Diabetes Mellitus Type 2
Conditions
Brief summary
This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor compared to placebo in patients with type 2 diabetes. The anticipated time on study treatment is \< 3 months and the target sample size is 100-500 individuals.
Interventions
DRUGDPP-IV Inhibitor
Escalating doses po bid or qd
DRUGPlacebo
po bid or qd
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 diagnosed \>=1 month before screening; * no previous treatment, or previous treatment with no more than 2 oral medications.
Exclusion criteria
* type 1 diabetes; * type 2 diabetes treated with insulin or a PPAR gamma agonist during the 3 months before screening; * patients who are pregnant, breastfeeding or not using a reliable contraceptive method.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change from baseline in HbAlc\n\n | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, lipid profile, response rate | Week 12 |
| AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n | Throughout study |
Countries
Bulgaria, Costa Rica, Estonia, Latvia, Lithuania, Mexico, Puerto Rico, Romania, United States
Outcome results
None listed