Diabetes Mellitus Type 2
Conditions
Brief summary
This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients with type 2 diabetes receiving a stable dose of metformin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
Interventions
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* adult patients 18-75 years of age; * type 2 diabetes; * stable metformin therapy for \>=3 months before screening.
Exclusion criteria
* women who are pregnant, breast-feeding, or not using an adequate contraceptive method; * type 1 diabetes; * any anti-hyperglycemic medication other than metformin in the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change from baseline in HbAlc\n | Week 16 |
Secondary
| Measure | Time frame |
|---|---|
| AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n | Throughout study |
| Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, and lipid profile, response rate\n | Week 16 |
Countries
Australia, Canada, Germany, Italy, Puerto Rico, United States
Outcome results
None listed