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

Browse trials for

• Diabetes Mellitus 10,925
• Diabetes Mellitus, Type 2 9,359

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 143 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Study arms

• Experimental
  Ipragliflozin + Sitagliptin

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

  Drug: Ipragliflozin · Drug: Sitagliptin

• Active comparator
  Placebo + Sitagliptin

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

  Drug: Placebo · Drug: Sitagliptin

Interventions

• DrugIpragliflozin

  50 mg tablet administered orally

• DrugPlacebo

  Placebo to ipragliflozin tablet administered orally

• DrugSitagliptin

  Background medication; 50 mg tablet administered orally

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

Primary outcomes

1. 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.

   Time frame: Baseline and Week 24

2. 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.

   Time frame: Up to 26 weeks

3. 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.

   Time frame: Up to 24 weeks

Secondary outcomes

1. Change From Baseline in FPG at 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.

   Time frame: Baseline and Week 24

2. Change From Baseline in 2-hr PMG at 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.

   Time frame: Baseline and Week 24

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

   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.

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

4. Change From Baseline in Body Weight at 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.

   Time frame: Baseline and Week 24

Baseline characteristics

1 further baseline measures are reported on the registry.

Publications

• 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. PubMed 34033212 ↗

Individual participant data

Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf