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

NCT02577003 | Completed Phase 3 Results

• 2 other identifiers: 0431J-843153097
• Study Type: interventional
• Target: 143
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in HbA1c at 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

• Percentage of Participants Who Experienced at Least One Adverse Event (AE)

  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

  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

Secondary Outcomes (4)

• Change From Baseline in FPG at Week 24

  Baseline and Week 24

• Change From Baseline in 2-hr PMG at Week 24

  Baseline and Week 24

• Change From Baseline in Glucose Total AUC0-2hr After Meal at Week 24

  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

  Baseline and Week 24

Study Arms (2)

Ipragliflozin + Sitagliptin

EXPERIMENTAL

Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.

Drug: Ipragliflozin; Drug: Sitagliptin

Placebo + Sitagliptin

ACTIVE COMPARATOR

Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.

Drug: Placebo; Drug: Sitagliptin

Interventions

Ipragliflozin DRUG

50 mg tablet administered orally

Ipragliflozin + Sitagliptin

Placebo DRUG

Placebo to ipragliflozin tablet administered orally

Placebo + Sitagliptin

Sitagliptin DRUG

Background medication; 50 mg tablet administered orally

Also known as: Januvia®, Tesavel®, Xelevia®, Ristaben®, Glactiv®

Ipragliflozin + Sitagliptin; Placebo + Sitagliptin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Kaku K, Kadowaki T, Seino Y, Okamoto T, Shirakawa M, Sato A, O'Neill EA, Engel SS, Kaufman KD. Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes and inadequate glycaemic control on sitagliptin. Diabetes Obes Metab. 2021 Sep;23(9):2099-2108. doi: 10.1111/dom.14448. Epub 2021 Jun 15.

  PMID: 34033212 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

ipragliflozin; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Results Point of Contact

• Title: Senior Vice President, Global Clinical Dvelopment
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 15, 2015
• Study Start: November 9, 2015
• Primary Completion: November 25, 2016
• Study Completion: November 25, 2016
• Last Updated: September 4, 2018
• Results First Posted: March 7, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share