Status:
COMPLETED
Study In Postmenopausal Women With Type 2 Diabetes Looking At Approved Diabetes Drugs And How They Affect Bone Health
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
FEMALE
55-80 years
Phase:
PHASE4
Brief 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
- 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
- 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
Key Trial Info
Start Date :
April 21 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2010
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT00679939
Start Date
April 21 2008
End Date
September 16 2010
Last Update
April 18 2018
Active Locations (42)
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1
GSK Investigational Site
Tucson, Arizona, United States, 85745
2
GSK Investigational Site
Huntington Park, California, United States, 90255
3
GSK Investigational Site
Los Angeles, California, United States, 90022
4
GSK Investigational Site
Sacramento, California, United States, 95823