A 52 Week Randomized, Double-Blind, Multicenter, Mechanistic Study With a 24 Week Open-Label Follow-Up to Evaluate the Effect of AVANDIA TM on Bone in Postmenopausal Women With Type 2 Diabetes Mellitus

CompletadoFase 4ClinicalTrials.gov

ID: NCT00679939Tipo: INTERVENTIONALInicio: 21 de abr de 2008Fin estimado: 16 de sept de 2010

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine the effects of rosiglitazone on the bone in postmenopausal women with type 2 diabetes mellitus

Elegibilidad

Edad mínima: 55 YearsEdad máxima: 80 YearsSexo: FEMALE

Criterios de inclusión

Female, \>55 to \<80 years
\>5 years menopausal
Type 2 Diabetes Mellitus (T2DM) diagnosis according to American Diabetes Association (ADA), American Association of Clinical Endocrinologists (AACE), Canadian Diabetes Association (CDA), World Health Organization/International Diabetes Federation (WHO/IDF)
Drug-naïve (HbA1c \< or = 9.0%); OR Prior monotherapy, submaximal doses of metformin (\< or = 1000mg Metformin), sulfonylureas (\< or = 5mg Glyburide, \< or = 10mg Glipizide or \< or = 8mg glimepiride) or full dose Januvia (100mg) (HbA1c \< or = 8.5%); OR Prior monotherapy, \> submaximal doses of metformin (\>1000mg) or sulfonylureas (\>5mg Glyburide, \>10mg Glipizide or \>8mg glimepiride) (HbA1c \< or = 7.0%)
Weighs \<300 lbs (136.4 kg)
Two or more vertebra (L1-L4) suitable for BMD measurement by dual x-ray absorptiometry (DXA)
Absolute BMD value consistent with T-score \>-2.5 at femoral neck, lumbar spine and total hip

Criterios de exclusión

Type 1 Diabetes Mellitus (T1DM) or history of diabetic ketoacidosis (DKA)
Renal or hepatic disease (clinically significant)
Hepatocellular reaction, severe edema, or medically serious fluid event associated with thiazolidinedione (TZD)
Recent (\<6mos) history or clinical intervention for angina or myocardial infarction or is taking nitrates
Any stage of heart failure, i.e. New York Heart Association (NYHA) class I-IV
Systolic BP \>160mmHg or diastolic BP \>90mmHg while on antihypertensive
Hypersensitivity to TZDs, biguanides
Prior treatment with two or more oral anti-diabetic (OAD) agents
Bilateral hip replacements
Concurrent diseases affecting bone metabolism
Active malabsorption syndrome
Serum calcium outside the central lab reference range
Thyroid replacement therapy, serum thyroid stimulating hormone (TSH) must be within range
Vitamin D deficiency
Previous treatment with: strontium, intravenous (IV) bisphosphonate, fluoride, hormones, calcineurin inhibitors or methotrexate
Chronic systemic corticosteroid \[e.g. glucocorticoid, mineralocorticoid\] treatment of no more than two intra-articular injections within the past year or use of oral parenteral, or long-term, high-dose inhaled corticosteroids

Intervenciones

drug

Rosiglitazone

up to 8mg/day

drug

Metformin

up to 2000mg/day

Ubicaciones

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

Patrocinadores

PrincipalGlaxoSmithKline

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