A Study of GSK256073 in Subjects With Type 2 Diabetes Mellitus Who Are Being Treated With Metformin
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
1 other identifier
interventional
92
4 countries
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 diabetes-mellitus-type-2
Started Jul 2011
Typical duration for phase_2 diabetes-mellitus-type-2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2011
CompletedFirst Posted
Study publicly available on registry
June 20, 2011
CompletedStudy Start
First participant enrolled
July 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 16, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 17, 2012
CompletedResults Posted
Study results publicly available
October 11, 2017
CompletedOctober 11, 2017
August 1, 2017
1.2 years
June 16, 2011
August 10, 2017
September 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
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 hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.
Up to Week 12
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
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.
Baseline (pre-dose Day 1) and up to Week 12
Change From Baseline in Heart Rate
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.
Baseline (pre-dose Day 1) and up to Week 12
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings
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.
Up to Week 20
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI)
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. Data for parameters with high and low of PCI is provided.
Up to Week 12
Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI)
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.
Up to Week 12
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick
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).
Up to Week 12
Change From Baseline in Glycated Hemoglobin (HbA1c) at 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.
Baseline (Day -1) and up to Week 12
Secondary Outcomes (7)
Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6
Baseline (Day 1) and up to Week 6
GSK256073 AUC and HbA1c at Week 12 Was Evaluated to Establish the Exposure-response Pharmacokinetic/Pharmacodynamic (PK/PD) Relationship
Up to Week 12
Change From Baseline in Fasting Plasma Glucose at Week 12
Baseline (Day 1) and up to Week 12
Change From Baseline in Fasting Insulin at Week 12
Baseline (Day 1) and up to Week 12
Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12
Baseline (Day 1) and up to Week 12
- +2 more secondary outcomes
Study Arms (10)
GSK256073 1mg bid
EXPERIMENTALGSK256073 1mg capsule taken orally twice a day
GSK256073 2mg qd
EXPERIMENTALGSK256073 2 x 1mg capsule taken orally once a day
GSK256073 5mg bid
EXPERIMENTALGSK256073 5mg capsule taken orally twice a day
GSK256073 10mg qd
EXPERIMENTALGSK256073 2 x 5mg capsule taken orally once a day
GSK256073 10mg bid
EXPERIMENTALGSK256073 10mg capsule taken orally twice a day
GSK256073 20mg qd
EXPERIMENTALGSK256073 2x 10mg capsule taken orally once a day
GSK256073 25mg bid
EXPERIMENTALGSK256073 25mg capsule taken orally twice a day
GSK256073 50mg qd
EXPERIMENTALGSK256073 2x 25mg capsule taken orally once a day
Placebo
PLACEBO COMPARATORMatching placebo capsules taken orally either once a day or twice a day
Sitagliptin 100mg qd
ACTIVE COMPARATORCommercially available Sitagliptin 100mg capsules taken once a day
Interventions
Eligibility Criteria
You may not qualify if:
- HbA1c levels greater than or equal to 7.0 % and less than or equal to 9.5% at Screening
- On monotherapy with metformin at the time of screening, and at a maximum tolerated dose greater than or equal to 1000 mg for at least 2 months prior to dosing.
- Fasting plasma glucose level less than 13.3 mmol/L (240 mg/dL) at Screening
- Male or female between 20 and 70 years of age, inclusive, at the time of signing the informed consent
- Fasting Triglycerides lower than 4.52 mmol/L (400 mg/dL)
- A female subject is able to participate is she if of non-child bearing potential
- Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until 3 days after last dose of the study medication
- Overweight with BMI greater than or equal to 25 kg/m2 for non-Asian Indians and greater than or equal to 24 kg/m2 for Asian-Indian, and less than 40 kg/m2
- The subject is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
- Subjects in France will be eligible only if they are affiliated to or a beneficiary of a social security category
- Subjects in other countries must meet all local and/or country-specific requirements for registration and reimbursement, as applicable
- Requiring insulin therapy or use of combination oral antidiabetic medications or use of monotherapy other than metformin within the 3 months prior to screening
- Past or present disease (other than type 2 diabetes mellitus) that in the opinion of the Investigator may affect the outcome of this study
- A positive pre-study Hepatitis B surface antigen, or positive Hepatitis C result within 3 months of screening
- Renal impairment as defined by a calculated GFR less than 60 mL/min
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (15)
GSK Investigational Site
Anniston, Alabama, 36207, United States
GSK Investigational Site
Miami, Florida, 33169, United States
GSK Investigational Site
Miramar, Florida, 33025, United States
GSK Investigational Site
Nantes, 44093, France
GSK Investigational Site
Pierre-Bénite, 69495, France
GSK Investigational Site
Rennes, 35046, France
GSK Investigational Site
Rueil-Malmaison, 92502, France
GSK Investigational Site
Alicante, 03114, Spain
GSK Investigational Site
Badalona, 08916, Spain
GSK Investigational Site
Granada, 18004, Spain
GSK Investigational Site
Madrid, 28046, Spain
GSK Investigational Site
Edinburgh, Midlothian, EH4 2XU, United Kingdom
GSK Investigational Site
Cambridge, CB2 0GG, United Kingdom
GSK Investigational Site
Coventry, CV2 2DX, United Kingdom
GSK Investigational Site
Newcastle upon Tyne, NE1 4LP, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2011
First Posted
June 20, 2011
Study Start
July 13, 2011
Primary Completion
September 16, 2012
Study Completion
September 17, 2012
Last Updated
October 11, 2017
Results First Posted
October 11, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.