Type 2 Diabetes Mellitus: bloodglucose
Conditions
Interventions
Pharmacodynamics : plasma and urine glucose concentrations, C-peptide, insulin,
GLP-1/glucagon concentrations.
Pharmacokinetics : Plasma DPP-4i concentrations.
Safety : adverse events, vital signs, E
Sponsors
PRA International EDS
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients diagnosed with DM Type 2 18-79 years, inclusive BMI 23-38 kg/m2 inclusive non smoker or smoke less than 5 cigarettes
Exclusion criteria
Exclusion criteria: Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters (males) or 1.0 liters (females) of blood in the 10 months prior the start of this study. Participation is also not permitted when participated in more than 3 other drug studies in the 10 months prior to the start of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints for analysis include: weighted mean glucose and HbA1c. Other endpoints for analysis include circulating GLP-1, glucagon and other analytes and CGM measurements. Blood will be collected for archived samples that may be analyzed for other study specific biomarkers. Safety and tolerability will be monitored throughout the study by clinical assessment of adverse experiences and by vital sign measurements, physical examinations, 12-lead ECGs, standard laboratory safety tests (hematology, chemistry, and urinalysis). These procedures may also be performed at various unscheduled time points, if deemed clinically necessary, by the Investigator. | — |
Countries
Netherlands
Outcome results
None listed