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This study will investigate if the effect of DPP-4 inhibitors is mediated in part by Glucose-dependent insulinotropic polypeptide.
A randomized, placebo controlled study. Using a GIP receptor antagonist, we will investigate the glucose lowering effect of GIP during treatment with DPP-4 inhibitors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo tablet for placebo treatment period. Following treatment: 2 separate interventions/study days (placebo infusion and GIP receptor antagonist) |
|
| DPP-4 inhibitor | Active Comparator | DPP-4 inhibitor treatment for active treatment period. Following treatment: 2 separate interventions/study days (placebo infusion and GIP receptor antagonist) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Saline infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| C-peptide | Concentrations of C-peptide during GIP receptor antagonism compared to placebo | 5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma glucose | Concentrations of plasma glucose during GIP receptor antagonism compared to placebo | 5 hours |
| Insulin | Concentrations of insulin during GIP receptor antagonism compared to placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Gallbladder volume | Measures from ultrasound sonography | 5 hours |
| Systolic and diastolic blood pressure | Repeated measures | 5 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Metabolic Research | Copenhagen | Hellerup | 2900 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35796651 | Derived | Stensen S, Gasbjerg LS, Rosenkilde MM, Vilsboll T, Holst JJ, Hartmann B, Christensen MB, Knop FK. Endogenous Glucose-Dependent Insulinotropic Polypeptide Contributes to Sitagliptin-Mediated Improvement in beta-Cell Function in Patients With Type 2 Diabetes. Diabetes. 2022 Oct 1;71(10):2209-2221. doi: 10.2337/db22-0059. |
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| ID | Term |
|---|---|
| D054873 | Dipeptidyl-Peptidase IV Inhibitors |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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Randomized, placebo-controlled, cross-over.
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Double blinded study. Both participants and investigators are blinded to interventions.
| GIP receptor antagonist |
| Other |
Used for infusion on study days |
|
| DPP-4 inhibitor | Drug | Oral administration of DPP-4 inhibitor in active treatment period |
|
|
| Placebo tablet | Other | Oral administration of placebo tablet in placebo treatment period |
|
| 5 hours |
| Total and intact GIP | Concentrations of total and intact GIP during GIP receptor antagonism compared to placebo | 5 hours |
| Total and intact GLP-1 | Concentrations of total and intact GLP-1 during GIP receptor antagonism compared to placebo | 5 hours |
| Glucagon | Concentrations of glucagon during GIP receptor antagonism compared to placebo | 5 hours |
| CTX | Concentrations of CTX during GIP receptor antagonism compared to placebo | 5 hours |
| Lipids | Concentrations of lipids during GIP receptor antagonism compared to placebo | 5 hours |
| heart rate | Repeated measures | 5 hours |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
| D045505 | Physiological Effects of Drugs |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |