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Type 1 Diabetes MellitusPhase 3NCT02897219

A Study of ASP1941 in Combination With Insulin in Patients With Type 1 Diabetes Mellitus

A Phase 3 study testing ipragliflozin and Insulin Therapy in people with Type 1 Diabetes Mellitus, run by Astellas Pharma Inc at 36 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 confirm efficacy of ASP1941 based on the changes in HbA1c and to assess its safety in subjects with type 1 diabetes mellitus receiving ASP1941 once daily in combination with insulin for 24 weeks. This study will also assess the safety/efficacy of long-term treatment (52 weeks). Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
ipragliflozin and Insulin Therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
175 participants
Where
36 sitesJapan
Study dates
29 Aug 2016to 15 Mar 2018
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject has been diagnosed with type 1 diabetes mellitus
  • The subject has been receiving insulin therapy for the treatment of diabetes mellitus.
  • The subject has not switched from an insulin product to another insulin product or switched between continuous subcutaneous insulin infusion (CSII) and multiple daily injections (MDI).
  • The subject has an HbA1c value between 7.5% and 11.0% and the difference of HbA1c value is within ± 2.0%.
  • The subject has a fasting blood C-peptide level < 0.6 ng/mL.
  • The subject has a body mass index (BMI) between 20.0 kg/m2 and 35.0 kg/m2.

Who cannot join

  • The subject has type 2 diabetes mellitus.
  • The subject has participated in a clinical study or post marketing study of another drug or medical equipment within 12 weeks (84 days) before providing written informed consent, or is currently participating in such a study.
  • The subject has received treatment with ASP1941 (ipragliflozin) or participated in a clinical study of ASP1941 (excluding subjects who discontinued before the investigational period).
  • The subject participated in this study previously.
  • The subject has received a hypoglycemic agent other than insulin or an α-glucosidase inhibitor.
  • The subject has proliferative retinopathy (except for those who have undergone photocoagulation etc. and whose symptoms are stable).
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  • The subject has experienced severe hypoglycemia.
  • The subject has experienced diabetic ketoacidosis.
  • The subject has chronic disease that requires the continuous use of corticosteroids, immunosuppressants, etc.
  • The subject has symptomatic urinary tract infection or symptomatic genital infection.
  • The subject has a history of recurrent urinary tract infection or recurrent genital infection.
  • The subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, or another serious heart disease.
  • The subject has a concomitant malignant tumor or a history of malignant tumor
  • The subject has a history of an allergy to ASP1941 (ipragliflozin) and/or similar drugs (drugs possessing SGLT2 inhibitory action).
  • The subject has psychiatric disorder that is inappropriate for participation in the study.
  • The subject has drug addiction or alcohol abuse.
  • The subject has severe infection or serious trauma, or is perioperative.
  • The subject has a history of medically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant.
  • The subject has any symptoms of dysuria, anuria, oliguria, or urinary retention.
  • The subject has severe renal impairment or end-stage renal failure requiring dialysis.
  • The subject has an Aspartate Aminotransferase and/or Alanine Aminotransferase value that exceeds 2 times, or a total bilirubin value that exceeds 1.5 times the upper limit of the reference range.
  • The subject has uncontrolled severe hypertension.
  • The subject has serious gastrointestinal disease or a history of operation for serious gastrointestinal disease.

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

Japan36 sites

  • Site JP00005

    Aichi

  • Site JP00028

    Aichi

  • Site JP00003

    Chiba

  • Site JP00013

    Chiba

  • Site JP00035

    Chiba

  • Site JP00022

    Fukuoka

  • Site JP00023

    Fukuoka

  • Site JP00031

    Fukuoka

  • Site JP00002

    Gunma

  • Site JP00011

    Gunma

  • Site JP00006

    Hiroshima

  • Site JP00033

    Hokkaido

  • Site JP00034

    Hokkaido

  • Site JP00021

    Hyōgo

  • Site JP00009

    Ibaraki

  • Site JP00010

    Ibaraki

  • Site JP00004

    Kanagawa

  • Site JP00015

    Kanagawa

  • Site JP00016

    Kanagawa

  • Site JP00019

    Mie

  • Site JP00008

    Nagasaki

  • Site JP00024

    Nagasaki

  • Site JP00025

    Nagasaki

  • Site JP00032

    Nagasaki

  • Site JP00026

    Niigata

  • Site JP00020

    Osaka

  • Site JP00029

    Osaka

  • Site JP00036

    Osaka

  • Site JP00012

    Saitama

  • Site JP00017

    Shizuoka

  • Site JP00018

    Shizuoka

  • Site JP00001

    Tochigi

  • Site JP00030

    Tokushima

  • Site JP00014

    Tokyo

  • Site JP00027

    Toyama

  • Site JP00007

    Yamaguchi

Other trials in Japan

About this study

Official title: Phase III Study of ASP1941 Double-blind, Parallel-group Study in Combination With Insulin in Patients With Type 1 Diabetes Mellitus

The objective of this study is to confirm efficacy of ASP1941 based on the changes in HbA1c and to assess its safety in subjects with type 1 diabetes mellitus receiving ASP1941 once daily in combination with insulin for 24 weeks. This study will also assess the safety/efficacy of long-term treatment (52 weeks).

Read the detailed description

This study consists of two parts. In Part 1, ASP1941 or placebo will be administered orally in a blind manner. In Part 2, the long-term safety and efficacy of ASP1941 will be evaluated in patients who have participated in the study and completed the Part 1.

Being tested
ipragliflozin, Placebo, Insulin Therapy
Keywords
SGLT2 inhibitor, ASP1941, type 1 diabetes mellitus
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.

  • ipragliflozinDrug

    Also called ASP1941

    Oral administration once daily

  • PlaceboDrug

    Oral administration once daily

  • Insulin TherapyOther

    Continuous subcutaneous insulin infusion or multiple daily injections as standard of care

Study groups in NCT02897219
Study groupRoleWhat they receive
Part 1 ASP1941ExperimentalASP1941 will be administered for 24 weeks under double blind conditions.
Receives: Drug: ipragliflozin; Other: Insulin Therapy
Part 1 PlaceboPlacebo comparatorPlacebo will be administered for 24 weeks under double blind conditions.
Receives: Drug: Placebo; Other: Insulin Therapy
Part 2 ASP1941ExperimentalASP1941 will be administered for 28 weeks under open label conditions.
Receives: Drug: ipragliflozin; Other: Insulin Therapy

What is being measured

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

  1. Change from baseline in HbA1c

    Measured: Baseline and Week 24 (end of treatment period 1)

Secondary outcomes (17)

  1. Change from baseline in HbA1c

    Measured: Baseline and up to Week 56

  2. Change from baseline in Fasting plasma glucose

    Measured: Baseline and up to Week 56

  3. Change from baseline in self-monitored blood glucose level

    Measured: Baseline and up to Week 56

  4. Change from baseline in leptin

    Measured: Baseline and up to Week 52

  5. Change from baseline in glycoalbumin

    Measured: Baseline and up to Week 52

  6. Change from baseline in adiponectin

    Measured: Baseline and up to Week 52

  7. Change from baseline in glucagon

    Measured: Baseline and up to Week 52

  8. Change from baseline in number of units of insulin administered concomitantly

    Comprehensively assessed by basal insulin daily dose, bolus insulin daily dose and total insulin daily dose.

    Measured: Baseline and up to Week 56

  9. Change from baseline in body weight

    Measured: Baseline and up to Week 56

  10. Change from baseline in waist circumference

    Measured: Baseline and up to Week 52

  11. Safety assessed by incidence of adverse events

    Measured: Up to Week 56

  12. Safety assessed by sitting blood pressure

    Measured: Up to Week 56

  13. Safety assessed by sitting pulse rate

    Measured: Up to Week 56

  14. Safety assessed by standard 12-lead electrocardiogram

    Measured: Up to Week 56

  15. Safety assessed by laboratory tests: Hematology

    Measured: Up to Week 56

  16. Safety assessed by laboratory tests: Biochemistry

    Measured: Up to Week 56

  17. Safety assessed by laboratory tests: Urinalysis

    Measured: Up to Week 56

Timeline

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

  1. First posted13 Sep 2016 (estimated)
  2. Study start29 Aug 2016
  3. Primary completion22 Jul 2017
  4. Study completion15 Mar 2018

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02897219
Sponsor's protocol ID
1941-CL-6002
Status last verified
Nov 2024
First submitted
27 Jul 2016
Last updated
12 Nov 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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 products 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. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ipragliflozin and Insulin Therapy in people with Type 1 Diabetes Mellitus, run by Astellas Pharma Inc at 36 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 6 inclusion and 23 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 36 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Change from baseline in HbA1c (time frame: Baseline and Week 24 (end of treatment period 1)). 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 NCT02897219.

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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