A Study to Assess the Safety and Efficacy of ASP1941 in Combination With α-glucosidase Inhibitor in Type 2 Diabetic Patients
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ClinicalTrials.gov Identifier: NCT01242202 |
Recruitment Status
:
Completed
First Posted
: November 16, 2010
Last Update Posted
: January 20, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Mellitus | Drug: ASP1941 Drug: alpha glucosidase inhibitor | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 113 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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. |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | May 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: ASP group
Concomitant administration of ASP1941 and α- glucosidase inhibitor
|
Drug: ASP1941
oral
Drug: alpha glucosidase inhibitor
oral
Other Name: Acarbose, Miglitol, Voglibose
|
- Change from baseline in HbA1c [ Time Frame: baseline and 52 weeks ]
- Change from baseline in fasting plasma glucose [ Time Frame: baseline and 52 weeks ]
- Change from baseline in fasting serum insulin [ Time Frame: baseline and 52 weeks ]
- Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs) [ Time Frame: for 52 weeks ]

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Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01242202
Japan | |
Chubu, Japan | |
Hokkaido, Japan | |
Kansai, Japan | |
Kantou, Japan | |
Kyushu, Japan | |
Touhoku, Japan |
Study Chair: | Use Central Contact | Astellas Pharma Inc |
Additional Information:
Responsible Party: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT01242202 History of Changes |
Other Study ID Numbers: |
1941-CL-0108 |
First Posted: | November 16, 2010 Key Record Dates |
Last Update Posted: | January 20, 2016 |
Last Verified: | January 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
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 |