Trial Outcomes & Findings for A Study of the Co-administration of Sitagliptin and Atorvastatin in Inadequately Controlled Type 2 Diabetes Mellitus (MK-0431E-211) (NCT NCT01477853)
NCT ID: NCT01477853
Last Updated: 2018-07-26
Results Overview
A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
166 participants
Primary outcome timeframe
Baseline and Week 16
Results posted on
2018-07-26
Participant Flow
Note: 10 participants were enrolled in the study more than once (at more than 1 study site). Nine participants were enrolled twice and one participant was randomized at 3 different sites. Therefore, data of 10 actual participants (counted as 21 participants due to multiple screening/randomization) were removed from the efficacy analyses.
Participant milestones
| Measure |
Sitagliptin/Sitagliptin + Atorvastatin
In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
|
Atorvastatin/Atorvastatin + Glimepiride
In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
|
Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin
In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
|
|---|---|---|---|
|
Phase A
STARTED
|
55
|
56
|
55
|
|
Phase A
COMPLETED
|
12
|
11
|
11
|
|
Phase A
NOT COMPLETED
|
43
|
45
|
44
|
|
Phase B
STARTED
|
12
|
11
|
11
|
|
Phase B
COMPLETED
|
0
|
0
|
0
|
|
Phase B
NOT COMPLETED
|
12
|
11
|
11
|
Reasons for withdrawal
| Measure |
Sitagliptin/Sitagliptin + Atorvastatin
In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
|
Atorvastatin/Atorvastatin + Glimepiride
In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
|
Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin
In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
|
|---|---|---|---|
|
Phase A
Adverse Event
|
1
|
2
|
2
|
|
Phase A
Lost to Follow-up
|
4
|
3
|
2
|
|
Phase A
Physician Decision
|
1
|
0
|
1
|
|
Phase A
Study terminated by sponsor
|
37
|
40
|
39
|
|
Phase B
Lost to Follow-up
|
0
|
1
|
0
|
|
Phase B
Study terminated by sponsor
|
12
|
10
|
11
|
Baseline Characteristics
A Study of the Co-administration of Sitagliptin and Atorvastatin in Inadequately Controlled Type 2 Diabetes Mellitus (MK-0431E-211)
Baseline characteristics by cohort
| Measure |
Sitagliptin/Sitagliptin + Atorvastatin
n=55 Participants
In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
|
Atorvastatin/Atorvastatin + Glimepiride
n=56 Participants
In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
|
Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin
n=55 Participants
In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
|
Total
n=166 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.2 Years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
56.3 Years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
53.7 Years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
55.4 Years
STANDARD_DEVIATION 9.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 16Population: Full analysis set (FAS) population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.
A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent.
Outcome measures
| Measure |
Sitagliptin/Sitagliptin + Atorvastatin
n=15 Participants
In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
|
Atorvastatin/Atorvastatin + Glimepiride
n=17 Participants
In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
|
Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin
n=14 Participants
In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
|
|---|---|---|---|
|
Change From Baseline in Hemoglobin A1C (A1C) at Week 16
|
-1.17 Percent
Standard Error 0.20
|
0.04 Percent
Standard Error 0.31
|
-1.01 Percent
Standard Error 0.22
|
PRIMARY outcome
Timeframe: Baseline and Week 16Population: FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.
Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
Outcome measures
| Measure |
Sitagliptin/Sitagliptin + Atorvastatin
n=16 Participants
In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
|
Atorvastatin/Atorvastatin + Glimepiride
n=18 Participants
In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
|
Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin
n=14 Participants
In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 16
|
4.9 Percent change
Standard Deviation 10.4
|
-35.7 Percent change
Standard Deviation 7.1
|
-38.7 Percent change
Standard Deviation 6.6
|
PRIMARY outcome
Timeframe: Up to 56 weeks (including 2-week follow-up)Population: All participants as treated population included all randomized participants who received at least 1 dose of study treatment.
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 investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an adverse event. Data presented exclude data following the initiation of glycemic rescue therapy.
Outcome measures
| Measure |
Sitagliptin/Sitagliptin + Atorvastatin
n=55 Participants
In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
|
Atorvastatin/Atorvastatin + Glimepiride
n=56 Participants
In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
|
Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin
n=55 Participants
In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
|
|---|---|---|---|
|
Number of Participants Who Experienced at Least One Adverse Event
|
10 Participants
|
13 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Up to 54 weeksPopulation: All participants as treated population included all randomized participants who received at least 1 dose of study treatment.
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 investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an adverse event. Data presented exclude data following the initiation of glycemic rescue therapy.
Outcome measures
| Measure |
Sitagliptin/Sitagliptin + Atorvastatin
n=55 Participants
In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
|
Atorvastatin/Atorvastatin + Glimepiride
n=56 Participants
In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
|
Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin
n=55 Participants
In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
|
|---|---|---|---|
|
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
|
1 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.
Change from baseline reflects the Week 16 value minus the Week 0 value.
Outcome measures
| Measure |
Sitagliptin/Sitagliptin + Atorvastatin
n=15 Participants
In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
|
Atorvastatin/Atorvastatin + Glimepiride
n=18 Participants
In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
|
Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin
n=14 Participants
In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16
|
-15.7 mg/dL
Standard Error 6.4
|
22.7 mg/dL
Standard Error 10.1
|
-26.0 mg/dL
Standard Error 14.0
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.
Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
Outcome measures
| Measure |
Sitagliptin/Sitagliptin + Atorvastatin
n=16 Participants
In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
|
Atorvastatin/Atorvastatin + Glimepiride
n=18 Participants
In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
|
Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin
n=14 Participants
In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Total Cholesterol at Week 16
|
-1.7 Percent change
Standard Error 6.2
|
-28.3 Percent change
Standard Error 4.8
|
-25.7 Percent change
Standard Error 6.0
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.
Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
Outcome measures
| Measure |
Sitagliptin/Sitagliptin + Atorvastatin
n=16 Participants
In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
|
Atorvastatin/Atorvastatin + Glimepiride
n=18 Participants
In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
|
Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin
n=14 Participants
In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16
|
-4.8 Percent change
Standard Error 6.5
|
-32.9 Percent change
Standard Error 5.6
|
-29.0 Percent change
Standard Error 4.6
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.
Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
Outcome measures
| Measure |
Sitagliptin/Sitagliptin + Atorvastatin
n=16 Participants
In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
|
Atorvastatin/Atorvastatin + Glimepiride
n=18 Participants
In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
|
Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin
n=14 Participants
In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16
|
-1.0 Percent change
Standard Error 8.8
|
-34.4 Percent change
Standard Error 6.7
|
-34.6 Percent change
Standard Error 6.7
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.
Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
Outcome measures
| Measure |
Sitagliptin/Sitagliptin + Atorvastatin
n=16 Participants
In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
|
Atorvastatin/Atorvastatin + Glimepiride
n=18 Participants
In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
|
Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin
n=14 Participants
In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Triglycerides at Week 16
|
-9.9 Percent change
Standard Error 8.6
|
-28.7 Percent change
Standard Error 6.5
|
-10.5 Percent change
Standard Error 13.5
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.
Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
Outcome measures
| Measure |
Sitagliptin/Sitagliptin + Atorvastatin
n=15 Participants
In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
|
Atorvastatin/Atorvastatin + Glimepiride
n=18 Participants
In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
|
Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin
n=14 Participants
In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16
|
-15.5 Percent change
Standard Error 7.2
|
-28.6 Percent change
Standard Error 6.6
|
-10.4 Percent change
Standard Error 13.5
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.
Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
Outcome measures
| Measure |
Sitagliptin/Sitagliptin + Atorvastatin
n=16 Participants
In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
|
Atorvastatin/Atorvastatin + Glimepiride
n=18 Participants
In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
|
Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin
n=14 Participants
In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 16
|
-0.3 Percent change
Standard Error 3.2
|
-5.8 Percent change
Standard Error 3.5
|
1.5 Percent change
Standard Error 6.0
|
Adverse Events
Sitagliptin/Sitagliptin + Atorvastatin
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Atorvastatin/Atorvastatin + Glimepiride
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitagliptin/Sitagliptin + Atorvastatin
n=55 participants at risk
In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
|
Atorvastatin/Atorvastatin + Glimepiride
n=56 participants at risk
In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
|
Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin
n=55 participants at risk
In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/55 • Up to 56 weeks including 2-week follow-up (up to 56 weeks for serious adverse events, up to 54 weeks for non-serious adverse events)
All participants as treated population included all randomized participants who received at least 1 dose of study treatment. Serious adverse events include data after the initiation of rescue therapy and non-serious adverse events exclude data after the initiation of rescue therapy.
|
0.00%
0/56 • Up to 56 weeks including 2-week follow-up (up to 56 weeks for serious adverse events, up to 54 weeks for non-serious adverse events)
All participants as treated population included all randomized participants who received at least 1 dose of study treatment. Serious adverse events include data after the initiation of rescue therapy and non-serious adverse events exclude data after the initiation of rescue therapy.
|
1.8%
1/55 • Number of events 1 • Up to 56 weeks including 2-week follow-up (up to 56 weeks for serious adverse events, up to 54 weeks for non-serious adverse events)
All participants as treated population included all randomized participants who received at least 1 dose of study treatment. Serious adverse events include data after the initiation of rescue therapy and non-serious adverse events exclude data after the initiation of rescue therapy.
|
Other adverse events
| Measure |
Sitagliptin/Sitagliptin + Atorvastatin
n=55 participants at risk
In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
|
Atorvastatin/Atorvastatin + Glimepiride
n=56 participants at risk
In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
|
Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin
n=55 participants at risk
In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Intentional overdose
|
3.6%
2/55 • Number of events 2 • Up to 56 weeks including 2-week follow-up (up to 56 weeks for serious adverse events, up to 54 weeks for non-serious adverse events)
All participants as treated population included all randomized participants who received at least 1 dose of study treatment. Serious adverse events include data after the initiation of rescue therapy and non-serious adverse events exclude data after the initiation of rescue therapy.
|
5.4%
3/56 • Number of events 3 • Up to 56 weeks including 2-week follow-up (up to 56 weeks for serious adverse events, up to 54 weeks for non-serious adverse events)
All participants as treated population included all randomized participants who received at least 1 dose of study treatment. Serious adverse events include data after the initiation of rescue therapy and non-serious adverse events exclude data after the initiation of rescue therapy.
|
3.6%
2/55 • Number of events 2 • Up to 56 weeks including 2-week follow-up (up to 56 weeks for serious adverse events, up to 54 weeks for non-serious adverse events)
All participants as treated population included all randomized participants who received at least 1 dose of study treatment. Serious adverse events include data after the initiation of rescue therapy and non-serious adverse events exclude data after the initiation of rescue therapy.
|
|
Investigations
Glomerular filtration rate decreased
|
1.8%
1/55 • Number of events 1 • Up to 56 weeks including 2-week follow-up (up to 56 weeks for serious adverse events, up to 54 weeks for non-serious adverse events)
All participants as treated population included all randomized participants who received at least 1 dose of study treatment. Serious adverse events include data after the initiation of rescue therapy and non-serious adverse events exclude data after the initiation of rescue therapy.
|
0.00%
0/56 • Up to 56 weeks including 2-week follow-up (up to 56 weeks for serious adverse events, up to 54 weeks for non-serious adverse events)
All participants as treated population included all randomized participants who received at least 1 dose of study treatment. Serious adverse events include data after the initiation of rescue therapy and non-serious adverse events exclude data after the initiation of rescue therapy.
|
5.5%
3/55 • Number of events 3 • Up to 56 weeks including 2-week follow-up (up to 56 weeks for serious adverse events, up to 54 weeks for non-serious adverse events)
All participants as treated population included all randomized participants who received at least 1 dose of study treatment. Serious adverse events include data after the initiation of rescue therapy and non-serious adverse events exclude data after the initiation of rescue therapy.
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Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER