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Completed

NCT Number: NCT02529449

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site JP00006, Aichi, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Oral

ASP1941

Drug

Oral

Other names: Suglat, Ipragliflozin

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

A Phase 2, Clinical Pharmacological Study of ASP1941 in Japanese Patients With Type 1 Diabetes Mellitus

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 20, 2015
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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