CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 92 enrolled
Drug / intervention
GSK256073 1mg +5 moredrug
Likely dose
GSK256073 1, 5, 10, or 25 mg once or twice daily for 12 weeksAI-extracted
Key inclusion· 7
  • ✓Diagnosed with Type 2 Diabetes Mellitus at least 6 months prior to screening
  • ✓HbA1c between 7.0% and 9.5% at screening
  • ✓Currently on metformin monotherapy at maximum tolerated dose ≥1000 mg/day for at least 2 months prior to dosing
  • ✓Fasting plasma glucose <13.3 mmol/L (240 mg/dL) at screening
Key exclusion· 13
  • ✕Requiring insulin therapy or using combination oral antidiabetic medications or monotherapy other than metformin within 3 months prior to screening
  • ✕Renal impairment: calculated GFR <60 mL/min
  • ✕Positive Hepatitis B surface antigen or Hepatitis C result within 3 months of screening
  • ✕Serious concurrent illness (e.g., severe COPD, malignancy other than skin cancer within 5 years or with evidence of recurrence)

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

Search/NCT01376323
NCT01376323Phase 2Completed
CompareCT.gov

A Multicenter, Two Part, Randomized, Parallel Group, Placebo and Sitagliptin Controlled Study to Evaluate the Safety and Efficacy of GSK256073 Administered Once or Twice Daily for 12 Weeks in Subjects With Type 2 Diabetes Mellitus Who Are Being Treated With Metformin

GlaxoSmithKline·interventional·Posted Jun 20, 2011·Updated Oct 11, 2017

In Brief

A Phase 2 clinical trial evaluating GSK256073 1mg, GSK256073 5mg, and 4 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 92 participants across 15 sites in 4 countries.

Detailed Summary

The aim of this combined, two part study is to evaluate the safety and glucose lowering effects of GSK256073 when administered to diabetic subjects for 12 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesFrance, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 20, 2011
Enrollment StartJul 13, 2011
Primary CompletionSep 16, 2012
Study CompletionSep 17, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 15.0 years ago

Interventions

GSK256073 1mgdrug

GSK256073 1mg capsule

GSK256073 5mgdrug

GSK256073 5mg capsule

GSK256073 10mgdrug

GSK256073 10mg capsule

GSK256073 25mgdrug

GSK256073 25mg capsule

Placebodrug

placebo capsule

Sitagliptin 100mgdrug

Sitagliptin 100mg capsule