Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01071850
First received: February 18, 2010
Last updated: October 16, 2014
Last verified: October 2014

February 18, 2010
October 16, 2014
March 2010
April 2011   (final data collection date for primary outcome measure)
Mean change from baseline in Hemoglobin A1c (HbA1c) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01071850 on ClinicalTrials.gov Archive Site
  • Mean change from baseline in fasting plasma glucose (FPG) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving target goal of HbA1c <7.0% [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving target goal of HbA1c <6.5% [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Effect of ASP1941 in Adult Patients With Type 2 Diabetes Mellitus
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: ASP1941
    oral tablet
  • Drug: Metformin
    oral tablet
  • Drug: Placebo
    oral tablet
  • Experimental: ASP1941 lowest dose
    Intervention: Drug: ASP1941
  • Experimental: ASP1941 low dose
    Intervention: Drug: ASP1941
  • Experimental: ASP1941 high dose
    Intervention: Drug: ASP1941
  • Experimental: ASP1941 highest dose
    Intervention: Drug: ASP1941
  • Active Comparator: Metformin
    Intervention: Drug: Metformin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Fonseca VA, Ferrannini E, Wilding JP, Wilpshaar W, Dhanjal P, Ball G, Klasen S. Active- and placebo-controlled dose-finding study to assess the efficacy, safety, and tolerability of multiple doses of ipragliflozin in patients with type 2 diabetes mellitus. J Diabetes Complications. 2013 May-Jun;27(3):268-73. doi: 10.1016/j.jdiacomp.2012.11.005. Epub 2012 Dec 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
412
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Colombia,   India,   Mexico,   Philippines
 
NCT01071850
1941-CL-0004
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Director: Medical Director Astellas Pharma Global Development
Astellas Pharma Inc
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP