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A Study to Assess the Efficacy and Safety of Ipragliflozin in Combination With Insulin in Subjects With Type 2 Diabetes Mellitus

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.
 
ClinicalTrials.gov Identifier: NCT02175784
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
The purpose of this study is to assess the efficacy (superiority to placebo) of ipragliflozin based on the changes in HbA1C, as well as its safety, in patients with type 2 diabetes mellitus in combination with an insulin preparation once daily for 16 weeks. The long-term (52 weeks) safety and the persistence of the efficacy will also be evaluated.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: ipragliflozin Drug: placebo Phase 4

Detailed Description:
This study consists of two parts. First part is a placebo-controlled multicenter, double-blind, parallel group study, in which subjects will receive ipragliflozin or placebo once daily in combination with an insulin preparation for 16 weeks. Second part is a multicenter, open-label period (36 weeks) with no placebo group. The dose of ipragliflozin can be doubled in combination with an insulin preparation during the second part.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postmarketing Clinical Study of Ipragliflozin - Double-blind, Parallel-group Study in Combination With Insulin in Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : March 31, 2014
Actual Primary Completion Date : March 31, 2015
Actual Study Completion Date : December 7, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ipragliflozin group
oral
Drug: ipragliflozin
oral
Other Names:
  • ASP1941
  • Suglat

Experimental: placebo group
oral
Drug: placebo
oral




Primary Outcome Measures :
  1. Change in HbA1C from baseline [ Time Frame: Baseline and Week 16 ]

Secondary Outcome Measures :
  1. Fasting plasma glucose [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ]
  2. Leptin concentration [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 24, 36, 52 ]
  3. Fructosamine concentration [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 24, 36, 52 ]
  4. Adiponectin concentration [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 24, 36, 52 ]
  5. Body weight [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ]
  6. Waist circumference [ Time Frame: Baseline, Week 16, 24, 52 ]
  7. Blood glucose values of self monitoring [ Time Frame: Baseline, Week 8, 16, 24, 52 ]
    written in a diary

  8. Safety assessed by the adverse events, vital signs. and laboratory tests [ Time Frame: Up to 52 Weeks ]


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

Inclusion Criteria:

  • Subject has been diagnosed with type 2 diabetes mellitus for at least 12 weeks (84 days) at signing of informed consent.
  • Subject takes constant dosage and administration of insulin preparation for more than 6 weeks (42 days)
  • Subject has an HbA1C value between 7.5 and 10.0% at Visit 2 and the difference of HbA1C value within ± 1.0% between Visit 1 and Visit 2
  • Subject has a body mass index (BMI) 20.0 - 45.0 kg/m2

Exclusion Criteria:

  • Subject has type 1 diabetes mellitus
  • Subject has proliferative diabetic retinopathy
  • Subject has a history of clinically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant
  • Subject has a history of recurrent urinary tract infection (more than three times within before 24 weeks of obtaining informed consent)
  • Subject has a symptomatic urinary tract infection or symptomatic genital infection
  • Subject has chronic disease which requires the continuous use of adrenocortical steroids and immunosuppressant (oral medication, injection, or inhalation)
  • Subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, and heart disease (NYHA Class III-IV) within 1 year (52 weeks) prior to Visit 1
  • Subject has unstable psychiatric disorder
  • Female subject who is currently pregnant or lactating, or who is possibly pregnant
  • Male and pre-menopausal female subject who cannot use an appropriate contraception during the study
  • Subject has severe infection, perioperative, or serious trauma
  • Subject has drug addiction or alcohol abuse
  • Subject has a history of malignant tumors (except for those who have not received treatment for malignant tumors for at least 5 years before informed consent acquisition and was not considered to have recurrence)
  • Subject has a history of an allergy with ipragliflozin and/or similar drugs (study drugs possessing SGLT 2 inhibitory action)
  • Subject has participated in another clinical study, post marketing study, or medical equipment study within 12 weeks (84 days) before providing written informed consent, or who is currently participating in any of those studies
  • Subject is unable, unwilling to adhere to compliances such as hospital visits and dose instruction specified in this study

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): NCT02175784


Locations
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Japan
Chubu, Japan
Chugoku, Japan
Hokkaido, Japan
Kansai, Japan
Kanto, Japan
Kyushu, Japan
Shikoku, Japan
Touhoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Medical Director Astellas Pharma Inc
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT02175784    
Other Study ID Numbers: 1941-CL-0131
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
URL: https://www.clinicalstudydatarequest.com/
Keywords provided by Astellas Pharma Inc:
Blood glucose
insulin
ipragliflozin
SGLT2 inhibitor
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ipragliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs