Trial Outcomes & Findings for Rosiglitazone-Metformin Combination Versus Metformin-Sulfonylurea Combination On Beta-Cell Function In Type 2 Diabetes (NCT NCT00367055)
NCT ID: NCT00367055
Last Updated: 2010-07-27
Results Overview
Change from baseline in the insulin secretory capacity was measured by the assesment of blood insulin concentrations (conc.) using the hyperglycaemic clamp (HC) technique, per intravenous glucose perfusion by a catheter. Change from baseline for insulin conc peaks (highest conc level) was calculated as the Month 36 value minus the baseline value. Insulin secretion was assessed by calculating AUC during the first 10 minutes of HC (incremental and total AUC0-10 min) and the AUC after the first 10 minutes of the HC (10-180min).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
84 participants
Primary outcome timeframe
Baseline and Month 36
Results posted on
2010-07-27
Participant Flow
Participant milestones
| Measure |
Rosiglitazone + Metformin 4 mg/2 g/Day
Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
|
Gliclazide + Metformin 80 mg/2 g/Day
Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
41
|
|
Overall Study
COMPLETED
|
32
|
30
|
|
Overall Study
NOT COMPLETED
|
11
|
11
|
Reasons for withdrawal
| Measure |
Rosiglitazone + Metformin 4 mg/2 g/Day
Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
|
Gliclazide + Metformin 80 mg/2 g/Day
Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
3
|
|
Overall Study
Patient's Willing
|
3
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Stopping Criterion Met
|
0
|
1
|
|
Overall Study
Participant Living too Far from Hospital
|
0
|
1
|
Baseline Characteristics
Rosiglitazone-Metformin Combination Versus Metformin-Sulfonylurea Combination On Beta-Cell Function In Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Rosiglitazone + Metformin 4 mg/2 g/Day
n=43 Participants
Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
|
Gliclazide + Metformin 80 mg/2 g/Day
n=41 Participants
Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
58.3 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
58.1 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
58.2 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
<25
|
3 kilograms per square meter (kg/m2)
n=5 Participants
|
0 kilograms per square meter (kg/m2)
n=7 Participants
|
3 kilograms per square meter (kg/m2)
n=5 Participants
|
|
Body Mass Index (BMI)
25-30
|
21 kilograms per square meter (kg/m2)
n=5 Participants
|
20 kilograms per square meter (kg/m2)
n=7 Participants
|
41 kilograms per square meter (kg/m2)
n=5 Participants
|
|
Body Mass Index (BMI)
>30
|
19 kilograms per square meter (kg/m2)
n=5 Participants
|
21 kilograms per square meter (kg/m2)
n=7 Participants
|
40 kilograms per square meter (kg/m2)
n=5 Participants
|
|
FBG
|
9.10 Millimoles/Liter (mmol/L)
STANDARD_DEVIATION 1.72 • n=5 Participants
|
8.28 Millimoles/Liter (mmol/L)
STANDARD_DEVIATION 1.11 • n=7 Participants
|
8.70 Millimoles/Liter (mmol/L)
STANDARD_DEVIATION 1.50 • n=5 Participants
|
|
HbA1c
|
7.5 percentage
STANDARD_DEVIATION 0.55 • n=5 Participants
|
7.3 percentage
STANDARD_DEVIATION 0.55 • n=7 Participants
|
7.4 percentage
STANDARD_DEVIATION 0.57 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 36Population: Intent-to-Treat (ITT) Population: participants receiving at least one dose of study drug with an available efficacy evaluation (HC at M18 or M36). The measurement was conducted on participants who had baseline and M18 and M36 HC test data available. Each HC was validated at both Baseline and Month 36, resulting in different "n"s for each category.
Change from baseline in the insulin secretory capacity was measured by the assesment of blood insulin concentrations (conc.) using the hyperglycaemic clamp (HC) technique, per intravenous glucose perfusion by a catheter. Change from baseline for insulin conc peaks (highest conc level) was calculated as the Month 36 value minus the baseline value. Insulin secretion was assessed by calculating AUC during the first 10 minutes of HC (incremental and total AUC0-10 min) and the AUC after the first 10 minutes of the HC (10-180min).
Outcome measures
| Measure |
Rosiglitazone + Metformin 4 mg/2 g/Day
n=27 Participants
Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
|
Gliclazide + Metformin 80 mg/2 g/Day
n=29 Participants
Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
|
|---|---|---|
|
Median Change From Baseline in the Insulin Secretory Capacity After a 36-month Treatment
Total AUC(0-10 min), n=24, 26
|
-3.9 picomoles/L per minute (pmol/L*min)
Interval -688.3 to 2211.2
|
-75.3 picomoles/L per minute (pmol/L*min)
Interval -919.9 to 1507.1
|
|
Median Change From Baseline in the Insulin Secretory Capacity After a 36-month Treatment
Incremental AUC(0-10 min), n=22, 23
|
7.0 picomoles/L per minute (pmol/L*min)
Interval -308.3 to 2781.2
|
74.6 picomoles/L per minute (pmol/L*min)
Interval -822.2 to 1193.8
|
|
Median Change From Baseline in the Insulin Secretory Capacity After a 36-month Treatment
Total concentration peak(0-10 min), n=25, 26
|
-8.6 picomoles/L per minute (pmol/L*min)
Interval -89.6 to 386.5
|
3.6 picomoles/L per minute (pmol/L*min)
Interval -121.2 to 52.3
|
|
Median Change From Baseline in the Insulin Secretory Capacity After a 36-month Treatment
Incremental concentration peak(0-10 min), n=24, 26
|
-1.8 picomoles/L per minute (pmol/L*min)
Interval -60.9 to 443.8
|
10.8 picomoles/L per minute (pmol/L*min)
Interval -128.3 to 56.6
|
|
Median Change From Baseline in the Insulin Secretory Capacity After a 36-month Treatment
Total AUC(10-180 min), n=20, 24
|
40.6 picomoles/L per minute (pmol/L*min)
Interval -411.9 to 500.2
|
-21.2 picomoles/L per minute (pmol/L*min)
Interval -344.2 to 787.3
|
|
Median Change From Baseline in the Insulin Secretory Capacity After a 36-month Treatment
Incremental AUC(10-180 min), n=19, 24
|
67.0 picomoles/L per minute (pmol/L*min)
Interval -304.2 to 518.4
|
13.6 picomoles/L per minute (pmol/L*min)
Interval -264.9 to 793.4
|
|
Median Change From Baseline in the Insulin Secretory Capacity After a 36-month Treatment
Total concentration peak(10-180 min), n=27, 29
|
7.9 picomoles/L per minute (pmol/L*min)
Interval -223.0 to 286.1
|
-9.3 picomoles/L per minute (pmol/L*min)
Interval -120.5 to 229.4
|
|
Median Change From Baseline in the Insulin Secretory Capacity After a 36-month Treatment
Incremental concentation peak(10-180 min), n=25,29
|
10.8 picomoles/L per minute (pmol/L*min)
Interval -232.3 to 198.6
|
11.5 picomoles/L per minute (pmol/L*min)
Interval -116.9 to 231.6
|
SECONDARY outcome
Timeframe: Baseline and Month 36Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Month 18Population: Intent-to-Treat (ITT) Population: participants receiving at least one dose of study drug with an available efficacy evaluation (HC at M18 or M36). The measurement was conducted on participants who had baseline and M18 and M36 HC test data available. Each HC was validated at both Baseline and Month 36, resulting in different "n"s for each category.
Change from baseline was calculated as the Month 18 value minus the baseline value. Insulin secretion capacity is measured in blood (blood level of insulin) and is a response of the pancreatic beta-cells to hyperglycemia induced by a glucose IV bolus, then infusion. Hyperglycemic clamp (HC) is a reference technique to evaluate the initial and the secondary phases of insulin secretion.
Outcome measures
| Measure |
Rosiglitazone + Metformin 4 mg/2 g/Day
n=30 Participants
Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
|
Gliclazide + Metformin 80 mg/2 g/Day
n=31 Participants
Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
|
|---|---|---|
|
Median Change From Baseline in the Insulin Secretion Capacity After an 18-month Treatment
HC, Total AUC(0-10min), n=30, 31
|
18.3 pmol/L*min
Interval -1044.7 to 2211.2
|
-32.3 pmol/L*min
Interval -919.9 to 1612.5
|
|
Median Change From Baseline in the Insulin Secretion Capacity After an 18-month Treatment
HC, Incremental AUC(0-10min), n=27, 26
|
22.3 pmol/L*min
Interval -308.3 to 2781.2
|
60.7 pmol/L*min
Interval -822.2 to 1193.8
|
|
Median Change From Baseline in the Insulin Secretion Capacity After an 18-month Treatment
HC, Total AUC(10-180min), n=26, 30
|
55.9 pmol/L*min
Interval -411.9 to 500.2
|
-7.6 pmol/L*min
Interval -344.2 to 787.3
|
|
Median Change From Baseline in the Insulin Secretion Capacity After an 18-month Treatment
HC, Incremental AUC(10-180min), n=26, 29
|
72.9 pmol/L*min
Interval -304.2 to 518.4
|
14.6 pmol/L*min
Interval -264.9 to 1172.7
|
|
Median Change From Baseline in the Insulin Secretion Capacity After an 18-month Treatment
Arginine (Arg) test, Total AUC(0-30min), n=25, 25
|
38.4 pmol/L*min
Interval -367.0 to 225.0
|
10.9 pmol/L*min
Interval -163.9 to 93.1
|
|
Median Change From Baseline in the Insulin Secretion Capacity After an 18-month Treatment
Arg test, Incremental AUC(0-30min), n=25, 25
|
15.1 pmol/L*min
Interval -440.3 to 120.9
|
-8.0 pmol/L*min
Interval -153.3 to 49.3
|
|
Median Change From Baseline in the Insulin Secretion Capacity After an 18-month Treatment
Arg test, Incremental Conc. peak(0-30 min),n=26,29
|
23.3 pmol/L*min
Interval -2531.7 to 766.5
|
-111.1 pmol/L*min
Interval -1125.0 to 499.7
|
SECONDARY outcome
Timeframe: Baseline and Month 36Population: Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug and had an available efficacy evaluation (hyperglycaemic clamp at M18 or M36). This measurement was conducted on participants in the ITT Population who had baseline and M18 and M36 clamp test data available.
Change from baseline was calculated as the Month 36 value minus the baseline value. HbA1c levels were measured by blood draw.
Outcome measures
| Measure |
Rosiglitazone + Metformin 4 mg/2 g/Day
n=32 Participants
Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
|
Gliclazide + Metformin 80 mg/2 g/Day
n=31 Participants
Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
|
|---|---|---|
|
Mean Change From Baseline in HbA1c at Month 36
|
-0.22 percent change
Standard Deviation 1.3
|
0.3 percent change
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Baseline and Month 36Population: Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug and had an available efficacy evaluation (hyperglycaemic clamp at M18 or M36). This measurement was conducted on participants in the ITT Population who had baseline and M18 and M36 clamp test data available.
Change from baseline was calculated as the Month 36 value minus the baseline value. FBG levels were measured by blood draw.
Outcome measures
| Measure |
Rosiglitazone + Metformin 4 mg/2 g/Day
n=32 Participants
Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
|
Gliclazide + Metformin 80 mg/2 g/Day
n=30 Participants
Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
|
|---|---|---|
|
Mean Change From Baseline in FBG at Month 36
|
-1.6 millimoles per Liter (mmol/L)
Standard Deviation 1.9
|
-0.2 millimoles per Liter (mmol/L)
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Baseline and Month 36Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Month 36Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Month 36Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Month 36Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Months 18 and 36Population: ITT Population
Change from baseline was calculated as the Month 18 and 36 values minus the baseline value. Insulin sensitivity is measured as the quantity of glucose metabolized per unit of plasma insulin concentration.
Outcome measures
| Measure |
Rosiglitazone + Metformin 4 mg/2 g/Day
n=30 Participants
Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
|
Gliclazide + Metformin 80 mg/2 g/Day
n=33 Participants
Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
|
|---|---|---|
|
Mean Change From Baseline in Insulin Sensitivity Index at Months 18 and 36
Month 18
|
-0.00511 micromoles (umol)/kilogram/min/pmol/L
Standard Deviation 0.03451
|
-0.02045 micromoles (umol)/kilogram/min/pmol/L
Standard Deviation 0.05302
|
|
Mean Change From Baseline in Insulin Sensitivity Index at Months 18 and 36
Month 36
|
0.00040 micromoles (umol)/kilogram/min/pmol/L
Standard Deviation 0.04722
|
-0.01702 micromoles (umol)/kilogram/min/pmol/L
Standard Deviation 0.05109
|
Adverse Events
Rosiglitazone + Metformin 4 mg/2 g/Day
Serious events: 8 serious events
Other events: 31 other events
Deaths: 0 deaths
Gliclazide + Metformin 80 mg/2 g/Day
Serious events: 12 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rosiglitazone + Metformin 4 mg/2 g/Day
n=43 participants at risk
Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
|
Gliclazide + Metformin 80 mg/2 g/Day
n=41 participants at risk
Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
|
|---|---|---|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/43
|
2.4%
1/41
|
|
Gastrointestinal disorders
Oedematous pancreatitis
|
0.00%
0/43
|
2.4%
1/41
|
|
Gastrointestinal disorders
Inguinal hernia
|
2.3%
1/43
|
0.00%
0/41
|
|
Gastrointestinal disorders
Pancreatitis acute on chronic
|
2.3%
1/43
|
0.00%
0/41
|
|
Gastrointestinal disorders
Partial bowel obstruction
|
0.00%
0/43
|
2.4%
1/41
|
|
Gastrointestinal disorders
Proctorrhagia
|
0.00%
0/43
|
2.4%
1/41
|
|
Gastrointestinal disorders
Sigmoiditis
|
2.3%
1/43
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Coxarthrosis
|
2.3%
1/43
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Gonarthrosis
|
2.3%
1/43
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Herniated disc
|
2.3%
1/43
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/43
|
2.4%
1/41
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/43
|
2.4%
1/41
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/43
|
2.4%
1/41
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/43
|
2.4%
1/41
|
|
Nervous system disorders
Stroke
|
0.00%
0/43
|
2.4%
1/41
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/43
|
2.4%
1/41
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/43
|
2.4%
1/41
|
|
Renal and urinary disorders
Urinary incontinence aggravated
|
2.3%
1/43
|
0.00%
0/41
|
|
Renal and urinary disorders
Urinary tract infection
|
2.3%
1/43
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/43
|
7.3%
3/41
|
|
Vascular disorders
Digital necrosis
|
2.3%
1/43
|
0.00%
0/41
|
|
Vascular disorders
Femoral artery occlusion
|
2.3%
1/43
|
0.00%
0/41
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/43
|
2.4%
1/41
|
|
Cardiac disorders
Myocardial ischemia
|
2.3%
1/43
|
0.00%
0/41
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/43
|
2.4%
1/41
|
|
General disorders
Asthenia
|
0.00%
0/43
|
2.4%
1/41
|
|
Hepatobiliary disorders
Biliary colic
|
2.3%
1/43
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/43
|
2.4%
1/41
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritoneal carcinomatosis
|
0.00%
0/43
|
4.9%
2/41
|
Other adverse events
| Measure |
Rosiglitazone + Metformin 4 mg/2 g/Day
n=43 participants at risk
Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
|
Gliclazide + Metformin 80 mg/2 g/Day
n=41 participants at risk
Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
20.9%
9/43
|
7.3%
3/41
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
18.6%
8/43
|
2.4%
1/41
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.0%
3/43
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
Common cold
|
4.7%
2/43
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
4.7%
2/43
|
4.9%
2/41
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
4.7%
2/43
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/43
|
4.9%
2/41
|
|
Musculoskeletal and connective tissue disorders
Lumbago
|
9.3%
4/43
|
2.4%
1/41
|
|
Musculoskeletal and connective tissue disorders
Lumbar pain
|
7.0%
3/43
|
4.9%
2/41
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
4.7%
2/43
|
7.3%
3/41
|
|
Musculoskeletal and connective tissue disorders
Gonalgia
|
4.7%
2/43
|
4.9%
2/41
|
|
Musculoskeletal and connective tissue disorders
Gonarthrosis
|
4.7%
2/43
|
2.4%
1/41
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
2.3%
1/43
|
9.8%
4/41
|
|
Nervous system disorders
Carpal tunnel syndrome
|
2.3%
1/43
|
9.8%
4/41
|
|
Nervous system disorders
Sciatica
|
7.0%
3/43
|
4.9%
2/41
|
|
Nervous system disorders
Headache
|
7.0%
3/43
|
2.4%
1/41
|
|
Nervous system disorders
Formication
|
0.00%
0/43
|
4.9%
2/41
|
|
Gastrointestinal disorders
Diarrhea
|
7.0%
3/43
|
7.3%
3/41
|
|
Gastrointestinal disorders
Constipation
|
4.7%
2/43
|
2.4%
1/41
|
|
Gastrointestinal disorders
Sigmoiditis
|
4.7%
2/43
|
2.4%
1/41
|
|
Gastrointestinal disorders
Colopathy
|
4.7%
2/43
|
0.00%
0/41
|
|
Gastrointestinal disorders
Nausea
|
4.7%
2/43
|
0.00%
0/41
|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
1/43
|
4.9%
2/41
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.3%
1/43
|
19.5%
8/41
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.3%
1/43
|
4.9%
2/41
|
|
Infections and infestations
Tonsilitis
|
2.3%
1/43
|
4.9%
2/41
|
|
Infections and infestations
Fungal infection
|
0.00%
0/43
|
7.3%
3/41
|
|
Infections and infestations
Rhinitis
|
0.00%
0/43
|
7.3%
3/41
|
|
Infections and infestations
Orchitis
|
0.00%
0/43
|
4.9%
2/41
|
|
Ear and labyrinth disorders
Vertigo
|
2.3%
1/43
|
7.3%
3/41
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/43
|
4.9%
2/41
|
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