Study In Postmenopausal Women With Type 2 Diabetes Looking At Approved Diabetes Drugs And How They Affect Bone Health

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Rosiglitazone

Drug: Metformin

Study type

Interventional

Funder types

Industry

Identifiers

AVD111179

Details and patient eligibility

About

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

Enrollment

226 patients

Sex

Female

Ages

55 to 80 years old

Volunteers

No Healthy Volunteers

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