Type 2 Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to assess: 1. the safety and tolerability of two sitagliptin 50 mg/metformin 1000 mg XR tablets in pediatric participants with type 2 diabetes mellitus (T2DM), aged 10 to 17 years 2. the ability of pediatric participants with T2DM, aged 10 to 17 years, to swallow two sitagliptin 50 mg/metformin 1000 mg XR tablets or two matching placebo tablets (excluding marking) 3. the pharmacokinetics of sitagliptin and metformin following the administration of two sitagliptin 50 mg/metformin 1000 mg XR tablets to pediatric participants with T2DM, aged 10 to 17 years.
Interventions
DRUGSitagliptin/metformin XR
Fixed dose combination tablet of immediate-release sitagliptin 50 mg and extended-release (XR) metformin 1000 mg (total daily dose, sitagliptin 100 mg and metformin XR 2000 mg).
DRUGPlacebo
Matching placebo to fixed dose combination tablet of sitagliptin and metformin. Matching placebo tablets are same size, shape and color as the active product, but do not contain any markings.
DRUGMetformin
Concomitant use of metformin is permitted during the study provided the participant has been receiving a stable metformin dose for at least 12 weeks prior to the dose of study drug. Administration of metformin will be withheld for 24 hours prior to study drug administration and for 24 hours postdose.
DRUGThyroid hormone
Concomitant use of thyroid hormone (eg, levothyroxine) is permitted during the study provided the participant has been receiving a stable dose for at least 12 weeks prior to study drug administration and is euthyroid as documented by thyroid stimulating hormone testing at prestudy. Administration of thyroid hormone will be withheld for 24 hours prior to study drug administration and for 24 hours postdose.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Female participant of reproductive potential must not be pregnant and agrees to use (and/or have their partner use) two acceptable methods of birth control * T2DM diagnosed by American Diabetes Association criteria * No clinically significant abnormality on electrocardiogram * No clinical or laboratory evidence to indicate a diagnosis of type 1 diabetes * Nonsmoker
Exclusion criteria
* Mental or legal incapacitation * Estimated creatinine clearance of 80 mL/min or lower * History of stroke, chronic seizures, or major neurological disorder * History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases * History of neoplastic disease * Unable to refrain from or anticipates the use of any medication (with the exception of metformin and thyroid hormone) from approximately 2 weeks before the first dose of study drug through the poststudy visit * Consumes alcohol or consumes excessive amounts of coffee, tea, cola, or other caffeinated beverages * Had surgery, donated or lost 1 unit of blood, or participated in another investigational study within the past 4 weeks * History of multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food * Currently a regular user (including illicit drugs) or has a history of drug (including alcohol) abuse * Lactose intolerant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2 | 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. |
| Number of Participants Who Successfully Swallowed Study Med on Day 4 | 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. |
| Number of Participants Who Successfully Swallowed Study Med on Day 6 | 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. |
| Number of Participants Who Successfully Swallowed Study Med on Day 9 | 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. |
| Area Under the Curve 0 to Last (AUC 0-last) of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR | Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose | 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. |
| AUC 0-24 of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR | Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours post-dose | Due different units of measure for sitagliptin and metformin, metformin data are presented in another endpoint. |
| AUC 0-24 of Metformin Following Single Administration of Sitagliptin/Metformin XR | Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours post-dose | 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. |
| Area Under the Curve 0 to Infinity (AUC 0-∞) of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR | Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose | 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. |
| Cmax of Sitagliptin Following Single Dose Administration of Sitagliptin/Metformin XR | Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose | Due different units of measure for sitagliptin and metformin, metformin data are presented in another endpoint. |
| Cmax of Metformin Following Single Dose Administration of Sitagliptin/Metformin XR | Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose | 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. |
| Tmax of Sitagliptin and Metformin Following Single Dose Administration of Sitagliptin/Metformin XR | Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose | 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. |
| Apparent Terminal Half Life (t1/2) of Sitagliptin Following Single Dose Administration of Sitagliptin/Metformin XR | Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose | 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. |
| Number of Participants Who Experienced an Adverse Event (AE) | Up to 23 days (including approximately 10 to 14 days after the last 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. |
| Number of Participants Who Experienced an Abnormal Vital Sign Value | Up to 23 days (including approximately 10 to 14 days after the last dose of study drug) | Vital sign measurements included blood pressure, heart rate, respiratory rate, and oral temperature. |
| Number of Participants Who Discontinued Study Drug Due to an AE | Up to 9 days | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| 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. | 12 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Sitagliptin/Metformin XR Followed by Placebo | Placebo | Total |
|---|---|---|---|
| Age, Customized 10-13 years | 4 Participants | 3 Participants | 7 Participants |
| Age, Customized 14-17 years | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 13 | 5 / 12 |
| serious Total, serious adverse events | 0 / 13 | 0 / 12 |
Outcome results
Primary
Apparent Terminal Half Life (t1/2) of Sitagliptin Following Single Dose Administration of Sitagliptin/Metformin XR
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.
Time frame: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose
Population: Per protocol population defined as all participants who completed at least one period of treatment and had available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| All Treated Participants | 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
Area Under the Curve 0 to Infinity (AUC 0-∞) of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR
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.
Time frame: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose
Population: Per protocol population defined as all participants who completed at least one period of treatment and had available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| All Treated Participants | 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
Area Under the Curve 0 to Last (AUC 0-last) of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR
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.
Time frame: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| All Treated Participants | 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
AUC 0-24 of Metformin Following Single Administration of Sitagliptin/Metformin XR
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.
Time frame: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours post-dose
Population: Per protocol population defined as all participants who completed at least one period of treatment and had available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| All Treated Participants | AUC 0-24 of Metformin Following Single Administration of Sitagliptin/Metformin XR | 14200 ng*hr/mL | Geometric Coefficient of Variation 39.7 |
Primary
AUC 0-24 of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR
Due different units of measure for sitagliptin and metformin, metformin data are presented in another endpoint.
Time frame: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours post-dose
Population: Per protocol population defined as all participants who completed at least one period of treatment and had available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| All Treated Participants | AUC 0-24 of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR | 5310 nM*hr | Geometric Coefficient of Variation 22.4 |
Primary
Cmax of Metformin Following Single Dose Administration of Sitagliptin/Metformin XR
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.
Time frame: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose
Population: Per protocol population defined as all participants who completed at least one period of treatment and had available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| All Treated Participants | Cmax of Metformin Following Single Dose Administration of Sitagliptin/Metformin XR | 1490 ng/mL | Geometric Coefficient of Variation 29.1 |
Primary
Cmax of Sitagliptin Following Single Dose Administration of Sitagliptin/Metformin XR
Due different units of measure for sitagliptin and metformin, metformin data are presented in another endpoint.
Time frame: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose
Population: Per protocol population defined as all participants who completed at least one period of treatment and had available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| All Treated Participants | Cmax of Sitagliptin Following Single Dose Administration of Sitagliptin/Metformin XR | 757 nM | Geometric Coefficient of Variation 40.1 |
Primary
Number of Participants Who Discontinued Study Drug Due to an AE
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.
Time frame: Up to 9 days
Population: All participants as treated defined as all participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Treated Participants | Number of Participants Who Discontinued Study Drug Due to an AE | 0 Participants |
| Metformin | Number of Participants Who Discontinued Study Drug Due to an AE | 0 Participants |
Primary
Number of Participants Who Experienced an Abnormal Vital Sign Value
Vital sign measurements included blood pressure, heart rate, respiratory rate, and oral temperature.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Treated Participants | Number of Participants Who Experienced an Abnormal Vital Sign Value | 0 Participants |
| Metformin | Number of Participants Who Experienced an Abnormal Vital Sign Value | 0 Participants |
Primary
Number of Participants Who Experienced an Adverse Event (AE)
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Treated Participants | Number of Participants Who Experienced an Adverse Event (AE) | 5 Participants |
| Metformin | Number of Participants Who Experienced an Adverse Event (AE) | 5 Participants |
Primary
Number of Participants Who Successfully Swallowed Study Medication (Med) 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.
Time frame: Day 2
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2 | Strongly Agreed: Could Only Swallow Med With Help | 6 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2 | Agreed: Could Only Swallow Med With Help | 7 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2 | Strongly Agreed: Easy to Start Swallowing Med | 10 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2 | Agreed: Easy to Start Swallowing Med | 12 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2 | Strongly Agreed: Easy to Swallow Med | 13 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2 | Agreed: Easy to Swallow Med | 10 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2 | Strongly Agreed: Felt Like Med Got Stuck in Throat | 0 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2 | Agreed: Felt Like Med Got Stuck in Throat | 4 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2 | Strongly Agreed: Had to Swallow Med More Than Once | 2 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2 | Agreed: Had to Swallow Med More Than Once | 3 Participants |
Primary
Number of Participants Who Successfully Swallowed Study Med 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.
Time frame: Day 4
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 4 | Strongly Agreed: Could Only Swallow Med With Help | 6 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 4 | Agreed: Could Only Swallow Med With Help | 6 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 4 | Strongly Agreed: Easy to Start Swallowing Med | 8 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 4 | Agreed: Easy to Start Swallowing Med | 14 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 4 | Strongly Agreed: Easy to Swallow Med | 8 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 4 | Agreed: Easy to Swallow Med | 15 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 4 | Strongly Agreed: Felt Like Med Got Stuck in Throat | 0 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 4 | Agreed: Felt Like Med Got Stuck in Throat | 4 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 4 | Strongly Agreed: Had to Swallow Med More Than Once | 0 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 4 | Agreed: Had to Swallow Med More Than Once | 5 Participants |
Primary
Number of Participants Who Successfully Swallowed Study Med 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.
Time frame: Day 6
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 6 | Strongly Agreed: Could Only Swallow Med With Help | 5 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 6 | Agreed: Could Only Swallow Med With Help | 7 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 6 | Strongly Agreed: Easy to Start Swallowing Med | 10 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 6 | Agreed: Easy to Start Swallowing Med | 11 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 6 | Strongly Agreed: Easy to Swallow Med | 11 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 6 | Agreed: Easy to Swallow Med | 12 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 6 | Strongly Agreed: Felt Like Med Got Stuck in Throat | 0 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 6 | Agreed: Felt Like Med Got Stuck in Throat | 3 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 6 | Strongly Agreed: Had to Swallow Med More Than Once | 2 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 6 | Agreed: Had to Swallow Med More Than Once | 5 Participants |
Primary
Number of Participants Who Successfully Swallowed Study Med 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.
Time frame: Day 9
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 9 | Strongly Agreed: Felt Like Med Got Stuck in Throat | 1 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 9 | Strongly Agreed: Could Only Swallow Med With Help | 9 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 9 | Agreed: Could Only Swallow Med With Help | 5 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 9 | Strongly Agreed: Easy to Start Swallowing Med | 9 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 9 | Agreed: Easy to Start Swallowing Med | 13 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 9 | Strongly Agreed: Easy to Swallow Med | 12 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 9 | Agreed: Easy to Swallow Med | 11 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 9 | Agreed: Felt Like Med Got Stuck in Throat | 1 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 9 | Strongly Agreed: Had to Swallow Med More Than Once | 2 Participants |
| All Treated Participants | Number of Participants Who Successfully Swallowed Study Med on Day 9 | Agreed: Had to Swallow Med More Than Once | 5 Participants |
Primary
Tmax of Sitagliptin and Metformin Following Single Dose Administration of Sitagliptin/Metformin XR
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.
Time frame: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose
Population: Per protocol population defined as all participants who completed at least one period of treatment and had available data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Treated Participants | Tmax of Sitagliptin and Metformin Following Single Dose Administration of Sitagliptin/Metformin XR | 1.52 Hour |
| Metformin | Tmax of Sitagliptin and Metformin Following Single Dose Administration of Sitagliptin/Metformin XR | 5.00 Hour |