CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 27 enrolled
Drug / intervention
Trelagliptin +1 moredrug
Likely dose
Trelagliptin 100 mg tablet; Alogliptin 25 mg tabletAI-extracted
Key inclusion· 6
  • ✓Diagnosed with type 2 diabetes mellitus
  • ✓HbA1c (NGSP) 6.5–<8.5% at baseline
  • ✓HbA1c change ≤±1.0% over preceding 6 weeks
  • ✓Stable diet and exercise for ≥4 weeks before baseline
Key exclusion· 13
  • ✕Received antidiabetic medications within 4 weeks prior to baseline
  • ✕Changed or newly started HMG-CoA reductase inhibitors ≤4 weeks before baseline
  • ✕Clinically evident hepatic dysfunction (AST or ALT ≥2.5× upper limit of normal)
  • ✕Moderate, severe renal dysfunction, or renal failure (creatinine clearance <50 mL/min or serum creatinine >1.4 mg/dL in men or >1.2 mg/dL in women)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02771093
NCT02771093Phase 4Completed
CompareCT.gov

An Exploratory Study to Evaluate the Effects of Trelagliptin and Alogliptin by CGM on Glucose Variability for One Week in Patients With Type 2 Diabetes Mellitus

Takeda·interventional·Posted May 12, 2016·Updated Dec 12, 2023

In Brief

A Phase 4 clinical trial evaluating Trelagliptin and Alogliptin for Type 2 Diabetes Mellitus. Completed, enrolled 27 participants across 1 site.

Detailed Summary

This is a multi-center, randomized, open-label, parallel-group comparative, exploratory study to evaluate the effect of trelagliptin administered at a dose of 100 mg once weekly or alogliptin administered at a dose of 25 mg once daily for 4 weeks on glycemic variation in patients with type 2 diabetes mellitus using continuous glucose monitoring (CGM).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesJapan
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 12, 2016
Enrollment StartSep 8, 2016
Primary CompletionApr 27, 2017
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.1 years ago

Interventions

Trelagliptindrug

Trelagliptin 100 mg tablet

Alogliptindrug

Alogliptin 25 mg tablet