CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
GSK2330672 +3 moredrug
Likely dose
GSK2330672 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02202161
NCT02202161Phase 2Completed
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A Randomized, Placebo Controlled, Repeat Dose, Double Blind (Sponsor Unblind) Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2330672 Administered With Metformin to Type 2 Diabetes Patients

GlaxoSmithKline·interventional·Posted Jul 28, 2014·Updated Nov 6, 2017

In Brief

A Phase 2 clinical trial evaluating GSK2330672, Placebo, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 70 participants across 4 sites.

Detailed Summary

This study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of GSK2330672 compared to sitagliptin when administered with metformin for 14 days to subjects with type 2 diabetes mellitus (T2DM). Approximately 72 male and female subjects aged 30-64 years with T2DM and currently taking metformin will be recruited for this study. Eligible subjects will begin a run-in period of 13-15 days to stabilize on metformin 850 milligram (mg) twice a day (BID). Subjects will then be randomized to GSK2330672 10 mg, 20 mg, 30 mg, 90 mg, matching placebo or open-label sitagliptin 50 mg for 14 days BID. Subjects will return for a follow-up visit 7-10 days after discharge.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 28, 2014
Enrollment StartAug 27, 2014
Primary CompletionJan 30, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 11.9 years ago

Interventions

GSK2330672drug

GSK2330672 will be available in 10 mg, 20 mg, 30 mg, and 90 mg oral solution to be administered BID for 14 days. Subjects are to drink contents of dosing bottle (45 ml) followed by 2 x 50 ml rinses of bottle and then an additional 95 ml water for a total volume of 240 ml consumed

Placebodrug

Matching placebo will be available as oral solution to be administered for 14 days, BID. Subjects are to drink contents of dosing bottle (45 ml) followed by 2 x 50 ml rinses of bottle and then an additional 95 ml water for a total volume of 240 ml consumed

Sitagliptindrug

Sitagliptin will be available as film-coated tablets Tablet of 50 mg to be administered orally, BID, for 14 days

Metformindrug

Metformin will be available as 850 mg white to off-white, film-coated tablets; to be administered BID orally during run-in through Day 14