Thiazolidinedione Intervention With Vitamin D Evaluation (TIDE)

This study has been terminated.
(FDA has placed the trial on full clinical hold.)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00879970
First received: April 2, 2009
Last updated: April 9, 2015
Last verified: July 2013
  Purpose

This study will answer two separate questions.

The first question is to test the cardiovascular effects of long-term treatment with rosiglitazone or pioglitazone when used as part of standard of care compared to similar standard of care without rosiglitazone or pioglitazone in patients with type 2 diabetes who have a history of or are at risk for cardiovascular disease.

The second question will compare the effects of long-term supplementation of vitamin D on death and cancer


Condition Intervention Phase
Diabetes Mellitus, Type 2
Dietary Supplement: vitamin D
Drug: pioglitazone
Drug: rosiglitazone
Drug: placebo
Dietary Supplement: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Thiazolidinedione Intervention With Vitamin D Evaluation (TIDE) A Multicenter Randomized Double-Blind Placebo Controlled Trial of a Thiazolidinedione or Placebo and of Vitamin D or Placebo In People With Type 2 Diabetes at Risk For Cardiovascular Disease

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) [ Time Frame: From Randomization at Visit 3 up to the Final Visit (average of 162 days) ] [ Designated as safety issue: Yes ]
    An event adjudication committee (EAC) adjudicated all occurrences of the components of the composite cardiovascular (CV; related to heart) outcome for TZD. Components are the first occurrence of cardiovascular death for which a non-heart-related cause has not been identified; non-fatal myocardial infarction (MI) (death of heart muscle from sudden blockage of a coronary artery by blood clot not leading to death); and non-fatal stroke (rapidly developing loss of brain function[s] due to disturbance in the blood supply to the brain not leading to death).

  • Number of Participants With the Indicated Components of the Composite Outcome for Vitamin D [ Time Frame: From Randomization at Visit 3 to Final Visit (average of 130 days) ] [ Designated as safety issue: Yes ]
    An EAC adjudicated all occurrences of the components of the composite outcome for vitamin D. Components are the first occurrence of death or cancer requiring hospitalization, treatment with medicines (chemotherapy), or surgery. Participation in the vitamin D study was placed on full clinical hold. The length of follow-up was very short compared to the planned 10 years; thus, results are not presented.


Secondary Outcome Measures:
  • Number of Participants With Any Revascularization [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ] [ Designated as safety issue: Yes ]
    Revascularization is defined as any surgical procedure for the provision of a new, additional, or augmented blood supply to heart muscle. Data regarding the need for any revascularization were adjudicated by the EAC and sent to the data monitoring committee (IDMC) on a regular basis for unblinded review.

  • Number of Participants With Need for Hospitalization for Any Reason [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ] [ Designated as safety issue: Yes ]
    Data regarding the need for hospitalization for any reason were collected and were then forwarded to the independent data monitoring committee (IDMC) on a regular basis for unblinded review.

  • Number of Participants With Need for Hospitalization for Congestive Heart Failure (CHF), Shortness of Breath, Pneumonia, or Angina [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ] [ Designated as safety issue: Yes ]
    CHF is a condition in which the heart is not able to pump adequate blood to meet the body's needs. Shortness of breath is defined as difficulty in breathing. Pneumonia is an infection of the lungs, caused by various microorganisms. Angina is defined as severe chest pain due to lack of adequate blood supply of the heart muscle because of obstruction/spasm of the heart's blood vessels. Data regarding the need for hospitalization due to any of these reasons were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.

  • Number of Participants Who Died [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ] [ Designated as safety issue: Yes ]
    Data regarding the death of participants were forwarded to the IDMC on a regular basis for unblinded review.

  • Number of Participants With Any Cancer [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ] [ Designated as safety issue: Yes ]
    Cancer is a class of diseases characterized by out-of-control cell growth. Data regarding all occurences of any cancer were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.

  • Number of Participants With Composite Microvascular Outcome [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ] [ Designated as safety issue: Yes ]
    The components of the composite microvascular outcome are retinopathy, decline in eGFR, vitrectomy, and renal replacement surgery. Retinopathy is defined as damage to the inner lining of the eye (retina). Decline in eGFR is defined as a >=30% reduction in kidney function. Vitrectomy is a surgery to remove some or all of the fluid (vitreous humor) from the eye. Renal replacement therapy includes all the life-supporting treatments for renal failure. Data regarding the number of participants with changes in micro blood vessels (composite microvascular outcome) were collected at each visit.

  • Number of Participants With Retinopathy Requiring Laser Therapy, a Decline in Estimated Glomerular Filtration Rate (eGFR), Vitrectomy, and Renal Replacement Therapy [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ] [ Designated as safety issue: Yes ]
    Retinopathy is defined as damage to the inner lining of the eye (retina). Decline in eGFR is defined as a >=30% reduction in kidney function. Vitrectomy is a surgery to remove some or all of the fluid (vitreous humor) from the eye. Renal replacement therapy includes all the life-supporting treatments for renal failure. Data on the number of participants with all of these microvascular outcomes were collected at each visit. Data regarding the number of participants with these microvascular outcomes were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.

  • Number of Participants With Severe Lower Than Normal Blood Glucose Level (Hypoglycemia) [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ] [ Designated as safety issue: Yes ]
    Severe hypoglycemia is defined as hypoglycemia requiring assistance from another person with either a documented plasma glucose <=36 mg/deciliter (2.0 millimole per liter [mmol/L]) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration. Hypoglycemia data were obtained from outcomes reported by the site. Data regarding hypoglycemia were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.

  • Number of Participants With Clinical Proteinuria [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ] [ Designated as safety issue: Yes ]
    Clinical proteinuria is defined as a laboratory detection of urinary protein excretion > 0.5 grams (g) per 24 hours; spot urine analysis for albumin:creatinine ratio >=300 milligrams/g; timed urine collection for albumin excretion >=200 µg/minute or >=300 mg/24 hours. Clinical proteinuria data were obtained from outcomes reported by the site.

  • Number of Participants With a Fracture [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ] [ Designated as safety issue: Yes ]
    Fracture is defined as a medical condition in which there is a break in the continuity of the bone. Fractures are defined as those breaks that are self reported plus confirmed by an X-ray. Data regarding all occurrences of any fracture were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.

  • Number of Participants With Hepatic Enzyme Increased or Abnormal Liver Function Tests [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ] [ Designated as safety issue: Yes ]
    Liver function tests are groups of clinical biochemistry laboratory blood assays designed to give information about the health of the liver. "Liver function test abnormal" and "hepatic enzyme increased" were obtained from adverse event data as reported by investigators based on the reference range of the reporting local laboratory methodology.

  • Number of Participants With Cognitive (Mental Processes) Decline (CD) From Baseline to the Year 2 Visit and the Final Visit [ Time Frame: Baseline, Year 2 Visit, and Final Visit (up to Year 5.5) ] [ Designated as safety issue: No ]
    CD is equivalent to a difference of >=1.5 units on the Digit Symbol Substitution Test (DSST) score. The DSST is a neuropsychological test sensitive to brain damage, a serious loss of cognitive ability, age, and depression. It consists of digit-symbol pairs, followed by a list of digits. Under each digit the participant was asked to write the corresponding symbol as quickly as possible. The number of correct symbols within the allowed time (90 or 120 seconds) was measured in units (one correct score equals one unit).

  • Number of Participants With Erectile Dysfunction [ Time Frame: At Randomization at Visit 3 and Final Visit (up to Year 5.5) ] [ Designated as safety issue: No ]
    Erectile dysfunction (ED) is sexual dysfunction characterized by the inability to develop or maintain an erection of the penis during sexual performance. ED was assessed by using the International Index of Erectile Dysfunction (IIED) questionnaire. This standardized and validated 15-item self-evaluation scale provides pre- and post-treatment clinic evaluations of erectile and orgasmic function, sexual desire, satisfaction with sexual intercourse, and general satisfaction.

  • Mean Score on Euro-QoL (EQ)-5D [ Time Frame: At Randomization at Visit 3 and Final Visit (up to Year 5.5) ] [ Designated as safety issue: No ]
    Quality of life (QoL) was assessed by using the Euro-QoL (EQ)-5D, a short questionnaire used for measuring health-related QoL. The preference weights are elicited by asking participants to place hypothetical health states on a visual analogue scale from "0" to "1", whereby a score of "1" represents the best health state imaginable and "0" represents a health state equivalent to being dead. Negative states are those worse than being dead.

  • Mean Score on Montreal Cognitive Assessment (MoCA) Test, as an Assessment of Cognitive Function (CF) [ Time Frame: At Randomization at Visit 3 and Final Visit (up to Year 5.5) ] [ Designated as safety issue: No ]
    CF was assessed with the 30-point (pt) MoCA test, involving a short-term memory recall task (T) (5 pts), a clock-drawing T (3 pts), a 3-dimensional cube copy (1 pt), a trail-making B T (1 pt), a phonemic fluency T (1 pt), a 2-item verbal abstraction T (2 pts), an attention T (1 pt), a serial subtraction T (3 pts), digits forward/ backward (1 pt each), a 3-item confrontation naming T (3 pts), repetition of 2 syntactically complex sentences (2 pts), and orientation to time/ place (6 pts). A score of 26 or above is normal.


Enrollment: 1332
Study Start Date: May 2009
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: pioglitazone Drug: pioglitazone
thiazolidinedione factor intervention
Active Comparator: rosiglitazone Drug: rosiglitazone
thiazolidinedione factor intervention
Placebo Comparator: TZD placebo Drug: placebo
thiazolidinedione factor intervention
Active Comparator: vitamin D Dietary Supplement: vitamin D
vitamin D factor intervention
Placebo Comparator: vitamin D placebo Dietary Supplement: placebo
Vitamin D factor intervention

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women with: a) newly detected type 2 diabetes based on a fasting plasma glucose greater than or equal to 7.0 mmol/l (126 mg/dL) or a 2 hour plasma glucose (FPG) greater than or equal to 11.1 mmol/l (200 mg/dL) on an oral glucose tolerance test, or b) a history of type 2 diabetes
  • Hemoglobin A1c (A1C) 6.5-9.5% inclusive (for assays with upper limit of normal of 6%) within one month of screening
  • Age ≥ 50 years and evidence of vascular disease defined as ≥1of:

    • prior myocardial infarction
    • prior stroke
    • coronary, carotid or peripheral artery revascularization ≥ 4 years earlier
    • previous documented myocardial ischemia on either an exercise stress test or on any cardiac imaging, or previous unstable angina with ECG changes or cardiac enzyme elevation OR
  • Age ≥ 55 years and evidence of subclinical vascular disease defined as ≥1 of:

    • microalbuminuria or proteinuria
    • history of treated or untreated hypertension with left ventricular hypertrophy by electrocardiogram (ECG) or echocardiogram

      • 50% stenosis on any imaging of coronary, carotid or lower extremity arteries
    • ankle/brachial index <0.9 OR
  • Age ≥ 60 years and at least 2 of the following cardiovascular disease risk factors:

    • current tobacco use
    • LDL-c ≥3.4 mmol/L (130 mg/dL) or on a lipid lowering medication
    • HDL-c < 1.0 mmol/L (40 mg/dL) for men and < 1.3 mmol/L (50 mg/dL) for women or triglycerides ≥ 2.3 mmol/L (200 mg/dL)
    • BP lowering medication use or untreated SBP ≥ 140 mmHg or DBP ≥ 95 mmHg
    • Waist to hip ratio > 1.0 for men and > 0.8 for women
  • On no insulin and on less than or equal to 2 anti-diabetes drugs where at least one drug is at or below the half-maximal dose (as indicated in the MOP) with stable dosing for 10 weeks prior to screening

Exclusion Criteria:

  • Type 1 diabetes
  • Current need for insulin treatment
  • Symptomatic hyperglycemia requiring immediate therapy in the judgment of the physician
  • An acute cardiovascular event within 30 days prior to randomization
  • Symptomatic heart failure (i.e. New York Heart Association class II or higher) or any episode of previous pulmonary edema or known ejection fraction < 0.4 or current use of loop diuretics
  • Any fracture within the past 1 year
  • Currently planned coronary, carotid or peripheral artery revascularization or cardiac valve surgery
  • Coronary, carotid or peripheral artery revascularization within the 4 years prior to screening in the absence of angina, MI, or stroke in the intervening period
  • End stage renal disease requiring renal replacement therapy
  • Receiving drug therapy to treat liver disease
  • A diagnosis of cancer (other than superficial squamous, basal cell skin cancer, or adequately treated cervical carcinoma in situ) in the past 3 years or current treatment for the active cancer (other than prophylactic)
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level > 2.5 times the upper limit of normal
  • A prior heart transplant or awaiting a heart transplant
  • Previous or current hypercalcemia, hyperparathyroidism, osteomalacia or other contraindication for vitamin D therapy
  • Regular use of or indication for greater than 400IU of vitamin D daily
  • Clinically or medically unstable with expected survival < 1 year
  • Unwillingness to permit sites to contact their primary physicians to communicate information about the study and the participant's data
  • Any other factor likely to limit protocol compliance or reporting of adverse events
  • Inability to discontinue a TZD (if taking one) in the judgement of the physician/investigator
  • Contraindications to or history of hypersensitivity to the investigational products
  • History of renal stones within the past 2 years
  • Participation in another clinical trial of an investigational agent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00879970

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Locations
United States, California
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Long Beach, California, United States, 90822
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Los Angeles, California, United States, 90033
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Northbridge, California, United States, 91324
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San Diego, California, United States, 92109
United States, Georgia
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Decatur, Georgia, United States, 30033
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Tucker, Georgia, United States, 30084
United States, Idaho
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Pocatella, Idaho, United States, 83209
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Pocatello, Idaho, United States, 83201
United States, Louisiana
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New Orleans, Louisiana, United States, 70112
United States, Massachusetts
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Haverhill, Massachusetts, United States, 1830
United States, Minnesota
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Minneapolis, Minnesota, United States, 55454
United States, Missouri
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St. Louis, Missouri, United States, 63106
United States, Montana
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Kalispell, Montana, United States, 59901
United States, New York
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Westfield, New York, United States, 14787
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Durham, North Carolina, United States, 27710
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Cleveland, Ohio, United States, 44195
United States, Oregon
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Portland, Oregon, United States, 97216
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Portland, Oregon, United States, 97239
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Kingsport, Tennessee, United States, 37660
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Memphis, Tennessee, United States, 38104
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Dallas, Texas, United States, 75246
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Houston, Texas, United States, 77030
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Temple, Texas, United States, 76508
Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1090
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Coronel Suarez, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina, 7600
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San Nicolas, Buenos Aires, Argentina, B2900DMH
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Buenos Aires, Argentina, 1405
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Salta, Argentina, 4400
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San Miguel de Tucuman, Argentina, 4000
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Zárate, Argentina, B2800DGH
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Calgary, Alberta, Canada, T2T 5C7
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Calgary, Alberta, Canada, T3S OM3
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Edmonton, Alberta, Canada, T5A 4L8
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Surrey, British Columbia, Canada, V3R 3P1
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Vancouver, British Columbia, Canada, V6H 3X8
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Winnipeg, Manitoba, Canada, R2H 0R8
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Winnipeg, Manitoba, Canada, R3E 3P4
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Canada, Newfoundland and Labrador
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Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
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Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
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Barrie, Ontario, Canada, L4M 7G1
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Brampton, Ontario, Canada, L6Z 4N5
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Cambridge, Ontario, Canada, N1R 7L6
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Hamilton, Ontario, Canada, L8N 3Z5
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Hamilton, Ontario, Canada, L8L 2X2
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Hamilton., Ontario, Canada, L8N 3X5
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London, Ontario, Canada, N6A 4V2
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Mississauga, Ontario, Canada, L5M 2V8
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Ohsweken, Ontario, Canada, N0A 1M0
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Oshawa, Ontario, Canada, L1J 2K1
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Ottawa, Ontario, Canada, K1C 1S6
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Ottawa, Ontario, Canada, K1H 1A2
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Thornhill, Ontario, Canada, L4J 8L7
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Toronto, Ontario, Canada, M5C 2T2
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Toronto, Ontario, Canada, M9L 1W9
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Toronto, Ontario, Canada, M4R 2G4
Canada, Quebec
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Laval, Quebec, Canada, H7T 2P5
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Saint-Georges, Quebec, Canada, G5Y 4T8
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Sainte-Foy, Quebec, Canada, G1V 4G2
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Sherbrooke, Quebec, Canada, J1H 5N4
Chile
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Temuco, Región De La Araucania, Chile
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Santiago, Región Metro De Santiago, Chile, 8330024
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Santiago, Región Metro De Santiago, Chile, 8331143
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Santiago, Región Metro De Santiago, Chile
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Osorno, Chile
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Valdivia, Chile
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Victoria, Chile
Colombia
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Armenia, Colombia
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Barrangquilla, Colombia
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Barranquilla, Colombia
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Bogota, Colombia
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Bogotac, Colombia, 83012
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Cali, Colombia
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Cartagena, Colombia, 71 31-315
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Cartagena, Colombia
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Espinal, Colombia
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Floridablanca, Colombia
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Manizales, Colombia
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Medellín, Colombia
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Pereira, Colombia
Czech Republic
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Havirov, Czech Republic, 736 01
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Jihlava, Czech Republic, 586 01
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Mestec Kralove, Czech Republic, 289 03
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Ostrava, Czech Republic, 70030
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Prague, Czech Republic, 181 00
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Praha, Czech Republic, 102 00
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Praha 4, Czech Republic, 140 21
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Praha 5, Czech Republic, 150 00
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Praha 5, Czech Republic, 158 00
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Praha 6, Czech Republic, 160 00
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Pribram 8, Czech Republic, 261 01
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Rakovnik, Czech Republic, 269 01
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Uherske Hradiste, Czech Republic, 68601
Denmark
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Aarhus-N, Denmark, 8200
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Frederiksberg, Denmark, 2000
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Glostrup, Denmark, 2600
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Hellerup, Denmark, 2900
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Herlev, Denmark, DK-2730
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Koebenhavn, Denmark, 2300
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København NV, Denmark, 2400
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Odense C, Denmark, 5000
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Viborg, Denmark, 8800
Finland
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Helsinski, Finland, 00260
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Kuopio, Finland, 70210
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Oulu, Finland, 90100
Germany
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Deggingen, Baden-Wuerttemberg, Germany, 73326
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Villingen-Schwenningen, Baden-Wuerttemberg, Germany, 78048
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Wangen, Baden-Wuerttemberg, Germany, 88239
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Weinheim, Baden-Wuerttemberg, Germany, 69469
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Augsburg, Bayern, Germany, 86150
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Gars am Inn, Bayern, Germany, 83536
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Haag, Bayern, Germany, 83527
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Kuenzing, Bayern, Germany, 94550
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Muenchen, Bayern, Germany, 80339
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Muenchen, Bayern, Germany, 80809
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Vilshofen, Bayern, Germany, 94474
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Wallerfing, Bayern, Germany, 94574
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Angermuende, Brandenburg, Germany, 16278
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Elsterwerda, Brandenburg, Germany, 04910
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Potsdam, Brandenburg, Germany, 14469
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Grossalmerode, Hessen, Germany, 37247
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Kelkheim, Hessen, Germany, 65779
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Winsen/Lohe, Niedersachsen, Germany, 21423
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Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
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Bergkamen, Nordrhein-Westfalen, Germany, 59192
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Dorsten, Nordrhein-Westfalen, Germany, 46282
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Eschweiler, Nordrhein-Westfalen, Germany, 52249
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Essen, Nordrhein-Westfalen, Germany, 45329
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Essen, Nordrhein-Westfalen, Germany, 45355
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Goch, Nordrhein-Westfalen, Germany, 47574
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Koeln, Nordrhein-Westfalen, Germany, 50823
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Koeln, Nordrhein-Westfalen, Germany, 51069
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Witten, Nordrhein-Westfalen, Germany, 58455
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Ingelheim, Rheinland-Pfalz, Germany, 55218
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Mainz, Rheinland-Pfalz, Germany, 55116
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Rhaunen, Rheinland-Pfalz, Germany, 55624
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Neunkirchen, Saarland, Germany, 66539
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Koethen, Sachsen-Anhalt, Germany, 06366
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Schoenebeck, Sachsen-Anhalt, Germany, 39218
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Wolmirstedt, Sachsen-Anhalt, Germany, 39326
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Zerbst, Sachsen-Anhalt, Germany, 39261
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Borna, Sachsen, Germany, 04552
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Delitzsch, Sachsen, Germany, 04509
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Dresden, Sachsen, Germany, 01099
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Dresden, Sachsen, Germany, 01307
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Leipzg, Sachsen, Germany, 04109
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Leipzig, Sachsen, Germany, 04103
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Oschatz, Sachsen, Germany, 04758
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Pirna, Sachsen, Germany, 01796
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Berlin, Germany, 10787
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Berlin, Germany, 10629
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Berlin, Germany, 10367
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Berlin, Germany, 13125
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Berlin, Germany, 13158
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Hamburg, Germany, 22177
India
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Ahmedabad, India, 380006
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Bangalore, India, 560 010
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Bangalore, India, 560034
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Banjara Hills PO, Hyderabad, India, 500 034
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Belgaum, India, 590001
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Chennai, India, 600 008
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Chennai, India, 600 028
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Cochin, India, 683572
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Hyderabad, India, 500034
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Karnal, India, 132001
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Kerala, India, 688 524
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Kochi, India, 682 040
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Kochi, India, 682026
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Kottyam, India, 686 027
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Mumbai, India, 400007
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Nasik, India, 422013
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Nellore, India, 524001
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Pune, India, 411004
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Tamil Nadu, India, Trichy - 620 018
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Trivandrum, India, 695607
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Vijayawada, India, 520008
Italy
GSK Investigational Site
Milano (Milan), Lombardia, Italy, 20132
GSK Investigational Site
Sesto San Giovanni (MI), Lombardia, Italy, 20099
GSK Investigational Site
Pozzilli (IS), Molise, Italy, 86077
GSK Investigational Site
Chieri (Torino), Italy, 10023
Latvia
GSK Investigational Site
Cesis, Latvia, LV4100
GSK Investigational Site
Daugavpils, Latvia, LV5417
GSK Investigational Site
Jekabpils, Latvia, LV5201
GSK Investigational Site
Liepaja, Latvia, LV3401
GSK Investigational Site
Riga, Latvia, LV 1002
GSK Investigational Site
Riga, Latvia, LV 1011
GSK Investigational Site
Riga, Latvia, LV1024
GSK Investigational Site
Tukums, Latvia, LV 3100
Mexico
GSK Investigational Site
Tijuana, Baja California Norte, Mexico, 22010
GSK Investigational Site
Guadalajara, Jalisco, Mexico, CP 44340
GSK Investigational Site
Guadalajara, Jalisco, Mexico, 44380
GSK Investigational Site
Guadalajara, Jalisco, Mexico, 44600
GSK Investigational Site
Guadalajara, Jalisco, Mexico, 44150
GSK Investigational Site
Zapopan, Jalisco, Mexico, 45200
GSK Investigational Site
Morelia, Michoacán, Mexico
GSK Investigational Site
San Luis Potosi, San Luis Potosí, Mexico, 78200
GSK Investigational Site
Aguascalientes, Mexico, 20230
GSK Investigational Site
Guadalajara, Mexico
GSK Investigational Site
Tampico, Mexico
Netherlands
GSK Investigational Site
Amsterdam, Netherlands, 1061 AE
GSK Investigational Site
Heerlen, Netherlands, 6419 PC
GSK Investigational Site
Hoofddorp, Netherlands, 2134
GSK Investigational Site
Rotterdam, Netherlands, 3045 PM
GSK Investigational Site
Rotterdam, Netherlands, 3015 CE
Norway
GSK Investigational Site
Bodø, Norway, 8005
GSK Investigational Site
Hoenefoss, Norway, 3513
GSK Investigational Site
Kløfta, Norway, 2040
GSK Investigational Site
Oslo, Norway, 0514
GSK Investigational Site
Oslo, Norway, 0160
GSK Investigational Site
Oslo, Norway, 0319
GSK Investigational Site
Skedsmokorset, Norway, N-2020
GSK Investigational Site
Stavanger, Norway, 4005
GSK Investigational Site
Tromsø, Norway, 9038
GSK Investigational Site
Trondheim, Norway, 7212
Pakistan
GSK Investigational Site
Faisalabad, Pakistan, 37250
GSK Investigational Site
Islamabad, Pakistan, 44000
GSK Investigational Site
Lahore, Pakistan, 54000
Peru
GSK Investigational Site
Arequipa, Peru, 54
Philippines
GSK Investigational Site
Laoag City, Philippines, 2900
Romania
GSK Investigational Site
Bacau, Romania, 600114
GSK Investigational Site
Baia Mare, Romania, 435400
GSK Investigational Site
Bistrita, Romania, 420016
GSK Investigational Site
Brasov, Romania, 500365
GSK Investigational Site
Bucuresti, Romania, 020475
GSK Investigational Site
Buzau, Romania, 120203
GSK Investigational Site
Deva, Romania, 330084
GSK Investigational Site
Iasi, Romania, 700547
GSK Investigational Site
Oradea, Romania, 410469
GSK Investigational Site
Pitesti, Romania, 110084
GSK Investigational Site
Sibiu, Romania, 550245
Russian Federation
GSK Investigational Site
Arkhangelsk, Russian Federation, 163045
GSK Investigational Site
Barnaul, Russian Federation, 656 045
GSK Investigational Site
Barnaul, Russian Federation, 656055
GSK Investigational Site
Barnaul, Russian Federation, 656038
GSK Investigational Site
Ivanovo, Russian Federation, 153012
GSK Investigational Site
Ivanovo, Russian Federation, 153462
GSK Investigational Site
Kazan, Russian Federation, 420012
GSK Investigational Site
Kazan, Russian Federation, 420033
GSK Investigational Site
Kemerovo, Russian Federation, 650099
GSK Investigational Site
Kemerovo, Russian Federation, 650036
GSK Investigational Site
Kemerovo, Russian Federation, 650002
GSK Investigational Site
Kirov, Russian Federation, 610030
GSK Investigational Site
Kursk, Russian Federation, 305035
GSK Investigational Site
Moscow, Russian Federation, 123448
GSK Investigational Site
Moscow, Russian Federation, 115487
GSK Investigational Site
Moscow, Russian Federation, 129110
GSK Investigational Site
Moscow, Russian Federation, 117556
GSK Investigational Site
Moscow, Russian Federation, 121 552
GSK Investigational Site
Moscow, Russian Federation, 111539
GSK Investigational Site
Moscow, Russian Federation, 117 036
GSK Investigational Site
Moscow, Russian Federation, 125367
GSK Investigational Site
Moscow, Russian Federation, 121552
GSK Investigational Site
Nizhniy Novgorod, Russian Federation, 603126
GSK Investigational Site
Nizhniy Novgorod, Russian Federation, 603076
GSK Investigational Site
Nizhny Novgorod, Russian Federation, 603003
GSK Investigational Site
Ryazan, Russian Federation, 390026
GSK Investigational Site
Saint-Petersburg, Russian Federation, 198260
GSK Investigational Site
Saint-Petersburg, Russian Federation, 197341
GSK Investigational Site
Saratov, Russian Federation, 410031
GSK Investigational Site
Smolensk, Russian Federation, 214 019
GSK Investigational Site
St Pertersburg, Russian Federation, 196247
GSK Investigational Site
St Petersberg, Russian Federation, 192288
GSK Investigational Site
St'Petersburg, Russian Federation, 194156
GSK Investigational Site
St'Petersburg, Russian Federation, 197110
GSK Investigational Site
St-Petersburg, Russian Federation, 193312
GSK Investigational Site
St-Petersburg, Russian Federation, 194017
GSK Investigational Site
St-Petersburg, Russian Federation, 195197
GSK Investigational Site
St-Petersburg, Russian Federation, 195067
GSK Investigational Site
St. Petersburg, Russian Federation, 197758
GSK Investigational Site
St. Petersburg, Russian Federation, 198205
GSK Investigational Site
Syktyvkar, Russian Federation, 167 981
GSK Investigational Site
Tomsk, Russian Federation, 634063
GSK Investigational Site
Tomsk, Russian Federation, 634012
GSK Investigational Site
Tomsk, Russian Federation, 634050
GSK Investigational Site
Vladivostok, Russian Federation, 690034
GSK Investigational Site
Vladivostok, Russian Federation, 690105
GSK Investigational Site
Volgograd, Russian Federation, 400008
GSK Investigational Site
Voronezh, Russian Federation, 394018
GSK Investigational Site
Yaroslavl, Russian Federation, 150003
Slovakia
GSK Investigational Site
Bratislava, Slovakia, 826 06
GSK Investigational Site
Bratislava, Slovakia, 831 01
GSK Investigational Site
Nitra, Slovakia, 949 11
South Africa
GSK Investigational Site
Port Elizabeth, Eastern Cape, South Africa, 6014
GSK Investigational Site
Meyerspark, Gauteng, South Africa, 0184
GSK Investigational Site
Parktown, Gauteng, South Africa, 2193
GSK Investigational Site
Chatsworth, KwaZulu- Natal, South Africa, 4092
GSK Investigational Site
Umhlanga Rocks, KwaZulu- Natal, South Africa, 4320
GSK Investigational Site
Bellville, South Africa, 7531
GSK Investigational Site
Benoni, South Africa, 1501
GSK Investigational Site
Bloemfontein, South Africa, 9301
GSK Investigational Site
Cape Town, South Africa, 7500
GSK Investigational Site
Cape Town, South Africa, 7800
GSK Investigational Site
Durban, South Africa, 4001
GSK Investigational Site
Newton, South Africa, 2113
GSK Investigational Site
Observatory, South Africa, 7925
GSK Investigational Site
Parktown, South Africa, 2193
GSK Investigational Site
Pretoria, South Africa, 0002
GSK Investigational Site
Somerset West, South Africa, 7130
GSK Investigational Site
Soweto, South Africa, 2013
GSK Investigational Site
Soweto, South Africa, 1111
GSK Investigational Site
Worcester, South Africa, 6850
Sweden
GSK Investigational Site
Eksjö, Sweden, SE-575 36
GSK Investigational Site
Göteborg, Sweden, SE-417 17
GSK Investigational Site
Göteborg, Sweden, SE-416 85
GSK Investigational Site
Göteborg, Sweden, SE-413 45
GSK Investigational Site
Härnösand, Sweden, SE-871 82
GSK Investigational Site
Karlshamn, Sweden, SE-374 80
GSK Investigational Site
Kristianstad, Sweden, SE-291 85
GSK Investigational Site
Ljungby, Sweden, SE-341 82
GSK Investigational Site
Malmö, Sweden, SE-214 22
GSK Investigational Site
Malmö, Sweden, SE-205 02
GSK Investigational Site
Oskarshamn, Sweden, SE-572 28
GSK Investigational Site
Skene, Sweden, SE-511 62
GSK Investigational Site
Stockholm, Sweden, SE-111 57
GSK Investigational Site
Stockholm, Sweden, SE-171 76
GSK Investigational Site
Vällingby, Sweden, SE-162 68
GSK Investigational Site
Växjö, Sweden, SE-351 85
Thailand
GSK Investigational Site
Bangkok, Thailand, 10400
United Kingdom
GSK Investigational Site
Bath, Somerset, United Kingdom, BA1 3NG
GSK Investigational Site
Chippenham, United Kingdom, SN15 2SB
GSK Investigational Site
Doncaster, United Kingdom, DN9 1EP
GSK Investigational Site
Harrogate, United Kingdom, HG1 5JP
GSK Investigational Site
London, United Kingdom, E1 1BB
GSK Investigational Site
Manchester, United Kingdom, M13 9Wl
GSK Investigational Site
Sheffield, United Kingdom, S10 2RX
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00879970     History of Changes
Other Study ID Numbers: 111960
Study First Received: April 2, 2009
Results First Received: November 10, 2011
Last Updated: April 9, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Cardiovascular Outcomes
Academic Research Collaborator: Population Health Research Institute / Hamilton Health Sciences / McMaster University / Ontario Canada

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
2,4-thiazolidinedione
Ergocalciferols
Pioglitazone
Rosiglitazone
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Hypoglycemic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 31, 2015