A Study to Assess the Safety and Efficacy of ASP1941 in Combination With α-glucosidase Inhibitor in Type 2 Diabetic Patients - Full Text View

Purpose

This study is to evaluate long-term safety and efficacy after concomitant administration of ASP1941 and α-glucosidase inhibitor in Japanese patients with type 2 diabetes mellitus.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: ASP1941 Drug: alpha glucosidase inhibitor	Phase 3


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 3, Open-Label, Non-comparative Study to Assess the Long-Term Safety, Tolerability and Efficacy of ASP1941 in Combination With an α-Glucosidase Inhibitor in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With an α-glucosidase Inhibitor Alone.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Type 2

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Change from baseline in HbA1c [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in fasting plasma glucose [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
Change from baseline in fasting serum insulin [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs) [ Time Frame: for 52 weeks ] [ Designated as safety issue: No ]


Enrollment:	113
Study Start Date:	October 2010
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ASP group Concomitant administration of ASP1941 and α- glucosidase inhibitor	Drug: ASP1941 oral Drug: alpha glucosidase inhibitor oral Other Name: Acarbose, Miglitol, Voglibose

Detailed Description:

This is a 52-week multi-center study in subjects with type 2 diabetes mellitus who have inadequate glycemic control on an α-Glucosidase Inhibitor alone. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.

Eligibility


Ages Eligible for Study:	20 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetic patients receiving with α-glucosidase inhibitor mono-therapy for at least 4 weeks
HbA1c value between 6.5 and 9.5%
Body Mass Index (BMI) 20.0 - 45.0 kg/m2

Exclusion Criteria:

Type 1 diabetes mellitus patients
Serum creatinine > upper limit of normal
Proteinuria (albumin/creatinine ratio > 300mg/g)
Dysuria and/or urinary tract infection, genital infection
Significant renal, hepatic or cardiovascular diseases
Severe gastrointestinal diseases

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242202

Locations


Japan

Chubu, Japan

Hokkaido, Japan

Kansai, Japan

Kantou, Japan

Kyushu, Japan

Touhoku, Japan

Sponsors and Collaborators

Astellas Pharma Inc

Investigators


Study Chair:	Use Central Contact	Astellas Pharma Inc

More Information

Additional Information:

Link to Results on JAPIC - enter 140622 in the JapicCTI-RNo. field This link exits the ClinicalTrials.gov site

Link to results on Astellas Clinical Study Results Web site This link exits the ClinicalTrials.gov site


Responsible Party:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT01242202 History of Changes
Other Study ID Numbers:	1941-CL-0108
Study First Received:	November 15, 2010
Last Updated:	January 18, 2016
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency
Individual Participant Data
Plan to Share IPD:	Undecided

Keywords provided by Astellas Pharma Inc:


ASP1941 Diabetes mellitus alpha glucosidase inhibitor long-term safety

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases	Glycoside Hydrolase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Hypoglycemic Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 27, 2016