Trial Outcomes & Findings for Antidiabetic Effects of Adding a DPP-4 Inhibitor to Pre-Existing Treatment With an Incretin Mimetic in Patients With T2D (NCT NCT01937598)
NCT ID: NCT01937598
Last Updated: 2017-01-30
Results Overview
Incremental area under the plasma glucose (BG) concentration-time profile (AUC) immediately before to 300 min after a mixed meal test. In addition, the time course of BG values will be analysed with an ANCOVA model for repeated measurements with placebo baseline values as covariate. Time points to create the curce were 0, 15, 30, 45, 60, 90, 120, 150, 180, 240 and 300 minutes post mixed meal test.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
16 participants
Primary outcome timeframe
0 to 300 min post mixed meal test
Results posted on
2017-01-30
Participant Flow
Participant milestones
| Measure |
Sitagliptin, Then Placebo
Participants first received Sitagliptin tablet before mixed meal test, after washout they then received Placebo before the mixed meal test.
|
Placebo, Than Sitagliptin
Participants first received Placebo tablet before mixed meal test, after washout they then received Sitagliptin before the mixed meal test.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antidiabetic Effects of Adding a DPP-4 Inhibitor to Pre-Existing Treatment With an Incretin Mimetic in Patients With T2D
Baseline characteristics by cohort
| Measure |
All Study Participants
n=16 Participants
All study participants (cross-over design) received all interventions.
|
|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 11 • n=99 Participants
|
|
Gender
Female
|
5 Participants
n=99 Participants
|
|
Gender
Male
|
11 Participants
n=99 Participants
|
|
BMI
|
31.7 kg/m^2
STANDARD_DEVIATION 4.4 • n=99 Participants
|
PRIMARY outcome
Timeframe: 0 to 300 min post mixed meal testIncremental area under the plasma glucose (BG) concentration-time profile (AUC) immediately before to 300 min after a mixed meal test. In addition, the time course of BG values will be analysed with an ANCOVA model for repeated measurements with placebo baseline values as covariate. Time points to create the curce were 0, 15, 30, 45, 60, 90, 120, 150, 180, 240 and 300 minutes post mixed meal test.
Outcome measures
| Measure |
Sitagliptin
n=16 Participants
Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP \& DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet
Sitagliptin
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study.
|
Placebo
n=16 Participants
Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP \& DOHME GMBH Doses: - Route of administration: p.o. as tablets
Placebo
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study.
|
|---|---|---|
|
Incremental Area Under the Plasma Glucose (BG) Concentration-time Profile (AUC)
|
5678 [mg*min/dL]
Standard Error 329
|
5557 [mg*min/dL]
Standard Error 547
|
SECONDARY outcome
Timeframe: Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)Incremental AUC from 0 to 300 min
Outcome measures
| Measure |
Sitagliptin
n=16 Participants
Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP \& DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet
Sitagliptin
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study.
|
Placebo
n=16 Participants
Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP \& DOHME GMBH Doses: - Route of administration: p.o. as tablets
Placebo
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study.
|
|---|---|---|
|
AUC Plasma Glucose
|
315.4 mmol/l*min
Standard Error 18.3
|
308.7 mmol/l*min
Standard Error 30.4
|
SECONDARY outcome
Timeframe: Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)Outcome measures
| Measure |
Sitagliptin
n=16 Participants
Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP \& DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet
Sitagliptin
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study.
|
Placebo
n=16 Participants
Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP \& DOHME GMBH Doses: - Route of administration: p.o. as tablets
Placebo
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study.
|
|---|---|---|
|
AUC Insulin
|
45.8 nmol/l*min
Standard Error 7.9
|
42.6 nmol/l*min
Standard Error 6.6
|
SECONDARY outcome
Timeframe: Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)Outcome measures
| Measure |
Sitagliptin
n=16 Participants
Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP \& DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet
Sitagliptin
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study.
|
Placebo
n=16 Participants
Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP \& DOHME GMBH Doses: - Route of administration: p.o. as tablets
Placebo
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study.
|
|---|---|---|
|
AUC C-peptide
|
171.5 nmol/l*min
Standard Error 16.5
|
159.2 nmol/l*min
Standard Error 17.3
|
SECONDARY outcome
Timeframe: Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)Outcome measures
| Measure |
Sitagliptin
n=16 Participants
Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP \& DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet
Sitagliptin
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study.
|
Placebo
n=16 Participants
Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP \& DOHME GMBH Doses: - Route of administration: p.o. as tablets
Placebo
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study.
|
|---|---|---|
|
AUC Glucagon
|
6933 pmol/l*min
Standard Error 1056
|
7004 pmol/l*min
Standard Error 1124
|
SECONDARY outcome
Timeframe: Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)Outcome measures
| Measure |
Sitagliptin
n=16 Participants
Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP \& DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet
Sitagliptin
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study.
|
Placebo
n=16 Participants
Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP \& DOHME GMBH Doses: - Route of administration: p.o. as tablets
Placebo
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study.
|
|---|---|---|
|
AUC Total GLP-1
|
748 pmol/l*min
Standard Error 115
|
1143 pmol/l*min
Standard Error 218
|
SECONDARY outcome
Timeframe: Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)Outcome measures
| Measure |
Sitagliptin
n=16 Participants
Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP \& DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet
Sitagliptin
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study.
|
Placebo
n=16 Participants
Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP \& DOHME GMBH Doses: - Route of administration: p.o. as tablets
Placebo
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study.
|
|---|---|---|
|
AUC Total GIP
|
6242 pmol/l*min
Standard Error 645
|
7523 pmol/l*min
Standard Error 548
|
SECONDARY outcome
Timeframe: Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)Outcome measures
| Measure |
Sitagliptin
n=16 Participants
Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP \& DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet
Sitagliptin
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study.
|
Placebo
n=16 Participants
Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP \& DOHME GMBH Doses: - Route of administration: p.o. as tablets
Placebo
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study.
|
|---|---|---|
|
AUC Active GLP-1
|
607.9 pmol/l*min
Standard Error 97.1
|
418.4 pmol/l*min
Standard Error 75.6
|
SECONDARY outcome
Timeframe: Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)Outcome measures
| Measure |
Sitagliptin
n=16 Participants
Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP \& DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet
Sitagliptin
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study.
|
Placebo
n=16 Participants
Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP \& DOHME GMBH Doses: - Route of administration: p.o. as tablets
Placebo
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study.
|
|---|---|---|
|
AUC Active GIP
|
6270 pmol/l*min
Standard Error 441
|
3496 pmol/l*min
Standard Error 623
|
Adverse Events
Sitagliptin
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sitagliptin
n=16 participants at risk
Substance: Sitagliptin phosphate 1H2O Pharmaceutical form: tablets Source: MSD SHARP \& DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet
Sitagliptin
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study.
|
Placebo
n=16 participants at risk
Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP \& DOHME GMBH Doses: - Route of administration: p.o. as tablets
Placebo
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study.
|
|---|---|---|
|
General disorders
Headache
|
12.5%
2/16 • Number of events 2 • up to 32 days after randomisation
|
12.5%
2/16 • Number of events 2 • up to 32 days after randomisation
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 15 • up to 32 days after randomisation
|
0.00%
0/16 • up to 32 days after randomisation
|
|
Metabolism and nutrition disorders
asympomatic hyppglycaemia
|
6.2%
1/16 • Number of events 1 • up to 32 days after randomisation
|
0.00%
0/16 • up to 32 days after randomisation
|
Additional Information
Prof. Dr. M. A. Nauck, Principle Investigator
Div. Diabetology, Med. Dep. I, St. Josef-Hospital (Ruhr-Univeristy Bochum), change of address 01.01.20015
Phone: +49-234-509
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place