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Type 1 Diabetes MellitusPhase 2NCT02529449

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

A Phase 2 study testing ASP1941 in people with Type 1 Diabetes Mellitus, run by Astellas Pharma Inc at 11 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 74 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
ASP1941
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
43 participants
Where
11 sitesJapan
Study dates
1 Sep 2015to 19 Mar 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Japan11 sites

  • Site JP00006

    Aichi

  • Site JP00002

    Fukuoka

  • Site JP00009

    Gunma

  • Site JP00001

    Ibaraki

  • Site JP00005

    Kanagawa

  • Site JP00008

    Kanagawa

  • Site JP00003

    Okayama

  • Site JP00004

    Osaka

  • Site JP00010

    Osaka

  • Site JP00011

    Osaka

  • Site JP00007

    Tokyo

Other trials in Japan

About this study

Official title: A Phase 2, Clinical Pharmacological Study of ASP1941 in Japanese 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.

Being tested
Placebo, ASP1941
Keywords
ASP1941, type 1 diabetes mellitus, SGLT2 inhibitor
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Oral

  • ASP1941Drug

    Also called Suglat, Ipragliflozin

    Oral

Study groups in NCT02529449
Study groupRoleWhat they receive
PlaceboPlacebo comparatoronce daily
Receives: Drug: Placebo
ASP1941 Low dose groupExperimentalonce daily
Receives: Drug: ASP1941
ASP1941 Middle dose groupExperimentalonce daily
Receives: Drug: ASP1941
ASP1941 High dose groupExperimentalonce daily
Receives: Drug: ASP1941

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Daily profile of plasma glucose levels

    Measured: up to Day 14

  2. Area under the concentration-time curve (AUC) 0-24hr (AUC0-24h) of plasma glucose levels

    Measured: at Day -1, Day 1 and Day 14

  3. AUC0-3h of plasma glucose levels

    Measured: at Day -1, Day 1 and Day 14

  4. AUC0-4h of plasma glucose levels

    Measured: up to Day 14

  5. AUC0-10h of plasma glucose levels

    Measured: up to Day 14

  6. Fasting plasma glucose levels

    Measured: up to Day 21

  7. Glycoalbumin

    Measured: up to Day 21

  8. Urinary glucose excretion

    Measured: up to Day 14

  9. Urinary glucose excretion rate

    Measured: up to Day 14

  10. Urine volume

    Measured: up to Day 14

  11. Urinary glucose concentration

    Measured: up to Day 15

  12. Body weight

    Measured: up to Day 21

  13. Renal glucose clearance

    Measured: up to Day 14

  14. Plasma concentration of unchanged ASP1941

    Measured: up to Day 14

  15. Urinary concentration of unchanged ASP1941

    Measured: up to Day 14

  16. Pharmacokinetics (PK) parameter of ASP1941 in plasma: AUC from time 0 extrapolated to infinity (AUCinf)

    Measured: at Day 1

  17. PK parameter of ASP1941 in plasma: AUC from the time of dosing to the last measurable concentration (AUClast)

    Measured: at Day 1 and Day 14

  18. PK parameter of ASP1941 in plasma: AUC from the time of dosing to 24 hr (AUC0-24h)

    Measured: at Day 1 and Day 14

  19. PK parameter of ASP1941 in plasma: Oral Clearance (CL/F)

    Measured: at Day 1 and Day 14

  20. PK parameter of ASP1941 in plasma: Maximum concentration (Cmax)

    Measured: at Day 1 and Day 14

  21. PK parameter of ASP1941 in plasma: Terminal Elimination Half-life (t1/2)

    Measured: at Day 1 and Day 14

  22. PK parameter of ASP1941 in plasma: Time of the Maximum Concentration (tmax)

    Measured: at Day 1 and Day 14

  23. PK parameter of ASP1941 in urine: Amount excreted in urine between time (Ae)

    Measured: at Day 1 and Day 14

  24. PK parameter of ASP1941 in urine: % of the dose of excreted in urine (Ae%)

    Measured: at Day 1 and Day 14

  25. PK parameter of ASP1941 in plasma and urine: Renal Clearance (CLr)

    Measured: at Day 1 and Day 14

  26. Safety assessed by vital signs

    Supine blood pressure and supine pulse rate

    Measured: up to Day 21

  27. Safety assessed by 12-lead electrocardiogram

    Measured: up to Day 21

  28. Safety assessed by laboratory tests

    Hematology, biochemistry and urinalysis

    Measured: up to Day 21

  29. Safety assessed by self-monitored blood glucose levels

    Measured: up to Day 21

  30. Safety assessed by Adverse events

    Measured: up to Day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2015 (estimated)
  2. Study start1 Sep 2015
  3. Primary completion19 Mar 2016
  4. Study completion19 Mar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02529449
Sponsor's protocol ID
1941-CL-6001
Status last verified
Nov 2024
First submitted
18 Aug 2015
Last updated
12 Nov 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Publications

  • Toyoshima J, Saito M, Kaibara A, Isaka H, Sakatani T. Comparison of the Pharmacokinetic and Pharmacodynamic Relationship of Ipragliflozin Between Patients With Type 1 and Type 2 Diabetes Mellitus. Clin Ther. 2020 Sep;42(9):1787-1798.e3. doi: 10.1016/j.clinthera.2020.07.009. Epub 2020 Aug 21.

    PubMed 32839028

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ASP1941 in people with Type 1 Diabetes Mellitus, run by Astellas Pharma Inc at 11 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily profile of plasma glucose levels (time frame: up to Day 14). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02529449, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.

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