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

Overview[ - collapse ][ - ]

Purpose 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
ConditionType 2 Diabetes Mellitus
InterventionDrug: Metformin XR
PhasePhase 4
SponsorBristol-Myers Squibb
Responsible PartyBristol-Myers Squibb
ClinicalTrials.gov IdentifierNCT00778622
First ReceivedOctober 22, 2008
Last UpdatedAugust 19, 2013
Last verifiedAugust 2013

Tracking Information[ + expand ][ + ]

First Received DateOctober 22, 2008
Last Updated DateAugust 19, 2013
Start DateNovember 2009
Estimated Primary Completion DateMarch 2011
Current Primary Outcome MeasuresMean Change From Baseline at Week 16 (95% Confidence Interval) in Glycosated Hemoglobin A1c (HbA1c) (Last Observation Carried Forward) - Full Analysis Set (FAS) [Time Frame: Baseline to Week 16] [Designated as safety issue: No]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.
Current Secondary Outcome Measures
  • Mean Change From Baseline at Week 16 (95% Confidence Interval) of Fasting Plasma Glucose (FPG) - Full Analysis Set [Time Frame: Baseline to Week 16] [Designated as safety issue: No]Baseline was defined as the value obtained at the screening visit. FPG was measured in millimoles/Liter (mmol/L) and obtained through local laboratories.
  • Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Total Cholesterol (TC) - Full Analysis Set [Time Frame: Baseline to Week 16] [Designated as safety issue: No]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.
  • Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Low-density Lipoprotein Cholesterol (LDL-C) - Full Analysis Set [Time Frame: Baseline to Week 16] [Designated as safety issue: No]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.
  • Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting High-density Lipoprotein Cholesterol (HDL-C) - Full Analysis Set [Time Frame: Baseline to Week 16] [Designated as safety issue: No]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.
  • Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Triglycerides (TG) - Full Analysis Set [Time Frame: Baseline to Week 16] [Designated as safety issue: No]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.
  • Mean Change From Baseline at Week 16 (95% Confidence Interval) in C-Reactive Protein (CRP) - Full Analysis Set [Time Frame: Baseline to Week 16] [Designated as safety issue: No]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.
  • Mean Change From Baseline at Week 16 (95% Confidence Interval) in Plasminogen Activator Inhibitor-1 (PAI-1) - Full Analysis Set [Time Frame: Baseline to Week 16] [Designated as safety issue: No]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.
  • Mean Change From Baseline at Week 16 (95% Confidence Interval) in Adiponectin - Full Analysis Set [Time Frame: Baseline to Week 16] [Designated as safety issue: No]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.

Descriptive Information[ + expand ][ + ]

Brief TitleBody Weight Effects on Glucophage's Efficacy in Chinese Diagnosed T2DM Patients
Official TitleThe Relationship Between Baseline Body Weight and Glycemic Control Following Metformin Extended-Release Tablets (Glucophage XR) Monotherapy in Chinese Patients With Newly Diagnosed Type 2 Diabetes
Brief Summary
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
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionType 2 Diabetes Mellitus
InterventionDrug: Metformin XR
Tablets, Oral, 500mg tid, 1500 mg/day, 16 weeks
Study Arm (s)
  • Experimental: A1
    Normal Weight by Body Weight Index
  • Experimental: A2
    Overweight by Body Weight Index
  • Experimental: A3
    Obese by Body Weight Index

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment371
Estimated Completion DateMarch 2011
Estimated Primary Completion DateMarch 2011
Eligibility Criteria
Inclusion Criteria:

- Signed Written Informed Consent

- Age≥ 17 and <80 years,

- Newly diagnosed T2DM (defined as T2DM diagnosed within 6 months prior to enrollment)

- Oral antidiabetic agents naïve (defined as without receiving any anti-diabetic
medication therapy before, or having received anti-diabetic medication ≤ 14 days but
not received any antidiabetic medication within the last 1 month prior to enrollment)

- HbA1c ≥ 7.0% and ≤10.0%

Exclusion Criteria:

- Women of child bearing potential

- body mass index (BMI)≥35 Kg/m2 or BMI <18.5 Kg/m2

- Hemoglobin A1c (HbA1c)>10.0% or <7.0%

- Active liver disease and/or significant abnormal liver function

- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without
coma

- Congestive heart failure defined as New York Heart Association (NYHA) class III or IV
and /or left ventricular ejection fraction ≤40%

- Significant cardiovascular history with the past 6 months

- Severe retinopathy, persistent uncontrolled hypertension (SBP≥180mmHg, or
DBP≥105mmHg)

- Severe chronic gastrointestinal disease

- History of alcohol abuse or illegal drug abuse within the past 12 months

- Diagnosed anemia

- Creatine kinase ≥3 X ULN

- Serum creatinine ≥1.5 mg/dL(133μmol/L) [males], ≥1.4 mg/dL(124 μmol/L)[females]

- Alanine amino transferase (ALT) and/or aspartate amino transferase (AST)> 1.5 X ULN
and/or total bilirubin > 2 X ULN

- Hemoglobin <12g/dL [males], <11g/dL [females]

- Allergies and Adverse Drug Reactions

- Prohibited Treatments and/or Therapies

- Prisoners or subjects who are involuntarily incarcerated

- Subjects who are compulsorily detained for treatment of either a psychiatric or
physical (eg, infectious disease) illness

- Subjects decline to participate
GenderBoth
Ages17 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesChina

Administrative Information[ + expand ][ + ]

NCT Number NCT00778622
Other Study ID NumbersCV138-097
Has Data Monitoring CommitteeNo
Information Provided ByBristol-Myers Squibb
Study SponsorBristol-Myers Squibb
CollaboratorsNot Provided
Investigators Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Verification DateAugust 2013

Locations[ + expand ][ + ]

Local Institution
Beijing, Beijing, China, 100044
Local Institution
Beijing, Beijing, China, 100034
Local Institution
Beijing, Beijing, China, 100730
Local Institution
Beijing, Beijing, China, 100088
Local Institution
Beijing, Beijing, China, 101100
Local Institution
Beijing, Beijing, China, 200016
Local Institution
Beijing, Beijing, China, 100028
Local Institution
Guangdong, Guangdong, China, 510180
Local Institution
Guangdong Province, Guangdong, China, 510180
Local Institution
Guangdong Province, Guangdong, China, 528000
Local Institution
Shanghai, Shanghai, China, 200003
Local Institution
Shanghai, Shanghai, China, 200092
Local Institution
Shanghai, Shanghai, China, 201200
Local Institution
Shanghai, Shanghai, China, 201100