metformin and Myocardial Infarction

metformin has been researched along with Myocardial Infarction in 168 studies

Metformin: A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)
metformin : A member of the class of guanidines that is biguanide the carrying two methyl substituents at position 1.

Myocardial Infarction: NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION).

Research

Studies (168)

Authors

Clinical Trials (45)

Trial Overview

Trial Outcomes

Development of Diabetes.

Primary outcome for years 2002-2008 defined according to American Diabetes Association criteria (fasting plasma glucose level >= 126 mg/dL [7.0 mmol/L] or 2-hour plasma glucose >= 200 mg/dL [11.1 mmol/L], after a 75 gram oral glucose tolerance test (OGTT), and confirmed with a repeat test). (NCT00038727)
Timeframe: Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).

Mortality

All cause-mortality through clinic reports and National Death Index search (NCT00038727)
Timeframe: Outcomes were assessed throughout follow-up from 1996 to 2022. National Death Index search conducted in 2019 using early release data as of Dec 2018.

Prevalence of Aggregate Microvascular Complication

Aggregate microvascular disease is defined as the average prevalence of 3 components: (1) retinopathy measured by photography (ETDRS of 20 or greater); (2) neuropathy detected by Semmes Weinstein 10 gram monofilament, and (3) nephropathy based on estimated glomerular filtration rate (eGFR by chronic kidney disease (CKD-Epi) equation ) (<45 ml/min, confirmed) and albumin-to-creatinine ratio in spot urine (> 30mg/gm, confirmed). (NCT00038727)
Timeframe: Outcomes were assessed from 2012-2013 (approximately 2 years).

Subclinical Atherosclerosis

Measured using coronary artery calcification (CAC). (NCT00038727)
Timeframe: Outcomes were assessed from 2012-2013 (approximately 2 years).

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. (NCT00679939)
Timeframe: Baseline and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Baseline and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Baseline and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Baseline and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Baseline and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Baseline and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Baseline and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Baseline and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Week 52 and Week 76

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. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Baseline and Week 52

Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 76+10 Days

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. (NCT00679939)
Timeframe: Baseline and Week 76+10 days

Adjusted Percent Change in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) From Week 52 +10 Days to Week 76+10 Days

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. (NCT00679939)
Timeframe: Week 52+10 days and Week 76+10 days

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%. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

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%. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

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%. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

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%. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Baseline, Week 52, and Week 76

Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76

Vitamin D levels were measured in nanomoles per Liter (nmol/L) from blood samples. Vitamin D is required for good bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Baseline, Week 52, and Week 76

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. (NCT00679939)
Timeframe: Baseline, Week 52, and Week 76

Adjusted Percent Change From Baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76

CTX levels were measured in picograms per milliliter (pg/ml) from blood samples. CTX is an indicator of bone break down or resorption. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Baseline, Week 52, and Week 76

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%. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

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%. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

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%. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Baseline, Week 52 plus 30 days, and Week 76 + 30 days

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% (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Baseline and Week 52

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. (NCT00679939)
Timeframe: Baseline, Week 52 + 10 days, and Week 76 + 10 days

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. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Baseline, Week 52, and Week 76

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. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Week 52 and Week 76

Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76

BSAP and P1NP levels were measured in micrograms per liter (mcg/L) from blood samples. BSAP and P1NP are indicators of bone buildup or formation. GM, geometric mean; SE, standard error. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Week 52 and Week 76

Adjusted Percent Change in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) From Week 52 to Week 76

CTX levels were measured in picograms per milliliter (pg/ml) from blood samples. CTX is an indicator of bone break down or resorption. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Week 52 and Week 76

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. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Week 52 + 10 days and Week 76 + 10 days

Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA From Week 52+30 Days to Week 76 + 30 Days

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. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Week 52 and Week 76

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. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

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. (NCT00679939)
Timeframe: Baseline, Week 52, and Week 76

Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76

Serum estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Estradiol is one form of the female sex hormone estrogen and influences bone health. Percent change from baseline was based on log-transformed data. (NCT00679939)
Timeframe: Baseline, Week 52, and Week 76

Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76

SHBG levels were measured in nanomoles per liter (nmol/L) from blood samples. SHBG binds to estradiol and testosterone and influences the amount of estradiol or testosterone available to the body for use. Percent change from baseline was based on log-transformed data. (NCT00679939)
Timeframe: Baseline, Week 52, and Week 76

Percent Change From Baseline in Total Testosterone at Week 52 and Week 76

Total testosterone levels were measured in nanomoles per Liter (nmol/L) from blood samples. Testosterone is a male sex hormone and influences bone health; total testosterone is the entire amount circulating in blood. Percent change from baseline was based on log-transformed data. (NCT00679939)
Timeframe: Baseline, Week 52, and Week 76

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. (NCT00679939)
Timeframe: Week 52 and Week 76

Percent Change in Free Testosterone From Week 52 to Week 76

Free testosterone levels were measured as a percentage of total testosterone from blood samples. Free testosterone is the amount of testosterone available to the body for use. Percent change from baseline was based on log-transformed data. (NCT00679939)
Timeframe: Week 52 and Week 76

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. (NCT00679939)
Timeframe: Week 52 and Week 76

Percent Change in Serum Estradiol From Week 52 to Week 76

Serum estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Estradiol is one form of the female sex hormone estrogen and influences bone health. Percent change from baseline was based on log-transformed data. (NCT00679939)
Timeframe: Week 52 and Week 76

Percent Change in Sex Hormone Binding Globulin (SHBG) From Week 52 to Week 76

SHBG levels were measured in nanomoles per liter (nmol/L) from blood samples. SHBG binds to estradiol and testosterone and influences the amount of estradiol or testosterone available to the body for use. Percent change from baseline was based on log-transformed data. (NCT00679939)
Timeframe: Week 52 and Week 76

Percent Change in Total Testosterone From Week 52 to Week 76

Total testosterone levels were measured in nanomoles per Liter (nmol/L) from blood samples. Testosterone is a male sex hormone and influences bone health; total testosterone is the entire amount circulating in blood. Percent change from baseline was based on log-transformed data. (NCT00679939)
Timeframe: Week 52 and Week 76

Differences in Augmentation Index at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.

Differences in augmentation index (AI, %) using oscillometry at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R. (NCT03010683)
Timeframe: Baseline, 3 months, 6 months, and 12 months.

Differences in Endothelial Glycocalyx Thickness at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.

Differences in endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R. High PBR values represent reduced glycocalyx thickness. (NCT03010683)
Timeframe: Baseline, 3 months, 6 months, and 12 months.

Differences in Pulse Wave Velocity at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.

Differences in carotid-femoral pulse wave velocity (PWV, m/sec) using tonometry at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R. (NCT03010683)
Timeframe: Baseline, 3 months, 6 months and 12 months

Endothelial Glycocalyx and Pulse Wave Velocity.

Association of endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels with pulse wave velocity (PWV, m/sec) at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R. (NCT03010683)
Timeframe: Baseline, 3 months, 6 months, and 12 months.

Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus metformin alone at Week 24. (NCT00327015)
Timeframe: Week 24

Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24. (NCT00327015)
Timeframe: Week 24

Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus metformin alone at Week 24. (NCT00327015)
Timeframe: Week 24

Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24. (NCT00327015)
Timeframe: Week 24

Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus metformin alone. (NCT00327015)
Timeframe: Week 24

Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus saxagliptin alone. (NCT00327015)
Timeframe: Week 24

Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Mean change from baseline in A1C at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Mean change from baseline in FPG at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Mean change from baseline in FPG at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24

Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Mean change from baseline in A1C at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24

Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjsuted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24

Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24

Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 104

Change from baseline at Week 104 is defined as Week 104 minus Week 0. (NCT00103857)
Timeframe: Week 104

Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24

Change from baseline at Week 24 is defined as Week 24 minus Week 0. (NCT00103857)
Timeframe: Week 24

Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54

Change from baseline at Week 54 is defined as Week 54 minus Week 0. (NCT00103857)
Timeframe: Week 54

Change From Baseline in FPG (Fasting Plasma Glucose) at Week 104

Change from baseline at Week 104 is defined as Week 104 minus Week 0. (NCT00103857)
Timeframe: Week 104

Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24

Change from baseline at Week 24 is defined as Week 24 minus Week 0. (NCT00103857)
Timeframe: Week 24

Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54

Change from baseline at Week 54 is defined as Week 54 minus Week 0. (NCT00103857)
Timeframe: Week 54

Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104

HbA1c is measured as a percent. This change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent. (NCT00103857)
Timeframe: Week 104

Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24

HbA1c is measured as a percent. This change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent. (NCT00103857)
Timeframe: Week 24

Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54

HbA1c is measured as a percent. This change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent. (NCT00103857)
Timeframe: Week 54

ACPRg

First phase response from the hyperglycemic clamp (NCT01779362)
Timeframe: 3-months after a medication washout

Insulin Sensitivity, M/I

Clamp measure of insulin sensitivity (NCT01779362)
Timeframe: 3-months after a medication washout

ß-cell Function Measured by Hyperglycemic Clamp Techniques at M12

Participants had 12-months of active therapy. Secondary results at the end of active intervention. (NCT01779362)
Timeframe: Secondary analysis was on all participants with a Month 12 visit.

ß-cell Response Measured by Hyperglycemic Clamp

Clamp measures of ß-cell response, co-primary outcomes (NCT01779362)
Timeframe: 3-months after medication washout (Month 15)

Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)

Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group (previous oral antihyperglycemic medication [OAM] versus no previous OAM) as fixed effects and baseline HbA1c as a covariate. (NCT01126580)
Timeframe: Baseline, 26 weeks

Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)

Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group (previous oral antihyperglycemic medication [OAM] versus no previous OAM) as fixed effects and baseline HbA1c as a covariate. (NCT01126580)
Timeframe: Baseline, 52 weeks

Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Change Version

The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score. (NCT01126580)
Timeframe: 52 weeks

Measurement of LY2189265 Drug Concentration for Pharmacokinetics: Area Under the Concentration Curve (AUC)

Evaluable pharmacokinetic concentrations from the 4-week, 13-week, 26-week, and 52-week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state. (NCT01126580)
Timeframe: 4 weeks, 13 weeks, 26 weeks, and 52 weeks

Number of Participants With Adjudicated Pancreatitis at 52 Weeks Plus 30-day Follow up

The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 52 weeks plus 30-day follow up. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01126580)
Timeframe: Baseline through 52 weeks plus 30-day follow up

Number of Participants With Treatment Emergent Anti-LY2189265 Antibodies

A participant was considered to have treatment emergent LY2189265 anti-drug antibodies (ADA) if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement. The total number of treatment emergent ADA was not analyzed at 26 weeks. (NCT01126580)
Timeframe: Baseline through 52 weeks

Change From Baseline to 26 and 52 Weeks in Blood Pressure

Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Body Mass Index (BMI)

Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline BMI as a covariate. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Body Weight

Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline body weight as a covariate. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles

The SMBG data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. Least Squares (LS) means of the mean of the 8 time points (daily mean) were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline daily mean as a covariate. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval

The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate

Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects and baseline interval as a covariate. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Fasting Blood Glucose

Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Homeostasis Model Assessment of Beta-cell Function

The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults). The normal reference populations were set at 100%. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline HOMA2 as a covariate, and participant as a random effect. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes

Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Pulse Rate

Sitting pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Serum Calcitonin

(NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in the Diabetes Symptoms Checklist Participant-reported Outcome (DSC-r) Score

"The Diabetes Symptoms Checklist-revised (DSC-r) was designed to assess the presence and perceived burden of diabetes-related symptoms. Respondents were to consider troublesomeness of 34 symptoms on a 5-point scale ranging from 5=extremely to 1=not at all. For symptoms/side-effects not experienced, the item was scored as 0. Symptoms were grouped into the following subscales: psychology-fatigue, psychology-cognitive, neurology-pain, neurology-sensory, cardiology, ophthalmology, hypoglycemia, and hyperglycemia. Subscale scores were calculated as the sum of the given subscale divided by the total number of items in the scale. Total score was computed from the sum of the 8 subscales and ranged from 0 to 40. Higher scores indicate greater symptom burden. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score." (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Status Version

The Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) is used to assess participant treatment satisfaction at each study visit. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL) Score

"The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living [APPADL]) questionnaire contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = not at all difficult and 1 = unable to do. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score." (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP) Score

The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks Plus 30-day Follow up

Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new CV event was prospectively collected using a CV event electronic case report form. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 52 weeks plus 30-day follow up. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module. (NCT01126580)
Timeframe: Baseline through 52 weeks plus 30-day follow up

Number of Participants With Treatment Emergent Adverse Events at 26 and 52 Weeks

A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 and 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01126580)
Timeframe: 26 weeks and 52 weeks

Number of Self-reported Hypoglycemic Events at 26 and 52 Weeks

Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 70 milligrams per deciliter [mg/dL]), or asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 70 mg/dL). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01126580)
Timeframe: Baseline through 26 weeks and 52 weeks

Percent Change From Baseline to 26 and 52 Weeks in Total Cholesterol

Percent changes in total cholesterol were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Percentage Change From Baseline to 26 and 52 Weeks in High Density Lipoprotein Cholesterol (HDL-C)

Percentage changes in HDL-C were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Percentage Change From Baseline to 26 and 52 Weeks in Low Density Lipoprotein Cholesterol (LDL-C)

Percentage changes in LDL-C were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Percentage Change From Baseline to 26 and 52 Weeks in Triglycerides

Percentage changes in triglycerides were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of Less Than 7% and Less Than or Equal to 6.5% at 26 and 52 Weeks

The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, prior medication group, and treatment as factors included in the model. (NCT01126580)
Timeframe: 26 weeks and 52 weeks

Rate of Self-reported Hypoglycemic Events at 52 Weeks

Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 70 milligrams per deciliter [mg/dL]), or asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 70 mg/dL). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01126580)
Timeframe: Baseline through 52 weeks

Percent Incidence of All-cause Mortality (Intent to Treat Population)

Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause. (NCT00790205)
Timeframe: Up to 5 years

Percent Incidence of All-cause Mortality (Per Protocol Population)

Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause. (NCT00790205)
Timeframe: Up to 5 years

Percent Incidence of CHF Requiring Hospitalization (Intent to Treat Population)

Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF. (NCT00790205)
Timeframe: Up to 5 years

Percent Incidence of Congestive Heart Failure (CHF) Requiring Hospitalization (Per Protocol Population)

Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF. (NCT00790205)
Timeframe: Up to 5 years

Percentage of Participants Who Initiated Chronic Insulin Therapy (Intent to Treat Population)

Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months. (NCT00790205)
Timeframe: Up to 5 years

Percentage of Participants Who Initiated Chronic Insulin Therapy (Per Protocol Population)

Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months. (NCT00790205)
Timeframe: Up to 5 years

Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population)

Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization. (NCT00790205)
Timeframe: Up to 5 years

Percentage of Participants With First Confirmed CV Event of MACE (Intent to Treat Population)

CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke. (NCT00790205)
Timeframe: Up to 5 years

Percentage of Participants With First Confirmed CV Event of MACE (Per Protocol Population)

CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke. (NCT00790205)
Timeframe: Up to 5 years

Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population)

Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization. (NCT00790205)
Timeframe: Up to 5 years

Percentage of Participants With Initiation of Co-interventional Agent (Intent to Treat Population)

In participants not receiving insulin at baseline, time to addition of first co-interventional agent (i.e., next oral AHA or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.) (NCT00790205)
Timeframe: Up to 5 years

Percentage of Participants With Initiation of Co-interventional Agent (Per Protocol Population)

In participants not receiving insulin at baseline, time to addition of first co-interventional agent (i.e., next oral antihyperglycemic agent [AHA] or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.) (NCT00790205)
Timeframe: Up to 5 years

Change From Baseline in HbA1c Over Time (Intent to Treat Population)

HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Estimated mean difference between sitagliptin and placebo controlling for baseline HbA1c and region. (NCT00790205)
Timeframe: Baseline and up to 4 years

Change From Baseline in HbA1c Over Time (Per Protocol Population)

HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Estimated mean difference between sitagliptin and placebo controlling for baseline HbA1c and region. (NCT00790205)
Timeframe: Baseline and up to 4 years

Change From Baseline in Renal Function Over Time (Intent to Treat Population)

Change in renal function based on eGFR using the MDRD method. (NCT00790205)
Timeframe: Baseline and up to 5 years

Change From Baseline in Renal Function Over Time (Per Protocol Population)

Change in renal function based on estimated glomerular filtration rate [eGFR] using the Modification of Diet in Renal Disease [MDRD] method. (NCT00790205)
Timeframe: Baseline and up to 5 years

Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Intent to Treat Population)

Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value. (NCT00790205)
Timeframe: Baseline and up to 5 years

Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Per Protocol Population)

Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value. (NCT00790205)
Timeframe: Baseline and up to 5 years

Improvement in Left Ventricular Ejection Fraction

The primary efficacy parameter of the GIPS-III trial is LVEF measured by cardiac MRI 4 months after randomization, based on an intention-to-treat analysis. It is hypothesized that metformin therapy will result in a higher ejection fraction after 4 months. (NCT01217307)
Timeframe: 4 months

HbA1c(%) at Endpoint

(NCT01954771)
Timeframe: 12 weeks

Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS)

The peak value:>16.7mmol/L(which may precipitate ketosis),nadir:≤2.8mmol/L(Severe hypoglycemia). (NCT01954771)
Timeframe: 12 weeks

Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS

Severe hypoglycemia is defined as glucose concentration of ≤2.8mmol/L (50 mg/dL). (NCT01954771)
Timeframe: 12 weeks

The Correlation Study Between HbA1c and Glycemic Profiles of MBG (Mean Blood Glucose) From SMBG Protocols and CGMS

A correlation coefficient of 0.5 is defined as large effect size.(Cohen Jacob.Statistical power analysis for the the behavioral sciences.2nd edition.Lawrence Erlbaum Associates.1988:80) (NCT01954771)
Timeframe: 12 weeks

Independent Re-adjudication (IR) Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Original RECORD Endpoint Definitions

IR was based on original RECORD endpoint definitions. CV death= no unequivocal non-CV cause (sudden death, death from acute vascular events, heart failure, acute MI, other CV causes, and deaths adjudicated as unknown cause). MI event=hospitalization + elevation of specific cardiac biomarkers above the upper limit of normal + cardiac ischemia symptoms/new pathological electrocardiogram findings. Stroke event=hospitalization + rapidly developed clinical signs of focal/global disturbance of cerebral function for more than 24 hours, with no apparent cause other than a vascular origin. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)

Independent Re-adjudication Outcome: Number of Participants (Par.) With an Event of Stroke (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions

Par. with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. A stroke event=hospitalization plus rapidly developed clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours (unless interrupted by thrombolysis, surgery, or death), with no apparent cause other than a vascular origin, including par. presenting clinical signs/symptoms suggestive of subarachnoid haemorrhage/intracerebral haemorrhage/cerebral ischemic necrosis or cause of death adjudicated as stroke. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)

Independent Re-adjudication Outcome: Number of Participants Who Died Due to Any Cause

All deaths identified during the original record study and discovered after the re-adjudication efforts began were included. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)

Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Contemporary Endpoint Definitions

The number of participants with a CV (or unknown) death as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. CV death included death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, and death due to other CV causes. Deaths of unknown cause were counted as CV deaths. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)

Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Original RECORD Endpoint Definitions

"The number of participants with a CV death (or unknown) as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. CV death was defined as any death for which an unequivocal non-CV cause could not be established. CV death included death following heart failure, death following acute myocardial infarction (MI), sudden death, death due to acute vascular events, and other CV causes. Deaths due to unknown causes were classified as unknown deaths, but were counted as CV deaths for the analysis of this endpoint." (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)

Independent Re-adjudication Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Contemporary Endpoint Definitions

Independent re-adjudication was based on the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions. CV death included death resulting from an acute MI; sudden cardiac death and death due to heart failure, stroke, and to other CV causes. Deaths of unknown cause were counted as CV deaths. MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)

Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions

The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)

Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions

The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. An event of MI was defined as hospitalization plus elevation of cardiac biomarkers troponin (TN) I and/or TNT above the upper limit of normal (ULN) or creatinine kinase (CK) MB (M=muscle type; B=brain type) isoenzyme >= 2x the ULN or CK > 2x the ULN plus typical symptoms of cardiac ischemia or new pathological electrocardiogram findings, or cause of death adjudicated as MI. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)

Independent Re-adjudication Outcome: Number of Participants With an Event of Stroke (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions

The number of participants with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)

Model Adjusted Change From Baseline in Alanine Aminotransferase at Month 60

Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in alanine aminotransferase was calculated as the value at Month 60 minus the Baseline value. (NCT00379769)
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase

Model Adjusted Change From Baseline in Body Weight at Month 60

Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in body weight was calculated as the value at Month 60 minus the Baseline value. (NCT00379769)
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase

Model Adjusted Change From Baseline in Fasting Plasma Glucose at Month 60

Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in fasting plasma glucose was calculated as the value at Month 60 minus the Baseline value. (NCT00379769)
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment period

Model Adjusted Change From Baseline in HbA1c at Month 60

Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in HbA1c was calculated as the value at Month 60 minus the Baseline value. (NCT00379769)
Timeframe: Baseline and Month 60 of randomised dual therapy treatment period

Model Adjusted Change From Baseline in Waist Circumference at Month 60

Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in waist circumference was calculated as the value at Month 60 minus the Baseline value. (NCT00379769)
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase

Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Apolipoprotein B (Apo-B) at Month 60

The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in Apo-B was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]). (NCT00379769)
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment period

Model Adjusted Ratio to Baseline (Expressed as a Percentage) for C-Reactive Protein at Month 60

The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in C-Reactive Protein was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]). (NCT00379769)
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase

Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Fibrinogen at Month 60

The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in fibrinogen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]). (NCT00379769)
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase

Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Plasminogen Activator Inhibitor-1 (PAI-1) Antigen at Month 60

The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in plasminogen activator inhibitor-1 (PAI-1) antigen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]). (NCT00379769)
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase

Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Urinary Albumin Creatinine Ratio at Month 60

The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in urinary albumin creatinine ratio was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]). (NCT00379769)
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase

Number of Participants With an Event of Death Due to a Bone Fracture-related Event: Main Study + Observational Follow-up Combined

The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. (NCT00379769)
Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)

Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events

The number of participants with cardiovascular death events (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation events (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) was recorded. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)

Number of Participants With First Cardiovascular Hospitalisations/Cardiovascular Deaths by Stratum

Participants with first cardiovascular death (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) were recorded by study stratum. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)