| Trial ID: | L3280 |
| Source ID: | NCT00778622
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| Associated Drug: |
Metformin Xr
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| Title: |
Body Weight Effects on Glucophage's Efficacy in Chinese Diagnosed T2DM Patients
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT00778622/results
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| Conditions: |
Type 2 Diabetes Mellitus
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| Interventions: |
DRUG: Metformin XR
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| Outcome Measures: |
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., Baseline to Week 16 | 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., Baseline to Week 16|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., 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 | Other: 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., 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
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| Sponsor/Collaborators: |
Sponsor: Bristol-Myers Squibb
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| Gender: |
ALL
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| Age: |
CHILD, ADULT, OLDER_ADULT
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| Phases: |
PHASE4
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| Enrollment: |
371
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2009-11
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| Completion Date: |
2011-03
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| Results First Posted: |
2013-08-20
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| Last Update Posted: |
2013-08-23
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| Locations: |
Local Institution, Beijing, Beijing, 100028, China|Local Institution, Beijing, Beijing, 100034, China|Local Institution, Beijing, Beijing, 100044, China|Local Institution, Beijing, Beijing, 100088, China|Local Institution, Beijing, Beijing, 100730, China|Local Institution, Beijing, Beijing, 101100, China|Local Institution, Beijing, Beijing, 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, 200003, China|Local Institution, Shanghai, Shanghai, 200092, China|Local Institution, Shanghai, Shanghai, 201100, China|Local Institution, Shanghai, Shanghai, 201200, China
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| URL: |
https://clinicaltrials.gov/show/NCT00778622
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