Diabetes Mellitus, Type 2Phase 4NCT00679939

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

A Phase 4 study testing Rosiglitazone and Metformin in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 42 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 55 to 80 years, women only
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Rosiglitazone and Metformin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 226 participants
Where: 42 sitesin 8 countries
Study dates: 21 Apr 2008to 16 Sep 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 80 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 16Show fewer

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 locations and contacts

42 sites in 8 countries.

Country

City, postcode or hospital

42 sites in 8 countries

United States21 sites

GSK Investigational Site
Albuquerque, New Mexico, 87102
GSK Investigational Site
Albuquerque, New Mexico, 87106
GSK Investigational Site
Columbia, South Carolina, 29201
GSK Investigational Site
Columbia, South Carolina, 29204
GSK Investigational Site
East Syracuse, New York, 13057
GSK Investigational Site
Huntington Park, California, 90255
GSK Investigational Site
Kingsport, Tennessee, 37660
GSK Investigational Site
Kingston, New York, 12401
GSK Investigational Site
Las Vegas, Nevada, 89117
GSK Investigational Site
Lexington, Kentucky, 40504
GSK Investigational Site
Los Angeles, California, 90022
GSK Investigational Site
Miami, Florida, 33143
GSK Investigational Site
Miami, Florida, 33156
GSK Investigational Site
Sacramento, California, 95823
GSK Investigational Site
San Antonio, Texas, 78221
GSK Investigational Site
San Diego, California, 92117
GSK Investigational Site
Slidell, Louisiana, 70461
GSK Investigational Site
Torrance, California, 90502
GSK Investigational Site
Tucson, Arizona, 85745
GSK Investigational Site
Vista, California, 92081
GSK Investigational Site
Wenatchee, Washington, 98801

Other trials in United States

Spain5 sites

GSK Investigational Site
Alicante, 03114
GSK Investigational Site
Benidorm/Alicante, 03503
GSK Investigational Site
Granada, 18003
GSK Investigational Site
Granada, 18014
GSK Investigational Site
Petrel, 03610

Other trials in Spain

Argentina4 sites

GSK Investigational Site
Buenos Aires, 1425
GSK Investigational Site
Buenos Aires, C1128AAF
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, B1704ETD
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1012AAR

Other trials in Argentina

Mexico4 sites

GSK Investigational Site
Cuernavaca, Morelos, 62250
GSK Investigational Site
Durango, 34000
GSK Investigational Site
Mérida, Yucatán, 97129
GSK Investigational Site
Monterrey, Nuevo León, 64460

Other trials in Mexico

Canada3 sites

GSK Investigational Site
Brampton, Ontario, L6T 3T1
GSK Investigational Site
Granby, Quebec, J2G 8Z9
GSK Investigational Site
Vancouver, British Columbia, V6H 3X8

Other trials in Canada

Estonia2 sites

GSK Investigational Site
Tallinn, 13415
GSK Investigational Site
Tallinn, 13419

Other trials in Estonia

Philippines2 sites

GSK Investigational Site
Manila, 01008
GSK Investigational Site
Marikina City, 1810

Other trials in Philippines

Pakistan1 site

GSK Investigational Site
Lahore, 54000

Other trials in Pakistan

About this study

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

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

Conditions: Diabetes Mellitus, Type 2
Being tested: Rosiglitazone, Metformin
Keywords: Type 2 diabetes mellitus, bone, x-ray absorptiometry, bone biomarkers, dual-energy, bone mineral density
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RosiglitazoneDrug
up to 8mg/day
MetforminDrug
up to 2000mg/day

Study groups in NCT00679939
Study group	Role	What they receive
Arm 1 Treatment A	Active comparator	rosiglitazone up to 8mg/day Receives: Drug: Rosiglitazone
Arm 2 Treatment B	Active comparator	metformin up to 2000mg/day Receives: Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 52
FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Baseline at Week 52 was calculated as (BMD at Week 52 minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Change in FN BMD at Week 52 was only analyzed within the Rosiglitazone arm.
Measured: 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
FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Baseline at Week 76+10 days was calculated as (BMD at Week 76+10 days minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.
Measured: 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
FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Week 52+10 days to Week 76+10 days was calculated as (BMD at Week 76+10 days minus BMD at Week 52+10 days)/BMD at Week 52+10 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.
Measured: Week 52+10 days and Week 76+10 days

Secondary outcomes (19)

Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52
BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Baseline at Week 52 was calculated as (BMD at Week 52 minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.
Measured: 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
BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Week 52 + 10 days toat Week 76 + 10 days was calculated as (BMD at Week 76 + 10 days minus BMD at Week 52 + 10 days)/BMD at Week 52 + 10 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.
Measured: 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
BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (BMD at Week 76 + 30 days minus BMD at Week 52 + 30 days)/BMD at Week 52 + 30 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.
Measured: 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
BSAP and P1NP levels were measured in micrograms per liter (mcg/L) from blood samples. BSAP and P1NP are indicators of bone buildup or formation. GM, geometric mean; SE, standard error. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.
Measured: 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
BSAP and P1NP levels were measured in micrograms per liter (mcg/L) from blood samples. BSAP and P1NP are indicators of bone buildup or formation. GM, geometric mean; SE, standard error. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.
Measured: 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
CTX levels were measured in picograms per milliliter (pg/ml) from blood samples. CTX is an indicator of bone break down or resorption. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.
Measured: 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
CTX levels were measured in picograms per milliliter (pg/ml) from blood samples. CTX is an indicator of bone break down or resorption. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.
Measured: Week 52 and Week 76
Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76
Vitamin D levels were measured in nanomoles per Liter (nmol/L) from blood samples. Vitamin D is required for good bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.
Measured: Baseline, Week 52, and Week 76
Adjusted Percent Change in 25-Hydroxyvitamin D (Vitamin D) From Week 52 to Week 76
Vitamin D levels were measured in nanomoles per Liter (nmol/L) from blood samples. Vitamin D is required for good bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.
Measured: Week 52 and Week 76
Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76
Intact PTH levels were measured in nanograms per Liter (ng/L) from blood samples. Intact PTH is the amount of PTH circulating in the blood and influences bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.
Measured: Baseline, Week 52, and Week 76
Adjusted Percent Change in Intact Parathyroid Hormone (PTH) From Week 52 to Week 76
Intact PTH levels were measured in nanograms per Liter (ng/L) from blood samples. Intact PTH is the amount of PTH circulating in the blood and influences bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.
Measured: Week 52 and Week 76
Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76
Serum estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Estradiol is one form of the female sex hormone estrogen and influences bone health. Percent change from baseline was based on log-transformed data.
Measured: Baseline, Week 52, and Week 76
Percent Change in Serum Estradiol From Week 52 to Week 76
Serum estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Estradiol is one form of the female sex hormone estrogen and influences bone health. Percent change from baseline was based on log-transformed data.
Measured: Week 52 and Week 76
Percent Change From Baseline in Total Testosterone at Week 52 and Week 76
Total testosterone levels were measured in nanomoles per Liter (nmol/L) from blood samples. Testosterone is a male sex hormone and influences bone health; total testosterone is the entire amount circulating in blood. Percent change from baseline was based on log-transformed data.
Measured: Baseline, Week 52, and Week 76
Percent Change in Total Testosterone From Week 52 to Week 76
Total testosterone levels were measured in nanomoles per Liter (nmol/L) from blood samples. Testosterone is a male sex hormone and influences bone health; total testosterone is the entire amount circulating in blood. Percent change from baseline was based on log-transformed data.
Measured: Week 52 and Week 76
Percent Change From Baseline in Free Testosterone at Week 52 and Week 76
Free testosterone levels were measured as a percentage of total testosterone from blood samples. Free testosterone is the amount of testosterone available to the body for use. Percent change from baseline was based on log-transformed data.
Measured: Baseline, Week 52, and Week 76
Percent Change in Free Testosterone From Week 52 to Week 76
Free testosterone levels were measured as a percentage of total testosterone from blood samples. Free testosterone is the amount of testosterone available to the body for use. Percent change from baseline was based on log-transformed data.
Measured: Week 52 and Week 76
Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76
SHBG levels were measured in nanomoles per liter (nmol/L) from blood samples. SHBG binds to estradiol and testosterone and influences the amount of estradiol or testosterone available to the body for use. Percent change from baseline was based on log-transformed data.
Measured: Baseline, Week 52, and Week 76
Percent Change in Sex Hormone Binding Globulin (SHBG) From Week 52 to Week 76
SHBG levels were measured in nanomoles per liter (nmol/L) from blood samples. SHBG binds to estradiol and testosterone and influences the amount of estradiol or testosterone available to the body for use. Percent change from baseline was based on log-transformed data.
Measured: Week 52 and Week 76

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Apr 200816 Sep 2010

First posted19 May 2008 (estimated)
Study start21 Apr 2008
Primary completion16 Sep 2010
Study completion16 Sep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 226 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00679939
Sponsor's protocol ID: AVD111179
Status last verified: Mar 2018
First submitted: 15 May 2008
Last updated: 18 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Fitzpatrick LA, Bilezikian JP, Wooddell M, Paul G, Kolatkar NS, Nino AJ, Miller CG, Bogado CE, Arnaud CD, Cobitz AR. Mechanism of action study to evaluate the effect of rosiglitazone on bone in postmenopausal women with type 2 diabetes mellitus: rationale, study design and baseline characteristics. J Drug Assess. 2011 Dec 16;1(1):11-9. doi: 10.3109/21556660.2011.641703. eCollection 2012.
PubMed 27536422
Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
PubMed 32501595
Miller CG, Bogado CC, Nino AJ, Northcutt AR, Yu HJ, Lewiecki EM, Paul G, Cobitz AR, Wooddell MJ, Bilezikian JP, Fitzpatrick LA. Evaluation of Quantitative Computed Tomography Cortical Hip Quadrant in a Clinical Trial With Rosiglitazone: A Potential New Study Endpoint. J Clin Densitom. 2016 Oct;19(4):485-491. doi: 10.1016/j.jocd.2016.02.003. Epub 2016 Mar 24.
PubMed 27052635
Bilezikian JP, Josse RG, Eastell R, Lewiecki EM, Miller CG, Wooddell M, Northcutt AR, Kravitz BG, Paul G, Cobitz AR, Nino AJ, Fitzpatrick LA. Rosiglitazone decreases bone mineral density and increases bone turnover in postmenopausal women with type 2 diabetes mellitus. J Clin Endocrinol Metab. 2013 Apr;98(4):1519-28. doi: 10.1210/jc.2012-4018. Epub 2013 Feb 28.
PubMed 23450056

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00679939
Acronym / sponsor ID: AVD111179
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes mellitus, bone, x-ray absorptiometry, bone biomarkers, dual-energy, bone mineral density
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 226 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 21 Apr 2008
Primary completion: 16 Sep 2010 (actual)
Study completion: 16 Sep 2010 (actual)
First posted: 19 May 2008 (estimated)
Results: Posted 7 Mar 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Arm 1 Treatment A	Active comparator	Drug: Rosiglitazonerosiglitazone up to 8mg/day
Arm 2 Treatment B	Active comparator	Drug: Metforminmetformin up to 2000mg/day

Who may qualify

Ages: 55 to 80 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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)

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Rosiglitazoneup to 8mg/day	Drug	Arm 1 Treatment A
Metforminup to 2000mg/day	Drug	Arm 2 Treatment B

Primary outcome

Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 52
Time frame: Baseline and Week 52
FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Baseline at Week 52 was calculated as (BMD at Week 52 minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Change in FN BMD at Week 52 was only analyzed within the Rosiglitazone arm.
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
Time frame: Baseline and Week 76+10 days
FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Baseline at Week 76+10 days was calculated as (BMD at Week 76+10 days minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.
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
Time frame: Week 52+10 days and Week 76+10 days
FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Week 52+10 days to Week 76+10 days was calculated as (BMD at Week 76+10 days minus BMD at Week 52+10 days)/BMD at Week 52+10 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.

19 secondary outcomes

Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 52 and Week 76
Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76
Time frame: Baseline, Week 52, and Week 76
Adjusted Percent Change in 25-Hydroxyvitamin D (Vitamin D) From Week 52 to Week 76
Time frame: Week 52 and Week 76
Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76
Time frame: Baseline, Week 52, and Week 76
Adjusted Percent Change in Intact Parathyroid Hormone (PTH) From Week 52 to Week 76
Time frame: Week 52 and Week 76
Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76
Time frame: Baseline, Week 52, and Week 76
Percent Change in Serum Estradiol From Week 52 to Week 76
Time frame: Week 52 and Week 76
Percent Change From Baseline in Total Testosterone at Week 52 and Week 76
Time frame: Baseline, Week 52, and Week 76
Percent Change in Total Testosterone From Week 52 to Week 76
Time frame: Week 52 and Week 76
Percent Change From Baseline in Free Testosterone at Week 52 and Week 76
Time frame: Baseline, Week 52, and Week 76
Percent Change in Free Testosterone From Week 52 to Week 76
Time frame: Week 52 and Week 76
Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76
Time frame: Baseline, Week 52, and Week 76
Percent Change in Sex Hormone Binding Globulin (SHBG) From Week 52 to Week 76
Time frame: Week 52 and Week 76

Results and safety

Results posted to the registry on 7 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rosiglitazone in DB Period; Metformin in OL Period	114	77
Metformin in DB Period; Metformin in OL Period	112	85

Primary outcome: Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 52

Time frame: Baseline and Week 52. Mean (Standard Error). Unit: percent change

Measure	Rosiglitazone in DB Period; Metformin in OL Period n = 52
Value	-1.24 (0.619)

Population analysed: Safety Population. Only evaluable participants with a value at baseline and at Week 52 for the parameter of interest were analyzed. Only participants with Baseline DXA and Week 52 DXA measurements performed on or prior to initiating open-label MET are included in this primary analysis.

Primary outcome: 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

Time frame: Baseline and Week 76+10 days. Mean (Standard Error). Unit: percent change

Measure	Rosiglitazone in DB Period; Metformin in OL Period n = 65	Metformin in DB Period; Metformin in OL Period n = 70
Value	-1.91 (0.624)	0.31 (0.636)

Population analysed: Safety Population. Only evaluable participants with a value at baseline and at Week 76 performed up to 10 days after stopping OL MET for the parameter of interest were analyzed.

Primary outcome: 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

Time frame: Week 52+10 days and Week 76+10 days. Mean (Standard Error). Unit: percent change

Measure	Rosiglitazone in DB Period; Metformin in OL Period n = 56	Metformin in DB Period; Metformin in OL Period n = 62
Value	-0.07 (0.589)	-0.02 (0.585)

Population analysed: Safety Population. Only evaluable participants with a value at Week 52 performed up to 10 days after initiating OL MET and at Week 76 performed up to 10 days after stopping OL MET for the parameter of interest were analyzed.

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: 76 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rosiglitazone: DB	7 of 114 (6.1%)	47 of 115 (40.9%)	Not reported
Metformin: DB	5 of 111 (4.5%)	45 of 111 (40.5%)	Not reported
Rosiglitazone: MET OL	0 of 76 (0%)	12 of 76 (15.8%)	Not reported
Metformin: MET OL	0 of 84 (0%)	8 of 84 (9.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27536422Fitzpatrick LA, Bilezikian JP, Wooddell M, Paul G, Kolatkar NS, Nino AJ, Miller CG, Bogado CE, Arnaud CD, Cobitz AR. Mechanism of action study to evaluate the effect of rosiglitazone on bone in postmenopausal women with type 2 diabetes mellitus: rationale, study design and baseline characteristics. J Drug Assess. 2011 Dec 16;1(1):11-9. doi: 10.3109/21556660.2011.641703. eCollection 2012.
Derived from this study: PubMed 32501595Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
Derived from this study: PubMed 27052635Miller CG, Bogado CC, Nino AJ, Northcutt AR, Yu HJ, Lewiecki EM, Paul G, Cobitz AR, Wooddell MJ, Bilezikian JP, Fitzpatrick LA. Evaluation of Quantitative Computed Tomography Cortical Hip Quadrant in a Clinical Trial With Rosiglitazone: A Potential New Study Endpoint. J Clin Densitom. 2016 Oct;19(4):485-491. doi: 10.1016/j.jocd.2016.02.003. Epub 2016 Mar 24.
Derived from this study: PubMed 23450056Bilezikian JP, Josse RG, Eastell R, Lewiecki EM, Miller CG, Wooddell M, Northcutt AR, Kravitz BG, Paul G, Cobitz AR, Nino AJ, Fitzpatrick LA. Rosiglitazone decreases bone mineral density and increases bone turnover in postmenopausal women with type 2 diabetes mellitus. J Clin Endocrinol Metab. 2013 Apr;98(4):1519-28. doi: 10.1210/jc.2012-4018. Epub 2013 Feb 28.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

42 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rosiglitazone and Metformin in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 42 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Spain, Argentina, Mexico, Canada and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 52 (time frame: Baseline and Week 52). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00679939, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.