Trial Outcomes & Findings for A Study to Test the Effectiveness and Safety of MK0893 in Combination With Other Drugs Used to Treat Type 2 Diabetes (0893-015) (NCT NCT00631488)
NCT ID: NCT00631488
Last Updated: 2017-01-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
146 participants
Primary outcome timeframe
BL, 4 weeks (end of double-blind treatment period)
Results posted on
2017-01-02
Participant Flow
Participants received matching placebos to MK-0893, Sitagliptin, and Metformin during a 2-week run-in period.
Participant milestones
| Measure |
MK-0893 + Sitagliptin
Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
|
MK-0893 + Metformin
Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
|
Sitagliptin + Metformin
Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
48
|
49
|
49
|
|
Overall Study
Completed Post-Treatment Period
|
44
|
47
|
47
|
|
Overall Study
COMPLETED
|
44
|
47
|
47
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
2
|
Reasons for withdrawal
| Measure |
MK-0893 + Sitagliptin
Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
|
MK-0893 + Metformin
Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
|
Sitagliptin + Metformin
Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Test the Effectiveness and Safety of MK0893 in Combination With Other Drugs Used to Treat Type 2 Diabetes (0893-015)
Baseline characteristics by cohort
| Measure |
MK-0893 + Sitagliptin
n=48 Participants
Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
|
MK-0893 + Metformin
n=49 Participants
Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
|
Sitagliptin + Metformin
n=49 Participants
Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 8.0 • n=113 Participants
|
52.0 years
STANDARD_DEVIATION 9.7 • n=163 Participants
|
53.8 years
STANDARD_DEVIATION 8.7 • n=160 Participants
|
53.2 years
STANDARD_DEVIATION 8.8 • n=483 Participants
|
|
Gender
Female
|
16 Participants
n=113 Participants
|
26 Participants
n=163 Participants
|
15 Participants
n=160 Participants
|
57 Participants
n=483 Participants
|
|
Gender
Male
|
32 Participants
n=113 Participants
|
23 Participants
n=163 Participants
|
34 Participants
n=160 Participants
|
89 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: BL, 4 weeks (end of double-blind treatment period)Population: Full Analysis Set Population
Outcome measures
| Measure |
MK-0893 + Sitagliptin
n=48 Participants
Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
|
MK-0893 + Metformin
n=49 Participants
Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
|
Sitagliptin + Metformin
n=49 Participants
Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
|
|---|---|---|---|
|
Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels
|
-85.7 mg/dL
Standard Error 4.6 • Interval 4.6 to -117.4
|
-117.4 mg/dL
Standard Error 4.6 • Interval -99.6 to 4.6
|
-99.6 mg/dL
Standard Error 4.6
|
SECONDARY outcome
Timeframe: BL, 4 weeks (end of double-blind treatment period)Population: Full Analysis Set Population
Outcome measures
| Measure |
MK-0893 + Sitagliptin
n=48 Participants
Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
|
MK-0893 + Metformin
n=49 Participants
Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
|
Sitagliptin + Metformin
n=49 Participants
Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
|
|---|---|---|---|
|
Change From BL to Week 4 in Fasting Plasma Glucose (FPG)
|
-73.7 mg/dL
Standard Error 4.4
|
-101.9 mg/dL
Standard Error 4.3
|
-82.8 mg/dL
Standard Error 4.3
|
SECONDARY outcome
Timeframe: BL, 4 weeks (end of double-blind treatment period)Population: Full Analysis Set Population
Outcome measures
| Measure |
MK-0893 + Sitagliptin
n=48 Participants
Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
|
MK-0893 + Metformin
n=49 Participants
Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
|
Sitagliptin + Metformin
n=49 Participants
Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
|
|---|---|---|---|
|
Change From BL to Week 4 in 2-hr Glucose Area Under The Curve (AUC)
|
-187.7 mg.h/dL
Standard Error 11.4
|
-254.9 mg.h/dL
Standard Error 11.1
|
-210.3 mg.h/dL
Standard Error 11.4
|
SECONDARY outcome
Timeframe: BL, 4 weeks (end of double-blind treatment period)Population: Full Analysis Set Population
Glucagon-Like Peptide-1 (GLP-1) is an incretin hormone that acts as a potent insulin secretegogue in response to nutrient ingestion and stimulates glucose disposition. The total AUC of Total GLP-1 levels was calculated from blood sample data measured after the morning meal.
Outcome measures
| Measure |
MK-0893 + Sitagliptin
n=48 Participants
Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
|
MK-0893 + Metformin
n=49 Participants
Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
|
Sitagliptin + Metformin
n=49 Participants
Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
|
|---|---|---|---|
|
Change From BL to Week 4 in the 2-Hour Total GLP-1 Total AUC
|
7.4 pmol*h/L
Standard Error 1.0
|
16.4 pmol*h/L
Standard Error 1.0
|
3.2 pmol*h/L
Standard Error 1.0
|
SECONDARY outcome
Timeframe: BL, 4 weeks (end of double-blind treatment period)Population: Full Analysis Set Population
GLP-1 is cleaved from proglucagon to form the active peptide GLP-1. The active form promotes suppression of glucagon secretion. The total AUC of Active GLP-1 levels was calculated from blood sample data measured after the morning meal.
Outcome measures
| Measure |
MK-0893 + Sitagliptin
n=48 Participants
Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
|
MK-0893 + Metformin
n=49 Participants
Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
|
Sitagliptin + Metformin
n=49 Participants
Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
|
|---|---|---|---|
|
Change From BL to Week 4 in the 2-Hour Active GLP-1 Total AUC
|
11.0 pmole*h/L
Standard Error 1.1
|
6.3 pmole*h/L
Standard Error 1.1
|
17.6 pmole*h/L
Standard Error 1.1
|
Adverse Events
MK-0893 + Sitagliptin
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
MK-0893 + Metformin
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Sitagliptin + Metformin
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MK-0893 + Sitagliptin
n=48 participants at risk
Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
|
MK-0893 + Metformin
n=49 participants at risk
Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
|
Sitagliptin + Metformin
n=49 participants at risk
Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
|
|---|---|---|---|
|
Gastrointestinal disorders
diarrhoea
|
2.1%
1/48 • Number of events 1
|
12.2%
6/49 • Number of events 7
|
12.2%
6/49 • Number of events 9
|
|
Gastrointestinal disorders
nausea
|
4.2%
2/48 • Number of events 2
|
8.2%
4/49 • Number of events 5
|
4.1%
2/49 • Number of events 2
|
|
Infections and infestations
upper respiratory tract infection
|
8.3%
4/48 • Number of events 4
|
2.0%
1/49 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
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. SPONSOR review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER