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Type 2 Diabetes MellitusPhase 3IMPRESSIONNCT02794792

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

A Phase 3 study testing Ipragliflozin L-proline and Metformin in people with Type 2 Diabetes Mellitus, run by Astellas Pharma Europe B.V. at 14 sites in Russia.

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 main purpose of this study is to evaluate the efficacy in reducing glycated hemoglobin of ipragliflozin in combination with metformin compared with metformin plus placebo in subjects with type 2 diabetes mellitus who have inadequate glycemic control on metformin. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Ipragliflozin L-proline and Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
268 participants
Where
14 sitesRussia
Study dates
11 May 2016to 20 Jun 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has been diagnosed with type 2 diabetes mellitus at least 12 weeks before visit 1.
  • Subject has been on a stable dose and a daily dose regimen of metformin ≥ 1500 mg for at least 12 weeks prior to visit 1.
  • Subject has HbA1c ≥ 7.5% and ≤ 11.0% at visit 1.
  • Subject has been on a stable diet and exercise program for at least 12 weeks prior to visit 1 and is willing to maintain this program for the duration of the treatment period.
  • Subject has a body mass index (BMI) of 20 to 45 kg/m2, inclusive, at visit 1.
  • Subjects are allowed to continue taking their medication for concomitant diseases (including over-the-counter products), provided they have been on a stable dose for a minimum of 30 days prior to visit 1.
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  • Female subjects must either:
  • Be of non-childbearing potential:
  • postmenopausal (defined as at least 1 year without any menses) prior to screening, or
  • documented as surgically sterile
  • Or, if of childbearing potential,
  • Agree not to try to become pregnant during the study and for 28 days after the final study drug administration
  • And have a negative serum pregnancy test at visit 1
  • And, if heterosexually active, agree to consistently use 2 forms of highly effective birth control (at least 1 of which must be a barrier method) starting at screening, throughout the study period and for 28 days after the final study drug administration.
  • Female subjects must agree not to breastfeed starting at screening, throughout the study period and for 28 days after the final study drug administration.
  • Female subjects must not donate ova starting at screening, throughout the study period and for 28 days after the final study drug administration.
  • Male subjects and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (at least 1 of which must be a barrier method) starting at screening and continue throughout the study period.
  • Male subjects must not donate sperm starting at screening and throughout the study period.

Who cannot join

  • Subject has type 1 diabetes mellitus.
  • Subject has received any medication for glycemic control, with the exception of metformin, (e.g., oral antidiabetic drugs, insulin, etc.) within 12 weeks prior to visit 1.
  • Subject is currently receiving an excluded medication or has received insulin within 12 weeks prior to visit 1 or during the screening period.
  • Subject has a history of stroke, unstable angina, myocardial infarction, any vascular intervention or heart failure (New York Heart Association Class III-IV;) within 12 weeks prior to visit 1.
  • Subject has had a malignancy in the last 5 years, except for adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
  • Subject has a history of diabetic coma or precoma.
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  • Subject has a history of ketoacidosis or lactic acidosis.
  • History of drinking more than 21 units of alcohol per week (1 unit = 10 g pure alcohol = 250 mL of beer [5%] or 35 mL of spirits [35%] or 100 mL of wine [12%]) (> 14 units of alcohol for female subjects) or history of drugs abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates) within 3 months prior to visit 1.
  • Subject is known to have hepatitis or be a carrier of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or is known to be positive for human immunodeficiency virus (HIV)-1 and/or HIV-2.
  • Subject has a severe infection, has serious trauma, or is a perioperative subject.
  • Subject has symptomatic urinary tract infection or genital infection at visit 1 and/or just prior to randomization at visit 3.
  • Subject has uncontrolled severe hypertension (or subject whose systolic blood pressure is > 180 mmHg or diastolic blood pressure of > 110 mmHg measured in a sitting position after 5 minutes of rest at visit 1).
  • Subject has an alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 x the upper limit of normal (ULN) range or has a total bilirubin > 1.5 x ULN at visit 1.
  • Subject has a urinary microalbumin/creatinine ratio ≥ 300 mg/g at visit 1.
  • Subject has estimated glomerular filtration rate (GFR) value of < 60 mL/min/1.73 m2 at visit 1 (using the Modification of Diet in Renal Disease [MDRD] calculation).
  • Subject has known or suspected hypersensitivity to ipragliflozin or any components of the formulations used or a history of allergy for Sodium-glucose cotransporter (SGLT)2 inhibitors.
  • Subject has previously received ipragliflozin or other SGLT2 inhibitors.
  • Subject is concurrently participating in another drug study or has received an investigational drug within 30 days or the limit set by national law, whichever is longer, prior to visit 1 or plans to receive another investigational drug during the study.
  • Female subject who is currently pregnant or lactating
  • Male or female subject who does not use appropriate contraception during the study.
  • The subject is unable to adhere to the treatment regimen, protocol procedures or study requirements (including discontinuation criteria during the run-in period), in the investigator's judgment.
  • Subject has an unstable medical or psychiatric illness.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Russia14 sites

  • Site RU70011

    Moscow, 117036

  • Site RU70005

    Moscow, 119034

  • Site RU70003

    Moscow, 121374

  • Site RU70009

    Moscow, 125315

  • Site RU70010

    Nizhny Novgorod, 603018

  • Site RU70008

    Saint Petersburg, 191119

  • Site RU70014

    Saint Petersburg, 194354

  • Site RU70007

    Saint Petersburg, 197022

  • Site RU70002

    Saint Petersburg, 197706

  • Site RU70006

    Samara, 443067

  • Site RU70004

    Saratov, 410012

  • Site RU70015

    Volgograd, 400001

  • Site RU70001

    Yaroslavl, 150003

  • Site RU70013

    Yaroslavl, 150062

Other trials in Russia

About this study

Official title: A Phase 3, Double-blind, Randomized Study to Assess the Efficacy and Safety of Ipragliflozin in Combination With Metformin Compared to Metformin Plus Placebo in Subjects in Russia With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin

The main purpose of this study is to evaluate the efficacy in reducing glycated hemoglobin of ipragliflozin in combination with metformin compared with metformin plus placebo in subjects with type 2 diabetes mellitus who have inadequate glycemic control on metformin.

Read the detailed description

This is a phase 3, double-blind, randomized study to assess the efficacy and safety of ipragliflozin in combination with metformin compared to metformin plus placebo in subjects in Russia with type 2 diabetes mellitus who have inadequate glycemic control on metformin. Subjects will enter a 10-day (± 3 days) screening period, followed by a 2-week single-blind placebo run-in period, followed by a 24-week randomized double-blind treatment period and a 4-week follow-up period

Being tested
Ipragliflozin L-proline, Metformin, Placebo
Keywords
Type 2 Diabetes Mellitus, ASP1941, Ipragliflozin
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.

  • Ipragliflozin L-prolineDrug

    Also called Suglat, ASP1941

    Oral

  • MetforminDrug

    Also called Riomet, Glucophage, Glumetza, Glucophage XR

    Oral

  • PlaceboDrug

    Oral

Study groups in NCT02794792
Study groupRoleWhat they receive
Metformin and placeboActive comparatorParticipants will receive daily dosage of Metformin and Placebo as single tablets.
Receives: Drug: Metformin; Drug: Placebo
Metformin and IpragliflozinExperimentalParticipants will receive daily dosage of Metformin and Ipragliflozin (2 dose strengths) as single tablets.
Receives: Drug: Ipragliflozin L-proline; Drug: Metformin
Metformin, placebo and IpragliflozinOtherParticipants will receive daily dosage of Metformin, placebo and Ipragliflozin (1 dose strength) as single tablets.
Receives: Drug: Ipragliflozin L-proline; Drug: Metformin; 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 with ipragliflozin once daily added on to metformin compared to placebo added on to metformin

    Glycated hemoglobin (HbA1c)

    Measured: Baseline and 12 weeks

Secondary outcomes (14)

  1. Change from baseline in HbA1c in each treatment group

    Measured: Baseline and 24 weeks

  2. Change from baseline in FPG in each treatment group

    Fasting plasma glucose (FPG)

    Measured: Baseline, 12 weeks and 24 weeks

  3. Number of patients reaching a treatment goal in HbA1c of < 7.0% in each treatment group

    Measured: Up to 24 weeks

  4. Change in body weight in each treatment group

    Measured: Baseline, 12 weeks and 24 weeks

  5. Change in blood pressure in each treatment group

    Measured: Baseline, 12 weeks and 24 weeks

  6. Number of patients with AEs

    Adverse Events (AEs)

    Measured: Up to 24 weeks

  7. Number of patients with AEs of special interest

    AEs of special interest include: hypoglycemic events, dehydration/hypovolemia, urinary tract infections and genital infections

    Measured: Up to 24 weeks

  8. Percentage of patients reaching a treatment goal in HbA1c of < 7.0% in each treatment group

    Measured: Up to 24 weeks

  9. Change from baseline in PROs as measured by European Quality of Life 5 Dimensions 5 Levels [EQ-5D-5L] questionnaire

    Patient-reported outcomes (PROs)

    Measured: Baseline, 12 weeks and 24 weeks

  10. Change from baseline in PROs as measured by Audit of Diabetes Dependent Quality of Life [ADDQoL-19] questionnaire

    Measured: Baseline, 12 weeks and 24 weeks

  11. Change from baseline in PROs as measured by Work Productivity and Activity Impairment: General Health [WPAI:GH] questionnaire

    Measured: Baseline, 12 weeks and 24 weeks

  12. Change from baseline in PROs as measured by Diabetes Medication Satisfaction [Diab-MedSat] questionnaire

    Measured: Baseline, 12 weeks and 24 weeks

  13. Percentage of patients with AEs

    Measured: Up to 24 weeks

  14. Percentage of patients with AEs of special interest

    AEs of special interest include: hypoglycemic events, dehydration/hypovolemia, urinary tract infections and genital infections

    Measured: Up to 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 posted9 Jun 2016 (estimated)
  2. Study start11 May 2016
  3. Primary completion2 Mar 2017
  4. Study completion20 Jun 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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
268 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02794792
Sponsor's protocol ID
1941-CL-9001
Acronym
IMPRESSION
Status last verified
Nov 2024
First submitted
14 Mar 2016
Last updated
12 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
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 Ipragliflozin L-proline and Metformin in people with Type 2 Diabetes Mellitus, run by Astellas Pharma Europe B.V. at 14 sites in Russia.

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 18 inclusion and 22 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 14 sites in Russia. 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. 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 with ipragliflozin once daily added on to metformin compared to placebo added on to metformin (time frame: Baseline and 12 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 NCT02794792, 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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