Ipragliflozin Add-on Long-term Study in Japanese Participants With Type 2 Diabetes Mellitus on Sitagliptin (MK-0431J-849)

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02564211
• Other study ID #: 0431J-849
• Secondary ID: 153083MK-0431J-8
• Status: Completed
• Phase: Phase 3
• Start date: October 26, 2015
• Est. completion date: March 7, 2017

Study information

• Verified date: August 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: March 7, 2017
• Est. primary completion date: March 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Ipragliflozin
one 50 mg tablet QD
• Sitagliptin
one 50 mg tablet QD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Experienced at Least 1 Adverse Event (AE)	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.	Up to 54 weeks
Primary	Percentage of Participants Who Had Study Drug Discontinued Due to an AE	The percentage of participants who had study treatment stopped due to an AE regardless if they completed study.	Up to 52 weeks
Secondary	Change From Baseline in HbA1c	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.	Baseline and Week 52