Study In Postmenopausal Women With Type 2 Diabetes Looking At Approved Diabetes Drugs And How They Affect Bone Health
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Rosiglitazone; Metformin
Intervention description: up to 8mg/day; up to 2000mg/day
Intervention MeSH terms: Metformin; Rosiglitazone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 226.0
Sex: Female
Minimum age: 55 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Type 2 diabetes mellitus; bone; x-ray absorptiometry; bone biomarkers; dual-energy; bone mineral density

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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