Trial Outcomes & Findings for Pharmacokinetics Study of Dipeptidyl Peptidase 4 Inhibitor to Control Type 2 Diabetes Mellitus (NCT NCT01449747)
NCT ID: NCT01449747
Last Updated: 2015-12-14
Results Overview
Plasma concentrations of active GLP-1 were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test (MTT). Second measurement of active GLP-1 were measured with MTT after taking sitagliptin 100 mg 1 hour before the test.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose
Results posted on
2015-12-14
Participant Flow
Participant milestones
| Measure |
Non-responder
Sitagliptin non-response patients
|
Responder
Sitagliptin response patients
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics Study of Dipeptidyl Peptidase 4 Inhibitor to Control Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Non-responder
n=12 Participants
Sitagliptin non-response patients
|
Responder
n=12 Participants
Sitagliptin response patients
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
57.4 years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
58.1 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Duration of diabetes mellitus
|
7.2 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
5.2 years
STANDARD_DEVIATION 2.7 • n=7 Participants
|
6.2 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Body mass index
|
25.1 kg/m^2
STANDARD_DEVIATION 1.7 • n=5 Participants
|
24.4 kg/m^2
STANDARD_DEVIATION 3.8 • n=7 Participants
|
24.8 kg/m^2
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
HbA1c
|
7.7 %
STANDARD_DEVIATION 0.6 • n=5 Participants
|
6.6 %
STANDARD_DEVIATION 0.7 • n=7 Participants
|
7.2 %
STANDARD_DEVIATION 0.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dosePlasma concentrations of active GLP-1 were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test (MTT). Second measurement of active GLP-1 were measured with MTT after taking sitagliptin 100 mg 1 hour before the test.
Outcome measures
| Measure |
Non-responder
n=12 Participants
Sitagliptin non-response patients
|
Responder
n=12 Participants
Sitagliptin response patients
|
|---|---|---|
|
Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment
baseline 0 min
|
7.0 pmol/L
Standard Deviation 6.6
|
6.1 pmol/L
Standard Deviation 1.9
|
|
Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment
baseline 15 min
|
10.6 pmol/L
Standard Deviation 8.0
|
14.1 pmol/L
Standard Deviation 24.4
|
|
Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment
baseline 30 min
|
15.7 pmol/L
Standard Deviation 10.3
|
14.3 pmol/L
Standard Deviation 20.2
|
|
Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment
baseline 45 min
|
14.7 pmol/L
Standard Deviation 8.2
|
9.3 pmol/L
Standard Deviation 4.3
|
|
Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment
baseline 60 min
|
13.7 pmol/L
Standard Deviation 6.8
|
8.4 pmol/L
Standard Deviation 2.7
|
|
Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment
baseline 90 min
|
10.6 pmol/L
Standard Deviation 5.4
|
7.6 pmol/L
Standard Deviation 2.1
|
|
Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment
baseline 120 min
|
11.3 pmol/L
Standard Deviation 6.8
|
7.4 pmol/L
Standard Deviation 2.1
|
|
Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment
baseline 180 min
|
12.6 pmol/L
Standard Deviation 8.7
|
7.1 pmol/L
Standard Deviation 2.5
|
|
Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment
post-dose 0 min
|
13.6 pmol/L
Standard Deviation 9.4
|
10.5 pmol/L
Standard Deviation 4.5
|
|
Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment
post-dose 15 min
|
24.0 pmol/L
Standard Deviation 16.0
|
26.0 pmol/L
Standard Deviation 39.9
|
|
Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment
post-dose 30 min
|
28.4 pmol/L
Standard Deviation 11.0
|
34.3 pmol/L
Standard Deviation 53.1
|
|
Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment
post-dose 45 min
|
22.4 pmol/L
Standard Deviation 11.3
|
27.1 pmol/L
Standard Deviation 37.6
|
|
Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment
post-dose 60 min
|
21.7 pmol/L
Standard Deviation 11.3
|
22.8 pmol/L
Standard Deviation 27.1
|
|
Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment
post-dose 90 min
|
19.3 pmol/L
Standard Deviation 10.8
|
16.5 pmol/L
Standard Deviation 7.6
|
|
Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment
post-dose 120 min
|
22.0 pmol/L
Standard Deviation 10.8
|
16.4 pmol/L
Standard Deviation 6.5
|
|
Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment
post-dose 180 min
|
20.5 pmol/L
Standard Deviation 8.3
|
13.5 pmol/L
Standard Deviation 7.0
|
PRIMARY outcome
Timeframe: 0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dosePlasma concentrations of total GLP-1 were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test. Second measurement of total GLP-1 were measured with MTT after taking sitagliptin 100 mg 1 hour before the test.
Outcome measures
| Measure |
Non-responder
n=12 Participants
Sitagliptin non-response patients
|
Responder
n=12 Participants
Sitagliptin response patients
|
|---|---|---|
|
Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment
post-dose 0 min
|
23.0 pmol/L
Standard Deviation 27.8
|
16.4 pmol/L
Standard Deviation 17.6
|
|
Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment
baseline 0 min
|
25.6 pmol/L
Standard Deviation 26.9
|
15.6 pmol/L
Standard Deviation 16.2
|
|
Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment
baseline 15 min
|
30.5 pmol/L
Standard Deviation 26.1
|
20.4 pmol/L
Standard Deviation 19.7
|
|
Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment
baseline 30 min
|
36.2 pmol/L
Standard Deviation 26.8
|
22.4 pmol/L
Standard Deviation 17.0
|
|
Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment
baseline 45 min
|
30.9 pmol/L
Standard Deviation 18.9
|
25.5 pmol/L
Standard Deviation 21.0
|
|
Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment
baseline 60 min
|
31.8 pmol/L
Standard Deviation 20.9
|
21.7 pmol/L
Standard Deviation 19.9
|
|
Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment
baseline 90 min
|
31.8 pmol/L
Standard Deviation 24.3
|
19.2 pmol/L
Standard Deviation 17.1
|
|
Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment
baseline 120 min
|
31.3 pmol/L
Standard Deviation 22.2
|
19.9 pmol/L
Standard Deviation 18.0
|
|
Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment
baseline 180 min
|
34.5 pmol/L
Standard Deviation 28.3
|
19.3 pmol/L
Standard Deviation 17.5
|
|
Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment
post-dose 15 min
|
28.4 pmol/L
Standard Deviation 27.9
|
20.6 pmol/L
Standard Deviation 20.7
|
|
Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment
post-dose 30 min
|
26.3 pmol/L
Standard Deviation 19.4
|
20.6 pmol/L
Standard Deviation 18.1
|
|
Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment
post-dose 45 min
|
29.2 pmol/L
Standard Deviation 27.2
|
18.9 pmol/L
Standard Deviation 18.3
|
|
Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment
post-dose 60 min
|
26.5 pmol/L
Standard Deviation 29.1
|
18.6 pmol/L
Standard Deviation 19.2
|
|
Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment
post-dose 90 min
|
26.2 pmol/L
Standard Deviation 30.1
|
18.1 pmol/L
Standard Deviation 17.0
|
|
Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment
post-dose 120 min
|
26.7 pmol/L
Standard Deviation 30.5
|
18.7 pmol/L
Standard Deviation 16.1
|
|
Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment
post-dose 180 min
|
26.0 pmol/L
Standard Deviation 25.8
|
18.2 pmol/L
Standard Deviation 18.2
|
PRIMARY outcome
Timeframe: 0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dosePlasma concentrations of total GIP were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test. Second measurement of total GIP were measured with MTT after taking sitagliptin 100 mg 1 hour before the test.
Outcome measures
| Measure |
Non-responder
n=12 Participants
Sitagliptin non-response patients
|
Responder
n=12 Participants
Sitagliptin response patients
|
|---|---|---|
|
Plasma Concentration of Total Glucose-dependent Insulinotropic Polypeptide (GIP) Before and After Sitagliptin Treatment
post-dose 120 min
|
43.8 pmol/L
Standard Deviation 15.3
|
35.0 pmol/L
Standard Deviation 39.0
|
|
Plasma Concentration of Total Glucose-dependent Insulinotropic Polypeptide (GIP) Before and After Sitagliptin Treatment
baseline 0 min
|
13.8 pmol/L
Standard Deviation 4.5
|
12.3 pmol/L
Standard Deviation 6.9
|
|
Plasma Concentration of Total Glucose-dependent Insulinotropic Polypeptide (GIP) Before and After Sitagliptin Treatment
baseline 15 min
|
42.3 pmol/L
Standard Deviation 30.7
|
40.3 pmol/L
Standard Deviation 28.1
|
|
Plasma Concentration of Total Glucose-dependent Insulinotropic Polypeptide (GIP) Before and After Sitagliptin Treatment
baseline 30 min
|
109.6 pmol/L
Standard Deviation 49.9
|
60.2 pmol/L
Standard Deviation 39.8
|
|
Plasma Concentration of Total Glucose-dependent Insulinotropic Polypeptide (GIP) Before and After Sitagliptin Treatment
baseline 45 min
|
109.6 pmol/L
Standard Deviation 43.5
|
54.1 pmol/L
Standard Deviation 37.9
|
|
Plasma Concentration of Total Glucose-dependent Insulinotropic Polypeptide (GIP) Before and After Sitagliptin Treatment
baseline 60 min
|
83.0 pmol/L
Standard Deviation 22.6
|
52.0 pmol/L
Standard Deviation 37.7
|
|
Plasma Concentration of Total Glucose-dependent Insulinotropic Polypeptide (GIP) Before and After Sitagliptin Treatment
baseline 90 min
|
66.3 pmol/L
Standard Deviation 22.6
|
44.7 pmol/L
Standard Deviation 25.5
|
|
Plasma Concentration of Total Glucose-dependent Insulinotropic Polypeptide (GIP) Before and After Sitagliptin Treatment
baseline 120 min
|
61.7 pmol/L
Standard Deviation 27.9
|
39.0 pmol/L
Standard Deviation 23.9
|
|
Plasma Concentration of Total Glucose-dependent Insulinotropic Polypeptide (GIP) Before and After Sitagliptin Treatment
baseline 180 min
|
39.9 pmol/L
Standard Deviation 17.9
|
30.0 pmol/L
Standard Deviation 18.2
|
|
Plasma Concentration of Total Glucose-dependent Insulinotropic Polypeptide (GIP) Before and After Sitagliptin Treatment
post-dose 0 min
|
10.5 pmol/L
Standard Deviation 4.0
|
10.3 pmol/L
Standard Deviation 5.3
|
|
Plasma Concentration of Total Glucose-dependent Insulinotropic Polypeptide (GIP) Before and After Sitagliptin Treatment
post-dose 15 min
|
34.2 pmol/L
Standard Deviation 14.0
|
26.3 pmol/L
Standard Deviation 15.6
|
|
Plasma Concentration of Total Glucose-dependent Insulinotropic Polypeptide (GIP) Before and After Sitagliptin Treatment
post-dose 30 min
|
90.8 pmol/L
Standard Deviation 34.7
|
33.1 pmol/L
Standard Deviation 23.5
|
|
Plasma Concentration of Total Glucose-dependent Insulinotropic Polypeptide (GIP) Before and After Sitagliptin Treatment
post-dose 45 min
|
77.6 pmol/L
Standard Deviation 37.8
|
38.5 pmol/L
Standard Deviation 23.5
|
|
Plasma Concentration of Total Glucose-dependent Insulinotropic Polypeptide (GIP) Before and After Sitagliptin Treatment
post-dose 60 min
|
61.5 pmol/L
Standard Deviation 26.1
|
37.7 pmol/L
Standard Deviation 25.4
|
|
Plasma Concentration of Total Glucose-dependent Insulinotropic Polypeptide (GIP) Before and After Sitagliptin Treatment
post-dose 90 min
|
44.2 pmol/L
Standard Deviation 15.7
|
38.2 pmol/L
Standard Deviation 41.6
|
|
Plasma Concentration of Total Glucose-dependent Insulinotropic Polypeptide (GIP) Before and After Sitagliptin Treatment
post-dose 180 min
|
32.8 pmol/L
Standard Deviation 9.2
|
24.7 pmol/L
Standard Deviation 25.6
|
PRIMARY outcome
Timeframe: 0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dosePlasma concentrations of active GLP-1, total GLP-1 and total GIP were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test. Second measurements were measured with MTT after taking sitagliptin 100 mg 1 hour before the test. Comparisons were made using Area under the curve (AUC) values and incremental area under the curve (ΔAUC) of active GLP-1, total GLP-1 and total GIP before and after the addition of sitagliptin.
Outcome measures
| Measure |
Non-responder
n=12 Participants
Sitagliptin non-response patients
|
Responder
n=12 Participants
Sitagliptin response patients
|
|---|---|---|
|
Change in AUC of Active GLP-1, Total GLP-1 and Total GIP Between Before and After Sitagliptin Treatment
baseline AUC active GLP-1
|
2181.7 pmol*min/L
Standard Deviation 1099.6
|
1578.2 pmol*min/L
Standard Deviation 807.5
|
|
Change in AUC of Active GLP-1, Total GLP-1 and Total GIP Between Before and After Sitagliptin Treatment
baseline AUC total GLP-1
|
5766.5 pmol*min/L
Standard Deviation 4229.7
|
3680.2 pmol*min/L
Standard Deviation 3209.3
|
|
Change in AUC of Active GLP-1, Total GLP-1 and Total GIP Between Before and After Sitagliptin Treatment
baseline AUC total GIP
|
10216.7 pmol*min/L
Standard Deviation 4226.1
|
7575.6 pmol*min/L
Standard Deviation 4608.3
|
|
Change in AUC of Active GLP-1, Total GLP-1 and Total GIP Between Before and After Sitagliptin Treatment
post-dose AUC active GLP-1
|
3898.5 pmol*min/L
Standard Deviation 1547.5
|
3535.1 pmol*min/L
Standard Deviation 2769.1
|
|
Change in AUC of Active GLP-1, Total GLP-1 and Total GIP Between Before and After Sitagliptin Treatment
post-dose AUC total GLP-1
|
4794.5 pmol*min/L
Standard Deviation 4949.8
|
3373.6 pmol*min/L
Standard Deviation 3169.8
|
|
Change in AUC of Active GLP-1, Total GLP-1 and Total GIP Between Before and After Sitagliptin Treatment
post-dose AUC total GIP
|
8784.6 pmol*min/L
Standard Deviation 2449.2
|
5929.4 pmol*min/L
Standard Deviation 4711.2
|
|
Change in AUC of Active GLP-1, Total GLP-1 and Total GIP Between Before and After Sitagliptin Treatment
ΔAUC active GLP-1
|
1716.8 pmol*min/L
Standard Deviation 1350.7
|
1956.8 pmol*min/L
Standard Deviation 2910.7
|
|
Change in AUC of Active GLP-1, Total GLP-1 and Total GIP Between Before and After Sitagliptin Treatment
ΔAUC total GLP-1
|
-972.0 pmol*min/L
Standard Deviation 1030.4
|
-306.7 pmol*min/L
Standard Deviation 883.6
|
|
Change in AUC of Active GLP-1, Total GLP-1 and Total GIP Between Before and After Sitagliptin Treatment
ΔAUC total GIP
|
-1432.1 pmol*min/L
Standard Deviation 2738.0
|
-1646.2 pmol*min/L
Standard Deviation 1817.7
|
SECONDARY outcome
Timeframe: 0, 15, 30, 45, 60 min post-doseThe DPP-4 activity was measured at baseline and 0, 15, 30, 45 and 60 min during the meal tolerance test. Second measurement of DPP-4 activity was measured with MTT after taking sitagliptin 100 mg 1 hour before the test. Plasma DPP-4 activity during meal tolerance test is expressed as percentage activity relative to baseline. DPP-4 activity % was calculated using the following formula : (DPP-4 activity at time t / Baseline DPP-4 activity) × 100.
Outcome measures
| Measure |
Non-responder
n=12 Participants
Sitagliptin non-response patients
|
Responder
n=12 Participants
Sitagliptin response patients
|
|---|---|---|
|
Differences of DPP-4 Activity After Sitagliptin Treatment Between Responder and Non-responder Groups
baseline
|
100 percentage of DPP4 activity
Standard Deviation 0
|
100 percentage of DPP4 activity
Standard Deviation 0
|
|
Differences of DPP-4 Activity After Sitagliptin Treatment Between Responder and Non-responder Groups
Sitagliptin 0 min
|
67.2 percentage of DPP4 activity
Standard Deviation 13.2
|
40.5 percentage of DPP4 activity
Standard Deviation 9.9
|
|
Differences of DPP-4 Activity After Sitagliptin Treatment Between Responder and Non-responder Groups
Sitagliptin 15 min
|
67.3 percentage of DPP4 activity
Standard Deviation 18.6
|
39.2 percentage of DPP4 activity
Standard Deviation 11.2
|
|
Differences of DPP-4 Activity After Sitagliptin Treatment Between Responder and Non-responder Groups
Sitagliptin 30 min
|
67.7 percentage of DPP4 activity
Standard Deviation 13.1
|
38.7 percentage of DPP4 activity
Standard Deviation 9.2
|
|
Differences of DPP-4 Activity After Sitagliptin Treatment Between Responder and Non-responder Groups
Sitagliptin 45 min
|
59.6 percentage of DPP4 activity
Standard Deviation 18.7
|
33.5 percentage of DPP4 activity
Standard Deviation 8.4
|
|
Differences of DPP-4 Activity After Sitagliptin Treatment Between Responder and Non-responder Groups
Sitagliptin 60 min
|
58.5 percentage of DPP4 activity
Standard Deviation 12.5
|
44.3 percentage of DPP4 activity
Standard Deviation 7.7
|
Adverse Events
Non-responder
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Responder
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place