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Type 2 Diabetes MellitusPhase 3NCT02452632

A Study to Assess the Efficacy and Safety of ASP1941 in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin

A Phase 3 study testing ASP1941 in people with Type 2 Diabetes Mellitus, run by Astellas Pharma Korea, Inc. at 22 sites in South Korea.

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 purpose of this study is to compare the efficacy and safety of ASP1941 50mg once daily in combination with metformin and sitagliptin against placebo in combination with metformin and sitagliptin over a 24 week treatment period in subjects with type 2 diabetes mellitus with inadequate glycemic control on metformin… Read more about this study

Who is it for?
Ages 19 to 74 years
Conditions the study is for
Type 2 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
143 participants
Where
22 sitesSouth Korea
Study dates
22 Jun 2015to 5 Jan 2017
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 19 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has been diagnosed with type 2 diabetes mellitus.
  • Subject has an HbA1c value between 7.0% and 10.5 % at visit 1.
  • Subject shows FPG (Fasting Plasma Glucose) value is less than 270mg/dL.
  • Subject shows a BMI of 20.0 to 45.0 kg/m2.
  • Subject is on stable diet and exercise program at least 8 weeks prior to study participation.
  • Postmenopausal female or surgically sterile female or agree not to become pregnant.

Who cannot join

  • Subject has type 1 diabetes mellitus.
  • Subject has proliferative diabetic retinopathy.
  • Subject has a history of clinically significant renal disease(s) such as renovascular occlusive disease, nephrectomy, or renal transplant.
  • Subject has significant dysuria caused by a neurogenic bladder or a benign prostatic hypertrophy etc.
  • Subject has a symptomatic urinary tract infection or genital infection.
  • Subject has chronic disease(s) that require the continuous use of systemic corticosteroids or immunosuppressants.
Show all 26Show fewer
  • Subject has cardiovascular disease or cerebrovascular disease that may affect the administration of ASP1941 or its safety assessment in the opinion of the investigator or sub-investigator.
  • Subject has uncontrollable psychiatric disorder(s) with medication.
  • Male subject is not willing to use appropriate contraception during the study.
  • Subject has severe infection, serious trauma, or perioperative subject.
  • Subject has a malignant tumor or has a history of malignant tumor.
  • Subject has severe gastrointestinal disease, or history of operation for serious gastrointestinal disease.
  • Subject has diabetic ketoacidosis.
  • Subject has lactic acidosis or has history of lactic acidosis.
  • Subject has hepatitis or is a carrier of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or is positive for HIV-1 and/or HIV-2.
  • Subject has a history of thyroid dysfunction and acute pancreatitis.
  • Subject is on weight-loss program or weight-loss medication (e.g. orlistat, phentermine/topiramate, lorcaserin) within 12 weeks of study participation.
  • Subject has a history of serious cardiac diseases (NYHA Class III to IV), congestive heart failure, arrhythmia in need of medical treatment.
  • Subject has a history of cerebrovascular attack, unstable angina, myocardial infarction, angioplasty, within 52 weeks (364 days) of study participation.
  • Subject has uncontrollable severe hypertension, i.e., systolic blood pressure of higher than 180 mmHg or diastolic blood pressure of higher than 110mmHg measured in a sitting position after a 5-minute rest.
  • Subject has following AST or ALT value:
  • AST: Male > 100 U/L, Female > 80 U/L
  • ALT: Male > 102.5 U/L, Female > 82.5 U/L
  • Subject has following serum creatinine value:
  • Creatinine: Male > 1.3 mg/dL, Female > 1.2 mg/dL
  • Subject has estimated GFR values, of < 60 mL/min/1.73m2.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

South Korea22 sites

  • Site KR00002

    Busan

  • Site KR00003

    Busan

  • Site KR00007

    Daegu

  • Site KR00011

    Daegu

  • Site KR00019

    Dong Gu Gwangju, Dong Gu Gwangju

  • Site KR00008

    Gangwon-do, Gangwon-do

  • Site KR00018

    Gyeonggi-do

  • Site KR00022

    Gyeonggi-do

  • Site KR00014

    Incheon

  • Site KR00020

    Jeollabuk-do, Jeollabuk-do

  • Site KR00021

    Kyungsangnam-do, Kyungsangnam-do

  • Site KR00001

    Seoul

  • Site KR00004

    Seoul

  • Site KR00005

    Seoul

  • Site KR00006

    Seoul

  • Site KR00009

    Seoul

  • Site KR00010

    Seoul

  • Site KR00012

    Seoul

  • Site KR00013

    Seoul

  • Site KR00016

    Seoul

  • Site KR00017

    Seoul

  • Site KR00015

    Suwon

Other trials in South Korea

About this study

Official title: A Phase 3, Multicenter, Double-Blind, Randomized, Parallel-group, Placebo-Controlled Study to Assess the Efficacy and Safety of ASP1941 in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin

The purpose of this study is to compare the efficacy and safety of ASP1941 50mg once daily in combination with metformin and sitagliptin against placebo in combination with metformin and sitagliptin over a 24 week treatment period in subjects with type 2 diabetes mellitus with inadequate glycemic control on metformin and sitagliptin.

Being tested
ASP1941, Placebo
Keywords
ASP1941, Type 2 diabetes mellitus
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • ASP1941Drug

    Also called ipragliflozin, Suglat

    oral

  • PlaceboDrug

    oral

Study groups in NCT02452632
Study groupRoleWhat they receive
ASP1941 groupExperimentalonce daily over a 24 week treatment
Receives: Drug: ASP1941
Placebo groupPlacebo comparatoronce daily over a 24 week treatment
Receives: Drug: Placebo

What is being measured

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

  1. Change from baseline in HbA1c at the end of treatment

    Measured: at 24 weeks

Secondary outcomes (7)

  1. Change from baseline in Fasting plasma glucose at the end of treatment

    Measured: at 24 weeks

  2. Change from baseline in Fasting serum insulin at the end of treatment

    Measured: at 24 weeks

  3. Change from baseline in Body weight at the end of treatment

    Measured: at 24 weeks

  4. Change from baseline in Waist circumference at the end of treatment

    Measured: at 24 weeks

  5. Safety assessed by development of adverse events, vital signs, laboratory tests, and 12-lead ECG

    ECG: Electrocardiogram

    Measured: up to 24 weeks

  6. Number of subjects achieving the target HbA1c(<6.5% and <7.0%) at each visit

    Measured: at 4, 8, 12, 16 and 24 weeks

  7. Percentage of subjects achieving the target HbA1c(<6.5% and <7.0%) at each visit

    Measured: at 4, 8, 12, 16 and 24 weeks

Timeline

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

  1. First posted22 May 2015 (estimated)
  2. Study start22 Jun 2015
  3. Primary completion5 Jan 2017
  4. Study completion5 Jan 2017

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02452632
Sponsor's protocol ID
1941-CL-2009
Status last verified
Nov 2024
First submitted
14 May 2015
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/.

Publications

  • Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH. Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. Diabetes Ther. 2019 Dec;10(6):2201-2217. doi: 10.1007/s13300-019-00699-8. Epub 2019 Oct 12.

    PubMed 31606880

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ASP1941 in people with Type 2 Diabetes Mellitus, run by Astellas Pharma Korea, Inc. at 22 sites in South Korea.

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 26 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 22 sites in South Korea. 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 at the end of treatment (time frame: at 24 weeks). 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 NCT02452632, 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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