Last updated: 11/04/2018 05:20:28
Study In Postmenopausal Women With Type 2 Diabetes Looking At Approved Diabetes Drugs And How They Affect Bone Health
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: The purpose of this study is to determine the effects of rosiglitazone on the bone in postmenopausal women with type 2 diabetes mellitus
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Adjusted percent change from baseline in femoral neck (FN) bone mineral density (BMD) via dual-energy x-ray absorptiometry (DXA) at Week 52
Timeframe: Baseline and Week 52
Adjusted percent change from baseline in femoral neck (FN) bone mineral density (BMD) via dual-energy x-ray absorptiometry (DXA) at Week 76+10 days
Timeframe: Baseline and Week 76+10 days
Adjusted percent change in femoral neck (FN) bone mineral density (BMD) via dual-energy x-ray absorptiometry (DXA) from Week 52 +10 days to Week 76+10 days
Timeframe: Week 52+10 days and Week 76+10 days
Secondary outcomes:
Adjusted percent change from baseline in femoral neck, total hip, trochanter, and lumbar spine BMD via DXA at Week 52
Timeframe: Baseline and Week 52
Adjusted percent change in femoral neck, total hip, trochanter, and lumbar spine BMD via DXA from Week 52+10 days to Week 76 + 10 days
Timeframe: Week 52 + 10 days and Week 76 + 10 days
Adjusted percent change in femoral neck, total hip, trochanter, and lumbar spine BMD via DXA from Week 52+30 days to Week 76 + 30 days
Timeframe: Week 52 + 30 days and Week 76 + 30 days
Adjusted percent change from baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76
Timeframe: Baseline, Week 52, and Week 76
Adjusted percent change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) from Week 52 to Week 76
Timeframe: Week 52 and Week 76
Adjusted percent change from baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76
Timeframe: Baseline, Week 52, and Week 76
Adjusted percent change in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) from Week 52 to Week 76
Timeframe: Week 52 and Week 76
Adjusted percent change from baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76
Timeframe: Baseline, Week 52, and Week 76
Adjusted percent change in 25-Hydroxyvitamin D (Vitamin D) from Week 52 to Week 76
Timeframe: Week 52 and Week 76
Adjusted percent change from baseline in intact parathyroid hormone (PTH) at Week 52 and Week 76
Timeframe: Baseline, Week 52, and Week 76
Adjusted percent change in intact parathyroid hormone (PTH) from Week 52 to Week 76
Timeframe: Week 52 and Week 76
Percent change from baseline in serum estradiol at Week 52 and Week 76
Timeframe: Baseline, Week 52, and Week 76
Percent change in serum estradiol from Week 52 to Week 76
Timeframe: Week 52 and Week 76
Percent change from baseline in total testosterone at Week 52 and Week 76
Timeframe: Baseline, Week 52, and Week 76
Percent change in total testosterone from Week 52 to Week 76
Timeframe: Week 52 and Week 76
Percent change from baseline in free testosterone at Week 52 and Week 76
Timeframe: Baseline, Week 52, and Week 76
Percent change in free testosterone from Week 52 to Week 76
Timeframe: Week 52 and Week 76
Percent change from baseline in sex hormone binding globulin (SHBG) at Week 52 and Week 76
Timeframe: Baseline, Week 52, and Week 76
Percent change in sex hormone binding globulin (SHBG) from Week 52 to Week 76
Timeframe: Week 52 and Week 76
Interventions:
Drug: Rosiglitazone
Drug: Metformin
Enrollment:
226
Observational study model:
Not applicable
Primary completion date:
2010-16-09
Time perspective:
Not applicable
Clinical publications:
Fitzpatrick L, BilezikianJ, Wooddell M, Paul G, Kolatkar N, Nino A, Miller C, Bogado C, Arnaud C, Cobitz A. AVD111179 Mechanism of Action Study to Evaluate the Effect of Rosiglitazone on Bone in Postmenopausal Women with Type 2 Diabetes Mellitus: Study Design and Baseline Characteristics. J Drug Asses. 2011;1(.):11-19.
Bilezikian J; Lewiecki M; Miller C; Lang T; Kravitz B; Nino A; Northcutt A; Fitzpatrick L; Brannan T; Paul G. Rosiglitazone Decreases Bone Mineral Density and Increases Bone Turnover in Postmenopausal Women with Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2013;8(4):1519-28.
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
April 2008 to September 2010
Type
Interventional
Phase
4
Participation criteria
Sex
Female
Age
55 - 80 years
Accepts healthy volunteers
No
- Female, >55 to <80 years
- >5 years menopausal
- Type 1 Diabetes Mellitus (T1DM) or history of diabetic ketoacidosis (DKA)
- Renal or hepatic disease (clinically significant)
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1012AAR
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95823
Status
Study Complete
Location
GSK Investigational Site
Kingston, New York, United States, 12401
Status
Study Complete
Location
GSK Investigational Site
Wenatchee, Washington, United States, 98801
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90022
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87106
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29201
Status
Study Complete
Location
GSK Investigational Site
East Syracuse, New York, United States, 13057
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Slidell, Louisiana, United States, 70461
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89117
Status
Study Complete
Location
GSK Investigational Site
Huntington Park, California, United States, 90255
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87102
Status
Study Complete
Location
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V6H 3X8
Status
Study Complete
Location
GSK Investigational Site
Vista, California, United States, 92081
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40504
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1128AAF
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92117
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78221
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, 1425
Status
Study Complete
Location
GSK Investigational Site
Torrance, California, United States, 90502
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29204
Status
Study Complete
Location
GSK Investigational Site
Cuernavaca, Morelos, Mexico, 62250
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2010-16-09
Actual study completion date
2010-16-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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