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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: November 21, 2017
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
February 18, 2010
February 19, 2010
November 21, 2017
March 3, 2010
April 11, 2011   (Final data collection date for primary outcome measure)
Mean change from baseline in Hemoglobin A1c (HbA1c) [ Time Frame: 12 weeks ]
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 ]
  • 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 ]
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
    oral tablet
    Intervention: Drug: ASP1941
  • Experimental: ASP1941 low dose
    oral tablet
    Intervention: Drug: ASP1941
  • Experimental: ASP1941 high dose
    oral tablet
    Intervention: Drug: ASP1941
  • Experimental: ASP1941 highest dose
    oral tablet
    Intervention: Drug: ASP1941
  • Active Comparator: Metformin
    oral tablet
    Intervention: Drug: Metformin
  • Placebo Comparator: Placebo
    oral tablet
    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 11, 2011
April 11, 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Colombia,   India,   Mexico,   Philippines,   United States
 
 
NCT01071850
1941-CL-0004
No
Not Provided
Plan to Share IPD: Yes
Plan Description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.
URL: http://
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Director: Medical Director Astellas Pharma Global Development
Astellas Pharma Inc
November 2017

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