NCT01376323 is a Phase 2 clinical trial of GSK256073 1mg in Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline.

Who is sponsoring NCT01376323?

NCT01376323 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT01376323?

Interventions in NCT01376323: GSK256073 1mg, GSK256073 5mg, GSK256073 10mg, GSK256073 25mg, Placebo, Sitagliptin 100mg.

What condition does NCT01376323 study?

NCT01376323 studies Diabetes Mellitus, Type 2.

Is NCT01376323 still recruiting?

NCT01376323 is currently completed. Last updated 11 October 2017.

Are results published for NCT01376323?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-10-11 · How we verify

NCT01376323

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of GSK256073 in Subjects With Type 2 Diabetes Mellitus Who Are Being Treated With Metformin

Completed Phase 2 Results posted Last updated 11 October 2017

What this trial tests

Phase 2 trial testing GSK256073 1mg in Diabetes Mellitus, Type 2 in 92 participants. Completed in 17 September 2012.

Timeline

13 July 2011

Primary endpoint
16 September 2012

17 September 2012

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	92
Start date	13 July 2011
Primary completion	16 September 2012
Estimated completion	17 September 2012
Sites	15 locations across France, United Kingdom, United States, Spain

Drugs / interventions tested

GSK256073 1mg — full drug profile →
GSK256073 5mg — full drug profile →
GSK256073 10mg — full drug profile →
GSK256073 25mg — full drug profile →
Placebo
Sitagliptin 100mg — full drug profile →

Conditions studied

Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 20 to 70, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) Primary · Up to Week 12

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospit

Any AE

Group	Value	95% CI
Placebo (Pooled)	11
GSK256073 5 mg BID	12
GSK256073 10 mg Once Daily	12
GSK256073 25 mg BID	11
GSK256073 50 mg Once Daily	10

Any SAE

Group	Value	95% CI
Placebo (Pooled)	1
GSK256073 5 mg BID	0
GSK256073 10 mg Once Daily	0
GSK256073 25 mg BID	2
GSK256073 50 mg Once Daily	0

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Primary · Baseline (pre-dose Day 1) and up to Week 12

Mean of triplicate measurements at each time point was considered for the summary. Baseline was defined as pre-dose of Day 1 visit. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. It was assessed on Baseline, Day 1 (12 hours), Day 2 (pre-dose and 12 hours), Week 3, 6 (pre-dose and 12 hours), 9 and 12.

SBP, Day 1,12 hours

Group	Value	95% CI
Placebo (Pooled)	3.4	± 10.48
GSK256073 5mg BID	0.9	± 10.73
GSK256073 10mg Once Daily	4.9	± 19.88
GSK256073 25mg BID	3.0	± 12.90
GSK256073 50mg Once Daily	1.9	± 11.04

SBP, Day 2, pre-dose

Group	Value	95% CI
Placebo (Pooled)	-0.8	± 10.66
GSK256073 5mg BID	-6.5	± 11.30
GSK256073 10mg Once Daily	-7.7	± 10.97
GSK256073 25mg BID	-1.7	± 7.73
GSK256073 50mg Once Daily	-4.7	± 9.25

SBP, Day 2, 12 hours

Group	Value	95% CI
Placebo (Pooled)	0.7	± 11.84
GSK256073 5mg BID	-3.8	± 8.34
GSK256073 10mg Once Daily	1.1	± 11.76
GSK256073 25mg BID	1.7	± 7.86
GSK256073 50mg Once Daily	-1.8	± 11.16

SBP, Week 3

Group	Value	95% CI
Placebo (Pooled)	3.7	± 13.68
GSK256073 5mg BID	-3.9	± 11.83
GSK256073 10mg Once Daily	0.5	± 12.41
GSK256073 25mg BID	-1.7	± 10.71
GSK256073 50mg Once Daily	-1.1	± 8.78

SBP, Day 6, pre-dose

Group	Value	95% CI
Placebo (Pooled)	-0.1	± 11.26
GSK256073 5mg BID	-7.7	± 12.96
GSK256073 10mg Once Daily	-3.4	± 9.07
GSK256073 25mg BID	-5.3	± 16.93
GSK256073 50mg Once Daily	-5.8	± 8.19

SBP, Day 6, 12 hours

Group	Value	95% CI
Placebo (Pooled)	6.6	± 15.32
GSK256073 5mg BID	-2.5	± 14.05
GSK256073 10mg Once Daily	1.0	± 10.83
GSK256073 25mg BID	2.7	± 12.76
GSK256073 50mg Once Daily	1.6	± 7.51

SBP, Week 9

Group	Value	95% CI
Placebo (Pooled)	4.0	± 11.93
GSK256073 5mg BID	-9.1	± 14.02
GSK256073 10mg Once Daily	-1.6	± 10.27
GSK256073 25mg BID	-2.0	± 11.73
GSK256073 50mg Once Daily	-3.8	± 10.57

SBP, Week 12

Group	Value	95% CI
Placebo (Pooled)	2.3	± 9.85
GSK256073 5mg BID	-6.4	± 8.08
GSK256073 10mg Once Daily	-0.3	± 7.95
GSK256073 25mg BID	2.8	± 13.13
GSK256073 50mg Once Daily	0.4	± 10.59

Change From Baseline in Heart Rate Primary · Baseline (pre-dose Day 1) and up to Week 12

Mean of triplicate measurements at each time point was considered for the summary. Baseline was defined as pre-dose of Day 1 visit. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. It was assessed on Baseline (pre-dose Day 1), Day 1 (12 hours), Day 2, Week 3, 6, 9 and 12.

Day 1,12 hours

Group	Value	95% CI
Placebo (Pooled)	2.5	± 5.39
GSK256073 5mg BID	-1.0	± 4.64
GSK256073 10mg Once Daily	1.1	± 7.77
GSK256073 25mg BID	1.3	± 7.07
GSK256073 50mg Once Daily	0.7	± 7.93

Day 2, pre-dose

Group	Value	95% CI
Placebo (Pooled)	1.2	± 4.79
GSK256073 5mg BID	1.2	± 6.93
GSK256073 10mg Once Daily	2.6	± 5.01
GSK256073 25mg BID	0.9	± 6.99
GSK256073 50mg Once Daily	1.3	± 7.74

Day 2, 12 hours

Group	Value	95% CI
Placebo (Pooled)	3.3	± 6.80
GSK256073 5mg BID	1.9	± 6.81
GSK256073 10mg Once Daily	4.6	± 7.02
GSK256073 25mg BID	3.8	± 7.62
GSK256073 50mg Once Daily	1.5	± 7.71

Week 3

Group	Value	95% CI
Placebo (Pooled)	3.2	± 5.44
GSK256073 5mg BID	1.2	± 8.41
GSK256073 10mg Once Daily	3.1	± 7.47
GSK256073 25mg BID	0.1	± 4.81
GSK256073 50mg Once Daily	1.2	± 7.95

Day 6, pre-dose

Group	Value	95% CI
Placebo (Pooled)	-0.9	± 6.53
GSK256073 5mg BID	-1.6	± 7.62
GSK256073 10mg Once Daily	0.5	± 6.89
GSK256073 25mg BID	3.1	± 14.29
GSK256073 50mg Once Daily	-1.2	± 9.88

Day 6, 12 hours

Group	Value	95% CI
Placebo (Pooled)	2.9	± 6.56
GSK256073 5mg BID	2.2	± 9.13
GSK256073 10mg Once Daily	3.3	± 7.48
GSK256073 25mg BID	6.6	± 11.16
GSK256073 50mg Once Daily	-3.8	± 9.14

Week 9

Group	Value	95% CI
Placebo (Pooled)	1.7	± 6.44
GSK256073 5mg BID	3.6	± 8.71
GSK256073 10mg Once Daily	4.9	± 11.40
GSK256073 25mg BID	4.4	± 9.26
GSK256073 50mg Once Daily	3.2	± 9.10

Week 12

Group	Value	95% CI
Placebo (Pooled)	2.8	± 6.95
GSK256073 5mg BID	1.1	± 10.59
GSK256073 10mg Once Daily	4.1	± 10.12
GSK256073 25mg BID	3.9	± 9.98
GSK256073 50mg Once Daily	-0.5	± 8.46

Number of Participants With Abnormal Electrocardiograms (ECGs) Findings Primary · Up to Week 20

Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QTc intervals. It was assessed at Baseline (pre-dose Day 1), Day 2, Week 3, Week 6 and 12. Participants with normal, abnormal not clinically significant and abnormal clinically significant ECG were presented.

Day 1

Group	Value	95% CI
Placebo (Pooled)	12
GSK256073 5 mg BID	14
GSK256073 10 mg Once Daily	13
GSK256073 25 mg BID	18
GSK256073 50 mg Once Daily	12
Placebo (Pooled)	8
GSK256073 5 mg BID	4
GSK256073 10 mg Once Daily	6
GSK256073 25 mg BID	1
GSK256073 50 mg Once Daily	6
Placebo (Pooled)	0
GSK256073 5 mg BID	0
GSK256073 10 mg Once Daily	0
GSK256073 25 mg BID	0
GSK256073 50 mg Once Daily	0

Day 2

Group	Value	95% CI
Placebo (Pooled)	14
GSK256073 5 mg BID	14
GSK256073 10 mg Once Daily	13
GSK256073 25 mg BID	16
GSK256073 50 mg Once Daily	12
Placebo (Pooled)	6
GSK256073 5 mg BID	3
GSK256073 10 mg Once Daily	5
GSK256073 25 mg BID	1
GSK256073 50 mg Once Daily	6
Placebo (Pooled)	0
GSK256073 5 mg BID	0
GSK256073 10 mg Once Daily	0
GSK256073 25 mg BID	0
GSK256073 50 mg Once Daily	0

Week 3

Group	Value	95% CI
Placebo (Pooled)	17
GSK256073 5 mg BID	14
GSK256073 10 mg Once Daily	13
GSK256073 25 mg BID	16
GSK256073 50 mg Once Daily	13
Placebo (Pooled)	3
GSK256073 5 mg BID	3
GSK256073 10 mg Once Daily	3
GSK256073 25 mg BID	2
GSK256073 50 mg Once Daily	4
Placebo (Pooled)	0
GSK256073 5 mg BID	0
GSK256073 10 mg Once Daily	0
GSK256073 25 mg BID	0
GSK256073 50 mg Once Daily	0

Week 6

Group	Value	95% CI
Placebo (Pooled)	16
GSK256073 5 mg BID	14
GSK256073 10 mg Once Daily	14
GSK256073 25 mg BID	12
GSK256073 50 mg Once Daily	12
Placebo (Pooled)	3
GSK256073 5 mg BID	3
GSK256073 10 mg Once Daily	3
GSK256073 25 mg BID	4
GSK256073 50 mg Once Daily	6
Placebo (Pooled)	0
GSK256073 5 mg BID	0
GSK256073 10 mg Once Daily	0
GSK256073 25 mg BID	1
GSK256073 50 mg Once Daily	0

Week 12

Group	Value	95% CI
Placebo (Pooled)	10
GSK256073 5 mg BID	14
GSK256073 10 mg Once Daily	13
GSK256073 25 mg BID	12
GSK256073 50 mg Once Daily	14
Placebo (Pooled)	8
GSK256073 5 mg BID	3
GSK256073 10 mg Once Daily	3
GSK256073 25 mg BID	3
GSK256073 50 mg Once Daily	3
Placebo (Pooled)	0
GSK256073 5 mg BID	0
GSK256073 10 mg Once Daily	0
GSK256073 25 mg BID	0
GSK256073 50 mg Once Daily	0

Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) Primary · Up to Week 12

Clinical chemistry parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), total bilirubin, direct bilirubin, creatinine, chloride, alanine aminotransferase (ALT), uric acid, fasting glucose, total carbon dioxide, gamma glutamyltransferase (GGT), albumin, sodium, calcium, alkaline phosphatase (ALP), total protein, creatine phosphokinase (CPK) and fasting lipid panel including total cholesterol, triglycerides, high density lipoprotein (HDL) cholesterol and low density lipoprotein (LDL) cholesterol. It was assessed on Baseline (pre-dose Day 1), Week 3 and 12.

Potassium, high

Group	Value	95% CI
Placebo (Pooled)	1
GSK256073 5 mg BID	0
GSK256073 10 mg Once Daily	1
GSK256073 25 mg BID	0
GSK256073 50 mg Once Daily	1

Potassium, low

Group	Value	95% CI
Placebo (Pooled)	1
GSK256073 5 mg BID	0
GSK256073 10 mg Once Daily	0
GSK256073 25 mg BID	0
GSK256073 50 mg Once Daily	0

Albumin, low

Group	Value	95% CI
Placebo (Pooled)	2
GSK256073 5 mg BID	0
GSK256073 10 mg Once Daily	0
GSK256073 25 mg BID	0
GSK256073 50 mg Once Daily	0

Creatine kinase, high

Group	Value	95% CI
Placebo (Pooled)	2
GSK256073 5 mg BID	1
GSK256073 10 mg Once Daily	1
GSK256073 25 mg BID	0
GSK256073 50 mg Once Daily	0

Creatinine, high

Group	Value	95% CI
Placebo (Pooled)	1
GSK256073 5 mg BID	0
GSK256073 10 mg Once Daily	0
GSK256073 25 mg BID	0
GSK256073 50 mg Once Daily	0

Total bilirubin, high

Group	Value	95% CI
Placebo (Pooled)	0
GSK256073 5 mg BID	0
GSK256073 10 mg Once Daily	0
GSK256073 25 mg BID	1
GSK256073 50 mg Once Daily	0

Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) Primary · Up to Week 12

Hematology parameters included platelet, red blood cell (RBC) count, mean corpuscular volume (MCV), neutrophils, white blood cell (WBC) count (absolute), mean corpuscular hemoglobin (MCH), lymphocytes, reticulocyte count, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. It was assessed on Baseline (pre-dose Day 1) and 12. Data for parameters with high and low of PCI is provided.

Total neutrophils, low

Group	Value	95% CI
Placebo (Pooled)	3
GSK256073 5 mg BID	0
GSK256073 10 mg Once Daily	0
GSK256073 25 mg BID	1
GSK256073 50 mg Once Daily	0

Platelet count, low

Group	Value	95% CI
Placebo (Pooled)	1
GSK256073 5 mg BID	1
GSK256073 10 mg Once Daily	0
GSK256073 25 mg BID	0
GSK256073 50 mg Once Daily	1

Lymphocytes, low

Group	Value	95% CI
Placebo (Pooled)	0
GSK256073 5 mg BID	0
GSK256073 10 mg Once Daily	0
GSK256073 25 mg BID	2
GSK256073 50 mg Once Daily	0

WBC, low

Group	Value	95% CI
Placebo (Pooled)	0
GSK256073 5 mg BID	0
GSK256073 10 mg Once Daily	0
GSK256073 25 mg BID	1
GSK256073 50 mg Once Daily	0

Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Primary · Up to Week 12

Urinalysis parameters included glucose, protein, blood and ketones by dipstick. It was assessed on Baseline (Day -1) and 12. Urine glucose was measured as grams per deciliter (G/dL).

Urine glucose, Day -1, Negative

Group	Value	95% CI
Placebo (Pooled)	13
GSK256073 5 mg BID	11
GSK256073 10 mg Once Daily	14
GSK256073 25 mg BID	10
GSK256073 50 mg Once Daily	14

Urine glucose, Day -1, Trace

Group	Value	95% CI
Placebo (Pooled)	0
GSK256073 5 mg BID	0
GSK256073 10 mg Once Daily	0
GSK256073 25 mg BID	2
GSK256073 50 mg Once Daily	0

Urine glucose, Day -1, Trace or 1/10 g/dL

Group	Value	95% CI
Placebo (Pooled)	1
GSK256073 5 mg BID	4
GSK256073 10 mg Once Daily	2
GSK256073 25 mg BID	3
GSK256073 50 mg Once Daily	1

Urine glucose, Day -1, 1+ or 1/4 g/dL

Group	Value	95% CI
Placebo (Pooled)	2
GSK256073 5 mg BID	1
GSK256073 10 mg Once Daily	2
GSK256073 25 mg BID	3
GSK256073 50 mg Once Daily	2

Urine glucose, Day -1, 2+ or 1/2 g/dL

Group	Value	95% CI
Placebo (Pooled)	0
GSK256073 5 mg BID	1
GSK256073 10 mg Once Daily	1
GSK256073 25 mg BID	0
GSK256073 50 mg Once Daily	0

Urine glucose, Day -1, 3+ or 1 g/dL

Group	Value	95% CI
Placebo (Pooled)	3
GSK256073 5 mg BID	1
GSK256073 10 mg Once Daily	0
GSK256073 25 mg BID	1
GSK256073 50 mg Once Daily	1

Urine glucose, Day 41, Negative

Group	Value	95% CI
Placebo (Pooled)	13
GSK256073 5 mg BID	12
GSK256073 10 mg Once Daily	13
GSK256073 25 mg BID	12
GSK256073 50 mg Once Daily	13

Urine glucose, Day 41, Trace

Group	Value	95% CI
Placebo (Pooled)	1
GSK256073 5 mg BID	0
GSK256073 10 mg Once Daily	0
GSK256073 25 mg BID	0
GSK256073 50 mg Once Daily	0

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 Primary · Baseline (Day -1) and up to Week 12

Blood samples for analysis of HbA1c were collected at Baseline (Day -1), Day 41, Week 9 and Week 12. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as Day -1 visit. Statistics is provided for least square mean at Week 12.

Day 41

Group	Value	95% CI
Placebo (Pooled)	-0.34	± 0.709
GSK256073 5 mg BID	-0.18	± 0.555
GSK256073 10 mg Once Daily	-0.37	± 0.443
GSK256073 25 mg BID	-0.42	± 0.423
GSK256073 50 mg Once Daily	-0.44	± 0.370

Week 9

Group	Value	95% CI
Placebo (Pooled)	-0.44	± 0.808
GSK256073 5 mg BID	-0.24	± 0.608
GSK256073 10 mg Once Daily	-0.48	± 0.503
GSK256073 25 mg BID	-0.56	± 0.512
GSK256073 50 mg Once Daily	-0.59	± 0.464

Week 12

Group	Value	95% CI
Placebo (Pooled)	-0.36	± 0.698
GSK256073 5 mg BID	-0.14	± 0.778
GSK256073 10 mg Once Daily	-0.46	± 0.507
GSK256073 25 mg BID	-0.56	± 0.562
GSK256073 50 mg Once Daily	-0.64	± 0.630

Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 Secondary · Baseline (Day 1) and up to Week 6

Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as weighted mean value at Day 1 visit. Statistics is provided for least square mean at Week 6. It was assessed on Baseline (Day 1), Day 2 and Week 6.

Glucose, Day 2

Group	Value	95% CI
Placebo (Pooled)	0.462	± 1.0525
GSK256073 5 mg Bid	-0.502	± 2.0948
GSK256073 10 mg qd	0.036	± 1.0464
GSK256073 25 mg Bid	-0.517	± 0.8577
GSK256073 50 mg qd	-0.076	± 0.9745

Glucose, Week 6

Group	Value	95% CI
Placebo (Pooled)	0.009	± 1.8099
GSK256073 5 mg Bid	-0.786	± 3.1101
GSK256073 10 mg qd	-0.502	± 1.2995
GSK256073 25 mg Bid	-0.647	± 1.0043
GSK256073 50 mg qd	-0.544	± 1.3403

NEFA, Day 2

Group	Value	95% CI
Placebo (Pooled)	-0.0152	± 0.08082
GSK256073 5 mg Bid	-0.1307	± 0.09016
GSK256073 10 mg qd	-0.1326	± 0.12437
GSK256073 25 mg Bid	-0.1926	± 0.13820
GSK256073 50 mg qd	-0.1503	± 0.09720

NEFA, Week 6

Group	Value	95% CI
Placebo (Pooled)	-0.0457	± 0.07154
GSK256073 5 mg Bid	-0.0342	± 0.17352
GSK256073 10 mg qd	-0.0423	± 0.08431
GSK256073 25 mg Bid	-0.0293	± 0.22736
GSK256073 50 mg qd	-0.1032	± 0.11673

Change From Baseline in Fasting Plasma Glucose at Week 12 Secondary · Baseline (Day 1) and up to Week 12

Mean of triplicate measurements at pre-dose time point were considered for the summary. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day 1 pre-dose visit. Statistics is provided for least square mean at Week 12. It was assessed on Day 1 (pre-dose), 2 (pre-dose), Week 6 (pre-dose) and Week 12.

Day 2

Group	Value	95% CI
Placebo (Pooled)	0.09	± 0.723
GSK256073 5 mg BID	-0.05	± 1.186
GSK256073 10 mg Once Daily	0.04	± 1.019
GSK256073 25 mg BID	0.04	± 1.611
GSK256073 50 mg Once Daily	-0.34	± 0.590

Week 6

Group	Value	95% CI
Placebo (Pooled)	-0.25	± 1.933
GSK256073 5 mg BID	-0.82	± 2.910
GSK256073 10 mg Once Daily	-1.06	± 1.472
GSK256073 25 mg BID	-0.62	± 1.289
GSK256073 50 mg Once Daily	-0.91	± 1.030

Week 12

Group	Value	95% CI
Placebo (Pooled)	-0.64	± 1.439
GSK256073 5 mg BID	-0.85	± 2.547
GSK256073 10 mg Once Daily	-0.71	± 1.290
GSK256073 25 mg BID	-0.44	± 0.913
GSK256073 50 mg Once Daily	-0.83	± 1.497

Change From Baseline in Fasting Insulin at Week 12 Secondary · Baseline (Day 1) and up to Week 12

Day 2

Group	Value	95% CI
Placebo (Pooled)	-1.1	± 73.81
GSK256073 5 mg BID	19.1	± 52.10
GSK256073 10 mg qd	6.6	± 34.90
GSK256073 25 mg BID	-2.8	± 26.41
GSK256073 50 mg qd	0.2	± 22.75

Week 6

Group	Value	95% CI
Placebo (Pooled)	-3.9	± 25.74
GSK256073 5 mg BID	-9.1	± 38.84
GSK256073 10 mg qd	2.9	± 20.77
GSK256073 25 mg BID	-6.0	± 50.97
GSK256073 50 mg qd	2.6	± 78.83

Week 12

Group	Value	95% CI
Placebo (Pooled)	27.3	± 139.30
GSK256073 5 mg BID	14.7	± 38.66
GSK256073 10 mg qd	-2.0	± 25.80
GSK256073 25 mg BID	33.4	± 80.94
GSK256073 50 mg qd	4.7	± 43.42

Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12 Secondary · Baseline (Day 1) and up to Week 12

Mean of triplicate measurements at pre-dose time point was considered for the summary. HOMA was calculated by multiplying insulin concentration with glucose concentration divided by 22.5. Change from Baseline for insulin and glucose was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day 1 pre-dose visit. Statistics is provided for least square mean. It was assessed on Day 1 (pre-dose), 2 (pre-dose), Week 6 (pre-dose) and Week 12.

Day 2

Group	Value	95% CI
Placebo (Pooled)	0.2	± 4.24
GSK256073 5 mg BID	1.1	± 3.83
GSK256073 10 mg Once Daily	0.3	± 1.98
GSK256073 25 mg BID	-0.2	± 1.73
GSK256073 50 mg Once Daily	-0.2	± 1.33

Week 6

Group	Value	95% CI
Placebo (Pooled)	-0.6	± 3.13
GSK256073 5 mg BID	-1.4	± 4.11
GSK256073 10 mg Once Daily	-0.3	± 1.75
GSK256073 25 mg BID	-0.4	± 3.46
GSK256073 50 mg Once Daily	-0.7	± 3.76

Week 12

Group	Value	95% CI
Placebo (Pooled)	-0.0	± 3.57
GSK256073 5 mg BID	0.0	± 2.47
GSK256073 10 mg Once Daily	-0.3	± 2.08
GSK256073 25 mg BID	1.5	± 4.17
GSK256073 50 mg Once Daily	-0.1	± 3.44

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to Week 12.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo (Pooled)

Serious: 1/20 (5%)

Deaths: 0/20

GSK256073 5 mg BID

Serious: 0/18 (0%)

Deaths: 0/18

GSK256073 10 mg Once Daily

Serious: 0/19 (0%)

Deaths: 0/19

GSK256073 25 mg BID

Serious: 2/19 (11%)

Deaths: 0/19

GSK256073 50 mg Once Daily

Serious: 0/18 (0%)

Deaths: 0/18

Serious adverse events (3 terms)

Reaction	System	Placebo (Pooled)	GSK256073 5 mg BID	GSK256073 10 mg Once Daily	GSK256073 25 mg BID	GSK256073 50 mg Once Daily
Atrial fibrillation	Cardiac disorders	—	—	—	—	—
Joint dislocation	Injury, poisoning and procedural complications	—	—	—	—	—
Nephrotic syndrome	Renal and urinary disorders	—	—	—	—	—

Other adverse events (76 terms — click to expand)

Reaction	System	Placebo (Pooled)	GSK256073 5 mg BID	GSK256073 10 mg Once Daily	GSK256073 25 mg BID	GSK256073 50 mg Once Daily
Nasopharyngitis	Infections and infestations	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—
Enterocolitis	Gastrointestinal disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Blood uric acid decreased	Investigations	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Haemoglobin decreased	Investigations	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—	—
Reticulocyte count increased	Investigations	—	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—	—
Sciatica	Nervous system disorders	—	—	—	—	—
Sinus congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—
Abdominal pain lower	Gastrointestinal disorders	—	—	—	—	—
Angina pectoris	Cardiac disorders	—	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—	—
Asthmatic crisis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Atrial flutter	Cardiac disorders	—	—	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—
Blood pressure increased	Investigations	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—
Cheilitis	Gastrointestinal disorders	—	—	—	—	—
Cold sweat	Skin and subcutaneous tissue disorders	—	—	—	—	—
Contrast media reaction	Injury, poisoning and procedural complications	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Dysaesthesia	Nervous system disorders	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—

Most-reported serious reactions: Atrial fibrillation, Joint dislocation, Nephrotic syndrome.

Data from ClinicalTrials.gov NCT01376323 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Signaling pathways and intervention for therapy of type 2 diabetes mellitus.
Cao R, Tian H, Zhang Y, Liu G, et al · · 2023 · cited 30× · PMID 37303813 · DOI 10.1002/mco2.283
GPCRs involved in metabolic diseases: pharmacotherapeutic development updates.
Jin C, Chen H, Xie L, Zhou Y, et al · · 2024 · cited 25× · PMID 38326623 · DOI 10.1038/s41401-023-01215-2

Verify or expand the search:

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Currently open trials in the same condition.

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Other GlaxoSmithKline trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01376323 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 11 October 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01376323.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01376323

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (3 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Diabetes Mellitus, Type 2

Other GlaxoSmithKline trials

Verify against primary sources