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Body Weight Effects on Glucophage's Efficacy in Chinese Diagnosed T2DM Patients

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ClinicalTrials.gov Identifier: NCT00778622
Recruitment Status : Completed
First Posted : October 23, 2008
Results First Posted : August 20, 2013
Last Update Posted : August 23, 2013
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Intervention Drug: Metformin XR
Enrollment 371

Recruitment Details Started November 2009, Completed March 2011 at Peking University People's Hospital. Participants diagnosed with Type 2 diabetes mellitus 6 months prior to enrollment; were oral antidiabetic agent naive (either having received no antidiabetic agents or received agents 14 days or less, or received none within a month of enrollment in the study.
Pre-assignment Details Participants had glycosated hemoglobin A1c (HbA1c) screening values greater than, equal to 7.0% and less than, equal to 10.0%. Participants were between the ages of 17 and 80 years of age and Chinese Asian. Screening visit was up to 7 days prior to Day 1 (treatment).
Arm/Group Title Glucophage XR in Normal Weight Participants Glucophage XR in Overweight Participants Glucophage XR in Obese Participants
Hide Arm/Group Description Normal weight was defined as body mass index (BMI) greater than, equal to (>=)18.5 kilogram per meter squared (kg/m^2) and less than (<) 24 kg/m^2. Initial dose of Glucophage extended release (XR) on Day 1 was 500 mg taken once daily orally with the evening meal. Drug was titrated up by increments of 500 mg each week to a maximum dose of 2000 mg at Week 4 and for the remaining treatment if the fasting plasma glucose (FPG) was greater than 7.0 mmol/L (126 mg/dL). If the FPG was more than 10.0 mmol/L (greater than 180 mg/dL) at Weeks 4, 8, or 12 and the values were confirmed at a repeated measurement, the participant was discontinued from the treatment. Participants were dosed for a total of 16 weeks. Overweight was defined as body mass index (BMI) greater than, equal to (>=) 24 kg/m^2 and less than (<) 28 kg/m^2. Initial dose of Glucophage extended release (XR) on Day 1 was 500 mg taken once daily orally with the evening meal. Drug was titrated up by increments of 500 mg each week to a maximum dose of 2000 mg at Week 4 and for the remaining treatment if the fasting plasma glucose (FPG) was greater than 7.0 mmol/L (126 mg/dL). If the FPG was more than 10.0 mmol/L (greater than 180 mg/dL) at Weeks 4, 8, or 12 and the values were confirmed at a repeated measurement, the participant was discontinued from the treatment. Participants were dosed for a total of 16 weeks Obese was defined as body mass index (BMI) greater than, equal to (>=) 28 kg/m^2. Initial dose of Glucophage extended release (XR)on Day 1 was 500 mg taken once daily orally with the evening meal. Drug was titrated up by increments of 500 mg each week to a maximum dose of 2000 mg at Week 4 and for the remaining treatment if the fasting plasma glucose (FPG) was greater than 7.0 mmol/L (126 mg/dL). If the FPG was more than 10.0 mmol/L (greater than 180 mg/dL) at Weeks 4, 8, or 12 and the values were confirmed at a repeated measurement, the participant was discontinued from the treatment. Participants were dosed for a total of 16 weeks
Period Title: Overall Study
Started 125 122 124
Completed 109 107 109
Not Completed 16 15 15
Reason Not Completed
Adverse Event             5             4             7
Withdrawal by Subject             4             5             5
Lost to Follow-up             3             3             2
Protocol Violation             0             3             0
Lack of Efficacy             2             0             0
immigration             1             0             0
Other             1             0             1
Arm/Group Title Glucophage XR in Normal Weight Participants Glucophage XR in Overweight Participants Glucophage XR in Obese Participants Total
Hide Arm/Group Description Normal weight was defined as body mass index (BMI) greater than, equal to 18.5 kg/m^2 and < 24 kg/m^2 ). Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks. Overweight was defined as body mass index (BMI) greater than, equal to 24 kg/m^2 and less than 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks. Obese was defined as body mass index (BMI) greater than, equal to 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks. Total of all reporting groups
Overall Number of Baseline Participants 125 122 124 371
Hide Baseline Analysis Population Description
Baseline population consisted of: all participants enrolled into one of three body weight arms, normal, overweight or obese, based on body mass index at screening; and who were assigned to treatment with Glucophage XR. This population was used for analysis of demographics.
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 125 participants 122 participants 124 participants 371 participants
53.0
(28 to 77)
51.0
(32 to 77)
52.5
(23 to 74)
52.0
(23 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 122 participants 124 participants 371 participants
Female
64
  51.2%
45
  36.9%
52
  41.9%
161
  43.4%
Male
61
  48.8%
77
  63.1%
72
  58.1%
210
  56.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 125 participants 122 participants 124 participants 371 participants
125 122 124 371
1.Primary Outcome
Title Mean Change From Baseline at Week 16 (95% Confidence Interval) in Glycosated Hemoglobin A1c (HbA1c) (Last Observation Carried Forward) - Full Analysis Set (FAS)
Hide Description Baseline for HbA1c is defined as that value obtained at screening visit. HbA1c was measured as a percent (%) of hemoglobin; normal range was 4.7 to 6.4% and values were obtained through a central laboratory. The Last Observation Carried Forward (LOCF) data set includes data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit.
Time Frame Baseline to Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. Baseline data was not carried forward or averaged with on-treatment data to impute missing values for the LOCF data set.
Arm/Group Title Glucophage XR in Normal Weight Participants Glucophage XR in Overweight Participants Glucophage XR in Obese Participants
Hide Arm/Group Description:
Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 .
Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
Obese was defined as BMI >= 28 kg/m^2.
Overall Number of Participants Analyzed 111 111 112
Mean (95% Confidence Interval)
Unit of Measure: percentage of hemoglobin
-1.95
(-2.12 to -1.77)
-1.79
(-1.96 to -1.61)
-1.68
(-1.83 to -1.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glucophage XR in Normal Weight Participants, Glucophage XR in Overweight Participants, Glucophage XR in Obese Participants
Comments Standard deviation assumed for changes from baseline in HbA1c maximally was 1.0 across the baseline BMI subgroups. 97 participants in a single subgroup would be sufficient to estimate mean change in HbA1c with precision of 0.20% within the subgroup. Given number of baseline BMI subgroups and no correction for reason of multiplicity was made to the 95% CI within each BMI subgroup, total sample size calculated as 291. Sample size used the method "CI for mean for one group" in nQuery Advisor v6.0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0806
Comments Interpretation based on 2-sided 5% significance level.
Method ANCOVA
Comments Change from baseline in HbA1c at Week 16 was dependent variable, BMI was fixed main effect, baseline HbA1c was covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Glucophage XR in Normal Weight Participants, Glucophage XR in Overweight Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1984
Comments Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Glucophage XR in Normal Weight Participants, Glucophage XR in Obese Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0232
Comments Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Glucophage XR in Overweight Participants, Glucophage XR in Obese Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3589
Comments Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Mean Change From Baseline at Week 16 (95% Confidence Interval) of Fasting Plasma Glucose (FPG) - Full Analysis Set
Hide Description Baseline was defined as the value obtained at the screening visit. FPG was measured in millimoles/Liter (mmol/L) and obtained through local laboratories.
Time Frame Baseline to Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included enrolled participants,who took at least 1 dose of drug and had at least 1 post baseline HbA1c assessment. For this outcome measure, 1, 1, and 1 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.
Arm/Group Title Glucophage XR in Normal Weight Participants Glucophage XR in Overweight Participants Glucophage XR in Obese Participants
Hide Arm/Group Description:
Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
Obese was defined as BMI >= 28 kg/m^2.
Overall Number of Participants Analyzed 110 110 111
Mean (95% Confidence Interval)
Unit of Measure: mmol/L
-1.979
(-2.317 to -1.641)
-2.171
(-2.572 to -1.770)
-2.141
(-2.522 to -1.759)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glucophage XR in Normal Weight Participants, Glucophage XR in Overweight Participants, Glucophage XR in Obese Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4614
Comments Interpretation based on 2-sided 5% significance level.
Method ANCOVA
Comments Change from baseline in FPG at Week 16 was dependent variable, BMI was fixed main effect, baseline FPG was covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Glucophage XR in Normal Weight Participants, Glucophage XR in Overweight Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4696
Comments Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Glucophage XR in Normal Weight Participants, Glucophage XR in Obese Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5305
Comments Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Glucophage XR in Overweight Participants, Glucophage XR in Obese Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9145
Comments Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Total Cholesterol (TC) - Full Analysis Set
Hide Description For fasting total cholesterol (TC), baseline is defined as Day 1 (first day of treatment). Total cholesterol was measured in millimoles per liter (mmol/L) and obtained through local laboratories.
Time Frame Baseline to Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 1, 3, and 8 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.
Arm/Group Title Glucophage XR in Normal Weight Participants Glucophage XR in Overweight Participants Glucophage XR in Obese Participants
Hide Arm/Group Description:
Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
Obese was defined as BMI >= 28 kg/m^2.
Overall Number of Participants Analyzed 110 108 104
Mean (95% Confidence Interval)
Unit of Measure: mmol/L
-0.388
(-0.561 to -0.214)
-0.048
(-0.231 to 0.134)
-0.144
(-0.304 to 0.015)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glucophage XR in Normal Weight Participants, Glucophage XR in Overweight Participants, Glucophage XR in Obese Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0305
Comments Interpretation based on 2-sided 5% significance level.
Method ANCOVA
Comments Change from baseline in TC at Week 16 was dependent variable, BMI was fixed main effect, baseline TC was covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Glucophage XR in Normal Weight Participants, Glucophage XR in Overweight Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0080
Comments Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Glucophage XR in Normal Weight Participants, Glucophage XR in Obese Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0422
Comments Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Low-density Lipoprotein Cholesterol (LDL-C) - Full Analysis Set
Hide Description Baseline was defined as values obtained on Day 1. Low-density lipoprotein cholesterol (LDL-C) was measured in millimoles per liter (mmol/L) and obtained through local laboratories.
Time Frame Baseline to Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 1, 3, and 9 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.
Arm/Group Title Glucophage XR in Normal Weight Participants Glucophage XR in Overweight Participants Glucophage XR in Obese Participants
Hide Arm/Group Description:
Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
Obese was defined as BMI >= 28 kg/m^2.
Overall Number of Participants Analyzed 110 108 103
Mean (95% Confidence Interval)
Unit of Measure: mmol/L
-0.306
(-0.415 to -0.198)
-0.143
(-0.269 to -0.017)
-0.181
(-0.303 to -0.059)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glucophage XR in Normal Weight Participants, Glucophage XR in Overweight Participants, Glucophage XR in Obese Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4508
Comments Interpretation based on 2-sided 5% significance level.
Method ANCOVA
Comments Change from baseline in LDL-C at Week 16 was dependent variable, BMI was fixed main effect, baseline LDL-C was covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Glucophage XR in Normal Weight Participants, Glucophage XR in Overweight Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0526
Comments Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Glucophage XR in Normal Weight Participants, Glucophage XR in Obese Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1295
Comments Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting High-density Lipoprotein Cholesterol (HDL-C) - Full Analysis Set
Hide Description Baseline was defined as value obtained on Day 1 (first day of treatment). High-density lipoprotein cholesterol (HDL-C) was measured in millimoles per liter (mmol/L) and obtained through local laboratories.
Time Frame Baseline to Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 2, 3, and 8 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.
Arm/Group Title Glucophage XR in Normal Weight Participants Glucophage XR in Overweight Participants Glucophage XR in Obese Participants
Hide Arm/Group Description:
Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
Obese was defined as BMI >= 28 kg/m^2.
Overall Number of Participants Analyzed 109 108 104
Mean (95% Confidence Interval)
Unit of Measure: mmol/L
0.056
(0.017 to 0.094)
0.024
(-0.042 to 0.089)
0.032
(-0.007 to 0.072)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glucophage XR in Normal Weight Participants, Glucophage XR in Overweight Participants, Glucophage XR in Obese Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1431
Comments Interpretation based on 2-sided 5% significance level.
Method ANCOVA
Comments Change from baseline in HDL-C at Week 16 was dependent variable, BMI was fixed main effect, baseline HDL-C was covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Glucophage XR in Normal Weight Participants, Glucophage XR in Overweight Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4066
Comments Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Glucophage XR in Normal Weight Participants, Glucophage XR in Obese Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4071
Comments Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Triglycerides (TG) - Full Analysis Set
Hide Description Baseline was defined as value obtained on Day 1 (first day of treatment). Triglycerides (TG) were measured in millimoles per liter (mmol/L)and values obtained through local laboratories.
Time Frame Baseline to Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 1, 4, and 8 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.
Arm/Group Title Glucophage XR in Normal Weight Participants Glucophage XR in Overweight Participants Glucophage XR in Obese Participants
Hide Arm/Group Description:
Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
Obese was defined as BMI >= 28 kg/m^2.
Overall Number of Participants Analyzed 110 107 104
Mean (95% Confidence Interval)
Unit of Measure: mmol/L
-0.172
(-0.563 to 0.219)
0.262
(-0.374 to 0.898)
-0.041
(-0.470 to 0.387)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glucophage XR in Normal Weight Participants, Glucophage XR in Overweight Participants, Glucophage XR in Obese Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0210
Comments Interpretation based on 2-sided 5% significance level.
Method ANCOVA
Comments Change from baseline in TG at Week 16 was dependent variable, BMI was fixed main effect, baseline TG was covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Glucophage XR in Normal Weight Participants, Glucophage XR in Overweight Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2507
Comments Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Glucophage XR in Normal Weight Participants, Glucophage XR in Obese Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6546
Comments Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Mean Change From Baseline at Week 16 (95% Confidence Interval) in C-Reactive Protein (CRP) - Full Analysis Set
Hide Description Baseline was defined as value obtained on Day 1 (first day of treatment). C-Reactive Protein (CRP) was measured in milligrams/liter (mg/L) and values were obtained through a central laboratory; normal was less than 5.0 mg/L.
Time Frame Baseline to Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 102, 95, and 85 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.
Arm/Group Title Glucophage XR in Normal Weight Participants Glucophage XR in Overweight Participants Glucophage XR in Obese Participants
Hide Arm/Group Description:
Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
Obese was defined as BMI >= 28 kg/m^2.
Overall Number of Participants Analyzed 9 16 27
Mean (95% Confidence Interval)
Unit of Measure: mg/L
-0.589
(-1.428 to 0.250)
3.144
(-5.596 to 11.884)
1.633
(-1.559 to 4.826)
8.Secondary Outcome
Title Mean Change From Baseline at Week 16 (95% Confidence Interval) in Plasminogen Activator Inhibitor-1 (PAI-1) - Full Analysis Set
Hide Description Baseline was defined as value obtained on Day 1 (first day of treatment). PAI-1 (activity) was measured in units/milliliter (U/mL)and values obtained through a central laboratory; normal was less than 25.00 U/mL.
Time Frame Baseline to Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) population = 111, 111, 112 in normal, overweight, obese participants respectively. For this outcome measure, 84, 79, and 75 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.
Arm/Group Title Glucophage XR in Normal Weight Participants Glucophage XR in Overweight Participants Glucophage XR in Obese Participants
Hide Arm/Group Description:
Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
Obese was defined as BMI >= 28 kg/m^2.
Overall Number of Participants Analyzed 27 32 37
Mean (95% Confidence Interval)
Unit of Measure: U/mL
0.465
(-2.907 to 3.837)
1.177
(-2.047 to 4.400)
-1.792
(-4.434 to 0.849)
9.Secondary Outcome
Title Mean Change From Baseline at Week 16 (95% Confidence Interval) in Adiponectin - Full Analysis Set
Hide Description Baseline was defined as value obtained on Day 1 (first day of treatment). Adiponectin was measured in milligrams/liter (mg/L) and values obtained through a central laboratory; normal range was 1.20 to 20.00 mg/L.
Time Frame Baseline to Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 78, 70, and 72 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.
Arm/Group Title Glucophage XR in Normal Weight Participants Glucophage XR in Overweight Participants Glucophage XR in Obese Participants
Hide Arm/Group Description:
Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
Obese was defined as BMI >= 28 kg/m^2.
Overall Number of Participants Analyzed 33 41 40
Mean (95% Confidence Interval)
Unit of Measure: mg/L
1.742
(-1.325 to 4.810)
1.102
(0.404 to 1.801)
0.050
(-1.086 to 1.186)
10.Other Pre-specified Outcome
Title Number of Participants With Episodes of Lactic Acidosis or Hypoglycemia From Day 1 to Week 16 - Safety Population
Hide Description Day 1 was first day of treatment. Lactic acidosis defined as elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and increased lactate/pyruvate ratio. Hypoglycemia (low levels of blood glucose) was reported as an adverse event. Safety population included participants who had enrolled in the study and took at least 1 dose of glucophage extended release (glucophage XR). If a subject experienced more than one adverse event, the subject was counted once at the highest severity.
Time Frame Day 1 to Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in the study and who received at least 1 dose of Glucophage XR.
Arm/Group Title Glucophage XR in Normal Weight Participants Glucophage XR in Overweight Participants Glucophage XR in Obese Participants
Hide Arm/Group Description:
Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
Obese was defined as BMI >= 28 kg/m^2.
Overall Number of Participants Analyzed 125 122 124
Measure Type: Number
Unit of Measure: participants
Lactic Acidosis 0 0 0
Hypoglycemia 1 0 0
11.Other Pre-specified Outcome
Title Number of Participants With Clinically Significant Changes From Baseline at Week 16 in the Hematology Laboratory Test Profile - Safety Population
Hide Description Hematology profile = hematocrit, hemoglobin, red blood cell count (RBC), white blood cell count(WBC), lymphocytes, monocytes, basophils, eosinophils, neutrophils, platelet count. Baseline: value obtained at screening or last value obtained before treatment. LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Hemoglobin (g/dL): >3 g/dL decrease from preRX; hematocrit (%): <0.75*preRX; RBC (*10^6 c/uL): <0.75*preRX; platelet count (*10^9 c/uL): <0.67*LLN or >1.5*ULN, of if preRX<LLN, use 0.5*preRX and <100,000/mm^3; WBC (*10^3 c/uL): <0.75*LLN or >1.25*ULN, or if preRX <LLN, use <0.8*preRX or >ULN, or if preRX>ULN, use >1.2*preRX or <LLN; neutrophils+bands (*10^3 c/uL): if value <1.0*10^3 c/uL; eosinophils (*10^3 c/uL): if value >0.750*10^3 c/uL; basophils (*10^3 c/uL): if value >400/mm^3; monocytes (*10^3 c/uL): if value >2000/mm^3; lymphocytes (*10^3 c/uL): if value <0.750*10^3 c/uL or if value >7.50*10^3 c/uL.
Time Frame Baseline to Week 16
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Hide Analysis Population Description
Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.
Arm/Group Title Glucophage XR in Normal Weight Participants Glucophage XR in Overweight Participants Glucophage XR in Obese Participants
Hide Arm/Group Description:
Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
Obese was defined as BMI >= 28 kg/m^2.
Overall Number of Participants Analyzed 125 122 124
Measure Type: Number
Unit of Measure: participants
0 0 0
12.Other Pre-specified Outcome
Title Number of Participants Who Had Abnormal Increase From Baseline at Week 16 in Kidney or Liver Function Serum Chemistry Values - Safety Population
Hide Description Baseline defined as value obtained either in screening visit or last value obtained before glucophage XR treatment given on Day 1. Serum chemistries evaluating kidney or liver function: blood urea nitrogen(BUN), serum creatinine (SCr), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), total bilirubin (BR), uric acid (UA). Abnormal increase in kidney and liver function tests defined as 1.25 - less than, equal to (<=)2.6 times (x) upper limit of normal (ULN)in ALT, AST, total BR, UA; abnormal increase defined as 1.25 to <= 5.1 x ULN in BUN. Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.
Time Frame Baseline to Week 16
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Hide Analysis Population Description
Number of participants (normal, overweight, obese, respectively) who were missing values and were not included in the Week 16 analysis for the following serum chemistry tests: ALT = 14, 11, 13; AST = 14, 11, 13; total BR = 14, 11, 13; creatinine = 14, 12, 13; BUN = 14, 12, 13; UA = 14, 12, 13.
Arm/Group Title Glucophage XR in Normal Weight Participants Glucophage XR in Overweight Participants Glucophage XR in Obese Participants
Hide Arm/Group Description:
Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
Obese was defined as BMI >= 28 kg/m^2.
Overall Number of Participants Analyzed 125 122 124
Measure Type: Number
Unit of Measure: participants
Number with Week 16 ALT 1.25 to <= 2.6xULN 2 11 9
Number with Week 16 ALT > 2.6 x ULN 0 0 0
Number with Week 16 AST 1.25 to <= 2.6xULN 0 5 4
Number with Week 16 AST > 2.6 x ULN 0 0 0
Number with Week 16 Total BR 1.25 to <=2.6xULN 3 2 1
Number with Week 16 Total BR > 2.6 x ULN 0 0 0
Number with Week 16 BUN1.25 to <=5.1xULN 0 1 0
Number with Week 16 BUN > 5.1 x ULN 0 0 0
Number with Week 16 UA 1.25 to <=2.6xULN 3 5 7
Number with Week 16 UA > 2.6 x ULN 0 0 0
Number with Week 16 SCr 1.25 to <=2.6xULN 0 0 0
Number with Week 16 SCr > 1.25 x ULN 0 0 0
13.Other Pre-specified Outcome
Title Number of Participants With Clinically Significant Changes From Baseline at Week 16 in Urinalysis - Safety Population
Hide Description Urinalysis included pH and specific gravity. Baseline defined as values obtained at screening visit. Clinically significant: outside the reference range (low/high)and judged to be significant by the investigator: Specific gravity 1.003 - 1.035; ph 5 - 8. Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.
Time Frame Baseline to Week 16
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glucophage XR in Normal Weight Participants Glucophage XR in Overweight Participants Glucophage XR in Obese Participants
Hide Arm/Group Description:
Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
Obese was defined as BMI >= 28 kg/m^2.
Overall Number of Participants Analyzed 125 122 124
Measure Type: Number
Unit of Measure: participants
0 0 0
14.Other Pre-specified Outcome
Title Mean Change From Baseline at Week at Week 16 in ECG Parameter Heart Rate (HR) - Safety Population
Hide Description Baseline was defined as ECG obtained at the screening visit. ECG was 12-lead. Heart rate (HR) was measured in beats per minute (beats/min). Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.
Time Frame Baseline to Week 16
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Hide Analysis Population Description
Safety population included 125, 122, 124 participants in each arm, respectively. Participants missing from analysis for change at Week 16 for Heart Rate were 17, 18, 20 participants in the normal, overweight, obese arms, respectively.
Arm/Group Title Glucophage XR in Normal Weight Participants Glucophage XR in Overweight Participants Glucophage XR in Obese Participants
Hide Arm/Group Description:
Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
Obese was defined as BMI >= 28 kg/m^2.
Overall Number of Participants Analyzed 108 104 104
Mean (Standard Deviation)
Unit of Measure: beats/min
0.4  (8.91) 1.2  (9.56) 1.1  (12.36)
15.Other Pre-specified Outcome
Title Mean Change From Baseline at Week 16 in Diastolic and Systolic Blood Pressure - Safety Population
Hide Description Baseline was defined as the value obtained at screening or value obtained on Day 1 before treatment. Diastolic and systolic blood pressure was measured in millimeters of mercury (mm Hg). Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.
Time Frame Baseline to Week 16
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glucophage XR in Normal Weight Participants Glucophage XR in Overweight Participants Glucophage XR in Obese Participants
Hide Arm/Group Description:
Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
Obese was defined as BMI >= 28 kg/m^2.
Overall Number of Participants Analyzed 125 122 124
Mean (Standard Deviation)
Unit of Measure: mm Hg
Week 16 change in diastolic blood pressure -2.2  (8.63) -4.1  (9.31) -1.4  (9.37)
Week 16 change in systolic blood pressure -4.6  (14.21) -5.5  (12.14) -1.7  (14.55)
16.Other Pre-specified Outcome
Title Number of Participants Who Had a Normal Electrocardiogram (ECG) at Baseline and an ECG at Week 16 (or Termination Visit) Which Was Considered to be Abnormal With Clinical Significance - Safety Population
Hide Description Baseline was defined as ECG obtained at the screening visit. A judgment of clinical significance was at the discretion of the investigator. Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.
Time Frame Baseline to Week 16
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Hide Analysis Population Description
number of participants with a normal ECG at baseline for normal weight, overweight, and obese arms were 71, 62, 65, respectively.
Arm/Group Title Glucophage XR in Normal Weight Participants Glucophage XR in Overweight Participants Glucophage XR in Obese Participants
Hide Arm/Group Description:
Normal weight was defined as body mass index (BMI) greater than, equal to 18.5 kg/m^2 and < 24 kg/m^2 ). Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
Overweight was defined as body mass index (BMI) greater than, equal to 24 kg/m^2 and less than 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
Obese was defined as body mass index (BMI) greater than, equal to 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
Overall Number of Participants Analyzed 125 122 124
Measure Type: Number
Unit of Measure: participants
0 1 3
Time Frame 16 Weeks
Adverse Event Reporting Description A treatment-emergent AE (TEAE) was defined as an event that occurs during the treatment period.
 
Arm/Group Title Glucophage XR in Normal Weight Participants Glucophage XR in Overweight Participants Glucophage XR in Obese Participants
Hide Arm/Group Description Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ). Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2. Obese was defined as BMI >= 28 kg/m^2.
All-Cause Mortality
Glucophage XR in Normal Weight Participants Glucophage XR in Overweight Participants Glucophage XR in Obese Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Glucophage XR in Normal Weight Participants Glucophage XR in Overweight Participants Glucophage XR in Obese Participants
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/125 (0.80%)      0/122 (0.00%)      1/124 (0.81%)    
Blood and lymphatic system disorders       
Hypertension * 1 [1]  0/125 (0.00%)  0 0/122 (0.00%)  0 1/124 (0.81%)  1
Respiratory, thoracic and mediastinal disorders       
Right upper lung cancer * 1 [2]  1/125 (0.80%)  1 0/122 (0.00%)  0 0/124 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
[1]
SAE was moderate in severity and not considered related to treatment
[2]
SAE was moderate in severity and not related to treatment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Glucophage XR in Normal Weight Participants Glucophage XR in Overweight Participants Glucophage XR in Obese Participants
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   43/125 (34.40%)      47/122 (38.52%)      46/124 (37.10%)    
Blood and lymphatic system disorders       
Leukopenia * 1  1/125 (0.80%)  1 0/122 (0.00%)  0 0/124 (0.00%)  0
Cardiac disorders       
palpitations * 1  6/125 (4.80%)  6 4/122 (3.28%)  5 1/124 (0.81%)  1
Tachycardia * 1  0/125 (0.00%)  0 1/122 (0.82%)  1 0/124 (0.00%)  0
Ear and labyrinth disorders       
ear pain * 1  1/125 (0.80%)  1 0/122 (0.00%)  0 0/124 (0.00%)  0
Eye disorders       
eyelid edema * 1  0/125 (0.00%)  0 1/122 (0.82%)  1 0/124 (0.00%)  0
visual impairment * 1  0/125 (0.00%)  0 0/122 (0.00%)  0 1/124 (0.81%)  1
Gastrointestinal disorders       
Diarrhea * 1  18/125 (14.40%)  20 12/122 (9.84%)  17 4/124 (3.23%)  6
Abdominal discomfort * 1  2/125 (1.60%)  4 13/122 (10.66%)  14 2/124 (1.61%)  2
Abdominal distension * 1  6/125 (4.80%)  8 9/122 (7.38%)  13 2/124 (1.61%)  3
Nausea * 1  2/125 (1.60%)  4 5/122 (4.10%)  5 4/124 (3.23%)  4
Abdominal pain upper * 1  3/125 (2.40%)  5 3/122 (2.46%)  3 2/124 (1.61%)  2
Constipation * 1  4/125 (3.20%)  4 1/122 (0.82%)  1 2/124 (1.61%)  3
Epigastric discomfort * 1  2/125 (1.60%)  2 1/122 (0.82%)  1 1/124 (0.81%)  1
abdominal pain * 1  0/125 (0.00%)  0 1/122 (0.82%)  1 1/124 (0.81%)  1
breath odor * 1  0/125 (0.00%)  0 1/122 (0.82%)  1 0/124 (0.00%)  0
dry mouth * 1  1/125 (0.80%)  1 1/122 (0.82%)  1 1/124 (0.81%)  1
dyspepsia * 1  1/125 (0.80%)  1 1/122 (0.82%)  1 1/124 (0.81%)  1
feces hard * 1  1/125 (0.80%)  1 1/122 (0.82%)  1 1/124 (0.81%)  1
flatulence * 1  1/125 (0.80%)  1 1/122 (0.82%)  1 0/124 (0.00%)  0
frequent bowel movements * 1  0/125 (0.00%)  0 1/122 (0.82%)  1 2/124 (1.61%)  2
gastric disorder * 1  0/125 (0.00%)  0 0/122 (0.00%)  0 1/124 (0.81%)  1
gastric hemorrhage * 1  1/125 (0.80%)  1 0/122 (0.00%)  0 0/124 (0.00%)  0
hypoesthesia oral * 1  0/125 (0.00%)  0 1/122 (0.82%)  1 0/124 (0.00%)  0
vomiting * 1  0/125 (0.00%)  0 1/122 (0.82%)  1 0/124 (0.00%)  0
enteritis * 1  1/125 (0.80%)  1 0/122 (0.00%)  0 0/124 (0.00%)  0
toothache * 1  2/125 (1.60%)  2 1/122 (0.82%)  1 0/124 (0.00%)  0
General disorders       
Asthenia * 1  2/125 (1.60%)  2 2/122 (1.64%)  3 0/124 (0.00%)  0
Chest pain * 1  1/125 (0.80%)  1 1/122 (0.82%)  1 2/124 (1.61%)  2
Fatigue * 1  0/125 (0.00%)  0 3/122 (2.46%)  3 1/124 (0.81%)  1
chest discomfort * 1  0/125 (0.00%)  0 0/122 (0.00%)  0 1/124 (0.81%)  1
hunger * 1  1/125 (0.80%)  1 2/122 (1.64%)  3 0/124 (0.00%)  0
thirst * 1  1/125 (0.80%)  1 1/122 (0.82%)  1 0/124 (0.00%)  0
Hepatobiliary disorders       
Hepatic function abnormal * 1  2/125 (1.60%)  2 1/122 (0.82%)  1 1/124 (0.81%)  1
Infections and infestations       
nasopharyngitis * 1  1/125 (0.80%)  1 1/122 (0.82%)  1 0/124 (0.00%)  0
urinary tract infection * 1  1/125 (0.80%)  1 1/122 (0.82%)  1 1/124 (0.81%)  1
rhinorrhoea * 1  0/125 (0.00%)  0 2/122 (1.64%)  2 0/124 (0.00%)  0
Injury, poisoning and procedural complications       
humerus fracture * 1  0/125 (0.00%)  0 1/122 (0.82%)  1 0/124 (0.00%)  0
ankle fracture * 1  0/125 (0.00%)  0 0/122 (0.00%)  0 1/124 (0.81%)  1
Investigations       
Blood triglycerides increased * 1  1/125 (0.80%)  1 0/122 (0.00%)  0 3/124 (2.42%)  3
alanine aminotransferase increased * 1  0/125 (0.00%)  0 1/122 (0.82%)  1 1/124 (0.81%)  1
blood cholesterol increased * 1  0/125 (0.00%)  0 0/122 (0.00%)  0 1/124 (0.81%)  1
blood creatine phosphokinase increased * 1  1/125 (0.80%)  1 1/122 (0.82%)  1 1/124 (0.81%)  1
blood lactate dehydrogenase * 1  1/125 (0.80%)  1 0/122 (0.00%)  0 0/124 (0.00%)  0
blood uric acid increased * 1  2/125 (1.60%)  2 0/122 (0.00%)  0 0/124 (0.00%)  0
plasminogen activator inhibitor increased * 1  1/125 (0.80%)  1 0/122 (0.00%)  0 0/124 (0.00%)  0
protein urine present * 1  0/125 (0.00%)  0 1/122 (0.82%)  1 0/124 (0.00%)  0
white blood cells urine positive * 1  1/125 (0.80%)  1 0/122 (0.00%)  0 0/124 (0.00%)  0
hypoglycemia * 1  1/125 (0.80%)  3 0/122 (0.00%)  0 0/124 (0.00%)  0
High Density Lipoprotein cholesterol decreased * 1  0/125 (0.00%)  0 0/122 (0.00%)  0 1/124 (0.81%)  1
hypertriglyceridemia * 1  0/125 (0.00%)  0 0/122 (0.00%)  0 2/124 (1.61%)  2
hypocalcemia * 1  0/125 (0.00%)  0 0/122 (0.00%)  0 1/124 (0.81%)  1
lactose intolerance * 1  0/125 (0.00%)  0 0/122 (0.00%)  0 1/124 (0.81%)  4
Metabolism and nutrition disorders       
Hyperuricemia * 1  0/125 (0.00%)  0 2/122 (1.64%)  2 6/124 (4.84%)  6
Decreased appetite * 1  2/125 (1.60%)  2 1/122 (0.82%)  1 2/124 (1.61%)  2
Lipid metabolism disorder * 1  1/125 (0.80%)  1 1/122 (0.82%)  1 3/124 (2.42%)  3
Hyperlipidemia * 1  0/125 (0.00%)  0 2/122 (1.64%)  2 2/124 (1.61%)  2
hyponatremia * 1  0/125 (0.00%)  0 0/122 (0.00%)  0 1/124 (0.81%)  1
Musculoskeletal and connective tissue disorders       
back pain * 1  1/125 (0.80%)  1 0/122 (0.00%)  0 0/124 (0.00%)  0
limb discomfort * 1  0/125 (0.00%)  0 0/122 (0.00%)  0 1/124 (0.81%)  1
muscular weakness * 1  0/125 (0.00%)  0 2/122 (1.64%)  2 0/124 (0.00%)  0
osteoarthritis * 1  1/125 (0.80%)  1 0/122 (0.00%)  0 0/124 (0.00%)  0
musculoskeletal discomfort * 1  1/125 (0.80%)  4 0/122 (0.00%)  0 1/124 (0.81%)  2
Nervous system disorders       
Dizziness * 1  6/125 (4.80%)  9 4/122 (3.28%)  7 4/124 (3.23%)  5
headache * 1  1/125 (0.80%)  2 1/122 (0.82%)  1 0/124 (0.00%)  0
convulsion * 1  1/125 (0.80%)  1 0/122 (0.00%)  0 0/124 (0.00%)  0
somnolence * 1  0/125 (0.00%)  0 1/122 (0.82%)  1 0/124 (0.00%)  0
Psychiatric disorders       
insomnia * 1  0/125 (0.00%)  0 0/122 (0.00%)  0 1/124 (0.81%)  1
Renal and urinary disorders       
renal impairment * 1  1/125 (0.80%)  1 0/122 (0.00%)  0 0/124 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Upper Respiratory Tract infection * 1  3/125 (2.40%)  3 0/122 (0.00%)  0 2/124 (1.61%)  2
cough * 1  0/125 (0.00%)  0 2/122 (1.64%)  2 0/124 (0.00%)  0
hiccups * 1  0/125 (0.00%)  0 0/122 (0.00%)  0 1/124 (0.81%)  1
Skin and subcutaneous tissue disorders       
hyperhidrosis * 1  0/125 (0.00%)  0 2/122 (1.64%)  2 1/124 (0.81%)  1
pruritus * 1  0/125 (0.00%)  0 1/122 (0.82%)  2 0/124 (0.00%)  0
rash * 1  1/125 (0.80%)  1 0/122 (0.00%)  0 0/124 (0.00%)  0
alopecia * 1  0/125 (0.00%)  0 0/122 (0.00%)  0 1/124 (0.81%)  1
heat rash * 1  0/125 (0.00%)  0 0/122 (0.00%)  0 1/124 (0.81%)  1
Vascular disorders       
hypertension * 1  0/125 (0.00%)  0 1/122 (0.82%)  1 1/124 (0.81%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00778622     History of Changes
Other Study ID Numbers: CV138-097
First Submitted: October 22, 2008
First Posted: October 23, 2008
Results First Submitted: June 14, 2013
Results First Posted: August 20, 2013
Last Update Posted: August 23, 2013