Trial Outcomes & Findings for A Study to Assess the Pharmacokinetics and the Ability for Pediatric Participants With Type 2 Diabetes to Swallow MK-0431A XR Tablets (MK-0431A-296) (NCT NCT01557504)
NCT ID: NCT01557504
Last Updated: 2020-10-28
Results Overview
The Swallowing Ability Questionnaire was completed on Day 2 after the participant received two matching placebo tablets (excluding marking) following consumption of a low- to moderate-fat meal in pediatric participants aged 10 to 17 years. The questionnaire consisted of five parts: could only swallow study med with help, easy to start swallowing study med, easy to swallow study med, felt like study med got stuck in throat, and had to swallow study med more than once. The number of participants who strongly agreed or agreed in each of the five parts is reported.
COMPLETED
PHASE1
25 participants
Day 2
2020-10-28
Participant Flow
Participant milestones
| Measure |
Sitagliptin/Metformin XR Followed by Placebo
Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
|
Placebo
Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Sitagliptin/Metformin XR Followed by Placebo
Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
|
Placebo
Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
A Study to Assess the Pharmacokinetics and the Ability for Pediatric Participants With Type 2 Diabetes to Swallow MK-0431A XR Tablets (MK-0431A-296)
Baseline characteristics by cohort
| Measure |
Sitagliptin/Metformin XR Followed by Placebo
n=13 Participants
Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
|
Placebo
n=12 Participants
Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
10-13 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Customized
14-17 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 2Population: Per protocol population defined as all participants who completed at least one period of treatment and had available data. On Day 2, all participants received matching placebo, so the two treatment groups were pooled on Day 2.
The Swallowing Ability Questionnaire was completed on Day 2 after the participant received two matching placebo tablets (excluding marking) following consumption of a low- to moderate-fat meal in pediatric participants aged 10 to 17 years. The questionnaire consisted of five parts: could only swallow study med with help, easy to start swallowing study med, easy to swallow study med, felt like study med got stuck in throat, and had to swallow study med more than once. The number of participants who strongly agreed or agreed in each of the five parts is reported.
Outcome measures
| Measure |
All Treated Participants
n=24 Participants
All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 2.
|
Metformin
Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
|
|---|---|---|
|
Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2
Strongly Agreed: Could Only Swallow Med With Help
|
6 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2
Agreed: Could Only Swallow Med With Help
|
7 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2
Strongly Agreed: Easy to Start Swallowing Med
|
10 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2
Agreed: Easy to Start Swallowing Med
|
12 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2
Strongly Agreed: Easy to Swallow Med
|
13 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2
Agreed: Easy to Swallow Med
|
10 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2
Strongly Agreed: Felt Like Med Got Stuck in Throat
|
0 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2
Agreed: Felt Like Med Got Stuck in Throat
|
4 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2
Strongly Agreed: Had to Swallow Med More Than Once
|
2 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2
Agreed: Had to Swallow Med More Than Once
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 4Population: Per protocol population defined as all participants who completed at least one period of treatment and had available data. On Day 4, all participants received matching placebo, so the two treatment groups were pooled on Day 4.
The Swallowing Ability Questionnaire was completed on Day 4 after the participant received two matching placebo tablets (excluding marking) following consumption of a low- to moderate-fat meal in pediatric participants aged 10 to 17 years. The questionnaire consisted of five parts: could only swallow study med with help, easy to start swallowing study med, easy to swallow study med, felt like study med got stuck in throat, and had to swallow study med more than once. The number of participants who strongly agreed or agreed in each of the five parts is reported.
Outcome measures
| Measure |
All Treated Participants
n=24 Participants
All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 2.
|
Metformin
Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
|
|---|---|---|
|
Number of Participants Who Successfully Swallowed Study Med on Day 4
Strongly Agreed: Could Only Swallow Med With Help
|
6 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 4
Agreed: Could Only Swallow Med With Help
|
6 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 4
Strongly Agreed: Easy to Start Swallowing Med
|
8 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 4
Agreed: Easy to Start Swallowing Med
|
14 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 4
Strongly Agreed: Easy to Swallow Med
|
8 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 4
Agreed: Easy to Swallow Med
|
15 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 4
Strongly Agreed: Felt Like Med Got Stuck in Throat
|
0 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 4
Agreed: Felt Like Med Got Stuck in Throat
|
4 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 4
Strongly Agreed: Had to Swallow Med More Than Once
|
0 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 4
Agreed: Had to Swallow Med More Than Once
|
5 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 6Population: Per protocol population defined as all participants who completed at least one period of treatment and had available data. On Day 6, all participants received matching placebo, so the two treatment groups were pooled on Day 6.
The Swallowing Ability Questionnaire was completed on Day 6 after the participant received two matching placebo tablets (excluding marking) following consumption of a low- to moderate-fat meal in pediatric participants aged 10 to 17 years. The questionnaire consisted of five parts: could only swallow study med with help, easy to start swallowing study med, easy to swallow study med, felt like study med got stuck in throat, and had to swallow study med more than once. The number of participants who strongly agreed or agreed in each of the five parts is reported.
Outcome measures
| Measure |
All Treated Participants
n=24 Participants
All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 2.
|
Metformin
Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
|
|---|---|---|
|
Number of Participants Who Successfully Swallowed Study Med on Day 6
Strongly Agreed: Could Only Swallow Med With Help
|
5 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 6
Agreed: Could Only Swallow Med With Help
|
7 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 6
Strongly Agreed: Easy to Start Swallowing Med
|
10 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 6
Agreed: Easy to Start Swallowing Med
|
11 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 6
Strongly Agreed: Easy to Swallow Med
|
11 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 6
Agreed: Easy to Swallow Med
|
12 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 6
Strongly Agreed: Felt Like Med Got Stuck in Throat
|
0 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 6
Agreed: Felt Like Med Got Stuck in Throat
|
3 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 6
Strongly Agreed: Had to Swallow Med More Than Once
|
2 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 6
Agreed: Had to Swallow Med More Than Once
|
5 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 9Population: Per protocol population defined as all participants who completed at least one period of treatment and had available data. On Day 9, all participants received matching placebo, so the two treatment groups were pooled on Day 9.
The Swallowing Ability Questionnaire was completed on Day 9 after the participant received two matching placebo tablets (excluding marking) following consumption of a low- to moderate-fat meal in pediatric participants aged 10 to 17 years. The questionnaire consisted of five parts: could only swallow study med with help, easy to start swallowing study med, easy to swallow study med, felt like study med got stuck in throat, and had to swallow study med more than once. The number of participants who strongly agreed or agreed in each of the five parts is reported.
Outcome measures
| Measure |
All Treated Participants
n=24 Participants
All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 2.
|
Metformin
Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
|
|---|---|---|
|
Number of Participants Who Successfully Swallowed Study Med on Day 9
Strongly Agreed: Could Only Swallow Med With Help
|
9 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 9
Agreed: Could Only Swallow Med With Help
|
5 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 9
Strongly Agreed: Easy to Start Swallowing Med
|
9 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 9
Agreed: Easy to Start Swallowing Med
|
13 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 9
Strongly Agreed: Easy to Swallow Med
|
12 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 9
Agreed: Easy to Swallow Med
|
11 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 9
Strongly Agreed: Felt Like Med Got Stuck in Throat
|
1 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 9
Agreed: Felt Like Med Got Stuck in Throat
|
1 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 9
Strongly Agreed: Had to Swallow Med More Than Once
|
2 Participants
|
—
|
|
Number of Participants Who Successfully Swallowed Study Med on Day 9
Agreed: Had to Swallow Med More Than Once
|
5 Participants
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dosePopulation: Per protocol population defined as all participants who completed at least one period of treatment (Sitagliptin/Metformin XR Followed by Placebo arm) and had available data.
In this study, metformin products were withheld 24 hours (hrs) prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hrs post study drug administration. Owing to resumption of therapeutic metformin administration 24 hrs after sitagliptin/metformin XR administration for all participants, metformin pharmacokinetic analyses were restricted to maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax) and area under the curve 0 to 24 hrs (AUC0-24hr). Therefore, metformin arm is not included in this endpoint.
Outcome measures
| Measure |
All Treated Participants
n=12 Participants
All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 2.
|
Metformin
Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
|
|---|---|---|
|
Area Under the Curve 0 to Last (AUC 0-last) of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR
|
5940 nM*hr/mL
Geometric Coefficient of Variation 25.7
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours post-dosePopulation: Per protocol population defined as all participants who completed at least one period of treatment and had available data.
Due different units of measure for sitagliptin and metformin, metformin data are presented in another endpoint.
Outcome measures
| Measure |
All Treated Participants
n=12 Participants
All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 2.
|
Metformin
Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
|
|---|---|---|
|
AUC 0-24 of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR
|
5310 nM*hr
Geometric Coefficient of Variation 22.4
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours post-dosePopulation: Per protocol population defined as all participants who completed at least one period of treatment and had available data.
In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration. Due different units of measure for sitagliptin and metformin, sitagliptin data are presented in another endpoint.
Outcome measures
| Measure |
All Treated Participants
n=12 Participants
All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 2.
|
Metformin
Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
|
|---|---|---|
|
AUC 0-24 of Metformin Following Single Administration of Sitagliptin/Metformin XR
|
14200 ng*hr/mL
Geometric Coefficient of Variation 39.7
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dosePopulation: Per protocol population defined as all participants who completed at least one period of treatment and had available data.
In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration. Owing to resumption of therapeutic metformin administration 24 hours after sitagliptin/metformin XR administration for all participants, metformin pharmacokinetic analyses were restricted to Cmax, Tmax and AUC0-24hr. Therefore, metformin arm is not included in this endpoint.
Outcome measures
| Measure |
All Treated Participants
n=12 Participants
All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 2.
|
Metformin
Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
|
|---|---|---|
|
Area Under the Curve 0 to Infinity (AUC 0-∞) of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR
|
6020 nM*hr
Geometric Coefficient of Variation 24.8
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dosePopulation: Per protocol population defined as all participants who completed at least one period of treatment and had available data.
Due different units of measure for sitagliptin and metformin, metformin data are presented in another endpoint.
Outcome measures
| Measure |
All Treated Participants
n=12 Participants
All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 2.
|
Metformin
Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
|
|---|---|---|
|
Cmax of Sitagliptin Following Single Dose Administration of Sitagliptin/Metformin XR
|
757 nM
Geometric Coefficient of Variation 40.1
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dosePopulation: Per protocol population defined as all participants who completed at least one period of treatment and had available data.
In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration. Due different units of measure for sitagliptin and metformin, sitagliptin data are presented in another endpoint.
Outcome measures
| Measure |
All Treated Participants
n=12 Participants
All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 2.
|
Metformin
Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
|
|---|---|---|
|
Cmax of Metformin Following Single Dose Administration of Sitagliptin/Metformin XR
|
1490 ng/mL
Geometric Coefficient of Variation 29.1
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dosePopulation: Per protocol population defined as all participants who completed at least one period of treatment and had available data.
In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration.
Outcome measures
| Measure |
All Treated Participants
n=12 Participants
All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 2.
|
Metformin
n=12 Participants
Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
|
|---|---|---|
|
Tmax of Sitagliptin and Metformin Following Single Dose Administration of Sitagliptin/Metformin XR
|
1.52 Hour
Interval 0.97 to 3.05
|
5.00 Hour
Interval 3.98 to 7.22
|
PRIMARY outcome
Timeframe: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dosePopulation: Per protocol population defined as all participants who completed at least one period of treatment and had available data.
In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration. Owing to resumption of therapeutic metformin administration 24 hours after sitagliptin/metformin XR administration for all participants, metformin pharmacokinetic analyses were restricted to Cmax, Tmax and AUC0-24hr. Therefore, metformin arm is not included in this endpoint.
Outcome measures
| Measure |
All Treated Participants
n=12 Participants
All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 2.
|
Metformin
Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
|
|---|---|---|
|
Apparent Terminal Half Life (t1/2) of Sitagliptin Following Single Dose Administration of Sitagliptin/Metformin XR
|
10.0 Hour
Geometric Coefficient of Variation 27.3
|
—
|
PRIMARY outcome
Timeframe: Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)Population: All participants as treated defined as all participants who received at least one dose of study drug.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Outcome measures
| Measure |
All Treated Participants
n=13 Participants
All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 2.
|
Metformin
n=12 Participants
Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
|
|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)Population: All participants as treated defined as all participants who received at least one dose of study drug.
Vital sign measurements included blood pressure, heart rate, respiratory rate, and oral temperature.
Outcome measures
| Measure |
All Treated Participants
n=13 Participants
All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 2.
|
Metformin
n=12 Participants
Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
|
|---|---|---|
|
Number of Participants Who Experienced an Abnormal Vital Sign Value
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 9 daysPopulation: All participants as treated defined as all participants who received at least one dose of study drug.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
Outcome measures
| Measure |
All Treated Participants
n=13 Participants
All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 2.
|
Metformin
n=12 Participants
Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
|
|---|---|---|
|
Number of Participants Who Discontinued Study Drug Due to an AE
|
0 Participants
|
0 Participants
|
Adverse Events
Sitagliptin/Metformin XR Followed by Placebo
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sitagliptin/Metformin XR Followed by Placebo
n=13 participants at risk
Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
|
Placebo
n=12 participants at risk
Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
1/13 • Number of events 1 • Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)
All participants as treated defined as all participants who received at least one dose of study drug.
|
0.00%
0/12 • Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)
All participants as treated defined as all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Number of events 1 • Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)
All participants as treated defined as all participants who received at least one dose of study drug.
|
0.00%
0/12 • Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)
All participants as treated defined as all participants who received at least one dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
7.7%
1/13 • Number of events 1 • Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)
All participants as treated defined as all participants who received at least one dose of study drug.
|
0.00%
0/12 • Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)
All participants as treated defined as all participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
1/13 • Number of events 1 • Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)
All participants as treated defined as all participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)
All participants as treated defined as all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/13 • Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)
All participants as treated defined as all participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)
All participants as treated defined as all participants who received at least one dose of study drug.
|
|
Investigations
Urine analysis abnormal
|
7.7%
1/13 • Number of events 1 • Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)
All participants as treated defined as all participants who received at least one dose of study drug.
|
0.00%
0/12 • Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)
All participants as treated defined as all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
7.7%
1/13 • Number of events 1 • Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)
All participants as treated defined as all participants who received at least one dose of study drug.
|
0.00%
0/12 • Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)
All participants as treated defined as all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)
All participants as treated defined as all participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)
All participants as treated defined as all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/13 • Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)
All participants as treated defined as all participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)
All participants as treated defined as all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Number of events 1 • Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)
All participants as treated defined as all participants who received at least one dose of study drug.
|
0.00%
0/12 • Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)
All participants as treated defined as all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/13 • Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)
All participants as treated defined as all participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)
All participants as treated defined as all participants who received at least one dose of study drug.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
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