CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,639 enrolled
Drug / intervention
Alogliptin +2 moredrug
Likely dose
Alogliptin (exact dose not specified in arms section); Metformin tablets; Glipizide tabletsAI-extracted
Key inclusion· 5
  • ✓Type 2 diabetes diagnosis
  • ✓Inadequately controlled on metformin monotherapy: either ≥1500 mg daily (or documented maximum tolerated dose) for ≥2 months, OR <1500 mg without documented max tolerated dose with HbA1c 7.5-10%
  • ✓No other antidiabetic agents besides metformin within 2 months before screening
  • ✓BMI 23-45 kg/m² (or 20-35 kg/m² if Asian)
Key exclusion· 17
  • ✕Systolic BP ≥150 mmHg or diastolic BP ≥90 mmHg
  • ✕Hemoglobin ≤12 g/dL (males) or ≤10 g/dL (females)
  • ✕ALT ≥2.5× upper limit of normal
  • ✕Serum creatinine ≥1.5 mg/dL (males) or ≥1.4 mg/dL (females), or creatinine clearance <60 mL/min

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

Search/NCT00856284
NCT00856284Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Durability of the Efficacy and Safety of Alogliptin Compared to Glipizide When Used in Combination With Metformin in Subjects With Type 2 Diabetes

Takeda·interventional·Posted Mar 5, 2009·Updated Dec 3, 2013

In Brief

A Phase 3 clinical trial evaluating Alogliptin, Metformin, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 2,639 participants across 261 sites in 32 countries.

Detailed Summary

The purpose of this study is to determine the safety and effectiveness of adding alogliptin, once daily (QD), compared to glipizide with metformin in diabetic patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesArgentina, Australia, Austria, Brazil, Canada, Chile, Germany, Guatemala, Hong Kong, Hungary, India, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Peru, Philippines, Poland, Puerto Rico, Romania, Russia, Singapore, South Africa, South Korea, Spain, Thailand, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 5, 2009
Enrollment StartMar 1, 2009
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 17.3 years ago

Interventions

Alogliptindrug

Alogliptin tablets

Metformindrug

Metformin tablets

Glipizidedrug

Glipizide tablets