Phase 1
Completed N=18
A Study of the Effects of Co-Administration of Sitagliptin (MK-0431) and Metformin on Incretin Hormone Concentrations (MK-0431-110)
Source: ClinicalTrials.gov NCT00830076 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Nov 2011
Primary outcomePrimary: Incremental Post-prandial 4-hour Weighted Mean Active Glucagon-like Peptide-1 (GLP-1) Plasma Concentrations — 6.00; 4.09; 7.22; 1.55 picomolar
Summary
This study will assess the effects of sitagliptin and metformin alone and after co-administration on incretin hormone concentrations in patients with Type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incremental Post-prandial 4-hour Weighted Mean Active Glucagon-like Peptide-1 (GLP-1) Plasma Concentrations |
6.00; 4.09; 7.22; 1.55 | — |
| SECONDARY β-cell Sensitivity |
19.50; 25.71; 26.39; 15.44 | — |
| SECONDARY Incremental Post-prandial 4-hour Weighted Mean Plasma Glucose Concentrations |
42.30; 29.33; 20.02; 51.02 | — |
Eligibility Criteria
Inclusion Criteria
- Female subjects must have a negative pregnancy test
- Subject has type 2 diabetes and is not currently receiving treatment with an oral AHA agent, has not received such treatment for 3 months prior to study, and/or has not received more than 4 total weeks treatment with an oral AHA agent for 12 to 18 months prior to the study
- Subject is a nonsmoker or has not smoked and/or used nicotine for at least 6 months
Exclusion Criteria
- Subject has a history of stroke, seizures, or major neurological disorders
- Female subject is breastfeeding
- Subject cannot refrain from use of any prescription or non-prescription drugs beginning 2 weeks prior to first dose of study drug
- Subject consumes more than 3 alcoholic beverages per day
- Subject consumes more than 6 caffeinated beverages per day
- Subject has had major surgery, or has donated or lost 1 unit of blood within 4 weeks of screening
- Subject has a history of cancer, except certain skin or cervical cancer or other cancers treated more than 10 years prior to screening
- Subject has a history of multiple and/or severe allergies or intolerance to drugs or food
Data sourced from ClinicalTrials.gov (NCT00830076). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.