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A Study to Evaluate the Effect of ASP1941 in Adult Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01071850
First Posted: February 19, 2010
Last Update Posted: July 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc
  Purpose
Evaluate the efficacy, safety, and tolerability of multiple doses of ASP1941 compared to placebo over 12 weeks of therapy in adult patients with type 2 diabetes mellitus.

Condition Intervention Phase
Diabetes Mellitus, Type 2 Drug: ASP1941 Drug: Metformin Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Mean change from baseline in Hemoglobin A1c (HbA1c) [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Mean change from baseline in fasting plasma glucose (FPG) [ Time Frame: 12 weeks ]
  • Proportion of subjects achieving target goal of HbA1c <7.0% [ Time Frame: 12 weeks ]
  • Proportion of subjects achieving target goal of HbA1c <6.5% [ Time Frame: 12 weeks ]

Enrollment: 412
Study Start Date: March 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP1941 lowest dose Drug: ASP1941
oral tablet
Experimental: ASP1941 low dose Drug: ASP1941
oral tablet
Experimental: ASP1941 high dose Drug: ASP1941
oral tablet
Experimental: ASP1941 highest dose Drug: ASP1941
oral tablet
Active Comparator: Metformin Drug: Metformin
oral tablet
Placebo Comparator: Placebo Drug: Placebo
oral tablet

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has been diagnosed with type 2 diabetes
  • Subject has a HbA1c value between 6.8 and 9.5%
  • Subject has never, is not currently taking anti-diabetic medication OR is receiving a single anti- diabetic agent or low-doses two anti-diabetic medications and is willing to discontinue them during the study
  • Subject is on a stable diet and exercise program
  • Female subject is not pregnant and agrees to use an acceptable form of contraception throughout the duration of the study

Exclusion Criteria:

  • Subject has type 1 diabetes mellitus
  • Subject is using insulin therapy
  • Subject has a serum creatinine higher than upper limit of normal
  • Subject has an ALT and/or AST value higher than 3 times upper limit of normal or a total bilirubin value more than 2 times upper limit of normal
  • Subject has persistent, uncontrolled severe hypertension as indicated by a systolic blood pressure >180 mmHg or a diastolic blood pressure of >110mmHg
  • Subject has had significant cardiovascular disease such as myocardial infarction or a vascular intervention (e.g., angioplasty or stent) in the last 3 months
  • Subject is known to have hepatitis or be a carrier of hepatitis B surface antigen, hepatitis C virus antibody or is known positive for HIV1 and/or HIV2
  • Subject has a history of lactic acidosis
  • Subject has a history of drug and alcohol abuse/dependency within last 12 months
  • Subject has had a malignancy in the last 5 years, except for successfully treated basal or squamous cell carcinoma of the skin or of the cervix
  • Subject has a symptomatic urinary tract infection or genital infection
  • Female subject is lactating
  • Subject has an unstable medical or psychiatric illness
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01071850


  Show 59 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Global Development
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01071850     History of Changes
Other Study ID Numbers: 1941-CL-0004
First Submitted: February 18, 2010
First Posted: February 19, 2010
Last Update Posted: July 3, 2015
Last Verified: June 2015

Keywords provided by Astellas Pharma Inc:
Type 2 diabetes
diabetes
ASP1941
Metformin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs