Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 diabetes mellitus, bone, x-ray absorptiometry, bone biomarkers, dual-energy, bone mineral density
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
Interventions
DRUGRosiglitazone
up to 8mg/day
DRUGMetformin
up to 2000mg/day
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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 From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 52 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Week 52 + 30 days and 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. |
| Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Baseline, 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. |
| Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76 | 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. |
| Adjusted Percent Change From Baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76 | Baseline, 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. |
| Adjusted Percent Change in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) From Week 52 to Week 76 | 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. |
| Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76 | Baseline, 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. |
| Adjusted Percent Change in 25-Hydroxyvitamin D (Vitamin D) From Week 52 to Week 76 | 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. |
| Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76 | Baseline, 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. |
| Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76 | Baseline, 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. |
| Percent Change in Serum Estradiol From Week 52 to Week 76 | 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. |
| Percent Change From Baseline in Total Testosterone at Week 52 and Week 76 | Baseline, 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. |
| Percent Change in Total Testosterone From Week 52 to Week 76 | 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. |
| Percent Change From Baseline in Free Testosterone at Week 52 and Week 76 | Baseline, 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. |
| Percent Change in Free Testosterone From Week 52 to Week 76 | 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. |
| Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76 | Baseline, 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. |
| Percent Change in Sex Hormone Binding Globulin (SHBG) From Week 52 to Week 76 | 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. |
| Adjusted Percent Change in Intact Parathyroid Hormone (PTH) From Week 52 to Week 76 | 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. |
| Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 | Baseline and 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. |
| 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 | Week 52 + 10 days and 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Percentage of Free Estradiol From Week 52 to Week 76 | Week 52 and Week 76 | Free estradiol levels were measured as a percentage of serum estrogen from blood samples. Free estradiol is the amount of estrogen available to the body for use. Percent change was based on log-transformed data. |
| Percent Change in Free Estradiol From Week 52 to Week 76 | Week 52 and Week 76 | Free estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Free estrodial is the amount of estrogen available to the body for use. Change was based on log-transformed data. |
Countries
Argentina, Canada, Estonia, Mexico, Pakistan, Philippines, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | 114 |
| Metformin in DB Period; Metformin in OL Period Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | 111 |
| Total | 225 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 24-Week Open-Label (OL) Period | Adverse Event | 0 | 1 |
| 24-Week Open-Label (OL) Period | Met Stopping Criteria | 3 | 1 |
| 24-Week Open-Label (OL) Period | Physician Decision | 1 | 0 |
| 24-Week Open-Label (OL) Period | Protocol Violation | 1 | 1 |
| 24-Week Open-Label (OL) Period | Withdrawal by Subject | 2 | 1 |
| 52-Week Double-Blind (DB) Period | Adverse Event | 14 | 12 |
| 52-Week Double-Blind (DB) Period | Investigator Discretion | 5 | 0 |
| 52-Week Double-Blind (DB) Period | Lost to Follow-up | 0 | 2 |
| 52-Week Double-Blind (DB) Period | Protocol Violation | 1 | 0 |
| 52-Week Double-Blind (DB) Period | Withdrew Consent | 17 | 13 |
Baseline characteristics
| Characteristic | Metformin in DB Period; Metformin in OL Period | Total | Rosiglitazone in DB Period; Metformin in OL Period |
|---|---|---|---|
| Age, Continuous | 64.0 Years STANDARD_DEVIATION 6.46 | 63.8 Years STANDARD_DEVIATION 6.52 | 63.6 Years STANDARD_DEVIATION 6.61 |
| Race/Ethnicity, Customized African American/African | 8 participants | 10 participants | 2 participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 5 participants | 11 participants | 6 participants |
| Race/Ethnicity, Customized Asian - Central/South Asian | 10 participants | 23 participants | 13 participants |
| Race/Ethnicity, Customized East Asia | 2 participants | 6 participants | 4 participants |
| Race/Ethnicity, Customized Mixed Race | 2 participants | 5 participants | 3 participants |
| Race/Ethnicity, Customized South East Asian | 6 participants | 10 participants | 4 participants |
| Race/Ethnicity, Customized White - White/Caucasian/European | 78 participants | 160 participants | 82 participants |
| Sex: Female, Male Female | 111 Participants | 225 Participants | 114 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 47 / 115 | 45 / 111 | 12 / 76 | 8 / 84 |
| serious Total, serious adverse events | 7 / 114 | 5 / 111 | 0 / 76 | 0 / 84 |
Outcome results
Primary
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.
Time frame: Baseline and Week 52
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 52 | -1.24 percent change | Standard Error 0.619 |
Primary
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.
Time frame: Baseline and Week 76+10 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | 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 | -1.91 percent change | Standard Error 0.624 |
| Metformin in DB Period; Metformin in OL Period | 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 | 0.31 percent change | Standard Error 0.636 |
Primary
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.
Time frame: Week 52+10 days and Week 76+10 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | 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 | -0.07 percent change | Standard Error 0.589 |
| Metformin in DB Period; Metformin in OL Period | 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 | -0.02 percent change | Standard Error 0.585 |
Secondary
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.
Time frame: Baseline, Week 52, and Week 76
Population: Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76 | Week 52, GM - SE, n=61, 65 | -27.9 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76 | Week 52, GM, n=61, 65 | -24.7 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76 | Week 52, GM + SE, n=61, 65 | -21.4 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76 | Week 76, GM - SE, n=55, 58 | -21.3 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76 | Week 76, GM, n=55, 58 | -18.1 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76 | Week 76, GM + SE, n=55, 58 | -14.6 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76 | Week 76, GM, n=55, 58 | -8.9 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76 | Week 52, GM - SE, n=61, 65 | -15.9 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76 | Week 76, GM - SE, n=55, 58 | -12.5 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76 | Week 52, GM, n=61, 65 | -12.2 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76 | Week 76, GM + SE, n=55, 58 | -5.2 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76 | Week 52, GM + SE, n=61, 65 | -8.4 percent change |
Secondary
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.
Time frame: Baseline, Week 52, and Week 76
Population: Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Week 52, GM - SE, BSAP, n=78, 84 | -15.2 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Week 52, GM, BSAP, n=78, 84 | -12.3 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Week 52, GM + SE, BSAP, n=78, 84 | -9.3 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Week 76, GM - SE, BSAP, n=64, 77 | -18.7 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Week 76, GM, BSAP, n=64, 77 | -15.9 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Week 76, GM + SE, BSAP, n=64, 77 | -12.9 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Week 52, GM - SE, P1NP, n=76, 83 | 5.0 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Week 52, GM, P1NP, n=76, 83 | 9.0 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Week 52, GM + SE, P1NP, n=76, 83 | 13.3 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Week 76 GM - SE, P1NP, n=63, 75 | -11.2 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Week 76, GM, P1NP, n=63, 75 | -6.9 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Week 76, GM + SE, P1NP, n=63, 75 | -2.4 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Week 76, GM, P1NP, n=63, 75 | -10.5 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Week 52, GM - SE, BSAP, n=78, 84 | -29.7 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Week 52, GM - SE, P1NP, n=76, 83 | -16.5 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Week 52, GM, BSAP, n=78, 84 | -27.3 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Week 76 GM - SE, P1NP, n=63, 75 | -14.5 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Week 52, GM + SE, BSAP, n=78, 84 | -24.8 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Week 52, GM, P1NP, n=76, 83 | -13.3 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Week 76, GM - SE, BSAP, n=64, 77 | -26.7 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Week 76, GM + SE, P1NP, n=63, 75 | -6.4 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Week 76, GM, BSAP, n=64, 77 | -24.3 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Week 52, GM + SE, P1NP, n=76, 83 | -9.9 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 | Week 76, GM + SE, BSAP, n=64, 77 | -21.8 percent change |
Secondary
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.
Time frame: Baseline, Week 52, and Week 76
Population: Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76 | Week 52, GM - SE, n=77, 84 | 11.3 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76 | Week 52, GM, n=77, 84 | 18.1 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76 | Week 52, GM + SE, n=77, 84 | 25.4 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76 | Week 76, GM - SE, n=63, 77 | -19.5 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76 | Week 76, GM, n=63, 77 | -13.1 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76 | Week 76, GM + SE, n=63, 77 | -6.1 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76 | Week 76, GM, n=63, 77 | 2.6 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76 | Week 52, GM - SE, n=77, 84 | -7.8 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76 | Week 76, GM - SE, n=63, 77 | -4.5 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76 | Week 52, GM, n=77, 84 | -2.3 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76 | Week 76, GM + SE, n=63, 77 | 10.3 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76 | Week 52, GM + SE, n=77, 84 | 3.7 percent change |
Secondary
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.
Time frame: Baseline and Week 52
Population: 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 were analyzed. Not all participants had correct positioning for the DXA lumbar spine measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 | Femoral neck, n=52, 54 | -1.24 percent change | Standard Error 0.619 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 | Total hip, n=52, 54 | -0.77 percent change | Standard Error 0.417 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 | Trochanter, n=52, 54 | -0.21 percent change | Standard Error 0.725 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 | Lumbar spine, n=51, 53 | -1.21 percent change | Standard Error 0.473 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 | Lumbar spine, n=51, 53 | 0.12 percent change | Standard Error 0.505 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 | Femoral neck, n=52, 54 | 0.72 percent change | Standard Error 0.659 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 | Trochanter, n=52, 54 | -0.78 percent change | Standard Error 0.768 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 | Total hip, n=52, 54 | -0.38 percent change | Standard Error 0.44 |
Secondary
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.
Time frame: Baseline, Week 52, and Week 76
Population: Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76 | Week 52, GM - SE, n=64, 71 | -16.5 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76 | Week 52, GM, n=64, 71 | -12.0 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76 | Week 52, GM + SE, n=64, 71 | -7.2 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76 | Week 76, GM - SE, n=56, 64 | -28.8 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76 | Week 76, GM, n=56, 64 | -23.1 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76 | Week 76, GM + SE, n=56, 64 | -17.0 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76 | Week 76, GM, n=56, 64 | -20.8 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76 | Week 52, GM - SE, n=64, 71 | -25.9 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76 | Week 76, GM - SE, n=56, 64 | -26.2 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76 | Week 52, GM, n=64, 71 | -22.0 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76 | Week 76, GM + SE, n=56, 64 | -15.0 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76 | Week 52, GM + SE, n=64, 71 | -17.8 percent change |
Secondary
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.
Time frame: Week 52 and Week 76
Population: Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in 25-Hydroxyvitamin D (Vitamin D) From Week 52 to Week 76 | GM - SE | -4.7 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in 25-Hydroxyvitamin D (Vitamin D) From Week 52 to Week 76 | GM | 0.1 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in 25-Hydroxyvitamin D (Vitamin D) From Week 52 to Week 76 | GM + SE | 5.1 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in 25-Hydroxyvitamin D (Vitamin D) From Week 52 to Week 76 | GM - SE | -7.7 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in 25-Hydroxyvitamin D (Vitamin D) From Week 52 to Week 76 | GM | -3.2 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in 25-Hydroxyvitamin D (Vitamin D) From Week 52 to Week 76 | GM + SE | 1.5 percent change |
Secondary
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.
Time frame: Week 52 and Week 76
Population: Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed. One participant did not have P1NP measured.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76 | GM - SE, BSAP, n=64, 76 | -5.6 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76 | GM, BSAP, n=64, 76 | -2.0 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76 | GM + SE, BSAP, n=64, 76 | 1.8 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76 | GM - SE, P1NP, n=63, 76 | -15.8 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76 | GM, P1NP, n=63, 76 | -12.4 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76 | GM + SE, P1NP, n=63, 76 | -9.0 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76 | GM, P1NP, n=63, 76 | 7.0 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76 | GM - SE, BSAP, n=64, 76 | 4.3 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76 | GM - SE, P1NP, n=63, 76 | 3.2 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76 | GM, BSAP, n=64, 76 | 8.0 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76 | GM + SE, P1NP, n=63, 76 | 11.0 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76 | GM + SE, BSAP, n=64, 76 | 11.8 percent change |
Secondary
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.
Time frame: Week 52 and Week 76
Population: Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) From Week 52 to Week 76 | GM - SE | -31.2 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) From Week 52 to Week 76 | GM | -26.7 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) From Week 52 to Week 76 | GM + SE | -21.9 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) From Week 52 to Week 76 | GM - SE | 2.2 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) From Week 52 to Week 76 | GM | 8.4 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) From Week 52 to Week 76 | GM + SE | 14.9 percent change |
Secondary
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.
Time frame: Week 52 + 10 days and Week 76 + 10 days
Population: 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. Not all participants had correct positioning for the DXA lumbar spine measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | 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 | Femoral neck, n=56, 62 | -0.07 percent change | Standard Error 0.589 |
| Rosiglitazone in DB Period; Metformin in OL Period | 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 | Total hip, n=56, 62 | 0.40 percent change | Standard Error 0.304 |
| Rosiglitazone in DB Period; Metformin in OL Period | 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 | Trochanter, n=56, 62 | -0.02 percent change | Standard Error 0.475 |
| Rosiglitazone in DB Period; Metformin in OL Period | 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 | Lumbar spine, n=55, 62 | 0.26 percent change | Standard Error 0.44 |
| Metformin in DB Period; Metformin in OL Period | 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 | Lumbar spine, n=55, 62 | 1.03 percent change | Standard Error 0.442 |
| Metformin in DB Period; Metformin in OL Period | 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 | Femoral neck, n=56, 62 | -0.02 percent change | Standard Error 0.585 |
| Metformin in DB Period; Metformin in OL Period | 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 | Trochanter, n=56, 62 | -0.68 percent change | Standard Error 0.469 |
| Metformin in DB Period; Metformin in OL Period | 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 | Total hip, n=56, 62 | -0.13 percent change | Standard Error 0.301 |
Secondary
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.
Time frame: Week 52 + 30 days and Week 76 + 30 days
Population: Safety Population. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET and Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. Not all participants had correct positioning for all of the DXA measurements.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | 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 | Femoral neck, n=64, 73 | -0.27 percent change | Standard Error 0.559 |
| Rosiglitazone in DB Period; Metformin in OL Period | 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 | Total hip, n=64, 73 | 0.00 percent change | Standard Error 0.298 |
| Rosiglitazone in DB Period; Metformin in OL Period | 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 | Trochanter, n=64, 73 | -0.17 percent change | Standard Error 0.495 |
| Rosiglitazone in DB Period; Metformin in OL Period | 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 | Lumbar spine, n=65, 70 | 0.54 percent change | Standard Error 0.445 |
| Metformin in DB Period; Metformin in OL Period | 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 | Lumbar spine, n=65, 70 | 0.90 percent change | Standard Error 0.442 |
| Metformin in DB Period; Metformin in OL Period | 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 | Femoral neck, n=64, 73 | -0.25 percent change | Standard Error 0.535 |
| Metformin in DB Period; Metformin in OL Period | 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 | Trochanter, n=64, 73 | -0.47 percent change | Standard Error 0.47 |
| Metformin in DB Period; Metformin in OL Period | 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 | Total hip, n=64, 73 | -0.27 percent change | Standard Error 0.283 |
Secondary
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.
Time frame: Week 52 and Week 76
Population: Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Intact Parathyroid Hormone (PTH) From Week 52 to Week 76 | GM - SE | -13.2 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Intact Parathyroid Hormone (PTH) From Week 52 to Week 76 | GM | -7.4 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Intact Parathyroid Hormone (PTH) From Week 52 to Week 76 | GM + SE | -1.3 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Intact Parathyroid Hormone (PTH) From Week 52 to Week 76 | GM - SE | -1.7 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Intact Parathyroid Hormone (PTH) From Week 52 to Week 76 | GM | 4.3 percent change |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Intact Parathyroid Hormone (PTH) From Week 52 to Week 76 | GM + SE | 10.7 percent change |
Secondary
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.
Time frame: Baseline, Week 52, and Week 76
Population: Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change From Baseline in Free Testosterone at Week 52 and Week 76 | Week 52, GM - SE, n=74, 82 | -9.9964 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change From Baseline in Free Testosterone at Week 52 and Week 76 | Week 52, GM, n=74, 82 | -5.940 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change From Baseline in Free Testosterone at Week 52 and Week 76 | Week 52, GM + SE, n=74, 82 | 1.7006 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change From Baseline in Free Testosterone at Week 52 and Week 76 | Week 76, GM - SE, n=64, 75 | -0.3232 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change From Baseline in Free Testosterone at Week 52 and Week 76 | Week 76, GM, n=64, 75 | 3.687 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change From Baseline in Free Testosterone at Week 52 and Week 76 | Week 76, GM + SE, n=64, 75 | 7.8593 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change From Baseline in Free Testosterone at Week 52 and Week 76 | Week 76, GM, n=64, 75 | 2.478 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change From Baseline in Free Testosterone at Week 52 and Week 76 | Week 52, GM - SE, n=74, 82 | 2.5725 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change From Baseline in Free Testosterone at Week 52 and Week 76 | Week 76, GM - SE, n=64, 75 | -1.9532 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change From Baseline in Free Testosterone at Week 52 and Week 76 | Week 52, GM, n=74, 82 | 6.266 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change From Baseline in Free Testosterone at Week 52 and Week 76 | Week 76, GM + SE, n=64, 75 | 7.1093 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change From Baseline in Free Testosterone at Week 52 and Week 76 | Week 52, GM + SE, n=74, 82 | 10.0934 percent change |
Secondary
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.
Time frame: Baseline, Week 52, and Week 76
Population: Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76 | Week 52, GM - SE, n=74, 82 | -17.0838 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76 | Week 52, GM, n=74, 82 | -3.453 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76 | Weel 52, GM + SE, n=74, 82 | 12.4189 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76 | Week 76, GM - SE, n=64, 76 | -16.0971 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76 | Week 76, GM, n=64, 76 | 0.215 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76 | Week 76, GM + SE, n=64, 76 | 19.6987 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76 | Week 76, GM, n=64, 76 | 21.389 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76 | Week 52, GM - SE, n=74, 82 | -31.4166 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76 | Week 76, GM - SE, n=64, 76 | 0.4372 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76 | Week 52, GM, n=74, 82 | -17.280 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76 | Week 76, GM + SE, n=64, 76 | 46.7122 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76 | Weel 52, GM + SE, n=74, 82 | -0.2292 percent change |
Secondary
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.
Time frame: Baseline, Week 52, and Week 76
Population: Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76 | Week 52, GM - SE, n=74, 83 | 33.2608 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76 | Week 52, GM, n=74, 83 | 37.563 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76 | Week 52, GM + SE, n=74, 83 | 42.0049 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76 | Week 76, GM - SE, n=61, 67 | -0.2973 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76 | Week 76, GM, n=61, 67 | 3.137 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76 | Week 76, GM + SE, n=61, 67 | 6.6896 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76 | Week 76, GM, n=61, 67 | 9.846 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76 | Week 52, GM - SE, n=74, 83 | 4.3929 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76 | Week 76, GM - SE, n=61, 67 | 4.0983 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76 | Week 52, GM, n=74, 83 | 8.146 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76 | Week 76, GM + SE, n=61, 67 | 15.9116 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76 | Week 52, GM + SE, n=74, 83 | 12.0349 percent change |
Secondary
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.
Time frame: Baseline, Week 52, and Week 76
Population: Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change From Baseline in Total Testosterone at Week 52 and Week 76 | Week 52, GM - SE, n=74, 82 | 14.1569 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change From Baseline in Total Testosterone at Week 52 and Week 76 | Week 52, GM, n=74, 82 | 19.689 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change From Baseline in Total Testosterone at Week 52 and Week 76 | Week 52, GM + SE, n=74, 82 | 25.4897 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change From Baseline in Total Testosterone at Week 52 and Week 76 | Week 76, GM - SE, n=64, 75 | -12.5441 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change From Baseline in Total Testosterone at Week 52 and Week 76 | Week 76, GM, n=64, 75 | -8.156 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change From Baseline in Total Testosterone at Week 52 and Week 76 | Week 76, GM + SE, n=64, 75 | -3.5470 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change From Baseline in Total Testosterone at Week 52 and Week 76 | Week 76, GM, n=64, 75 | -2.932 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change From Baseline in Total Testosterone at Week 52 and Week 76 | Week 52, GM - SE, n=74, 82 | -5.8206 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change From Baseline in Total Testosterone at Week 52 and Week 76 | Week 76, GM - SE, n=64, 75 | -8.2870 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change From Baseline in Total Testosterone at Week 52 and Week 76 | Week 52, GM, n=74, 82 | 1.044 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change From Baseline in Total Testosterone at Week 52 and Week 76 | Week 76, GM + SE, n=64, 75 | 2.7363 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change From Baseline in Total Testosterone at Week 52 and Week 76 | Week 52, GM + SE, n=74, 82 | 8.4082 percent change |
Secondary
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.
Time frame: Week 52 and Week 76
Population: Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change in Free Testosterone From Week 52 to Week 76 | GM - SE | 3.1109 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change in Free Testosterone From Week 52 to Week 76 | GM | 8.993 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change in Free Testosterone From Week 52 to Week 76 | GM + SE | 15.2100 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change in Free Testosterone From Week 52 to Week 76 | GM - SE | -6.9549 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change in Free Testosterone From Week 52 to Week 76 | GM | -3.537 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change in Free Testosterone From Week 52 to Week 76 | GM + SE | 0.0073 percent change |
Secondary
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.
Time frame: Week 52 and Week 76
Population: Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change in Serum Estradiol From Week 52 to Week 76 | GM - SE | -15.2056 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change in Serum Estradiol From Week 52 to Week 76 | GM | 0.513 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change in Serum Estradiol From Week 52 to Week 76 | GM + SE | 19.1447 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change in Serum Estradiol From Week 52 to Week 76 | GM - SE | 29.3058 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change in Serum Estradiol From Week 52 to Week 76 | GM | 50.823 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change in Serum Estradiol From Week 52 to Week 76 | GM + SE | 75.9217 percent change |
Secondary
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.
Time frame: Week 52 and Week 76
Population: Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change in Sex Hormone Binding Globulin (SHBG) From Week 52 to Week 76 | GM - SE | -27.0129 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change in Sex Hormone Binding Globulin (SHBG) From Week 52 to Week 76 | GM | -24.624 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change in Sex Hormone Binding Globulin (SHBG) From Week 52 to Week 76 | GM + SE | -22.1566 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change in Sex Hormone Binding Globulin (SHBG) From Week 52 to Week 76 | GM - SE | -3.9036 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change in Sex Hormone Binding Globulin (SHBG) From Week 52 to Week 76 | GM | -0.825 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change in Sex Hormone Binding Globulin (SHBG) From Week 52 to Week 76 | GM + SE | 2.3517 percent change |
Secondary
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.
Time frame: Week 52 and Week 76
Population: Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change in Total Testosterone From Week 52 to Week 76 | GM - SE | -29.0307 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change in Total Testosterone From Week 52 to Week 76 | GM | -24.373 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change in Total Testosterone From Week 52 to Week 76 | GM + SE | -19.4104 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change in Total Testosterone From Week 52 to Week 76 | GM - SE | -13.9923 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change in Total Testosterone From Week 52 to Week 76 | GM | -7.102 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change in Total Testosterone From Week 52 to Week 76 | GM + SE | 0.3411 percent change |
Post Hoc
Adjusted Change From Baseline in Albumin-adjusted Serum Calcium (AASC) at Week 52 and Week 76
AASC levels were measured from blood samples. AASC is the amount of free calcium circulating in the blood and calcium is required for good bone health. Change from baseline was calculated as the Week 52or Week 76 value minus the baseline value and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.
Time frame: Baseline, Week 52, and Week 76
Population: Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Change From Baseline in Albumin-adjusted Serum Calcium (AASC) at Week 52 and Week 76 | Week 52, n=73, 83 | 0.01 millimoles per Liter (mmol/L) | Standard Error 0.009 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Change From Baseline in Albumin-adjusted Serum Calcium (AASC) at Week 52 and Week 76 | Week 76, n=64, 75 | 0.03 millimoles per Liter (mmol/L) | Standard Error 0.01 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Change From Baseline in Albumin-adjusted Serum Calcium (AASC) at Week 52 and Week 76 | Week 52, n=73, 83 | 0.03 millimoles per Liter (mmol/L) | Standard Error 0.009 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Change From Baseline in Albumin-adjusted Serum Calcium (AASC) at Week 52 and Week 76 | Week 76, n=64, 75 | 0.04 millimoles per Liter (mmol/L) | Standard Error 0.01 |
Post Hoc
Adjusted Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT at Week 76 + 30 Days
Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Baseline.
Time frame: Baseline and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT at Week 76 + 30 Days | -0.120 millimeters | Standard Error 0.0931 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT at Week 76 + 30 Days | -0.040 millimeters | Standard Error 0.1135 |
Post Hoc
Adjusted Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical vBMD Via QCT at Week 76 + 30 Days
vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN.
Time frame: Baseline and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical vBMD Via QCT at Week 76 + 30 Days | 7.901 mg/cm^3 | Standard Error 6.9912 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical vBMD Via QCT at Week 76 + 30 Days | -5.025 mg/cm^3 | Standard Error 8.5722 |
Post Hoc
Adjusted Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT at Week 76 + 30 Days
Cortical thickness was measured by QCT. Change from Baseline was calculated as thickness at Week 76 + 30 days minus thickness at Baseline.
Time frame: Baseline and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT at Week 76 + 30 Days | -0.082 millimeters | Standard Error 0.0816 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT at Week 76 + 30 Days | -0.048 millimeters | Standard Error 0.0978 |
Post Hoc
Adjusted Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical vBMD Via QCT at Week 76 + 30 Days
vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN.
Time frame: Baseline and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical vBMD Via QCT at Week 76 + 30 Days | -12.424 mg/cm^3 | Standard Error 8.9945 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical vBMD Via QCT at Week 76 + 30 Days | -10.244 mg/cm^3 | Standard Error 10.8703 |
Post Hoc
Adjusted Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT at Week 76 + 30 Days
Cortical thickness was measured by QCT. Change from baseline was calculated as thickness at Week 76 + 30 days minus thickness at Baseline.
Time frame: Baseline and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT at Week 76 + 30 Days | -0.117 millimeters | Standard Error 0.0484 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT at Week 76 + 30 Days | -0.087 millimeters | Standard Error 0.0575 |
Post Hoc
Adjusted Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical vBMD Via QCT at Week 76 + 30 Days
vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN.
Time frame: Baseline and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical vBMD Via QCT at Week 76 + 30 Days | -4.555 mg/cm^3 | Standard Error 3.5006 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical vBMD Via QCT at Week 76 + 30 Days | -7.553 mg/cm^3 | Standard Error 4.1177 |
Post Hoc
Adjusted Change From Baseline in Femoral Neck (FN) Supero-posterior and Cortical vBMD Via QCT at Week 76 + 30 Days
vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-posterior is the upper and back section of the FN.
Time frame: Baseline and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Change From Baseline in Femoral Neck (FN) Supero-posterior and Cortical vBMD Via QCT at Week 76 + 30 Days | -8.007 mg/cm^3 | Standard Error 3.4199 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Change From Baseline in Femoral Neck (FN) Supero-posterior and Cortical vBMD Via QCT at Week 76 + 30 Days | -7.006 mg/cm^3 | Standard Error 4.1114 |
Post Hoc
Adjusted Change From Baseline in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT at Week 76 + 30 Days
Cortical thickness was measured by QCT. Change from baseline was calculated as thickness at Week 76 + 30 days minus thickness at Baseline.
Time frame: Baseline and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Change From Baseline in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT at Week 76 + 30 Days | -0.95 millimeters | Standard Error 0.0537 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Change From Baseline in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT at Week 76 + 30 Days | -0.067 millimeters | Standard Error 0.0647 |
Post Hoc
Adjusted Change in Albumin-adjusted Serum Calcium (AASC) From Week 52 to Week 76
AASC levels were measured from blood samples. AASC is the amount of free calcium circulating in the blood and calcium is required for good bone health. Change from Week 52 was calculated as the Week 76 value minus the Week 52 value and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.
Time frame: Week 52 and Week 76
Population: Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Change in Albumin-adjusted Serum Calcium (AASC) From Week 52 to Week 76 | 0.01 millimoles per Liter (mmol/L) | Standard Error 0.011 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Change in Albumin-adjusted Serum Calcium (AASC) From Week 52 to Week 76 | 0.00 millimoles per Liter (mmol/L) | Standard Error 0.01 |
Post Hoc
Adjusted Change in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days
Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days.
Time frame: Week 52 + 30 days and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Change in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days | 0.09 millimeters | Standard Error 0.065 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Change in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days | 0.01 millimeters | Standard Error 0.078 |
Post Hoc
Adjusted Change in Femoral Neck (FN) Infero-anterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days
vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN.
Time frame: Week 52 + 30 days and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Change in Femoral Neck (FN) Infero-anterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days | 20.15 mg/cm^3 | Standard Error 9.677 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Change in Femoral Neck (FN) Infero-anterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days | -10.73 mg/cm^3 | Standard Error 11.83 |
Post Hoc
Adjusted Change in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days
Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days.
Time frame: Week 52 + 30 days and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Change in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days | -0.08 millimeters | Standard Error 0.078 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Change in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days | 0.07 millimeters | Standard Error 0.093 |
Post Hoc
Adjusted Change in Femoral Neck (FN) Infero-posterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days
vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN.
Time frame: Week 52 + 30 days and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Change in Femoral Neck (FN) Infero-posterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days | 15.48 mg/cm^3 | Standard Error 11.544 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Change in Femoral Neck (FN) Infero-posterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days | -17.59 mg/cm^3 | Standard Error 13.865 |
Post Hoc
Adjusted Change in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT From Week 52+30 Days to Week 76 + 30 Days
Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days.
Time frame: Week 52 + 30 days and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Change in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT From Week 52+30 Days to Week 76 + 30 Days | 0.11 millimeters | Standard Error 0.052 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Change in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT From Week 52+30 Days to Week 76 + 30 Days | -0.13 millimeters | Standard Error 0.061 |
Post Hoc
Adjusted Change in Femoral Neck (FN) Supero-anterior Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days
vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN.
Time frame: Week 52 + 30 days and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Change in Femoral Neck (FN) Supero-anterior Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | 5.19 mg/cm^3 | Standard Error 3.686 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Change in Femoral Neck (FN) Supero-anterior Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | -6.24 mg/cm^3 | Standard Error 4.319 |
Post Hoc
Adjusted Change in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days
Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days.
Time frame: Week 52 + 30 days and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Change in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days | 0.18 millimeters | Standard Error 0.049 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Change in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days | -0.05 millimeters | Standard Error 0.059 |
Post Hoc
Adjusted Change in Femoral Neck (FN) Supero-posterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days
vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therpay, and region. Supero-posterior is the upper and back section of the FN.
Time frame: Week 52 + 30 days and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Change in Femoral Neck (FN) Supero-posterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days | 9.30 mg/cm^3 | Standard Error 4.287 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Change in Femoral Neck (FN) Supero-posterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days | -4.92 mg/cm^3 | Standard Error 5.13 |
Post Hoc
Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days
Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days (orWeek 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%.
Time frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, n=32, 35 | -6.05 percent change | Standard Error 2.393 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, n=31, 30 | -3.59 percent change | Standard Error 2.804 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, n=32, 35 | 0.64 percent change | Standard Error 2.656 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, n=31, 30 | 0.39 percent change | Standard Error 3.421 |
Post Hoc
Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days
vBMD (measured in milligrams per centimeters cubed \[mg/cm\^3\]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (orWeek 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN.
Time frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Integral, n=32, 35 | -4.35 percent change | Standard Error 1.95 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52, Trabecular, n=32, 35 | -161.59 percent change | Standard Error 774.589 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52, Cortical, n=32, 35 | -1.85 percent change | Standard Error 1.309 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Integral, n=31, 30 | -0.29 percent change | Standard Error 2.301 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Trabecular, n=31, 30 | 81.29 percent change | Standard Error 35.959 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Cortical, n=31, 30 | 1.45 percent change | Standard Error 1.149 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Trabecular, n=31, 30 | 37.81 percent change | Standard Error 42.791 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Integral, n=32, 35 | 1.26 percent change | Standard Error 2.163 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Integral, n=31, 30 | 0.54 percent change | Standard Error 2.81 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52, Trabecular, n=32, 35 | 930.71 percent change | Standard Error 851.727 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Cortical, n=31, 30 | -0.63 percent change | Standard Error 1.409 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52, Cortical, n=32, 35 | 0.85 percent change | Standard Error 1.563 |
Post Hoc
Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days
Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days (or Week 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%.
Time frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, n=32, 35 | 0.47 percent change | Standard Error 1.977 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, n=31, 30 | -1.46 percent change | Standard Error 1.593 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, n=32, 35 | -1.27 percent change | Standard Error 2.18 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, n=31, 30 | -0.11 percent change | Standard Error 1.91 |
Post Hoc
Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days
vBMD (measured in milligrams per centimeters cubed \[mg/cm\^3\]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN.
Time frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Integral, n=32, 35 | -4.11 percent change | Standard Error 1.074 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Trabecular, n=32, 35 | -84.08 percent change | Standard Error 270.7 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Cortical, n=32, 35 | -3.42 percent change | Standard Error 1.531 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Integral, n=31, 30 | -3.11 percent change | Standard Error 0.933 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Trabecular, n=31, 30 | 24.46 percent change | Standard Error 17.473 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Cortical, n=31, 30 | -1.32 percent change | Standard Error 1.234 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Trabecular, n=31, 30 | 13.54 percent change | Standard Error 20.79 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Integral, n=32, 35 | 1.74 percent change | Standard Error 1.2 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Integral, n=31, 30 | 0.01 percent change | Standard Error 1.147 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Trabecular, n=32, 35 | 282.16 percent change | Standard Error 297.445 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Cortical, n=31, 30 | -1.17 percent change | Standard Error 1.492 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Cortical, n=32, 35 | 1.14 percent change | Standard Error 1.694 |
Post Hoc
Adjusted Percent Change From Baseline in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days
vBMD (measured in milligrams per centimeters cubed \[mg/cm\^3\]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (orWeek 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.
Time frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Integral, n=32, 35 | -3.72 percent change | Standard Error 1.097 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Cortical, n=32, 35 | -1.00 percent change | Standard Error 0.735 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Cortical, n=31, 30 | -0.46 percent change | Standard Error 0.599 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Integral, n=31, 30 | -2.13 percent change | Standard Error 0.946 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Trabecular, n=32, 35 | -1.83 percent change | Standard Error 1.695 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Trabecular, n=31, 30 | -1.05 percent change | Standard Error 1.798 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Trabecular, n=32, 35 | 0.91 percent change | Standard Error 1.867 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Cortical, n=31, 30 | -1.60 percent change | Standard Error 0.723 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Integral, n=32, 35 | 0.58 percent change | Standard Error 1.208 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Trabecular, n=31, 30 | 2.27 percent change | Standard Error 2.141 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Cortical, n=32, 35 | -0.20 percent change | Standard Error 0.819 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Integral, n=31, 30 | -0.61 percent change | Standard Error 1.141 |
Post Hoc
Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days
Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days(or Week 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%.
Time frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, n=32, 35 | -13.45 percent change | Standard Error 5.002 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, n=31, 30 | -4.23 percent change | Standard Error 4.491 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, n=32, 35 | 5.05 percent change | Standard Error 5.453 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, n=31, 30 | -4.78 percent change | Standard Error 5.327 |
Post Hoc
Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days
vBMD (measured in milligrams per centimeters cubed \[mg/cm\^3\]) was measured by QCT. Percent change from Baseline at Week 52 + 30 daysor Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days(or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN.
Time frame: Baseline, Week 52 plus 30 days, and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Integral, n=32, 35 | -6.56 percent change | Standard Error 2.106 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Trabecular, n=32, 35 | 3.59 percent change | Standard Error 4.719 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Cortical, n=32, 35 | -1.91 percent change | Standard Error 0.901 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Integral, n=31, 30 | -4.97 percent change | Standard Error 2.384 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Trabecular, n=31, 30 | -0.85 percent change | Standard Error 6.05 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Cortical, n=31, 30 | -0.93 percent change | Standard Error 0.745 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Trabecular, n=31, 30 | 3.98 percent change | Standard Error 7.171 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Integral, n=32, 35 | -0.58 percent change | Standard Error 2.311 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Integral, n=31, 30 | -2.45 percent change | Standard Error 2.838 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Trabecular, n=32, 35 | 2.82 percent change | Standard Error 5.18 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Cortical, n=31, 30 | -1.49 percent change | Standard Error 0.876 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Cortical, n=32, 35 | -0.25 percent change | Standard Error 0.977 |
Post Hoc
Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days
Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days (or Week 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%
Time frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, n=32, 35 | -20.48 percent change | Standard Error 3.614 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, n=31,30 | -3.52 percent change | Standard Error 3.674 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, n=32, 35 | 1.00 percent change | Standard Error 3.986 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, n=31,30 | -1.50 percent change | Standard Error 4.423 |
Post Hoc
Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days
vBMD (measured in milligrams per centimeters cubed \[mg/cm\^3\]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days orWeek 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therpay, and region. Supero-posterior is the upper and back section of the FN.
Time frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Integral, n=32, 35 | -10.26 percent change | Standard Error 2.194 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Trabecular, n=32, 35 | 2.77 percent change | Standard Error 5.848 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Cortical, n=32, 35 | -3.76 percent change | Standard Error 0.836 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Integral, n=31, 30 | -4.21 percent change | Standard Error 2.094 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Trabecular, n=31, 30 | 2.37 percent change | Standard Error 7.04 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Cortical, n=31, 30 | -1.65 percent change | Standard Error 0.73 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Trabecular, n=31, 30 | 10.24 percent change | Standard Error 8.362 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Integral, n=32, 35 | -0.03 percent change | Standard Error 2.417 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Integral, n=31, 30 | 1.07 percent change | Standard Error 2.508 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Trabecular, n=32, 35 | 5.57 percent change | Standard Error 6.42 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Cortical, n=31, 30 | -1.30 percent change | Standard Error 0.877 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Cortical, n=32, 35 | -0.66 percent change | Standard Error 0.922 |
Post Hoc
Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) at Week 52 + 30 Days and Week 76 + 30 Days
BMD (measured in grams per centimeters squared \[g/cm\^2\]) was measured by QCT. BMD by QCT is the 2-dimensional volume that mimics the DXA measurement for the same region. Percent change from Baseline at Week 52 + 30 days orWeek 76 + 30 days was calculated as (BMD at Week 52 + 30 days (orWeek 76 + 30 days) minus BMD at baseline)/BMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.
Time frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days; Femoral neck (FN), n=32, 35 | -2.39 percent change | Standard Error 0.895 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days; Total hip (TH), n=32, 35 | -3.39 percent change | Standard Error 0.475 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days; Trochanter (Tro.), n=32, 35 | -4.53 percent change | Standard Error 0.612 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) at Week 52 + 30 Days and Week 76 + 30 Days | Week 52+30 days; Intertrochanter (Inter.),n=32, 35 | -3.36 percent change | Standard Error 0.515 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) at Week 52 + 30 Days and Week 76 + 30 Days | Week 76+30 days; Femoral neck (FN), n=31, 30 | -1.98 percent change | Standard Error 0.587 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days; TH, n=31, 30 | -2.11 percent change | Standard Error 0.495 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days; Tro., n=31, 30 | -2.86 percent change | Standard Error 0.752 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days; Inter., n=31, 30 | -1.66 percent change | Standard Error 0.525 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days; Inter., n=31, 30 | 0.30 percent change | Standard Error 0.627 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days; Femoral neck (FN), n=32, 35 | 0.09 percent change | Standard Error 0.986 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) at Week 52 + 30 Days and Week 76 + 30 Days | Week 76+30 days; Femoral neck (FN), n=31, 30 | -1.52 percent change | Standard Error 0.705 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days; Total hip (TH), n=32, 35 | 0.09 percent change | Standard Error 0.521 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days; Tro., n=31, 30 | -1.28 percent change | Standard Error 0.892 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days; Trochanter (Tro.), n=32, 35 | -0.23 percent change | Standard Error 0.669 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days; TH, n=31, 30 | -0.32 percent change | Standard Error 0.591 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) at Week 52 + 30 Days and Week 76 + 30 Days | Week 52+30 days; Intertrochanter (Inter.),n=32, 35 | 0.77 percent change | Standard Error 0.565 |
Post Hoc
Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 10 Days and Week 76 + 10 Days
BMD (measured in grams per centimeters squared \[g/cm\^2\]) was measured by DXA. Percent change from Baseline at Week 52 + 10 days or Week 76 + 10 days was calculated as (BMD at Week 52 + 10 days (or 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.
Time frame: Baseline, Week 52 + 10 days, and Week 76 + 10 days
Population: Safety Population. Only evaluable participants with a value at Baseline and at Week 52 performed up to 10 days after initiating OL MET or at Week 76 performed up to 10 days after stopping OL MET for the parameter of interest were analyzed. Not all participants had the correct positioning for the DXA lumbar spine measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 10 Days and Week 76 + 10 Days | Week 52 + 10 days; Total hip (TH), n=70, 78 | -1.62 percent change | Standard Error 0.386 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 10 Days and Week 76 + 10 Days | Week 76 + 10 days; FN, n=65, 70 | -1.91 percent change | Standard Error 0.624 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 10 Days and Week 76 + 10 Days | Week 76 + 10 days; TH, n=65, 70 | -1.70 percent change | Standard Error 0.415 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 10 Days and Week 76 + 10 Days | Week 52 + 10 days; Lumbar spine (LS), n=70, 76 | -1.41 percent change | Standard Error 0.416 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 10 Days and Week 76 + 10 Days | Week 76 + 10 days; Tro., n=65, 70 | -2.14 percent change | Standard Error 0.644 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 10 Days and Week 76 + 10 Days | Week 52 + 10 days; Trochanter (Tro.), n=70, 78 | -1.45 percent change | Standard Error 0.602 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 10 Days and Week 76 + 10 Days | Week 76 + 10 days; LS, n=65, 71 | -1.24 percent change | Standard Error 0.452 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 10 Days and Week 76 + 10 Days | Week 52 + 10 days; Femoral neck (FN), n=70, 78 | -1.47 percent change | Standard Error 0.521 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 10 Days and Week 76 + 10 Days | Week 76 + 10 days; LS, n=65, 71 | 0.85 percent change | Standard Error 0.457 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 10 Days and Week 76 + 10 Days | Week 52 + 10 days; Femoral neck (FN), n=70, 78 | 0.22 percent change | Standard Error 0.512 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 10 Days and Week 76 + 10 Days | Week 52 + 10 days; Total hip (TH), n=70, 78 | -0.72 percent change | Standard Error 0.379 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 10 Days and Week 76 + 10 Days | Week 52 + 10 days; Trochanter (Tro.), n=70, 78 | -1.04 percent change | Standard Error 0.589 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 10 Days and Week 76 + 10 Days | Week 52 + 10 days; Lumbar spine (LS), n=70, 76 | 0.04 percent change | Standard Error 0.419 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 10 Days and Week 76 + 10 Days | Week 76 + 10 days; FN, n=65, 70 | 0.31 percent change | Standard Error 0.636 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 10 Days and Week 76 + 10 Days | Week 76 + 10 days; TH, n=65, 70 | -0.83 percent change | Standard Error 0.42 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 10 Days and Week 76 + 10 Days | Week 76 + 10 days; Tro., n=65, 70 | -1.35 percent change | Standard Error 0.65 |
Post Hoc
Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 30 Days and Week 76 + 30 Days
BMD (measured in grams per centimeters squared \[g/cm\^2\]) was measured by DXA. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (BMD at Week 52 + 30 days (or Week 76 + 30 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.
Time frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days
Population: Safety Population. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. Not all participants had the correct positioning for all of the DXA measurements.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days; Femoral neck (FN), n=77, 83 | -1.59 percent change | Standard Error 0.503 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days; Total hip (TH), n=77, 83 | -1.79 percent change | Standard Error 0.37 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days; Trochanter (Tro.), n=77, 83 | -1.83 percent change | Standard Error 0.583 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days; Lumbar spine (LS), n=79, 81 | -1.60 percent change | Standard Error 0.417 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days; FN, n=66, 74 | -2.05 percent change | Standard Error 0.62 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days; TH, n=66, 74 | -1.79 percent change | Standard Error 0.408 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days; Tro., n=66, 74 | -2.53 percent change | Standard Error 0.508 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days; LS, n=66, 72 | -1.15 percent change | Standard Error 0.464 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days; LS, n=66, 72 | 1.13 percent change | Standard Error 0.467 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days; Femoral neck (FN), n=77, 83 | 0.24 percent change | Standard Error 0.498 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days; FN, n=66, 74 | 0.29 percent change | Standard Error 0.619 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days; Total hip (TH), n=77, 83 | -0.72 percent change | Standard Error 0.364 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days; Tro., n=66, 74 | -0.96 percent change | Standard Error 0.575 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days; Trochanter (Tro.), n=77, 83 | -1.01 percent change | Standard Error 0.574 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days; TH, n=66, 74 | -0.68 percent change | Standard Error 0.404 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days; Lumbar spine (LS), n=79, 81 | 0.11 percent change | Standard Error 0.421 |
Post Hoc
Adjusted Percent Change From Baseline in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days
vBMD (measured in milligrams per centimeters cubed \[mg/cm\^3\]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.
Time frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Integral, n=32, 35 | -3.47 percent change | Standard Error 0.621 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Trabecular, n=32, 35 | -4.26 percent change | Standard Error 1.341 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Cortical, n=32, 35 | -0.76 percent change | Standard Error 0.568 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Integral, n=31, 30 | -0.92 percent change | Standard Error 0.746 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Trabecular, n=31, 30 | -3.09 percent change | Standard Error 1.278 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Cortical, n=31, 30 | 0.41 percent change | Standard Error 0.472 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Trabecular, n=31, 30 | 0.27 percent change | Standard Error 1.525 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Integral, n=32, 35 | 2.18 percent change | Standard Error 0.683 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Integral, n=31, 30 | 1.88 percent change | Standard Error 0.895 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Trabecular, n=32, 35 | -0.22 percent change | Standard Error 1.485 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Cortical, n=31, 30 | 0.79 percent change | Standard Error 0.573 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Cortical, n=32, 35 | 0.99 percent change | Standard Error 0.631 |
Post Hoc
Adjusted Percent Change From Baseline in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT at Week 52 + 30 Days and at Week 76 + 30 Days
Volumetric (v)BMD (measured in milligrams per centimeters cubed \[mg/cm\^3\]) was measured by QCT. vBMD is the 3-dimensional density of a region of bone. Cortical bone is dense bone. Trabecular bone is spongy bone. Integral bone is the sum of cortical and trabecular bone measurements. Cortical thickness is the width of the cortical shell. Percent change from Baseline was calculated as (vBMD at Week 52+30 days (or Week 76+30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by ANCOVA with terms for treatment, baseline value, prior therapy, and region.
Time frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT at Week 52 + 30 Days and at Week 76 + 30 Days | Week 52 + 30 days; Integral, n=32, 35 | -3.60 percent change | Standard Error 0.587 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT at Week 52 + 30 Days and at Week 76 + 30 Days | Week 52 + 30 days; Trabecular, n=32, 35 | -3.63 percent change | Standard Error 1.243 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT at Week 52 + 30 Days and at Week 76 + 30 Days | Week 52 + 30 days; Cortical, n=32, 35 | -0.54 percent change | Standard Error 0.537 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT at Week 52 + 30 Days and at Week 76 + 30 Days | Week 76 + 30 days; Integral, n=31, 30 | -1.70 percent change | Standard Error 0.657 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT at Week 52 + 30 Days and at Week 76 + 30 Days | Week 76 + 30 days; Trabecular, n=31, 30 | -2.66 percent change | Standard Error 1.211 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT at Week 52 + 30 Days and at Week 76 + 30 Days | Week 76 + 30 days; Cortical, n=31, 30 | 0.23 percent change | Standard Error 0.421 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT at Week 52 + 30 Days and at Week 76 + 30 Days | Week 76 + 30 days; Trabecular, n=31, 30 | 0.70 percent change | Standard Error 1.445 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT at Week 52 + 30 Days and at Week 76 + 30 Days | Week 52 + 30 days; Integral, n=32, 35 | 0.99 percent change | Standard Error 0.645 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT at Week 52 + 30 Days and at Week 76 + 30 Days | Week 76 + 30 days; Integral, n=31, 30 | 0.85 percent change | Standard Error 0.786 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT at Week 52 + 30 Days and at Week 76 + 30 Days | Week 52 + 30 days; Trabecular, n=32, 35 | 0.21 percent change | Standard Error 1.376 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT at Week 52 + 30 Days and at Week 76 + 30 Days | Week 76 + 30 days; Cortical, n=31, 30 | 0.50 percent change | Standard Error 0.518 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT at Week 52 + 30 Days and at Week 76 + 30 Days | Week 52 + 30 days; Cortical, n=32, 35 | 0.52 percent change | Standard Error 0.603 |
Post Hoc
Adjusted Percent Change From Baseline in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days
vBMD (measured in milligrams per centimeters cubed \[mg/cm\^3\]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.
Time frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Integral, n=32, 35 | -4.80 percent change | Standard Error 0.666 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Trabecular, n=32, 35 | -3.43 percent change | Standard Error 1.157 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Cortical, n=32, 35 | -1.26 percent change | Standard Error 0.49 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Integral, n=31, 30 | -2.88 percent change | Standard Error 0.748 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Trabecular, n=31, 30 | -2.42 percent change | Standard Error 1.085 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Cortical, n=31, 30 | -0.49 percent change | Standard Error 0.384 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Trabecular, n=31, 30 | 0.92 percent change | Standard Error 1.293 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Integral, n=32, 35 | 0.01 percent change | Standard Error 0.73 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Integral, n=31, 30 | -0.93 percent change | Standard Error 0.889 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Trabecular, n=32, 35 | 0.67 percent change | Standard Error 1.275 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, Cortical, n=31, 30 | -0.64 percent change | Standard Error 0.462 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, Cortical, n=32, 35 | -0.18 percent change | Standard Error 0.54 |
Post Hoc
Adjusted Percent Change From Baseline in Vertebral Trabecular vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days
BMD (measured in milligrams per centimeters cubed \[mg/cm\^3\]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (orWeek 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.
Time frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Vertebral Trabecular vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, n=32, 35 | -6.71 percent change | Standard Error 1.454 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Vertebral Trabecular vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, n=31, 30 | -5.15 percent change | Standard Error 1.121 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Vertebral Trabecular vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 52 + 30 days, n=32, 35 | -1.72 percent change | Standard Error 1.601 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change From Baseline in Vertebral Trabecular vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days | Week 76 + 30 days, n=31, 30 | -3.91 percent change | Standard Error 1.337 |
Post Hoc
Adjusted Percent Change in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days
Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%.
Time frame: Week 52 + 30 days and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days | 3.12 percent change | Standard Error 2.127 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days | 1.56 percent change | Standard Error 2.257 |
Post Hoc
Adjusted Percent Change in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days
vBMD (measured in milligrams per centimeters cubed \[mg/cm\^3\]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN.
Time frame: Week 52 + 30 days and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Integral | 5.05 percent change | Standard Error 1.878 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Trabecular | -90.60 percent change | Standard Error 167.792 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Cortical | 3.68 percent change | Standard Error 1.649 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Integral | 0.38 percent change | Standard Error 2.268 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Trabecular | 260.13 percent change | Standard Error 199.323 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Cortical | -1.64 percent change | Standard Error 2.016 |
Post Hoc
Adjusted Percent Change in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days
Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%.
Time frame: Week 52 + 30 days and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days | -1.48 percent change | Standard Error 1.552 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days | 2.04 percent change | Standard Error 1.846 |
Post Hoc
Adjusted Percent Change in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days
vBMD (measured in milligrams per centimeters cubed \[mg/cm\^3\]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN.
Time frame: Week 52 + 30 days and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Integral | 1.47 percent change | Standard Error 1.183 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Trabecular | -39.81 percent change | Standard Error 130.071 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Cortical | 2.67 percent change | Standard Error 1.728 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Integral | -1.87 percent change | Standard Error 1.435 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Trabecular | 161.81 percent change | Standard Error 154.179 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Cortical | -2.50 percent change | Standard Error 2.076 |
Post Hoc
Adjusted Percent Change in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days
vBMD (measured in milligrams per centimeters cubed \[mg/cm\^3\]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.
Time frame: Week 52 + 30 days and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Integral | 2.21 percent change | Standard Error 0.871 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Trabecular | 0.27 percent change | Standard Error 1.721 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Cortical | 1.03 percent change | Standard Error 0.774 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Integral | -1.37 percent change | Standard Error 1.04 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Trabecular | 2.21 percent change | Standard Error 2.044 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Cortical | -1.30 percent change | Standard Error 0.929 |
Post Hoc
Adjusted Percent Change in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days
Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%.
Time frame: Week 52 + 30 days and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days | 14.02 percent change | Standard Error 6.779 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days | -13.65 percent change | Standard Error 7.995 |
Post Hoc
Adjusted Percent Change in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days
vBMD (measured in milligrams per centimeters cubed \[mg/cm\^3\]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN.
Time frame: Week 52 + 30 days and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Integral | 2.96 percent change | Standard Error 2.202 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Trabecular | -2.78 percent change | Standard Error 4.677 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Cortical | 1.19 percent change | Standard Error 0.778 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Integral | -1.81 percent change | Standard Error 2.609 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Trabecular | 6.63 percent change | Standard Error 5.531 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Cortical | -1.28 percent change | Standard Error 0.912 |
Post Hoc
Adjusted Percent Change in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT From Week 52+30 Days to Week 76 + 30 Days
Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%.
Time frame: Week 52 + 30 days and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT From Week 52+30 Days to Week 76 + 30 Days | 32.42 percent change | Standard Error 10.358 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT From Week 52+30 Days to Week 76 + 30 Days | -7.80 percent change | Standard Error 2.383 |
Post Hoc
Adjusted Percent Change in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days
vBMD (measured in milligrams per centimeters cubed \[mg/cm\^3\]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therpay, and region. Supero-posterior is the upper and back section of the FN.
Time frame: Week 52 + 30 days and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Integral | 8.29 percent change | Standard Error 3.262 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Trabecular | 36.05 percent change | Standard Error 31.815 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Cortical | 2.17 percent change | Standard Error 0.944 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Integral | 0.52 percent change | Standard Error 3.884 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Trabecular | -11.69 percent change | Standard Error 37.721 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Cortical | -0.94 percent change | Standard Error 1.129 |
Post Hoc
Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) From Week 52+30 Days to Week 76 + 30 Days
BMD (measured in grams per centimeters squared \[g/cm\^2\]) was measured by QCT. BMD by QCT is the 2-dimensional volume that mimics the DXA measurement for the same region. 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 an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.
Time frame: Week 52 + 30 days and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) From Week 52+30 Days to Week 76 + 30 Days | percent change | 0.95 percent change | Standard Error 0.728 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) From Week 52+30 Days to Week 76 + 30 Days | Total hip | 1.61 percent change | Standard Error 0.346 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) From Week 52+30 Days to Week 76 + 30 Days | Trochanter | 1.81 percent change | Standard Error 0.534 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) From Week 52+30 Days to Week 76 + 30 Days | Intertrochanter | 2.05 percent change | Standard Error 0.428 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) From Week 52+30 Days to Week 76 + 30 Days | Intertrochanter | -0.25 percent change | Standard Error 0.507 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) From Week 52+30 Days to Week 76 + 30 Days | percent change | -1.39 percent change | Standard Error 0.866 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) From Week 52+30 Days to Week 76 + 30 Days | Trochanter | -0.91 percent change | Standard Error 0.632 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) From Week 52+30 Days to Week 76 + 30 Days | Total hip | -0.18 percent change | Standard Error 0.411 |
Post Hoc
Adjusted Percent Change in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days
vBMD (measured in milligrams per centimeters cubed \[mg/cm\^3\]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.
Time frame: Week 52 + 30 days and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | percent change | 2.83 percent change | Standard Error 0.563 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Trabecular | 1.16 percent change | Standard Error 1.298 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Cortical | 1.29 percent change | Standard Error 0.479 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | percent change | -0.46 percent change | Standard Error 0.671 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Trabecular | 1.21 percent change | Standard Error 1.545 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Cortical | -0.27 percent change | Standard Error 0.577 |
Post Hoc
Adjusted Percent Change in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days
Volumetric (v)BMD (measured in milligrams per centimeters cubed \[mg/cm\^3\]) was measured by QCT. vBMD is the 3-dimensional density of a region of bone. Cortical bone is dense bone. Trabecular bone is spongy bone. Integral bone is the sum of cortical and trabecular bone measurements. Cortical thickness is the width of the cortical shell. Percent change from Week 52 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/ vBMD at Week 52 + 30 days x 100% and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.
Time frame: Week 52 + 30 days and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Integral | 2.24 percent change | Standard Error 0.483 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Trabecular | 0.90 percent change | Standard Error 1.252 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Cortical | 0.94 percent change | Standard Error 0.449 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Integral | -0.20 percent change | Standard Error 0.5746 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Trabecular | 1.15 percent change | Standard Error 1.491 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Cortical | -0.06 percent change | Standard Error 0.548 |
Post Hoc
Adjusted Percent Change in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days
vBMD (measured in milligrams per centimeters cubed \[mg/cm\^3\]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.
Time frame: Week 52 + 30 days and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | percent change | 2.22 percent change | Standard Error 0.506 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Trabecular | 1.07 percent change | Standard Error 1.138 |
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Cortical | 0.78 percent change | Standard Error 0.396 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | percent change | -0.90 percent change | Standard Error 0.6 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Trabecular | 0.95 percent change | Standard Error 1.353 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | Cortical | -0.65 percent change | Standard Error 0.474 |
Post Hoc
Adjusted Percent Change in Vertebral Trabecular vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days
BMD (measured in milligrams per centimeters cubed \[mg/cm\^3\]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.
Time frame: Week 52 + 30 days and Week 76 + 30 days
Population: Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Adjusted Percent Change in Vertebral Trabecular vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | 3.53 percent change | Standard Error 1.454 |
| Metformin in DB Period; Metformin in OL Period | Adjusted Percent Change in Vertebral Trabecular vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days | -2.11 percent change | Standard Error 1.727 |
Other Pre-specified
Percent Change in Free Estradiol From Week 52 to Week 76
Free estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Free estrodial is the amount of estrogen available to the body for use. Change was based on log-transformed data.
Time frame: Week 52 and Week 76
Population: Safety Population. Only evaluable participants with a value at Week 52 and Week 76 for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change in Free Estradiol From Week 52 to Week 76 | GM - SE | -29.5250 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change in Free Estradiol From Week 52 to Week 76 | GM | -3.239 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change in Free Estradiol From Week 52 to Week 76 | GM + SE | 32.8525 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change in Free Estradiol From Week 52 to Week 76 | GM - SE | 96.1843 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change in Free Estradiol From Week 52 to Week 76 | GM | 173.932 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change in Free Estradiol From Week 52 to Week 76 | GM + SE | 282.4903 percent change |
Other Pre-specified
Percent Change in Percentage of Free Estradiol From Week 52 to Week 76
Free estradiol levels were measured as a percentage of serum estrogen from blood samples. Free estradiol is the amount of estrogen available to the body for use. Percent change was based on log-transformed data.
Time frame: Week 52 and Week 76
Population: Safety Population. Only evaluable participants with a value at Week 52 and Week 76 for the parameter of interest were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change in Percentage of Free Estradiol From Week 52 to Week 76 | GM - SE | -7.6337 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change in Percentage of Free Estradiol From Week 52 to Week 76 | GM | -2.683 percent change |
| Rosiglitazone in DB Period; Metformin in OL Period | Percent Change in Percentage of Free Estradiol From Week 52 to Week 76 | GM + SE | 2.5337 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change in Percentage of Free Estradiol From Week 52 to Week 76 | GM - SE | -5.4666 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change in Percentage of Free Estradiol From Week 52 to Week 76 | GM | -0.975 percent change |
| Metformin in DB Period; Metformin in OL Period | Percent Change in Percentage of Free Estradiol From Week 52 to Week 76 | GM + SE | 3.7301 percent change |