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The purpose of this study is to investigate the effect of the baseline body mass index (BMI) on the response to Glucophage XR monotherapy in glycemic control in Chinese patients with newly diagnosed type 2 diabetes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental | Normal Weight by Body Weight Index |
|
| A2 | Experimental | Overweight by Body Weight Index |
|
| A3 | Experimental | Obese by Body Weight Index |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin XR | Drug | Tablets, Oral, 500mg tid, 1500 mg/day, 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline at Week 16 (95% Confidence Interval) in Glycosated Hemoglobin A1c (HbA1c) (Last Observation Carried Forward) - Full Analysis Set (FAS) | 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. | Baseline to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline at Week 16 (95% Confidence Interval) of Fasting Plasma Glucose (FPG) - Full Analysis Set | Baseline was defined as the value obtained at the screening visit. FPG was measured in millimoles/Liter (mmol/L) and obtained through local laboratories. | Baseline to Week 16 |
| Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Total Cholesterol (TC) - Full Analysis Set |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Episodes of Lactic Acidosis or Hypoglycemia From Day 1 to Week 16 - Safety Population | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Beijing | Beijing Municipality | 100028 | China | ||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23468941 | Derived | Ji L, Li H, Guo X, Li Y, Hu R, Zhu Z. Impact of baseline BMI on glycemic control and weight change with metformin monotherapy in Chinese type 2 diabetes patients: phase IV open-label trial. PLoS One. 2013;8(2):e57222. doi: 10.1371/journal.pone.0057222. Epub 2013 Feb 28. |
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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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Glucophage XR in Normal Weight Participants | 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. |
| FG001 | Glucophage XR in Overweight Participants | 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 |
| FG002 | Glucophage XR in Obese Participants | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Glucophage XR in Normal Weight Participants | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline at Week 16 (95% Confidence Interval) in Glycosated Hemoglobin A1c (HbA1c) (Last Observation Carried Forward) - Full Analysis Set (FAS) | 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. | 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. | Posted | Mean | 95% Confidence Interval | percentage of hemoglobin | Baseline to Week 16 |
|
16 Weeks
A treatment-emergent AE (TEAE) was defined as an event that occurs during the treatment period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glucophage XR in Normal Weight Participants | Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right upper lung cancer | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment | SAE was moderate in severity and not related to treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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. |
| Baseline to Week 16 |
| Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Low-density Lipoprotein Cholesterol (LDL-C) - Full Analysis Set | 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. | Baseline to Week 16 |
| Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting High-density Lipoprotein Cholesterol (HDL-C) - Full Analysis Set | 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. | Baseline to Week 16 |
| Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Triglycerides (TG) - Full Analysis Set | 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. | Baseline to Week 16 |
| Mean Change From Baseline at Week 16 (95% Confidence Interval) in C-Reactive Protein (CRP) - Full Analysis Set | 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. | Baseline to Week 16 |
| Mean Change From Baseline at Week 16 (95% Confidence Interval) in Plasminogen Activator Inhibitor-1 (PAI-1) - Full Analysis Set | 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. | Baseline to Week 16 |
| Mean Change From Baseline at Week 16 (95% Confidence Interval) in Adiponectin - Full Analysis Set | 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. | Baseline to Week 16 |
| Day 1 to Week 16 |
| Number of Participants With Clinically Significant Changes From Baseline at Week 16 in the Hematology Laboratory Test Profile - Safety Population | 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. | Baseline to Week 16 |
| Number of Participants Who Had Abnormal Increase From Baseline at Week 16 in Kidney or Liver Function Serum Chemistry Values - Safety Population | 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. | Baseline to Week 16 |
| Number of Participants With Clinically Significant Changes From Baseline at Week 16 in Urinalysis - Safety Population | 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. | Baseline to Week 16 |
| Mean Change From Baseline at Week at Week 16 in ECG Parameter Heart Rate (HR) - Safety Population | 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. | Baseline to Week 16 |
| Mean Change From Baseline at Week 16 in Diastolic and Systolic Blood Pressure - Safety Population | 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. | Baseline to Week 16 |
| 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 | 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. | Baseline to Week 16 |
| Beijing |
| Beijing Municipality |
| 100034 |
| China |
| Local Institution | Beijing | Beijing Municipality | 100044 | China |
| Local Institution | Beijing | Beijing Municipality | 100088 | China |
| Local Institution | Beijing | Beijing Municipality | 100730 | China |
| Local Institution | Beijing | Beijing Municipality | 101100 | China |
| Local Institution | Beijing | Beijing Municipality | 200016 | China |
| Local Institution | Guangdong Province | Guangdong | 510180 | China |
| Local Institution | Guangdong Province | Guangdong | 528000 | China |
| Local Institution | Guangdong | Guangdong | 510180 | China |
| Local Institution | Shanghai | Shanghai Municipality | 200003 | China |
| Local Institution | Shanghai | Shanghai Municipality | 200092 | China |
| Local Institution | Shanghai | Shanghai Municipality | 201100 | China |
| Local Institution | Shanghai | Shanghai Municipality | 201200 | China |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Lack of Efficacy |
|
| immigration |
|
| Other |
|
| Glucophage XR in Overweight Participants |
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. |
| BG002 | Glucophage XR in Obese Participants | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 . |
| OG001 | Glucophage XR in Overweight Participants | Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2. |
| OG002 | Glucophage XR in Obese Participants | Obese was defined as BMI >= 28 kg/m^2. |
|
|
|
| Secondary | Mean Change From Baseline at Week 16 (95% Confidence Interval) of Fasting Plasma Glucose (FPG) - Full Analysis Set | Baseline was defined as the value obtained at the screening visit. FPG was measured in millimoles/Liter (mmol/L) and obtained through local laboratories. | 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. | Posted | Mean | 95% Confidence Interval | mmol/L | Baseline to Week 16 |
|
|
|
|
| Secondary | Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Total Cholesterol (TC) - Full Analysis Set | 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. | 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. | Posted | Mean | 95% Confidence Interval | mmol/L | Baseline to Week 16 |
|
|
|
|
| Secondary | Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Low-density Lipoprotein Cholesterol (LDL-C) - Full Analysis Set | 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. | 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. | Posted | Mean | 95% Confidence Interval | mmol/L | Baseline to Week 16 |
|
|
|
|
| Secondary | Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting High-density Lipoprotein Cholesterol (HDL-C) - Full Analysis Set | 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. | 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. | Posted | Mean | 95% Confidence Interval | mmol/L | Baseline to Week 16 |
|
|
|
|
| Secondary | Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Triglycerides (TG) - Full Analysis Set | 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. | 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. | Posted | Mean | 95% Confidence Interval | mmol/L | Baseline to Week 16 |
|
|
|
|
| Secondary | Mean Change From Baseline at Week 16 (95% Confidence Interval) in C-Reactive Protein (CRP) - Full Analysis Set | 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. | 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. | Posted | Mean | 95% Confidence Interval | mg/L | Baseline to Week 16 |
|
|
|
| Secondary | Mean Change From Baseline at Week 16 (95% Confidence Interval) in Plasminogen Activator Inhibitor-1 (PAI-1) - Full Analysis Set | 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. | 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. | Posted | Mean | 95% Confidence Interval | U/mL | Baseline to Week 16 |
|
|
|
| Secondary | Mean Change From Baseline at Week 16 (95% Confidence Interval) in Adiponectin - Full Analysis Set | 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. | 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. | Posted | Mean | 95% Confidence Interval | mg/L | Baseline to Week 16 |
|
|
|
| Other Pre-specified | Number of Participants With Episodes of Lactic Acidosis or Hypoglycemia From Day 1 to Week 16 - Safety Population | 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. | All participants enrolled in the study and who received at least 1 dose of Glucophage XR. | Posted | Number | participants | Day 1 to Week 16 |
|
|
|
| Other Pre-specified | Number of Participants With Clinically Significant Changes From Baseline at Week 16 in the Hematology Laboratory Test Profile - Safety Population | 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. | Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR. | Posted | Number | participants | Baseline to Week 16 |
|
|
|
| Other Pre-specified | Number of Participants Who Had Abnormal Increase From Baseline at Week 16 in Kidney or Liver Function Serum Chemistry Values - Safety Population | 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. | 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. | Posted | Number | participants | Baseline to Week 16 |
|
|
|
| Other Pre-specified | Number of Participants With Clinically Significant Changes From Baseline at Week 16 in Urinalysis - Safety Population | 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. | Posted | Number | participants | Baseline to Week 16 |
|
|
|
| Other Pre-specified | Mean Change From Baseline at Week at Week 16 in ECG Parameter Heart Rate (HR) - Safety Population | 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. | 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. | Posted | Mean | Standard Deviation | beats/min | Baseline to Week 16 |
|
|
|
| Other Pre-specified | Mean Change From Baseline at Week 16 in Diastolic and Systolic Blood Pressure - Safety Population | 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. | Posted | Mean | Standard Deviation | mm Hg | Baseline to Week 16 |
|
|
|
| Other Pre-specified | 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 | 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. | number of participants with a normal ECG at baseline for normal weight, overweight, and obese arms were 71, 62, 65, respectively. | Posted | Number | participants | Baseline to Week 16 |
|
|
|
| 1 |
| 125 |
| 43 |
| 125 |
| EG001 | Glucophage XR in Overweight Participants | Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2. | 0 | 122 | 47 | 122 |
| EG002 | Glucophage XR in Obese Participants | Obese was defined as BMI >= 28 kg/m^2. | 1 | 124 | 46 | 124 |
|
| Hypertension | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment | SAE was moderate in severity and not considered related to treatment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Upper Respiratory Tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Lipid metabolism disorder | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| Hyperlipidemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| palpitations | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| eyelid edema | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| breath odor | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| feces hard | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| flatulence | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| frequent bowel movements | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| gastric disorder | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| gastric hemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| hypoesthesia oral | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| chest discomfort | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| hunger | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| thirst | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| nasopharyngitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| alanine aminotransferase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| blood cholesterol increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| blood creatine phosphokinase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| blood lactate dehydrogenase | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| blood uric acid increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| plasminogen activator inhibitor increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| protein urine present | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| white blood cells urine positive | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| hypoglycemia | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| renal impairment | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| vomiting | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| urinary tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| humerus fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
|
| ankle fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
|
| hyponatremia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| convulsion | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| somnolence | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| ear pain | Ear and labyrinth disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| visual impairment | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| enteritis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| toothache | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| High Density Lipoprotein cholesterol decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| hypertriglyceridemia | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| hypocalcemia | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| lactose intolerance | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| insomnia | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| rhinorrhoea | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| alopecia | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| heat rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| hypertension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
|
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.
| D004700 | Endocrine System Diseases |
| t-test, 2 sided |
| 0.4696 |
Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.5305 | Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. | No | Superiority or Other |
| t-test, 2 sided | 0.9145 | Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. | No | Superiority or Other |
| t-test, 2 sided |
| 0.0080 |
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. |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.0422 | 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. | No | Superiority or Other |
| t-test, 2 sided |
| 0.0526 |
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. |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.1295 | 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. | No | Superiority or Other |
| t-test, 2 sided |
| 0.4066 |
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. |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.4071 | 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. | No | Superiority or Other |
| t-test, 2 sided |
| 0.2507 |
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. |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.6546 | 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. | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
|
| Number with Week 16 AST 1.25 to <= 2.6xULN |
|
| Number with Week 16 AST > 2.6 x ULN |
|
| Number with Week 16 Total BR 1.25 to <=2.6xULN |
|
| Number with Week 16 Total BR > 2.6 x ULN |
|
| Number with Week 16 BUN1.25 to <=5.1xULN |
|
| Number with Week 16 BUN > 5.1 x ULN |
|
| Number with Week 16 UA 1.25 to <=2.6xULN |
|
| Number with Week 16 UA > 2.6 x ULN |
|
| Number with Week 16 SCr 1.25 to <=2.6xULN |
|
| Number with Week 16 SCr > 1.25 x ULN |
|
|