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Pharmacodynamics, Pharmacokinetics, and Safety of ASP1941 in Patients With Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT02529449
Recruitment Status : Completed
First Posted : August 20, 2015
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
The objective of this study is to assess pharmacodynamics, pharmacokinetics, and safety of ASP1941 in patients with type 1 diabetes mellitus when administered once daily (q.d.) for 2 weeks.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Placebo Drug: ASP1941 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Clinical Pharmacological Study of ASP1941 in Japanese Patients With Type 1 Diabetes Mellitus
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : March 19, 2016
Actual Study Completion Date : March 19, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Placebo Comparator: Placebo
once daily
Drug: Placebo
Oral

Experimental: ASP1941 Low dose group
once daily
Drug: ASP1941
Oral
Other Names:
  • Suglat
  • Ipragliflozin

Experimental: ASP1941 Middle dose group
once daily
Drug: ASP1941
Oral
Other Names:
  • Suglat
  • Ipragliflozin

Experimental: ASP1941 High dose group
once daily
Drug: ASP1941
Oral
Other Names:
  • Suglat
  • Ipragliflozin




Primary Outcome Measures :
  1. Daily profile of plasma glucose levels [ Time Frame: up to Day 14 ]
  2. Area under the concentration-time curve (AUC) 0-24hr (AUC0-24h) of plasma glucose levels [ Time Frame: at Day -1, Day 1 and Day 14 ]
  3. AUC0-3h of plasma glucose levels [ Time Frame: at Day -1, Day 1 and Day 14 ]
  4. AUC0-4h of plasma glucose levels [ Time Frame: up to Day 14 ]
  5. AUC0-10h of plasma glucose levels [ Time Frame: up to Day 14 ]
  6. Fasting plasma glucose levels [ Time Frame: up to Day 21 ]
  7. Glycoalbumin [ Time Frame: up to Day 21 ]
  8. Urinary glucose excretion [ Time Frame: up to Day 14 ]
  9. Urinary glucose excretion rate [ Time Frame: up to Day 14 ]
  10. Urine volume [ Time Frame: up to Day 14 ]
  11. Urinary glucose concentration [ Time Frame: up to Day 15 ]
  12. Body weight [ Time Frame: up to Day 21 ]
  13. Renal glucose clearance [ Time Frame: up to Day 14 ]
  14. Plasma concentration of unchanged ASP1941 [ Time Frame: up to Day 14 ]
  15. Urinary concentration of unchanged ASP1941 [ Time Frame: up to Day 14 ]
  16. Pharmacokinetics (PK) parameter of ASP1941 in plasma: AUC from time 0 extrapolated to infinity (AUCinf) [ Time Frame: at Day 1 ]
  17. PK parameter of ASP1941 in plasma: AUC from the time of dosing to the last measurable concentration (AUClast) [ Time Frame: at Day 1 and Day 14 ]
  18. PK parameter of ASP1941 in plasma: AUC from the time of dosing to 24 hr (AUC0-24h) [ Time Frame: at Day 1 and Day 14 ]
  19. PK parameter of ASP1941 in plasma: Oral Clearance (CL/F) [ Time Frame: at Day 1 and Day 14 ]
  20. PK parameter of ASP1941 in plasma: Maximum concentration (Cmax) [ Time Frame: at Day 1 and Day 14 ]
  21. PK parameter of ASP1941 in plasma: Terminal Elimination Half-life (t1/2) [ Time Frame: at Day 1 and Day 14 ]
  22. PK parameter of ASP1941 in plasma: Time of the Maximum Concentration (tmax) [ Time Frame: at Day 1 and Day 14 ]
  23. PK parameter of ASP1941 in urine: Amount excreted in urine between time (Ae) [ Time Frame: at Day 1 and Day 14 ]
  24. PK parameter of ASP1941 in urine: % of the dose of excreted in urine (Ae%) [ Time Frame: at Day 1 and Day 14 ]
  25. PK parameter of ASP1941 in plasma and urine: Renal Clearance (CLr) [ Time Frame: at Day 1 and Day 14 ]
  26. Safety assessed by vital signs [ Time Frame: up to Day 21 ]
    Supine blood pressure and supine pulse rate

  27. Safety assessed by 12-lead electrocardiogram [ Time Frame: up to Day 21 ]
  28. Safety assessed by laboratory tests [ Time Frame: up to Day 21 ]
    Hematology, biochemistry and urinalysis

  29. Safety assessed by self-monitored blood glucose levels [ Time Frame: up to Day 21 ]
  30. Safety assessed by Adverse events [ Time Frame: up to Day 21 ]


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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

At the time of obtaining informed consent:

  • Subject is diagnosed with type 1 diabetes mellitus and has been treated with insulin therapy for at least 52 weeks (364 days).
  • Subject is able to be admitted to the site as scheduled.
  • Subject is able to record in Patient's diary from the first study drug dose in observation period until the day before the end of post observation.

At screening period:

  • Subject has an HbA1c (NGSP) value of between 7.5% and 10.0%. If subject has an HbA1c value of between 7.3% and 10.2% (out of the reference range), HbA1c may be re-measured only once within the allowance range in screening period. Re-measured HbA1c (NGSP) value will be adopted for the determination.
  • Subject has been receiving insulin therapy at daily doses (instructed by a doctor) within a ±20% range for at least 12weeks (83days) prior to the start of screening.
  • Subject has a fasting serum C-peptide level ≤0.5 ng/mL at screening.
  • Subject receives treatments for complications (except for transient diseases such as a cold) that, in the investigator's or sub-investigator's opinion, need not to be changed during the period from the start of screening to the end of the treatment period.
  • Subject has body mass index (BMI) value of 20.0 to 35.0 kg/m2 at screening.

Exclusion Criteria:

At the time of obtaining informed consent:

  • Subject has type 2 diabetes mellitus.
  • Subject has participated or has been participating in a clinical study or a post marketing study of another drug or medical equipment within 12 weeks (84 days) prior to obtaining informed consent.
  • Subject has received ASP1941 (ipragliflozin) with the exception of placebo.

At screening period:

  • Subject has proliferative retinopathy (subjects with stable condition after photocoagulation etc. may be enrolled in the study).
  • Subject has developed hypoglycemia unawareness (requires help of a third person) or severe hypoglycemia (diabetic coma, precoma, or convulsion) within 12 weeks (84 days) prior to the start of screening.
  • Subject has developed diabetic ketoacidosis within 12 weeks (84 days) prior to the start of screening.
  • Subject has chronic disease(s) which require the continuous use of corticosteroids or immunosuppressants (oral administration, injection, inhalation, or suppository).
  • Subject has received hypoglycemic agent(s) other than insulin within 12 weeks (83 days) prior to the start of screening.
  • Subject with perioperative, severe infection or serious injury.
  • Subject whose serum creatinine value exceeds the upper limit of normal range at screening.
  • Subject has a urinary albumin/urinary creatinine ratio>300 mg/g in urinalysis at screening.
  • Subject has a history of clinically significant renal disease(s) such as renovascular occlusive disease, nephrectomy, and/or renal transplant.
  • Subject has AST and ALT >2 ×ULN or T-Bil >1.5 × ULN at screening, or has a history of serious hepatic diseases.
  • Subject presents with symptoms of dysuria, anuria, oliguria and urinary retention.
  • Subject has a history of recurrent urinary tract infections and recurrent genital infections (developed 3 times or more within 24 weeks (168 days) prior to the start of screening).
  • Subject has urinary tract infection or genital infection with subjective symptoms.
  • Subject has a history of angina unstable, myocardial infarction, angioplasty, and serious heart disease (NYHA Class II-IV) within 24 weeks (168 days) prior to the start of screening, or has complications of heart disease that, in the investigator's or sub-investigator's opinion, may interfere with the evaluation of safety of ASP1941.
  • Subject has uncontrolled blood pressure (systolic blood pressure≥160 mmHg or diastolic blood pressure≥100 mmHg in the supine position after a 5-minute rest at screening ).
  • Subject has serious gastrointestinal disease or a history of serious gastrointestinal operation.
  • Subject has malignant tumors concomitantly (subject may be enrolled in the study if the subject has a history of a malignant tumor which has not recurred without any treatment within 5 years prior to the start of screening).
  • Subject has psychiatric disorder that makes the subject unsuitable for study participation.
  • Subject has drug addiction or alcohol abuse.
  • Subject has a history of drug allergies.
  • Subject is unable to adhere to any of the compliance such as hospital visits and dose instruction specified in this study, or does not agree with it.
  • Subject has donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days prior to the start of screening.
  • Subject has any condition that, in the investigator's or sub-investigator's opinion, makes the subject unsuitable for study participation.

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): NCT02529449


Locations
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Japan
Site JP00006
Aichi, Japan
Site JP00002
Fukuoka, Japan
Site JP00009
Gunma, Japan
Site JP00001
Ibaraki, Japan
Site JP00005
Kanagawa, Japan
Site JP00008
Kanagawa, Japan
Site JP00003
Okayama, Japan
Site JP00004
Osaka, Japan
Site JP00010
Osaka, Japan
Site JP00011
Osaka, Japan
Site JP00007
Tokyo, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Medical Director Astellas Pharma Inc

Additional Information:
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT02529449     History of Changes
Other Study ID Numbers: 1941-CL-6001
First Posted: August 20, 2015    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

Keywords provided by Astellas Pharma Inc:
ASP1941
type 1 diabetes mellitus
SGLT2 inhibitor

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Ipragliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs