Type 2 Diabetes Mellitus MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Trade Name: ACTOS
Product Name: Pioglitazone 30mg
Pharmaceutical Form: Tablet
INN or Proposed INN: PIOGLITAZONE HYDROCHLORIDE
CAS Number: 112529154
Other descriptive name: ACTOS
Concentration unit: mg
Sponsors
Merck Sharp & Dohme GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient has type 2 diabetes mellitus. 2) Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Patient has a history of type 1 diabetes mellitus or history of ketoacidosis. 2) Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 12 weeks. 3) Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 3 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: HbA1c after 32 weeks; safety and tolerability;Secondary Objective: After 1 week, FPG; After 32 weeks, 2-hr PPG, FPG;Primary end point(s): HbA1c, FPG, 2-hr PPG | — |
Countries
Austria, Hungary, Ireland, Slovenia, Sweden, United Kingdom
Outcome results
None listed