Diabetes Mellitus, Type 2Phase 2NCT01376323
A Study of GSK256073 in Subjects With Type 2 Diabetes Mellitus Who Are Being Treated With Metformin
A Phase 2 study testing GSK256073 1mg, GSK256073 5mg and GSK256073 10mg in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 15 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- GSK256073 1mg, GSK256073 5mg and GSK256073 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 13 Jul 2011to 17 Sep 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of T2DM as determined by a responsible physician based on a medical evaluation including medical history, physical examination, and laboratory tests, with onset at least 6 months prior to Screening. Subjects may be entered if they have stable hypertension or dyslipidemia on therapy. Subjects with other conditions except as noted in the Exclusion criteria may be included only if the investigator and GSK medical monitor agree that the condition is unlikely to introduce additional risk factors and will not interfere with study procedures
- 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)
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- 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
Who cannot join
- 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
- Any concurrent serious illness (e.g., severe COPD, history of malignancy other than skin cancer within 5 years of initial diagnosis or with evidence of recurrence) that may interfere with a subject completing the study
- Laboratory values as defined per protocol
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- ECG criteria as defined per protocol
- Systolic blood pressure greater than 160 mmHg, or diastolic blood pressure greater than 100 mmHg at Screening
- History of uric acid kidney stone, and being treated with drugs for hyperuricemia including Allopurinol or Probenecid
- History of peptic ulcer disease (PUD) and/or other gastrointestinal bleeding within the 12 months prior to screening
- Use of certain blood pressure medications or certain other medications that are renally excreted as defined per protocol
- History of myopathy or CPK value greater than 3 times upper limit of normal at screening
- The subject has participated in a clinical trial and has received an investigational product within 30 days or 5 half-lives or twice the biological effect (whichever is longer)
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day
- Any change in diet, exercise habits or smoking status within six weeks prior to screening. Any subject that cannot refrain from smoking while in the unit must be excluded
- History of sensitivity to any of the study medications, including sitagliptin or metformin, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation
- The subject has a positive pre-study drug screen
- History of regular alcohol consumption within 6 months of the study as defined per protocol
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period
- Pregnant females as determined by positive serum and/or urine hCG test at screening and prior to dosing
- Lactating females
- Subjects who are unwilling or unable to follow the procedures outlined in the protocol
- Subject is mentally or legally incapacitated
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
France4 sites
GSK Investigational Site
Nantes, 44093
GSK Investigational Site
Pierre-Bénite, 69495
GSK Investigational Site
Rennes, 35046
GSK Investigational Site
Rueil-Malmaison, 92502
Spain4 sites
GSK Investigational Site
Alicante, 03114
GSK Investigational Site
Badalona, 08916
GSK Investigational Site
Granada, 18004
GSK Investigational Site
Madrid, 28046
United Kingdom4 sites
GSK Investigational Site
Cambridge, CB2 0GG
GSK Investigational Site
Coventry, CV2 2DX
GSK Investigational Site
Edinburgh, Midlothian, EH4 2XU
GSK Investigational Site
Newcastle upon Tyne, NE1 4LP
United States3 sites
GSK Investigational Site
Anniston, Alabama, 36207
GSK Investigational Site
Miami, Florida, 33169
GSK Investigational Site
Miramar, Florida, 33025
About this study
Official title: 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
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.
Read the detailed description
The study will be conducted at centers in Europe and the United States. The study is being conducted in two parts. Part A (n = 90 subjects) will provide a preliminary evaluation of 12 weeks of treatment. Initiation of part B (n = 210 additional subjects) will be dependent on the results observed in part A. The emerging data from part A will be used to guide selection of the doses in Part B. Up to 8 dose levels of GSK256073 may be included in part B. The emerging exposure response relationships from the part A interim analysis will be used to guide dose selection.
Each subject enrolled in the study will undergo screening procedures, a 2 week placebo run-in period, baseline assessments, randomization, a twelve week treatment period, and a 2 week follow-up period. Following completion of the baseline visit and randomization into the study, subjects will return to the clinic for safety and efficacy assessments at Weeks 3, 6, 9, and 12. A subject's total participation in the study will last up to approximately 20 weeks. Subjects will continue their current prescribed regimen of metformin (glucophage) monotherapy and will monitor fasting blood glucose levels daily using a glucometer.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- GSK256073 1mg, GSK256073 5mg, GSK256073 10mg, GSK256073 25mg, Placebo
- Keywords
- Safety, Dose Ranging, Efficacy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| GSK256073 1mg bid | Experimental | GSK256073 1mg capsule taken orally twice a day Receives: Drug: GSK256073 1mg |
| GSK256073 2mg qd | Experimental | GSK256073 2 x 1mg capsule taken orally once a day Receives: Drug: GSK256073 1mg |
| GSK256073 5mg bid | Experimental | GSK256073 5mg capsule taken orally twice a day Receives: Drug: GSK256073 5mg |
| GSK256073 10mg qd | Experimental | GSK256073 2 x 5mg capsule taken orally once a day Receives: Drug: GSK256073 5mg |
| GSK256073 10mg bid | Experimental | GSK256073 10mg capsule taken orally twice a day Receives: Drug: GSK256073 10mg |
| GSK256073 20mg qd | Experimental | GSK256073 2x 10mg capsule taken orally once a day Receives: Drug: GSK256073 10mg |
| GSK256073 25mg bid | Experimental | GSK256073 25mg capsule taken orally twice a day Receives: Drug: GSK256073 25mg |
| GSK256073 50mg qd | Experimental | GSK256073 2x 25mg capsule taken orally once a day Receives: Drug: GSK256073 25mg |
| Placebo | Placebo comparator | Matching placebo capsules taken orally either once a day or twice a day Receives: Drug: Placebo |
| Sitagliptin 100mg qd | Active comparator | Commercially available Sitagliptin 100mg capsules taken once a day Receives: Drug: Sitagliptin 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
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.
Measured: 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
The relationships between drug exposure and HbA1c and relative PD endpoints of interest was planned to be plotted graphically. The data for this outcome measure was not collected.
Measured: Up to Week 12
Change From Baseline in Fasting Plasma Glucose at 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.
Measured: Baseline (Day 1) and up to Week 12
Change From Baseline in Fasting Insulin at 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.
Measured: 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
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.
Measured: Baseline (Day 1) and up to Week 12
Change From Baseline in Fructosamine at Week 6 and Week 12
Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day -1 visit. Statistics is provided for least square mean. It was assessed on Baseline (Day -1), Day 41 and Week 12.
Measured: Baseline (Day -1) and Week 12
Number of Participants With HbA1c < 7.0% and < 6.5%
Data has been presented for number of participants with their corresponding percentages with HbA1c <7.0% and <6.5%.
Measured: Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study start13 Jul 2011
- Primary completion16 Sep 2012
- Study completion17 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376323
- Sponsor's protocol ID
- 114728
- Status last verified
- Aug 2017
- First submitted
- 16 Jun 2011
- Last updated
- 11 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01376323
- Acronym / sponsor ID
- 114728
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Safety, Dose Ranging, Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2011 (actual)
- Primary completion
- 16 Sep 2012 (actual)
- Study completion
- 17 Sep 2012 (actual)
- First posted
- 20 Jun 2011 (estimated)
- Results
- Posted 11 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be conducted at centers in Europe and the United States. The study is being conducted in two parts. Part A (n = 90 subjects) will provide a preliminary evaluation of 12 weeks of treatment. Initiation of part B (n = 210 additional subjects) will be dependent on the results observed in part A. The emerging data from part A will be used to guide selection of the doses in Part B. Up to 8 dose levels of GSK256073 may be included in part B. The emerging exposure response relationships from the part A interim analysis will be used to guide dose selection.
Each subject enrolled in the study will undergo screening procedures, a 2 week placebo run-in period, baseline assessments, randomization, a twelve week treatment period, and a 2 week follow-up period. Following completion of the baseline visit and randomization into the study, subjects will return to the clinic for safety and efficacy assessments at Weeks 3, 6, 9, and 12. A subject's total participation in the study will last up to approximately 20 weeks. Subjects will continue their current prescribed regimen of metformin (glucophage) monotherapy and will monitor fasting blood glucose levels daily using a glucometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| GSK256073 1mg bid | Experimental | Drug: GSK256073 1mgGSK256073 1mg capsule taken orally twice a day |
| GSK256073 2mg qd | Experimental | Drug: GSK256073 1mgGSK256073 2 x 1mg capsule taken orally once a day |
| GSK256073 5mg bid | Experimental | Drug: GSK256073 5mgGSK256073 5mg capsule taken orally twice a day |
| GSK256073 10mg qd | Experimental | Drug: GSK256073 5mgGSK256073 2 x 5mg capsule taken orally once a day |
| GSK256073 10mg bid | Experimental | Drug: GSK256073 10mgGSK256073 10mg capsule taken orally twice a day |
| GSK256073 20mg qd | Experimental | Drug: GSK256073 10mgGSK256073 2x 10mg capsule taken orally once a day |
| GSK256073 25mg bid | Experimental | Drug: GSK256073 25mgGSK256073 25mg capsule taken orally twice a day |
| GSK256073 50mg qd | Experimental | Drug: GSK256073 25mgGSK256073 2x 25mg capsule taken orally once a day |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo capsules taken orally either once a day or twice a day |
| Sitagliptin 100mg qd | Active comparator | Drug: Sitagliptin 100mgCommercially available Sitagliptin 100mg capsules taken once a day |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- A diagnosis of T2DM as determined by a responsible physician based on a medical evaluation including medical history, physical examination, and laboratory tests, with onset at least 6 months prior to Screening. Subjects may be entered if they have stable hypertension or dyslipidemia on therapy. Subjects with other conditions except as noted in the Exclusion criteria may be included only if the investigator and GSK medical monitor agree that the condition is unlikely to introduce additional risk factors and will not interfere with study procedures
- 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
Key exclusion criteria (23 listed)
- 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
- Any concurrent serious illness (e.g., severe COPD, history of malignancy other than skin cancer within 5 years of initial diagnosis or with evidence of recurrence) that may interfere with a subject completing the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK256073 1mgGSK256073 1mg capsule | Drug | GSK256073 1mg bid, GSK256073 2mg qd |
| GSK256073 5mgGSK256073 5mg capsule | Drug | GSK256073 10mg qd, GSK256073 5mg bid |
| GSK256073 10mgGSK256073 10mg capsule | Drug | GSK256073 10mg bid, GSK256073 20mg qd |
| GSK256073 25mgGSK256073 25mg capsule | Drug | GSK256073 25mg bid, GSK256073 50mg qd |
| Placeboplacebo capsule | Drug | Placebo |
| Sitagliptin 100mgSitagliptin 100mg capsule | Drug | Sitagliptin 100mg qd |
Primary outcome
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: 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 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.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Time frame: 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.
Change From Baseline in Heart Rate
Time frame: 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.
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings
Time frame: 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.
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI)
Time frame: 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. Data for parameters with high and low of PCI is provided.
Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI)
Time frame: 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.
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick
Time frame: 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).
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
Time frame: 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.
7 secondary outcomes
Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6
Time frame: 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
Time frame: Up to Week 12
Change From Baseline in Fasting Plasma Glucose at Week 12
Time frame: Baseline (Day 1) and up to Week 12
Change From Baseline in Fasting Insulin at Week 12
Time frame: 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
Time frame: Baseline (Day 1) and up to Week 12
Change From Baseline in Fructosamine at Week 6 and Week 12
Time frame: Baseline (Day -1) and Week 12
Number of Participants With HbA1c < 7.0% and < 6.5%
Time frame: Up to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK256073 1mg, GSK256073 5mg and GSK256073 10mg in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 15 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, Spain, United Kingdom, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) (time frame: Up to Week 12). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017.