Type 2 Diabetes
Conditions
Brief summary
This Phase III clinical trial will examine the safety, tolerability, and efficacy of the addition of MK-0431/ONO-5435 to Japanese patients with Type 2 Diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and rapid-acting insulin secretagogue monotherapy.
Interventions
DRUGMK-0431/ONO-5435
Double-blind period (12 wk); 50 mg QD. The double-blind period will be followed by a 40 week open label extension period where MK-0431/ONO-5435 could be titrated from 50 mg to 100 mg QD.
DRUGPlacebo, MK-0431/ONO-5435
Double-blind period (12 wks); placebo QD. The double-blind period will be followed by a 40 wk open label extension period where MK-0431/ONO-5435 could be titrated from 50 mg to 100 mg QD.
Sponsors
MSD K.K.
Ono Pharmaceutical Co. Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Japanese patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on diet/exercise therapy and rapid-acting insulin secretagogue monotherapy
Exclusion criteria
* Patients with Type 1 Diabetes Mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidences of adverse experiences and change in vital sign, safety lab etc. as parameters of safety and tolerability | 12 weeks and 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c | 12 weeks |
| 2-hour postmeal glucose | 12 weeks |
| Fasting plasma glucose | 12 weeks |
Countries
Japan
Outcome results
None listed