Diabetes Mellitus Type 2
Conditions
Keywords
Diabetes mellitus Type two, T2DM, vildagliptin, sitagliptin, FPG, DPP-4
Brief summary
This study is designed to assess the potential difference in Fasting Plasma Glucose (FPG) lowering efficacy between the two DPP-4 inhibitors vildagliptin and sitagliptin, both after a two weeks treatment on top of metformin.
Interventions
DRUGVildagliptin
50mg vildagliptin bid
DRUGSitagliptin
100mg sitagliptin po qd
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Patients with type 2 diabetes 18 to 85 years Metformin monotherapy \> 4 weeks HbA1c 6.5 - 9.5%
Exclusion criteria
FPG \> 270 mg/dl Use of other antidiabetic drugs than metformin major cardiovascular event in the last 6 months (MI, stroke…)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| demonstrate that the FPG after 14 days of treatment with Vildagliptin is superior to the FPG after 14 days of treatment with Sitagliptin | 14 days | Fasting Plasma Glucose measured on day 14. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the difference in FPG between vildagliptin and sitagliptin in patients with type 2 diabetes mellitus on concomitant treatment with metformin | 14 days | Fasting Plasma Glucose on day 14 analyzed descriptively. |
Countries
Germany
Outcome results
None listed