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Trial record 1 of 3 for:    MK-0431J
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Ipragliflozin Add-on Long-term Study in Japanese Participants With Type 2 Diabetes Mellitus on Sitagliptin (MK-0431J-849)

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. Identifier: NCT02564211
Recruitment Status : Completed
First Posted : September 30, 2015
Results First Posted : March 14, 2018
Last Update Posted : September 4, 2018
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Brief Summary:
This is a study to assess the safety and efficacy of the addition of ipragliflozin to sitagliptin in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on sitagliptin, diet, and exercise therapy.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Ipragliflozin Drug: Sitagliptin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Open-label Long-term Treatment Trial to Assess the Safety and Efficacy of Addition of Ipragliflozin in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sitagliptin Monotherapy in Addition to Diet and Exercise Therapy
Actual Study Start Date : October 26, 2015
Actual Primary Completion Date : March 7, 2017
Actual Study Completion Date : March 7, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Ipragliflozin
Ipragliflozin one 50 mg tablet co-administered with one 50 mg sitagliptin once daily (QD) for 52 weeks in addition to diet and exercise therapy.
Drug: Ipragliflozin
one 50 mg tablet QD

Drug: Sitagliptin
one 50 mg tablet QD

Primary Outcome Measures :
  1. Percentage of Participants Who Experienced at Least 1 Adverse Event (AE) [ Time Frame: Up to 54 weeks ]
    An AE was any unfavorable or unintended sign, symptom, or disease, and a causal relationship to the relevant investigational product is not considered. An AE could therefore be any unfavorable and unintended sign, including results from laboratory assessments, physical examination, electrocardiograms, and vital sign assessments. The percentage of participants that had AE was recorded.

  2. Percentage of Participants Who Had Study Drug Discontinued Due to an AE [ Time Frame: Up to 52 weeks ]
    The percentage of participants who had study treatment stopped due to an AE regardless if they completed study.

Secondary Outcome Measures :
  1. Change From Baseline in HbA1c [ Time Frame: Baseline and Week 52 ]
    Participants had HbA1c levels determined at baseline and at Week 52. HbA1c is reported as a percentage. A negative number reflects a decrease in percentage.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Has Type 2 diabetes mellitus
  • Has inadequate glycemic control on diet/exercise therapy and sitagliptin monotherapy
  • Hemoglobin A1C (HbA1c) ≥7.0% and ≤10.0% before study participation

Exclusion Criteria:

  • History of type 1 diabetes mellitus or a history of ketoacidosis
  • History of any of the following medications: Thiazolidinediones (TZD) and/or insulin within 12 weeks prior to study participation, sodium glucose cotransporter 2 (SGLT2) inhibitors anytime
  • Currently has a urinary tract infection or genital infection with subjective symptom

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 identifier (NCT number): NCT02564211

Sponsors and Collaborators
Merck Sharp & Dohme LLC
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Study Director: Medical Director Merck Sharp & Dohme LLC
  Study Documents (Full-Text)

Documents provided by Merck Sharp & Dohme LLC:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme LLC Identifier: NCT02564211    
Other Study ID Numbers: 0431J-849
153083 ( Registry Identifier: JAPIC-CTI )
MK-0431J-849 ( Other Identifier: Merck )
First Posted: September 30, 2015    Key Record Dates
Results First Posted: March 14, 2018
Last Update Posted: September 4, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Sodium-Glucose Transporter 2 Inhibitors