Incremental Area Under the Plasma Glucose (BG) Concentration-time Profile (AUC)
| Group | Value ([mg*min/dL]) | Spread |
|---|---|---|
| Sitagliptin | 5678 | 329 |
| Placebo | 5557 | 547 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataGermany
1 trial · 1 completed · 1 with posted results
Antidiabetic Effects of Adding a DPP-4 Inhibitor to Pre-Existing Treatment With an Incretin Mimetic in Patients With T2D
NCT01937598Aug 2013 to Jun 2015
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Objectives: To quantify differences in control of glycemia (primary objective) and the secretion of endogenous incretin hormones (secondary objective) comparing sitagliptin or placebo added to pre-existing therapy with liraglutide and metformin
Experimental
Sitagliptin, then Placebo
Experimental
Placebo, then Sitagliptin
Outcomes the sponsor listed as primary.
Incremental Area Under the Plasma Glucose (BG) Concentration-time Profile (AUC)
Time frame · 0 to 300 min post mixed meal test
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.
AUC Plasma Glucose
Time frame · Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)
Incremental AUC from 0 to 300 min
AUC Insulin
Time frame · Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)
AUC C-peptide
Time frame · Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)
AUC Glucagon
Time frame · Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)
AUC Total GLP-1
Time frame · Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)
AUC Total GIP
Time frame · Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)
AUC Active GLP-1
Time frame · Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)
AUC Active GIP
Time frame · Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value ([mg*min/dL]) | Spread |
|---|---|---|
| Sitagliptin | 5678 | 329 |
| Placebo | 5557 | 547 |
| Group | Value (mmol/l*min) | Spread |
|---|---|---|
| Sitagliptin | 315.4 | 18.3 |
| Placebo | 308.7 | 30.4 |
| Group | Value (nmol/l*min) | Spread |
|---|---|---|
| Sitagliptin | 45.8 | 7.9 |
| Placebo | 42.6 | 6.6 |
| Group | Value (nmol/l*min) | Spread |
|---|---|---|
| Sitagliptin | 171.5 | 16.5 |
| Placebo | 159.2 | 17.3 |
| Group | Value (pmol/l*min) | Spread |
|---|---|---|
| Sitagliptin | 6933 | 1056 |
| Placebo | 7004 | 1124 |
| Group | Value (pmol/l*min) | Spread |
|---|---|---|
| Sitagliptin | 748 | 115 |
| Placebo | 1143 | 218 |
| Group | Value (pmol/l*min) | Spread |
|---|---|---|
| Sitagliptin | 6242 | 645 |
| Placebo | 7523 | 548 |
| Group | Value (pmol/l*min) | Spread |
|---|---|---|
| Sitagliptin | 607.9 | 97.1 |
| Placebo | 418.4 | 75.6 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| SitagliptinSubstance: 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. | – | 0 / 16 | 4 / 16 |
| PlaceboSubstance: 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. | – | 0 / 16 | 2 / 16 |
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