Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
55–80
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
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
Clareo Health | Study In Postmenopausal Women With Type 2 Diabetes Looking At Approved Diabetes Drugs And How They Affect Bone Health
