Double-blind Sitagliptin Add-on Study in Japanese Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Ipragliflozin (MK-0431J-842)

NCT02577016 | Completed Phase 3 Results

• 2 other identifiers: 0431J-842153096
• Study Type: interventional
• Target: 141
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a study to assess the safety and efficacy of the addition of sitagliptin in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on ipragliflozin, diet, and exercise therapy. The primary hypothesis of the study is that the addition of sitagliptin once daily compared with placebo provides greater reduction in hemoglobin A1C (HbA1c) as assessed by change from baseline (Week 0) to 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, and treatment by time by prior use of AHAs with the constraint that the mean baseline 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 (3)

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

  Baseline and Week 24

• Change From Baseline in Glucose Total Area Under the Plasma Concentration Curve From Hour 0 to Hour 2 (AUC0-2hr) After Meal at Week 24

  Baseline and Week 24 (just before loading meal [0 min], 30 min, 60 min and 120 min)

• Change From Baseline in FPG at Week 24

  Baseline and Week 24

Study Arms (2)

Sitagliptin + Ipragliflozin

EXPERIMENTAL

Sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.

Drug: Sitagliptin; Drug: Ipragliflozin

Placebo + Ipragliflozin

ACTIVE COMPARATOR

Placebo to sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.

Drug: Placebo; Drug: Ipragliflozin

Interventions

Sitagliptin DRUG

50 mg tablet administered orally

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

Sitagliptin + Ipragliflozin

Placebo DRUG

Placebo to sitagliptin administered orally

Placebo + Ipragliflozin

Ipragliflozin DRUG

50 mg tablet administered orally as background medication

Placebo + Ipragliflozin; Sitagliptin + Ipragliflozin

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 ipragliflozin 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, sitagliptin within 8 weeks prior to study participation.
• Currently has a urinary tract infection or genital infection with subjective symptom

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Seino Y, Kaku K, Kadowaki T, Okamoto T, Sato A, Shirakawa M, O'Neill EA, Engel SS, Kaufman KD. A randomized, placebo-controlled trial to assess the efficacy and safety of sitagliptin in Japanese patients with type 2 diabetes and inadequate glycaemic control on ipragliflozin. Diabetes Obes Metab. 2021 Jun;23(6):1342-1350. doi: 10.1111/dom.14346. Epub 2021 Feb 28.

  PMID: 33565686 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; ipragliflozin

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 Development
• 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 5, 2015
• Primary Completion: November 18, 2016
• Study Completion: November 18, 2016
• Last Updated: August 31, 2018
• Results First Posted: March 7, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share