent change |
| Sitagliptin | Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16 | 0.6 Percent change |
| Simvastatin | Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16 | -24.2 Percent change |
p-value: <0.00195% CI: [-32.6, -16.3]Longitudinal Data Analysis Model
p-value: 0.93795% CI: [-7.7, 8.3]Longitudinal Data Analysis Model
Secondary
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
Population: FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Sitagliptin/Simvastatin FDC | Percent Change From Baseline in Total Cholesterol (TC) at Week 16 | -18.4 Percent change |
| Sitagliptin | Percent Change From Baseline in Total Cholesterol (TC) at Week 16 | -0.4 Percent change |
| Simvastatin | Percent Change From Baseline in Total Cholesterol (TC) at Week 16 | -18.4 Percent change |
p-value: <0.00195% CI: [-24.2, -12]Longitudinal Data Analysis Model
p-value: 0.9995% CI: [-6, 6]Longitudinal Data Analysis Model
Secondary
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
Population: FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sitagliptin/Simvastatin FDC | Percent Change From Baseline in Triglycerides (TG) at Week 16 | -20.4 Percent change |
| Sitagliptin | Percent Change From Baseline in Triglycerides (TG) at Week 16 | -4.9 Percent change |
| Simvastatin | Percent Change From Baseline in Triglycerides (TG) at Week 16 | -10.1 Percent change |
p-value: 0.06895% CI: [-32.2, 1.2]Robust regression
p-value: 0.36595% CI: [-33.6, 13]Robust regression
Secondary
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
Population: FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Sitagliptin/Simvastatin FDC | Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16 | -17.5 Percent change |
| Sitagliptin | Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16 | 12.9 Percent change |
| Simvastatin | Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16 | -2.2 Percent change |
p-value: 0.00495% CI: [-51, -9.7]Longitudinal Data Analysis Model
p-value: 0.14195% CI: [-35.8, 5.1]Longitudinal Data Analysis Model