Clinical trial NCT00778622: Body Weight Effects on Glucophage's Efficacy in Chinese Diagnosed T2DM Patients
Official title: The 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-10-23
Enrollment: 371
Sex: ALL
Minimum age (years): 17
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Mean Change From Baseline at Week 16 (95% Confidence Interval) in Glycosated Hemoglobin A1c (HbA1c) (Last Observation Carried Forward) - Full Analysis Set (FAS)
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Mean Change From Baseline at Week 16 (95% Confidence Interval) of Fasting Plasma Glucose (FPG) - Full Analysis Set
timeFrame: Baseline to Week 16
measure: Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Total Cholesterol (TC) - Full Analysis Set
timeFrame: Baseline to Week 16
measure: Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Low-density Lipoprotein Cholesterol (LDL-C) - Full Analysis Set
timeFrame: Baseline to Week 16
measure: Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting High-density Lipoprotein Cholesterol (HDL-C) - Full Analysis Set
timeFrame: Baseline to Week 16
measure: Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Triglycerides (TG) - Full Analysis Set
timeFrame: Baseline to Week 16
measure: Mean Change From Baseline at Week 16 (95% Confidence Interval) in C-Reactive Protein (CRP) - Full Analysis Set
timeFrame: Baseline to Week 16
measure: Mean Change From Baseline at Week 16 (95% Confidence Interval) in Plasminogen Activator Inhibitor-1 (PAI-1) - Full Analysis Set
timeFrame: Baseline to Week 16
measure: Mean Change From Baseline at Week 16 (95% Confidence Interval) in Adiponectin - Full Analysis Set
timeFrame: Baseline to Week 16
Other outcomes:
measure: Number of Participants With Episodes of Lactic Acidosis or Hypoglycemia From Day 1 to Week 16 - Safety Population
timeFrame: Day 1 to Week 16
measure: Number of Participants With Clinically Significant Changes From Baseline at Week 16 in the Hematology Laboratory Test Profile - Safety Population
timeFrame: Baseline to Week 16
measure: Number of Participants Who Had Abnormal Increase From Baseline at Week 16 in Kidney or Liver Function Serum Chemistry Values - Safety Population
timeFrame: Baseline to Week 16
measure: Number of Participants With Clinically Significant Changes From Baseline at Week 16 in Urinalysis - Safety Population
timeFrame: Baseline to Week 16
measure: Mean Change From Baseline at Week at Week 16 in ECG Parameter Heart Rate (HR) - Safety Population
timeFrame: Baseline to Week 16
measure: Mean Change From Baseline at Week 16 in Diastolic and Systolic Blood Pressure - Safety Population
timeFrame: Baseline to Week 16
measure: 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
timeFrame: Baseline to Week 16
Locations:
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Guangdong Province
country: China
facility: Local Institution
state: Guangdong
city: Guangdong Province
country: China
facility: Local Institution
state: Guangdong
city: Guangdong
country: China
facility: Local Institution
state: Guangdong
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.