Trial intelligence / Profile preview

GSK256073 in Type 2 Diabetes Mellitus on Metformin

NCT01376323Phase 2

Key facts

Status: Completed
Start: Jul 2011
Primary completion: Sep 2012
Countries: 4
Sponsor: GSK
Modality: Small Molecules

Drugs: GSK256073
Conditions: type 2 diabetes mellitus (T2DM)

Overview

Phase 2, randomised, double-blind trial of GSK256073 in type 2 diabetes mellitus (T2DM) (10 arms), sponsored by GSK. Primary endpoints: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE), Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 12 and 6 more. Started Jul 2011; status: completed.

Design

10 arms

Study design: RandomizedDouble-blind

GSK256073 1mg bid
GSK256073 1mg capsule taken orally twice a day
GSK256073 2mg qd
GSK256073 2 x 1mg capsule taken orally once a day
GSK256073 5mg bid
GSK256073 5mg capsule taken orally twice a day
GSK256073 10mg qd
GSK256073 2 x 5mg capsule taken orally once a day
GSK256073 10mg bid
GSK256073 10mg capsule taken orally twice a day
GSK256073 20mg qd
GSK256073 2x 10mg capsule taken orally once a day

4 more in the full profile.

Who it enrols

Adults with Type 2 Diabetes Mellitus on stable metformin monotherapy with HbA1c 7.0-9.5% and BMI 25-40 kg/m^2.

Endpoints

Primary

Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)Up to Week 12
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Week 12
Change From Baseline in Heart RateWeek 12
Number of Participants With Abnormal Electrocardiograms (ECGs) FindingsUp to Week 20
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI)Up to Week 12

Secondary

Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration ValueWeek 6
GSK256073 AUC and HbA1c at Week 12 Was Evaluated to Establish the Exposure-response Pharmacokinetic/Pharmacodynamic (PK/PD) RelationshipWeek 12
Change From Baseline in Fasting Plasma GlucoseWeek 12
Change From Baseline in Fasting InsulinWeek 12
Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting GlucoseWeek 12
Change From Baseline in FructosamineWeek 12
Number of Participants With HbA1c < 7.0% and < 6.5%Week 12

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