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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794792
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Ipragliflozin L-proline Drug: Metformin Drug: Placebo Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : May 11, 2016
Actual Primary Completion Date : March 2, 2017
Actual Study Completion Date : June 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Metformin and placebo
Participants will receive daily dosage of Metformin and Placebo as single tablets.
Drug: Metformin
Oral
Other Names:
  • Riomet
  • Glucophage
  • Glumetza
  • Glucophage XR
  • Fortamet

Drug: Placebo
Oral

Experimental: Metformin and Ipragliflozin
Participants will receive daily dosage of Metformin and Ipragliflozin (2 dose strengths) as single tablets.
Drug: Ipragliflozin L-proline
Oral
Other Names:
  • Suglat
  • ASP1941

Drug: Metformin
Oral
Other Names:
  • Riomet
  • Glucophage
  • Glumetza
  • Glucophage XR
  • Fortamet

Metformin, placebo and Ipragliflozin
Participants will receive daily dosage of Metformin, placebo and Ipragliflozin (1 dose strength) as single tablets.
Drug: Ipragliflozin L-proline
Oral
Other Names:
  • Suglat
  • ASP1941

Drug: Metformin
Oral
Other Names:
  • Riomet
  • Glucophage
  • Glumetza
  • Glucophage XR
  • Fortamet

Drug: Placebo
Oral




Primary Outcome Measures :
  1. 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 ]
    Glycated hemoglobin (HbA1c)


Secondary Outcome Measures :
  1. Change from baseline in HbA1c in each treatment group [ Time Frame: Baseline and 24 weeks ]
  2. Change from baseline in FPG in each treatment group [ Time Frame: Baseline, 12 weeks and 24 weeks ]
    Fasting plasma glucose (FPG)

  3. Number of patients reaching a treatment goal in HbA1c of < 7.0% in each treatment group [ Time Frame: Up to 24 weeks ]
  4. Change in body weight in each treatment group [ Time Frame: Baseline, 12 weeks and 24 weeks ]
  5. Change in blood pressure in each treatment group [ Time Frame: Baseline, 12 weeks and 24 weeks ]
  6. Number of patients with AEs [ Time Frame: Up to 24 weeks ]
    Adverse Events (AEs)

  7. Number of patients with AEs of special interest [ Time Frame: Up to 24 weeks ]
    AEs of special interest include: hypoglycemic events, dehydration/hypovolemia, urinary tract infections and genital infections

  8. Percentage of patients reaching a treatment goal in HbA1c of < 7.0% in each treatment group [ Time Frame: 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 [ Time Frame: Baseline, 12 weeks and 24 weeks ]
    Patient-reported outcomes (PROs)

  10. Change from baseline in PROs as measured by Audit of Diabetes Dependent Quality of Life [ADDQoL-19] questionnaire [ Time Frame: 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 [ Time Frame: Baseline, 12 weeks and 24 weeks ]
  12. Change from baseline in PROs as measured by Diabetes Medication Satisfaction [Diab-MedSat] questionnaire [ Time Frame: Baseline, 12 weeks and 24 weeks ]
  13. Percentage of patients with AEs [ Time Frame: Up to 24 weeks ]
  14. Percentage of patients with AEs of special interest [ Time Frame: Up to 24 weeks ]
    AEs of special interest include: hypoglycemic events, dehydration/hypovolemia, urinary tract infections and genital infections



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • Female subjects must either:

    1. Be of non-childbearing potential:

      • postmenopausal (defined as at least 1 year without any menses) prior to screening, or
      • documented as surgically sterile
    2. 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794792


Locations
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Russian Federation
Site RU70011
Moscow, Russian Federation, 117036
Site RU70005
Moscow, Russian Federation, 119034
Site RU70003
Moscow, Russian Federation, 121374
Site RU70009
Moscow, Russian Federation, 125315
Site RU70010
Nizhniy Novgorod, Russian Federation, 603018
Site RU70006
Samara, Russian Federation, 443067
Site RU70004
Saratov, Russian Federation, 410012
Site RU70008
St. Petersburg, Russian Federation, 191119
Site RU70014
St. Petersburg, Russian Federation, 194354
Site RU70007
St. Petersburg, Russian Federation, 197022
Site RU70002
St. Petersburg, Russian Federation, 197706
Site RU70015
Volgograd, Russian Federation, 400001
Site RU70001
Yaroslavl, Russian Federation, 150003
Site RU70013
Yaroslavl, Russian Federation, 150062
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Investigators
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Study Director: Medical Monitor Astellas Pharma Europe B.V.
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier: NCT02794792    
Other Study ID Numbers: 1941-CL-9001
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
URL: https://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ):
Type 2 Diabetes Mellitus
ASP1941
Ipragliflozin
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Ipragliflozin
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action