- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02577003
Double-blind Ipragliflozin Add-on Study in Japanese Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sitagliptin (MK-0431J-843)
August 3, 2018 updated by: Merck Sharp & Dohme LLC
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
143
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ipragliflozin + Sitagliptin
Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
|
50 mg tablet administered orally
Background medication; 50 mg tablet administered orally
Other Names:
|
Active Comparator: Placebo + Sitagliptin
Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
|
Background medication; 50 mg tablet administered orally
Other Names:
Placebo to ipragliflozin tablet administered orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 26 weeks
|
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.
|
Up to 24 weeks
|
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.
|
Baseline and Week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and Week 24
|
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.
|
Baseline and Week 24
|
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.
|
Baseline and Week 24 (just before the loading meal [0 min], 30 min, 60 min and 120 min)
|
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.
|
Baseline and Week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 9, 2015
Primary Completion (Actual)
November 25, 2016
Study Completion (Actual)
November 25, 2016
Study Registration Dates
First Submitted
October 14, 2015
First Submitted That Met QC Criteria
October 14, 2015
First Posted (Estimate)
October 15, 2015
Study Record Updates
Last Update Posted (Actual)
September 4, 2018
Last Update Submitted That Met QC Criteria
August 3, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Sodium-Glucose Transporter 2 Inhibitors
- Dipeptidyl-Peptidase IV Inhibitors
- Sitagliptin Phosphate
- Ipragliflozin
Other Study ID Numbers
- 0431J-843
- 153097 (Registry Identifier: JAPIC-CTI)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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