Trial Outcomes & Findings for Dose-Ranging Study In Subjects With Type 2 Diabetes Mellitus Who Are Treatment-Naive (NCT NCT00495469)
NCT ID: NCT00495469
Last Updated: 2017-10-30
Results Overview
The blood samples were collected at Baseline, Week 4, Week 8 and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the Intent-to-Treat (ITT) Population with Last observation carried forward (LOCF). Adjusted mean is presented as least square (LS) mean.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
250 participants
Primary outcome timeframe
Baseline (Week 0) and at Week 12
Results posted on
2017-10-30
Participant Flow
The study was conducted at 130 centers in 14 countries (9 European, 3 International countries, Canada, and the United States) during the period from 17 August 2007 to 5 June 2008.
A total of 822 participants with Type 2 Diabetes Mellitus who were treatment naïve, entered the 2-week screening period. Of these, 570 were screen failures. The primary reason for screening failure was the participant not meeting eligibility criteria. Out of 252 randomized participants, 250 participants received study drug.
Participant milestones
| Measure |
Placebo
Participants received 2 placebo tablets matching for GSK189075 twice daily (BID) before breakfast and dinner and 1 placebo capsule matching for Pioglitazone once daily (QD) before breakfast for 12 weeks
|
GSK189075 100 mg QD
Participants received 2 tablets of GSK189075 50 milligrams (mg) each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg QD
Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 500 mg QD
Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 1000 mg QD
Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg BID
Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
|
Pioglitazone 30 mg QD
Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
36
|
37
|
34
|
36
|
36
|
36
|
35
|
|
Overall Study
COMPLETED
|
30
|
30
|
27
|
32
|
31
|
31
|
30
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
7
|
4
|
5
|
5
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Participants received 2 placebo tablets matching for GSK189075 twice daily (BID) before breakfast and dinner and 1 placebo capsule matching for Pioglitazone once daily (QD) before breakfast for 12 weeks
|
GSK189075 100 mg QD
Participants received 2 tablets of GSK189075 50 milligrams (mg) each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg QD
Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 500 mg QD
Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 1000 mg QD
Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg BID
Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
|
Pioglitazone 30 mg QD
Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
3
|
0
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
3
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
1
|
3
|
3
|
2
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Liver function test abnormality
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
ST depression at randomisation in ECG
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Dose-Ranging Study In Subjects With Type 2 Diabetes Mellitus Who Are Treatment-Naive
Baseline characteristics by cohort
| Measure |
Placebo
n=36 Participants
Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
|
GSK189075 100 mg QD
n=37 Participants
Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg QD
n=34 Participants
Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 500 mg QD
n=36 Participants
Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 1000 mg QD
n=36 Participants
Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg BID
n=36 Participants
Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
|
Pioglitazone 30 mg QD
n=35 Participants
Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
50.6 Years
STANDARD_DEVIATION 10.60 • n=5 Participants
|
53.5 Years
STANDARD_DEVIATION 9.35 • n=7 Participants
|
54.4 Years
STANDARD_DEVIATION 9.57 • n=5 Participants
|
52.6 Years
STANDARD_DEVIATION 10.91 • n=4 Participants
|
54.5 Years
STANDARD_DEVIATION 10.19 • n=21 Participants
|
50.0 Years
STANDARD_DEVIATION 10.21 • n=8 Participants
|
53.2 Years
STANDARD_DEVIATION 10.35 • n=8 Participants
|
52.7 Years
STANDARD_DEVIATION 10.19 • n=24 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
126 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
124 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
29 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
25 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
160 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
27 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) and at Week 12Population: ITT Population consisted of all randomized participants who received at least one dose of study medication, had a Baseline assessment, and had at least one corresponding on-therapy efficacy assessment. Only those participants with data available at the indicated time points were analyzed.
The blood samples were collected at Baseline, Week 4, Week 8 and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the Intent-to-Treat (ITT) Population with Last observation carried forward (LOCF). Adjusted mean is presented as least square (LS) mean.
Outcome measures
| Measure |
GSK189075 1000 mg QD
n=35 Participants
Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
Placebo
n=33 Participants
Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
|
GSK189075 100 mg QD
n=36 Participants
Participants received 2 tablets of 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg QD
n=32 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 500 mg QD
n=34 Participants
Participants received 2 tablets of 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg BID
n=35 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
|
Pioglitazone 30 mg QD
n=34 Participants
Participants received 2 placebo tablets matching GSK189075, 1 capsule of 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Hemoglobin A1c (Glycosylated Hemoglobin) (HbA1c) at Week 12
|
-0.85 Percentage
Standard Error 0.137
|
-0.19 Percentage
Standard Error 0.141
|
-0.53 Percentage
Standard Error 0.135
|
-0.75 Percentage
Standard Error 0.143
|
-0.53 Percentage
Standard Error 0.139
|
-0.78 Percentage
Standard Error 0.137
|
-0.38 Percentage
Standard Error 0.139
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and at Week 4 nad 8Population: ITT Population. Only those participants available at the specified time points were analyzed.
The blood samples were collected at Baseline, Week 4, Week 8 and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 4 and 8 minus Baseline value. The primary analysis was performed on the ITT Population with LOCF.
Outcome measures
| Measure |
GSK189075 1000 mg QD
n=35 Participants
Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
Placebo
n=33 Participants
Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
|
GSK189075 100 mg QD
n=37 Participants
Participants received 2 tablets of 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg QD
n=33 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 500 mg QD
n=34 Participants
Participants received 2 tablets of 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg BID
n=35 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
|
Pioglitazone 30 mg QD
n=34 Participants
Participants received 2 placebo tablets matching GSK189075, 1 capsule of 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in HbA1c at Weeks 4 and 8
Week 4
|
-0.45 Percentage
Standard Deviation 0.601
|
-0.18 Percentage
Standard Deviation 0.523
|
-0.37 Percentage
Standard Deviation 0.437
|
-0.57 Percentage
Standard Deviation 0.639
|
-0.40 Percentage
Standard Deviation 0.528
|
-0.31 Percentage
Standard Deviation 0.541
|
-0.07 Percentage
Standard Deviation 0.579
|
|
Mean Change From Baseline in HbA1c at Weeks 4 and 8
Week 8
|
-0.77 Percentage
Standard Deviation 0.660
|
-0.08 Percentage
Standard Deviation 0.943
|
-0.42 Percentage
Standard Deviation 0.720
|
-0.76 Percentage
Standard Deviation 0.671
|
-0.60 Percentage
Standard Deviation 0.827
|
-0.67 Percentage
Standard Deviation 0.646
|
-0.25 Percentage
Standard Deviation 0.819
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and at Week 12Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
The samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and Week 14 (follow up). Participants were asked to be on fast for at least 8 hours prior to each study visits and collection of lab samples. Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the ITT Population with LOCF. Adjusted mean is presented as LS mean.
Outcome measures
| Measure |
GSK189075 1000 mg QD
n=35 Participants
Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
Placebo
n=33 Participants
Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
|
GSK189075 100 mg QD
n=36 Participants
Participants received 2 tablets of 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg QD
n=33 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 500 mg QD
n=34 Participants
Participants received 2 tablets of 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg BID
n=35 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
|
Pioglitazone 30 mg QD
n=34 Participants
Participants received 2 placebo tablets matching GSK189075, 1 capsule of 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)
|
-1.45 millimoles per liter (mmol/L)
Standard Error 0.289
|
-0.50 millimoles per liter (mmol/L)
Standard Error 0.298
|
-1.35 millimoles per liter (mmol/L)
Standard Error 0.286
|
-1.56 millimoles per liter (mmol/L)
Standard Error 0.298
|
-1.13 millimoles per liter (mmol/L)
Standard Error 0.294
|
-1.63 millimoles per liter (mmol/L)
Standard Error 0.289
|
-1.01 millimoles per liter (mmol/L)
Standard Error 0.295
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and at Week 12Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
The blood samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and Week 14 (follow up). Participants were asked to be on fast for at least 8 hours prior to each study visits and collection of lab samples. Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the ITT Population with LOCF. Adjusted mean is presented as LS mean.
Outcome measures
| Measure |
GSK189075 1000 mg QD
n=33 Participants
Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
Placebo
n=33 Participants
Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
|
GSK189075 100 mg QD
n=36 Participants
Participants received 2 tablets of 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg QD
n=30 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 500 mg QD
n=33 Participants
Participants received 2 tablets of 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg BID
n=35 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
|
Pioglitazone 30 mg QD
n=33 Participants
Participants received 2 placebo tablets matching GSK189075, 1 capsule of 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline to Week 12 in Fructosamine (Corrected)
|
-37.9 micromoles per liter (µmol/L)
Standard Error 6.12
|
-1.4 micromoles per liter (µmol/L)
Standard Error 6.12
|
-25.5 micromoles per liter (µmol/L)
Standard Error 5.94
|
-36.3 micromoles per liter (µmol/L)
Standard Error 6.44
|
-31.2 micromoles per liter (µmol/L)
Standard Error 6.12
|
-30.9 micromoles per liter (µmol/L)
Standard Error 5.94
|
-15.2 micromoles per liter (µmol/L)
Standard Error 6.18
|
SECONDARY outcome
Timeframe: Week 12Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
Differences between treatment groups in the proportion of participants who achieved HbA1c targets of \<=6.5% and \<7% at Week 12 in the ITT population with LOCF were assessed based on a logistic regression model with terms included for treatment and Baseline HbA1c. Differences between treatment groups in the proportion of participants who achieved a clinically meaningful decreases from Baseline in HbA1c (\>=0.7%) at Week 12 were assessed in the same manner.
Outcome measures
| Measure |
GSK189075 1000 mg QD
n=35 Participants
Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
Placebo
n=33 Participants
Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
|
GSK189075 100 mg QD
n=36 Participants
Participants received 2 tablets of 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg QD
n=32 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 500 mg QD
n=34 Participants
Participants received 2 tablets of 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg BID
n=35 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
|
Pioglitazone 30 mg QD
n=34 Participants
Participants received 2 placebo tablets matching GSK189075, 1 capsule of 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Were HbA1c Responders at Week 12
Responders (<=6.5%)
|
7 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants Who Were HbA1c Responders at Week 12
Responders (<7%)
|
13 Participants
|
7 Participants
|
11 Participants
|
12 Participants
|
10 Participants
|
15 Participants
|
11 Participants
|
|
Number of Participants Who Were HbA1c Responders at Week 12
Responders (reduction>=0.7%)
|
18 Participants
|
9 Participants
|
13 Participants
|
18 Participants
|
13 Participants
|
21 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
Differences between treatment groups in the proportion of participants who achieved FPG targets of \<7.0 millimoles per liter (mmol/L) (126 milligrams per deciliter \[mg/dL\]) and \<7.8 mmol/L (140 mg/dL) at Week 12 in the ITT population with LOCF were assessed based on a logistic regression model with terms included for treatment and Baseline FPG. The proportion of participants who achieved the target of \<5.5 mmol/L (100 mg/dL) at Week 12 within each treatment group were summarized only. Differences between treatment groups in the proportion of participants who achieved a clinically meaningful decreases from Baseline in FPG (1.7 mmol/L \[\>=30 mg/dL\]) at Week 12 were assessed in the same manner.
Outcome measures
| Measure |
GSK189075 1000 mg QD
n=35 Participants
Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
Placebo
n=33 Participants
Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
|
GSK189075 100 mg QD
n=36 Participants
Participants received 2 tablets of 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg QD
n=33 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 500 mg QD
n=34 Participants
Participants received 2 tablets of 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg BID
n=35 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
|
Pioglitazone 30 mg QD
n=34 Participants
Participants received 2 placebo tablets matching GSK189075, 1 capsule of 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Were Fasting Plasma Glucose (FPG) Responders at Week 12
Responders (<7 mmol/L)
|
12 Participants
|
6 Participants
|
10 Participants
|
14 Participants
|
11 Participants
|
14 Participants
|
13 Participants
|
|
Number of Participants Who Were Fasting Plasma Glucose (FPG) Responders at Week 12
Responders (<7.8 mmol/L)
|
21 Participants
|
13 Participants
|
20 Participants
|
19 Participants
|
17 Participants
|
22 Participants
|
15 Participants
|
|
Number of Participants Who Were Fasting Plasma Glucose (FPG) Responders at Week 12
Responders (reduction >=1.7 mmol/L)
|
14 Participants
|
5 Participants
|
9 Participants
|
13 Participants
|
11 Participants
|
19 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and at Week 12Population: ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed.
Samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.
Outcome measures
| Measure |
GSK189075 1000 mg QD
n=31 Participants
Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
Placebo
n=32 Participants
Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
|
GSK189075 100 mg QD
n=34 Participants
Participants received 2 tablets of 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg QD
n=28 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 500 mg QD
n=33 Participants
Participants received 2 tablets of 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg BID
n=30 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
|
Pioglitazone 30 mg QD
n=32 Participants
Participants received 2 placebo tablets matching GSK189075, 1 capsule of 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline to Week 12 in Triglycerides
|
-0.05 mmol/L
Standard Error 0.144
|
-0.01 mmol/L
Standard Error 0.142
|
0.19 mmol/L
Standard Error 0.138
|
-0.32 mmol/L
Standard Error 0.152
|
-0.16 mmol/L
Standard Error 0.140
|
-0.18 mmol/L
Standard Error 0.147
|
-0.37 mmol/L
Standard Error 0.142
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and at Week 12Population: ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed.
Samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.
Outcome measures
| Measure |
GSK189075 1000 mg QD
n=31 Participants
Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
Placebo
n=32 Participants
Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
|
GSK189075 100 mg QD
n=34 Participants
Participants received 2 tablets of 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg QD
n=28 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 500 mg QD
n=33 Participants
Participants received 2 tablets of 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg BID
n=30 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
|
Pioglitazone 30 mg QD
n=32 Participants
Participants received 2 placebo tablets matching GSK189075, 1 capsule of 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline to Week 12 in Total Cholesterol
|
-0.02 mmol/L
Standard Error 0.129
|
-0.03 mmol/L
Standard Error 0.127
|
-0.08 mmol/L
Standard Error 0.124
|
-0.12 mmol/L
Standard Error 0.136
|
0.10 mmol/L
Standard Error 0.126
|
0.22 mmol/L
Standard Error 0.132
|
0.00 mmol/L
Standard Error 0.128
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.
Outcome measures
| Measure |
GSK189075 1000 mg QD
n=31 Participants
Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
Placebo
n=32 Participants
Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
|
GSK189075 100 mg QD
n=31 Participants
Participants received 2 tablets of 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg QD
n=28 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 500 mg QD
n=31 Participants
Participants received 2 tablets of 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg BID
n=30 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
|
Pioglitazone 30 mg QD
n=32 Participants
Participants received 2 placebo tablets matching GSK189075, 1 capsule of 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline to Week 12 in Low Density Lipoprotein Cholesterol (LDL-c)
|
-0.04 mmol/L
Standard Error 0.113
|
-0.02 mmol/L
Standard Error 0.111
|
-0.17 mmol/L
Standard Error 0.113
|
-0.03 mmol/L
Standard Error 0.119
|
0.08 mmol/L
Standard Error 0.114
|
0.23 mmol/L
Standard Error 0.115
|
0.07 mmol/L
Standard Error 0.112
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.
Outcome measures
| Measure |
GSK189075 1000 mg QD
n=31 Participants
Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
Placebo
n=32 Participants
Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
|
GSK189075 100 mg QD
n=34 Participants
Participants received 2 tablets of 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg QD
n=28 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 500 mg QD
n=33 Participants
Participants received 2 tablets of 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg BID
n=30 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
|
Pioglitazone 30 mg QD
n=32 Participants
Participants received 2 placebo tablets matching GSK189075, 1 capsule of 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline to Week 12 in High Density Lipoprotein Cholesterol (HDL-c)
|
0.05 mmol/L
Standard Error 0.027
|
-0.02 mmol/L
Standard Error 0.027
|
0.00 mmol/L
Standard Error 0.026
|
0.02 mmol/L
Standard Error 0.028
|
0.06 mmol/L
Standard Error 0.026
|
0.04 mmol/L
Standard Error 0.027
|
0.09 mmol/L
Standard Error 0.026
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.
Outcome measures
| Measure |
GSK189075 1000 mg QD
n=31 Participants
Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
Placebo
n=32 Participants
Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
|
GSK189075 100 mg QD
n=31 Participants
Participants received 2 tablets of 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg QD
n=28 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 500 mg QD
n=31 Participants
Participants received 2 tablets of 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg BID
n=30 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
|
Pioglitazone 30 mg QD
n=32 Participants
Participants received 2 placebo tablets matching GSK189075, 1 capsule of 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline to Week 12 in LDL-c/HDL-c Ratio
|
-0.07 Ratio
Standard Error 0.121
|
0.06 Ratio
Standard Error 0.119
|
-0.19 Ratio
Standard Error 0.121
|
-0.06 Ratio
Standard Error 0.127
|
-0.13 Ratio
Standard Error 0.120
|
0.10 Ratio
Standard Error 0.122
|
-0.07 Ratio
Standard Error 0.120
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.
Outcome measures
| Measure |
GSK189075 1000 mg QD
n=31 Participants
Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
Placebo
n=32 Participants
Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
|
GSK189075 100 mg QD
n=34 Participants
Participants received 2 tablets of 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg QD
n=28 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 500 mg QD
n=33 Participants
Participants received 2 tablets of 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg BID
n=30 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
|
Pioglitazone 30 mg QD
n=32 Participants
Participants received 2 placebo tablets matching GSK189075, 1 capsule of 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline to Week 12 in Total Cholesterol/HDL-c Ratio
|
-0.09 Ratio
Standard Error 0.149
|
0.14 Ratio
Standard Error 0.146
|
-0.05 Ratio
Standard Error 0.142
|
-0.20 Ratio
Standard Error 0.156
|
-0.22 Ratio
Standard Error 0.144
|
0.01 Ratio
Standard Error 0.151
|
-0.26 Ratio
Standard Error 0.147
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: ITT Population with LOCF.
Body weight measurement was taken at Baseline, Week 2, Week 4, Week 8, Week 12 and at Week 14 (follow up). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.
Outcome measures
| Measure |
GSK189075 1000 mg QD
n=35 Participants
Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
Placebo
n=33 Participants
Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
|
GSK189075 100 mg QD
n=37 Participants
Participants received 2 tablets of 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg QD
n=33 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 500 mg QD
n=34 Participants
Participants received 2 tablets of 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg BID
n=35 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
|
Pioglitazone 30 mg QD
n=34 Participants
Participants received 2 placebo tablets matching GSK189075, 1 capsule of 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline to Week 12 in Body Weight
|
-2.47 kilograms
Standard Error 0.413
|
-1.03 kilograms
Standard Error 0.426
|
-1.52 kilograms
Standard Error 0.402
|
-2.54 kilograms
Standard Error 0.425
|
-2.46 kilograms
Standard Error 0.419
|
-2.11 kilograms
Standard Error 0.413
|
0.00 kilograms
Standard Error 0.419
|
SECONDARY outcome
Timeframe: Up to Week 12Population: Safety Population consisted of all participants who received at least one dose of study medication.
AE was defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Outcome measures
| Measure |
GSK189075 1000 mg QD
n=36 Participants
Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
Placebo
n=36 Participants
Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
|
GSK189075 100 mg QD
n=37 Participants
Participants received 2 tablets of 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg QD
n=34 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 500 mg QD
n=36 Participants
Participants received 2 tablets of 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg BID
n=36 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
|
Pioglitazone 30 mg QD
n=35 Participants
Participants received 2 placebo tablets matching GSK189075, 1 capsule of 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Any On-therapy Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AEs
|
21 Participants
|
8 Participants
|
15 Participants
|
20 Participants
|
11 Participants
|
20 Participants
|
12 Participants
|
|
Number of Participants With Any On-therapy Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 12Population: Safety Population.
Participants were provided with a Daily Glucose Monitoring Log to record glucose meter readings and to record symptoms of hypoglycemia. A separate electronic case report form (eCRF) page was provided to capture events of hypoglycemia.
Outcome measures
| Measure |
GSK189075 1000 mg QD
n=36 Participants
Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
Placebo
n=36 Participants
Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
|
GSK189075 100 mg QD
n=37 Participants
Participants received 2 tablets of 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg QD
n=34 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 500 mg QD
n=36 Participants
Participants received 2 tablets of 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg BID
n=36 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
|
Pioglitazone 30 mg QD
n=35 Participants
Participants received 2 placebo tablets matching GSK189075, 1 capsule of 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With On-therapy Hypoglycemia
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 12Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) were measured pre-dose in duplicate, after the participant has been lying quietly for 5 minutes, and then in duplicate 3 minutes after standing up. Participants were asked to refrain from smoking for at least 30 minutes prior to vital sign measurements.
Outcome measures
| Measure |
GSK189075 1000 mg QD
n=35 Participants
Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
Placebo
n=33 Participants
Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
|
GSK189075 100 mg QD
n=37 Participants
Participants received 2 tablets of 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg QD
n=33 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 500 mg QD
n=34 Participants
Participants received 2 tablets of 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg BID
n=35 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
|
Pioglitazone 30 mg QD
n=34 Participants
Participants received 2 placebo tablets matching GSK189075, 1 capsule of 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs of Potential Clinical Importance (PCI) at Any Time on Therapy
SBP, supine, low
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Vital Signs of Potential Clinical Importance (PCI) at Any Time on Therapy
DBP, supine, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of Potential Clinical Importance (PCI) at Any Time on Therapy
HR, supine, low
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs of Potential Clinical Importance (PCI) at Any Time on Therapy
Orthostatic SBP, standing, low
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of Potential Clinical Importance (PCI) at Any Time on Therapy
Orthostatic DBP, standing, low
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs of Potential Clinical Importance (PCI) at Any Time on Therapy
Orthostatic HR, standing, high
|
5 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to Week 12Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
Full 12-lead ECGs were recorded at Randomization (Week 0), Week 4, and Week 12 or early withdrawal. If the QTc was \>500 milliseconds on the locally read ECG recording, an additional 2 ECG recordings at 10 minute intervals were made at that visit. If the average QTc for the 3 recordings was \>500 milliseconds, the participant was withdrawn from the study.
Outcome measures
| Measure |
GSK189075 1000 mg QD
n=35 Participants
Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
Placebo
n=33 Participants
Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
|
GSK189075 100 mg QD
n=36 Participants
Participants received 2 tablets of 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg QD
n=33 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 500 mg QD
n=34 Participants
Participants received 2 tablets of 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg BID
n=35 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
|
Pioglitazone 30 mg QD
n=34 Participants
Participants received 2 placebo tablets matching GSK189075, 1 capsule of 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings at Any Time Post-Baseline
|
14 Participants
|
9 Participants
|
12 Participants
|
11 Participants
|
7 Participants
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to Week 12Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
Chemistry parameters: Albumin, Alkaline phosphatase, Alanine animotransferase, Aspartate aminotransferase, Total billirubin, Calcium, Carbon dioxide/Bicarbonate, Glucose, Potassium, Sodium, Phosphorus and Total protein were assessed for abnormal PCI values. Participants were instructed to fast for at least 8 hours prior to all study visits for the collection of laboratory samples. Samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and at Week 14 (follow up).
Outcome measures
| Measure |
GSK189075 1000 mg QD
n=35 Participants
Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
Placebo
n=33 Participants
Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
|
GSK189075 100 mg QD
n=37 Participants
Participants received 2 tablets of 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg QD
n=33 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 500 mg QD
n=34 Participants
Participants received 2 tablets of 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg BID
n=35 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
|
Pioglitazone 30 mg QD
n=34 Participants
Participants received 2 placebo tablets matching GSK189075, 1 capsule of 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Chemistry Value of PCI at Any Time on Therapy
Alanine aminotransferase, high
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Chemistry Value of PCI at Any Time on Therapy
Calcium, low
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Chemistry Value of PCI at Any Time on Therapy
Albumin, low
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Chemistry Value of PCI at Any Time on Therapy
Alkaline phosphatase, high
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Chemistry Value of PCI at Any Time on Therapy
Aspartate aminotransferase, high
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Chemistry Value of PCI at Any Time on Therapy
Total bilirubin, high
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Chemistry Value of PCI at Any Time on Therapy
carbon dioxide content/Bicarbonate, low
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Chemistry Value of PCI at Any Time on Therapy
Glucose, high
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Chemistry Value of PCI at Any Time on Therapy
Potassium, high
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Chemistry Value of PCI at Any Time on Therapy
Potassium, low
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Chemistry Value of PCI at Any Time on Therapy
Sodium, high
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Chemistry Value of PCI at Any Time on Therapy
Phosphorus, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Chemistry Value of PCI at Any Time on Therapy
Total protein, high
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Chemistry Value of PCI at Any Time on Therapy
Total protein, low
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 12Population: Safety population. Only those participants available at the specified time points were analyzed.
Hematology parameters: Hemoglobin, Hematocrit, Platelet count and White blood cells were assessed for abnormal PCI values. Participants were instructed to fast for at least 8 hours prior to all study visits for the collection of laboratory samples. Samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and at Week 14 (follow up).
Outcome measures
| Measure |
GSK189075 1000 mg QD
n=36 Participants
Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
Placebo
n=36 Participants
Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
|
GSK189075 100 mg QD
n=37 Participants
Participants received 2 tablets of 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg QD
n=34 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 500 mg QD
n=36 Participants
Participants received 2 tablets of 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg BID
n=36 Participants
Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
|
Pioglitazone 30 mg QD
n=35 Participants
Participants received 2 placebo tablets matching GSK189075, 1 capsule of 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Hematology Value of PCI at Any Time on Therapy
Hemoglobin, high
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Value of PCI at Any Time on Therapy
Hemoglobin, low
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology Value of PCI at Any Time on Therapy
Hematocrit, high
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Value of PCI at Any Time on Therapy
Hematocrit, low
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Value of PCI at Any Time on Therapy
Platelet count, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Value of PCI at Any Time on Therapy
Platelet count, low
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Value of PCI at Any Time on Therapy
White blood cell count, low
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
GSK189075 100 mg QD
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
GSK189075 250 mg QD
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
GSK189075 500 mg QD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
GSK189075 1000 mg QD
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
GSK189075 250 mg BID
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Pioglitazone 30 mg QD
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=36 participants at risk
Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks.
|
GSK189075 100 mg QD
n=37 participants at risk
Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg QD
n=34 participants at risk
Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 500 mg QD
n=36 participants at risk
Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 1000 mg QD
n=36 participants at risk
Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg BID
n=36 participants at risk
Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
|
Pioglitazone 30 mg QD
n=35 participants at risk
Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
2.7%
1/37 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/34 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/35 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/37 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/34 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
2.8%
1/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/35 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
Other adverse events
| Measure |
Placebo
n=36 participants at risk
Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks.
|
GSK189075 100 mg QD
n=37 participants at risk
Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg QD
n=34 participants at risk
Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 500 mg QD
n=36 participants at risk
Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 1000 mg QD
n=36 participants at risk
Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
|
GSK189075 250 mg BID
n=36 participants at risk
Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
|
Pioglitazone 30 mg QD
n=35 participants at risk
Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
5.4%
2/37 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
2.9%
1/34 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
2.8%
1/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
11.1%
4/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
5.6%
2/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
5.7%
2/35 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
|
Infections and infestations
Influenza
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
5.4%
2/37 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
5.9%
2/34 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
5.6%
2/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
2.9%
1/35 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
8.1%
3/37 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/34 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
2.8%
1/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
8.6%
3/35 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
2.7%
1/37 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/34 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
2.8%
1/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
5.6%
2/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
2.8%
1/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/35 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
1/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/37 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
2.9%
1/34 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
5.6%
2/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/35 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
|
Nervous system disorders
Headache
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
10.8%
4/37 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
5.9%
2/34 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
5.6%
2/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
8.3%
3/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
2.9%
1/35 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
|
Nervous system disorders
Dizziness
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
2.7%
1/37 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
11.8%
4/34 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
5.6%
2/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/35 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/37 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
2.9%
1/34 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
2.8%
1/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
8.3%
3/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/35 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.6%
2/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/37 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/34 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
2.8%
1/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
2.9%
1/35 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/37 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
2.9%
1/34 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
5.6%
2/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
2.8%
1/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/35 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/37 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/34 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
5.6%
2/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/35 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/37 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/34 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
5.6%
2/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/35 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/37 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/34 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
0.00%
0/36 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
5.7%
2/35 • AEs were reported up to Week 14
Safety Population was used for reporting all AEs
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER