Recent Updates
Recently added Catalysts

Actos

Phase 2

Diabetes Mellitus Type 2 | Small molecule | Metabolic |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment522

FDA Designations

No designations recorded

Clinical trial landscape

Actos · 3 trials · 1 indication

Phase 2 3
NCT00461006A Comparison of the Effects of Aleglitazar and Actos on Renal Function on Patients With Type 2 Diabetes.Diabetes Mellitus Type 2
COMPLETED176 Analytics
NCT00461058A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and New York Heart Association (NYHA) Class II Heart Failure.Diabetes Mellitus Type 2
COMPLETED14 Analytics
NCT00388518A Study of Aleglitazar in Patients With Type 2 DiabetesDiabetes Mellitus Type 2
COMPLETED332 Analytics
PHASE2COMPLETED
A Comparison of the Effects of Aleglitazar and Actos on Renal Function on Patients With Type 2 Diabetes.
Diabetes Mellitus Type 2Unlock trial analytics
PHASE2COMPLETED
A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and New York Heart Association (NYHA) Class II Heart Failure.
Diabetes Mellitus Type 2Unlock trial analytics
PHASE2COMPLETED
A Study of Aleglitazar in Patients With Type 2 Diabetes
Diabetes Mellitus Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Relative change from baseline in glomerular filtration rate
26 weeks
Incidence of cardiovascular death, hospitalization or clinic visit for heart failure with i.v. administration of diuretics during 26 week treatment period.
26 week
Absolute change from baseline in Hemoglobin A1c (HbA1c)
16 weeks

Secondary Endpoints

Relative change from baseline in estimated renal plasma flow (ERPF) and urine albumin-creatinine ratio (UACR)
26 weeks
Absolute change in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and fasting plasma insulin (FPI).
End of treatment
Adverse events (AEs), laboratory parameters.
Throughout study
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AleglitazarEXPERIMENTAL -
ActosACTIVE_COMPARATOR -
Aleglitazar 1EXPERIMENTAL -
Aleglitazar 2EXPERIMENTAL -
Aleglitazar 3EXPERIMENTAL -
Aleglitazar 4EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
ActosDRUG45mg po daily
aleglitazarDRUG0.6mg po daily
PlaceboDRUGpo daily
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites52

Inclusion Criteria: * adult patients, 18-75 years of age; * type 2 diabetes for \>=1 month; * drug naive, or receiving stable oral antihyperglycemic medication; * HbA1c 6.5-10.0% at screening. Exclusion Criteria: * type 1 diabetes; * current or previous treatment with insulin; * history of renal ...

Countries:United StatesMexicoPuerto RicoRussiaUkraineIsraelRomaniaGreeceHong KongItalySerbia
Unlock Eligibility Criteria

Frequently asked questions about Actos

What is Actos used for in Diabetes Mellitus Type 2?

Actos is used for the treatment of Diabetes Mellitus Type 2. It is a small molecule being developed by Roche Holding AG (RHHBY). In clinical trials, Actos has been studied as a comparator in patients with type 2 diabetes, including those with NYHA Class II heart failure.

Who makes Actos?

Actos is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is a small molecule in the metabolic therapeutic area, specifically targeting Diabetes Mellitus Type 2. Roche has conducted Phase 2 clinical trials involving Actos as a comparator.

What phase is Actos in?

Actos is in Phase 2 clinical development. It has been studied in three completed Phase 2 trials, all of which were randomized, double-blind, and placebo-controlled. These trials enrolled a total of 522 patients with Diabetes Mellitus Type 2.

What clinical trials is Actos in?

Actos has been involved in three completed Phase 2 trials: NCT00388518, a study of aleglitazar in type 2 diabetes with 332 patients; NCT00461006, comparing effects on renal function with 176 patients; and NCT00461058, a comparative study in patients with NYHA Class II heart failure with 14 patients.

Is Actos the same as aleglitazar?

No, Actos is not the same as aleglitazar. In the clinical trials, Actos was used as a comparator against aleglitazar, which was the investigational drug being studied. Actos is a separate drug developed by Roche Holding AG for Diabetes Mellitus Type 2.