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

NCT02794792 | Completed Phase 3

• 1 other identifier: 1941-CL-9001
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 14

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus; ASP1941; Ipragliflozin

Outcome Measures

Primary Outcomes (1)

• Change from baseline in HbA1c with ipragliflozin once daily added on to metformin compared to placebo added on to metformin

  Glycated hemoglobin (HbA1c)

  Baseline and 12 weeks

Secondary Outcomes (14)

• Change from baseline in HbA1c in each treatment group

  Baseline and 24 weeks

• Change from baseline in FPG in each treatment group

  Baseline, 12 weeks and 24 weeks

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

  Up to 24 weeks

• Change in body weight in each treatment group

  Baseline, 12 weeks and 24 weeks

• Change in blood pressure in each treatment group

  Baseline, 12 weeks and 24 weeks

Study Arms (3)

Metformin and placebo

ACTIVE COMPARATOR

Participants will receive daily dosage of Metformin and Placebo as single tablets.

Drug: Metformin; Drug: Placebo

Metformin and Ipragliflozin

EXPERIMENTAL

Participants will receive daily dosage of Metformin and Ipragliflozin (2 dose strengths) as single tablets.

Drug: Ipragliflozin L-proline; Drug: Metformin

Metformin, placebo and Ipragliflozin

OTHER

Participants will receive daily dosage of Metformin, placebo and Ipragliflozin (1 dose strength) as single tablets.

Drug: Ipragliflozin L-proline; Drug: Metformin; Drug: Placebo

Interventions

Ipragliflozin L-proline DRUG

Oral

Also known as: Suglat, ASP1941

Metformin and Ipragliflozin; Metformin, placebo and Ipragliflozin

Metformin DRUG

Oral

Also known as: Riomet, Glucophage, Glumetza, Glucophage XR, Fortamet

Metformin and Ipragliflozin; Metformin and placebo; Metformin, placebo and Ipragliflozin

Placebo DRUG

Oral

Metformin and placebo; Metformin, placebo and Ipragliflozin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Astellas Pharma Europe B.V.: lead

Study Sites (14)

Site RU70011

Moscow, 117036, Russia

Location

Site RU70005

Moscow, 119034, Russia

Location

Site RU70003

Moscow, 121374, Russia

Location

Site RU70009

Moscow, 125315, Russia

Location

Site RU70010

Nizhny Novgorod, 603018, Russia

Location

Site RU70008

Saint Petersburg, 191119, Russia

Location

Site RU70014

Saint Petersburg, 194354, Russia

Location

Site RU70007

Saint Petersburg, 197022, Russia

Location

Site RU70002

Saint Petersburg, 197706, Russia

Location

Site RU70006

Samara, 443067, Russia

Location

Site RU70004

Saratov, 410012, Russia

Location

Site RU70015

Volgograd, 400001, Russia

Location

Site RU70001

Yaroslavl, 150003, Russia

Location

Site RU70013

Yaroslavl, 150062, Russia

Location

Related Publications (1)

• 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.

  PMID: 31606880 DERIVED

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

ipragliflozin; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Medical Monitor

  Astellas Pharma Europe B.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: June 9, 2016
• Study Start: May 11, 2016
• Primary Completion: March 2, 2017
• Study Completion: June 20, 2017
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

RU (14)