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Post-Marketing Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Ipragliflozin in Combination With GLP-1 Receptor Agonists in Japanese Patients With Type 2 Diabetes Mellitus (T2DM)

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: NCT02291874
Recruitment Status : Completed
First Posted : November 17, 2014
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
Purpose of this study is to evaluate the Long-term Safety, Tolerability, and Efficacy of Ipragliflozin in Combination with GLP-1 Receptor Agonists in Japanese Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control with GLP-1 Receptor Agonists.

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

Detailed Description:

This is a multicenter, open-label study in patients with T2DM who have inadequate glycemic control with GLP-1 receptor agonists for at least 6 weeks prior to Visit 1 (Week -6).

Patients on monotherapy with Victoza® or on combination therapy with GLP-1 receptor agonists and sulfonylurea (SU) are eligible. Patients on combination therapy with GLP-1 receptor agonists and non-SU hypoglycemic agents can also be included; however, these patients must undergo washout of the non-SU hypoglycemic agents administered with GLP-1 receptor agonists.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Postmarketing Clinical Study of Ipragliflozin - Long-term Study in Combination With GLP-1 Receptor Agonists in Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : October 8, 2014
Actual Primary Completion Date : July 7, 2016
Actual Study Completion Date : July 7, 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. HbA1c [ Time Frame: at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week ]
  2. Fasting plasma glucose [ Time Frame: at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week ]

Secondary Outcome Measures :
  1. Fasting serum insulin [ Time Frame: at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week ]
  2. Serum glucagon [ Time Frame: at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week ]
  3. Serum glycoalbumin [ Time Frame: at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week ]
  4. Serum leptin [ Time Frame: at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week ]
  5. Serum adiponectin [ Time Frame: at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week ]
  6. Body weight [ Time Frame: 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week ]
  7. Waist circumference [ Time Frame: at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week ]
  8. Self-measured blood glucose [ Time Frame: at 0, 20, 52-week ]
    Subjects measure blood glucose 7 times a day on any 3 days in a week before each scheduled visit and record the results in the patient diary

  9. Adverse events (AEs), vital signs, and laboratory tests [ Time Frame: All treatment period ]


Information from the National Library of Medicine

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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:

  • The subject has a diagnosis of T2DM that was determined at least 12 weeks (84 days) before providing informed consent.
  • The subject has been receiving the same GLP-1 receptor agonist at a fixed dose and mode of administration for at least 6 weeks (42 days) prior to Visit 1.
  • If on therapy with a concomitant SU, the subject has been receiving the same SU at a fixed dose and mode of administration for at least 6 weeks (42 days) prior to Visit 1.
  • The subject has HbA1c levels of ≥7.5% but ≤10.5% at Visit 2, and the difference in HbA1c levels between Visit 1 and Visit 2 is within ±1.0%.
  • The subject has a BMI of ≥20.0 kg/m2 but ≤45.0 kg/m2 at Visit 2.
  • If on therapy with a concomitant SU, the subject has fasting plasma glucose levels of ≥126 mg/dL at Visit 2.

Exclusion Criteria:

  • The subject has T1DM.
  • The subject has symptoms of dysuria, anuria, oliguria, or urinary retention.
  • The subject has proliferative retinopathy.
  • The subject has a history of clinically significant renal diseases such as renovascular occlusive disease, nephrectomy, or renal transplant.
  • The subject has a history of pancreatitis.
  • The subject has a history of recurrent urinary tract infections (≥3 episodes within 24 weeks before providing informed consent).
  • The subject has a symptomatic urinary tract infection or symptomatic genital infection.
  • The subject has a chronic disease that requires the continuous use of adrenocortical steroids and immunosuppressants (oral, injectable, or inhalational medications).
  • The subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, or serious heart disease (NYHA Class III-IV) within 1 year (52 weeks) prior to Visit 1, or the subject has heart disease or cerebral vascular disease that, as per the judgment of the investigator or sub-investigator, may interfere with the treatment with ipragliflozin or safety evaluation of this study.
  • The subject has an unstable psychiatric disorder.
  • The subject is a female who is currently pregnant or lactating or could be pregnant.
  • The subject is unable or unwilling to practice an appropriate contraception method during the study.
  • The subject has severe infection, perioperative or serious trauma.
  • The subject has drug addiction or abuses alcohol.
  • The subject has a history of malignant tumors (except when he/she has been free from treatment for at least 5 years before providing informed consent and is not considered to have any recurrence).
  • The subject has a history of allergy to ipragliflozin or similar drugs that have an SGLT2 inhibitory action.
  • The subject has participated in a clinical study of an investigational product or medical device or post-marketing study within 12 weeks (84 days) before providing informed consent or is currently participating in any of these studies.
  • The subject is unable or unwilling, or does not agree, to comply with the study requirements, including the hospital visits, dose instructions, and the subject's responsibilities.

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): NCT02291874


Locations
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Japan
Chubu, Japan
Chugoku, Japan
Hokkaido, Japan
Kansai, Japan
Kanto, Japan
Kyushu, 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: NCT02291874    
Other Study ID Numbers: 1941-CL-0132
First Posted: November 17, 2014    Key Record Dates
Last Update Posted: April 26, 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:
Diabetes
Ipragliflozin
GLP-1 receptor agonist
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