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Double-blind Ipragliflozin Add-on Study in Japanese Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sitagliptin (MK-0431J-843)

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ClinicalTrials.gov Identifier: NCT02577003
Recruitment Status : Completed
First Posted : October 15, 2015
Results First Posted : March 7, 2018
Last Update Posted : September 4, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This is a study to assess the safety and efficacy of the addition of ipragliflozin once daily in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on sitagliptin, diet, and exercise therapy. The primary hypothesis for this study is that the addition of ipragliflozin compared with placebo provides greater reduction in hemoglobin A1C (HbA1c) as assessed by change from baseline at Week 24.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind 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
Study Start Date : November 9, 2015
Actual Primary Completion Date : November 25, 2016
Actual Study Completion Date : November 25, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ipragliflozin + Sitagliptin
Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
Drug: Ipragliflozin
50 mg tablet administered orally

Drug: Sitagliptin
Background medication; 50 mg tablet administered orally
Other Name: Januvia®, Tesavel®, Xelevia®, Ristaben®, Glactiv®

Active Comparator: Placebo + Sitagliptin
Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
Drug: Placebo
Placebo to ipragliflozin tablet administered orally

Drug: Sitagliptin
Background medication; 50 mg tablet administered orally
Other Name: Januvia®, Tesavel®, Xelevia®, Ristaben®, Glactiv®




Primary Outcome Measures :
  1. Change From Baseline in HbA1c at Week 24 [ Time Frame: Baseline and Week 24 ]
    HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent. Statistical analysis based on a constrained longitudinal data analysis (cLDA) model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline HbA1c is the same for both treatment groups.

  2. Percentage of Participants Who Experienced at Least One Adverse Event (AE) [ Time Frame: Up to 26 weeks ]
    An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

  3. Percentage of Participants Who Discontinued Study Drug Due to an AE [ Time Frame: Up to 24 weeks ]
    An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.


Secondary Outcome Measures :
  1. Change From Baseline in FPG at Week 24 [ Time Frame: Baseline and Week 24 ]
    Change from baseline in FPG at Week 24 is defined as Week 24 FPG minus Week 0 FPG. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline FPG is the same for both treatment groups.

  2. Change From Baseline in 2-hr PMG at Week 24 [ Time Frame: Baseline and Week 24 ]
    Change from baseline in 2-hr PMG at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline 2-hr PMG is the same for both treatment groups.

  3. Change From Baseline in Glucose Total AUC0-2hr After Meal at Week 24 [ Time Frame: Baseline and Week 24 (just before the loading meal [0 min], 30 min, 60 min and 120 min) ]
    Change from baseline in glucose total AUC0-2hr after meal at Week 24 is defined as Week 24 glucose total AUC0-2hr after a meal minus Week 0 glucose total AUC0-2hr after a meal. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs and treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline glucose total AUC0-2hr after meal is the same for both treatment groups.

  4. Change From Baseline in Body Weight at Week 24 [ Time Frame: Baseline and Week 24 ]
    Change from baseline in body weight at Week 24 is defined as Week 24 body weight minus Week 0 body weight. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs and treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline body weight is the same for both treatment groups.



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
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Inadequate glycemic control on diet/exercise therapy and sitagliptin monotherapy
  • HbA1c ≥7.0% and ≤10.0% before study start

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 and 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 ClinicalTrials.gov identifier (NCT number): NCT02577003


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02577003    
Other Study ID Numbers: 0431J-843
153097 ( Registry Identifier: JAPIC-CTI )
First Posted: October 15, 2015    Key Record Dates
Results First Posted: March 7, 2018
Last Update Posted: September 4, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Ipragliflozin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Sodium-Glucose Transporter 2 Inhibitors