Thiazolidinedione Intervention With Vitamin D Evaluation

NCT ID: NCT00879970

Last Updated: 2017-04-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1332 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-11-30

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

pioglitazone

PIO tablet was administered in the dose of 30 milligrams (mg) OD initially and could be titrated to a maximum dose of 45 mg at or after the 6-month visit. After 1 year of treatment, the dose of PIO was increased to 45 mg OD for the duration of 5.5 years.

Group Type: ACTIVE_COMPARATOR

pioglitazone

Intervention Type: DRUG

Pioglitazone30 mg and 45 mg tablets are over-encapsulated with Swedish orange size DB-AA capsule shell.

rosiglitazone

RSG tablet was administered in the dose of 4 mg OD initially and could be titrated to a maximum dose of 8 mg at or after the 6-month visit. After 1 year of treatment, the dose of RSG was increased to 8 mg OD for the duration of 5.5 years.

Group Type: ACTIVE_COMPARATOR

rosiglitazone

Intervention Type: DRUG

Rosiglitazone 4 mg and 8 mg tablets are over-encapsulated with Swedish orange size DB-AA capsule shell.

TZD placebo

Matching placebo tablet was administered once a day (OD) for the duration of 5.5 years

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Placebo to match is Swedish orange size DB-AA capsule filled with white to off-white non-active powder blend.

Vitamin D

Active comparator

Group Type: ACTIVE_COMPARATOR

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D factor intervention

Vitamin D placebo

Placebo Comparator

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D factor intervention

Interventions

pioglitazone

Pioglitazone30 mg and 45 mg tablets are over-encapsulated with Swedish orange size DB-AA capsule shell.

Intervention Type: DRUG

rosiglitazone

Rosiglitazone 4 mg and 8 mg tablets are over-encapsulated with Swedish orange size DB-AA capsule shell.

Intervention Type: DRUG

placebo

Placebo to match is Swedish orange size DB-AA capsule filled with white to off-white non-active powder blend.

Intervention Type: DRUG

Vitamin D

Vitamin D factor intervention

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Vitamin D factor intervention

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Population Health Research Institute

OTHER

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Long Beach, California, United States

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Los Angeles, California, United States

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Northridge, California, United States

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San Diego, California, United States

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Decatur, Georgia, United States

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Tucker, Georgia, United States

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Pocatella, Idaho, United States

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Pocatello, Idaho, United States

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New Orleans, Louisiana, United States

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Haverhill, Massachusetts, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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Kalispell, Montana, United States

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Westfield, New York, United States

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Durham, North Carolina, United States

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Cleveland, Ohio, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Kingsport, Tennessee, United States

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Memphis, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Temple, Texas, United States

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Buenos Aires, Buenos Aires, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Coronel Suárez, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

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San Nicolás de los Arroyos, Buenos Aires, Argentina

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Salta, , Argentina

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San Miguel de Tucumán, , Argentina

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Zárate, , Argentina

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Calgary, Alberta, Canada

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Surrey, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Barrie, Ontario, Canada

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Brampton, Ontario, Canada

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Hamilton, Ontario, Canada

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Hamilton, Ontario, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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Mississauga, Ontario, Canada

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Ohsweken, Ontario, Canada

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Oshawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Thornhill, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Québec, Quebec, Canada

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Québec, Quebec, Canada

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Rimouski, Quebec, Canada

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Saint-Georges, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Temuco, Región de La Araucania, Chile

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Santiago, Región Metro de Santiago, Chile

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Santiago, Región Metro de Santiago, Chile

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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

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Armenia, , Colombia

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Barrangquilla, , Colombia

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Barranquilla, , Colombia

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Bogotac, , 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

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Havířov, , Czechia

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Jihlava, , Czechia

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Městec Králové, , Czechia

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Prague, , Czechia

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Příbram, , Czechia

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Rakovník, , Czechia

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Uherské Hradiště, , Czechia

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Aarhus N, , Denmark

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Copenhagen, , Denmark

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Frederiksberg, , Denmark

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Glostrup Municipality, , Denmark

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Hellerup, , Denmark

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Herlev, , Denmark

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København NV, , Denmark

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Odense C, , Denmark

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Viborg, , Denmark

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Helsinski, , Finland

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Kuopio, , Finland

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Oulu, , Finland

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Deggingen, Baden-Wurttemberg, Germany

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Villingen-Schwenningen, Baden-Wurttemberg, Germany

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Wangen, Baden-Wurttemberg, Germany

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Weinheim, Baden-Wurttemberg, Germany

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Augsburg, Bavaria, Germany

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Gars Am Inn, Bavaria, Germany

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Haag, Bavaria, Germany

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Künzing, Bavaria, Germany

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Munich, Bavaria, Germany

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Munich, Bavaria, Germany

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Vilshofen, Bavaria, Germany

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Wallerfing, Bavaria, Germany

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Angermünde, Brandenburg, Germany

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Elsterwerda, Brandenburg, Germany

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Potsdam, Brandenburg, Germany

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Hamburg, City state of Hamburg, Germany

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Großalmerode, Hesse, Germany

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Kelkheim, Hesse, Germany

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Winsen/Lohe, Lower Saxony, Germany

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Bad Oeynhausen, North Rhine-Westphalia, Germany

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Bergkamen, North Rhine-Westphalia, Germany

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Cologne, North Rhine-Westphalia, Germany

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Cologne, North Rhine-Westphalia, Germany

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Dorsten, North Rhine-Westphalia, Germany

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Eschweiler, North Rhine-Westphalia, Germany

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Essen, North Rhine-Westphalia, Germany

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Essen, North Rhine-Westphalia, Germany

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Goch, North Rhine-Westphalia, Germany

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Witten, North Rhine-Westphalia, Germany

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Ingelheim, Rhineland-Palatinate, Germany

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Mainz, Rhineland-Palatinate, Germany

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Rhaunen, Rhineland-Palatinate, Germany

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Neunkirchen, Saarland, Germany

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Borna, Saxony, Germany

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Delitzsch, Saxony, Germany

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Dresden, Saxony, Germany

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Dresden, Saxony, Germany

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Leipzg, Saxony, Germany

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Leipzig, Saxony, Germany

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Oschatz, Saxony, Germany

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Pirna, Saxony, Germany

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Köthen, Saxony-Anhalt, Germany

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Schönebeck, Saxony-Anhalt, Germany

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Wolmirstedt, Saxony-Anhalt, Germany

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Zerbst, Saxony-Anhalt, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Ahmedabad, , India

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Bangalore, , India

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Bangalore, , India

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Banjara Hills PO, Hyderabad, , India

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Belagavi, , India

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Chennai, , India

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Chennai, , India

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Hyderabad, , India

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Karnāl, , India

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Kerala, , India

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Kochi, , India

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Kochi, , India

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Kochi, , India

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Kottyam, , India

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Mumbai, , India

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Nashik, , India

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Nellore, , India

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Pune, , India

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Tamil Nadu, , India

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Trivandrum, , India

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Vijayawada, , India

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Milano (Milan), Lombardy, Italy

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Sesto San Giovanni (MI), Lombardy, Italy

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Pozzilli (IS), Molise, Italy

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Chieri (Torino), , Italy

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Cēsis, , Latvia

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Daugavpils, , Latvia

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Jēkabpils, , Latvia

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Liepāja, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Tukums, , Latvia

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Tijuana, Baja California Norte, Mexico

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Guadalajara, Jalisco, Mexico

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Guadalajara, Jalisco, Mexico

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Guadalajara, Jalisco, Mexico

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Guadalajara, Jalisco, Mexico

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Zapopan, Jalisco, Mexico

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Morelia, Michoacán, Mexico

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San Luis Potosí City, San Luis Potosí, Mexico

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Aguascalientes, , Mexico

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Guadalajara, , Mexico

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Tampico, , Mexico

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Amsterdam, , Netherlands

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Heerlen, , Netherlands

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Hoofddorp, , Netherlands

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Rotterdam, , Netherlands

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Rotterdam, , Netherlands

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Bodø, , Norway

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Hoenefoss, , Norway

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Kløfta, , Norway

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Oslo, , Norway

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Oslo, , Norway

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Oslo, , Norway

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Skedsmokorset, , Norway

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Stavanger, , Norway

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Tromsø, , Norway

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Trondheim, , Norway

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Faisalabad, , Pakistan

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Islamabad, , Pakistan

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Lahore, , Pakistan

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Arequipa, Arequipa, Peru

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Laoag, , Philippines

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Bacau, , Romania

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Baia Mare, , Romania

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Bistriţa, , Romania

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Brasov, , Romania

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Bucharest, , Romania

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Buzău, , Romania

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Deva, , Romania

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Iași, , Romania

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Oradea, , Romania

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Piteşti, , Romania

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Sibiu, , Romania

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Arkhangelsk, , Russia

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Barnaul, , Russia

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Barnaul, , Russia

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Barnaul, , Russia

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Ivanovo, , Russia

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Ivanovo, , Russia

GSK Investigational Site

Kazan', , Russia

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Kazan', , Russia

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Kemerovo, , Russia

GSK Investigational Site

Kemerovo, , Russia

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Kemerovo, , Russia

GSK Investigational Site

Kirov, , Russia

GSK Investigational Site

Kursk, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Nizhny Novgorod, , Russia

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Nizhny Novgorod, , Russia

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Ryazan, , Russia

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Saint Pertersburg, , Russia

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Saint Petersberg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Smolensk, , Russia

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St'Petersburg, , Russia

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St'Petersburg, , Russia

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Syktyvkar, , Russia

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Tomsk, , Russia

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Tomsk, , Russia

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Tomsk, , Russia

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Vladivostok, , Russia

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Vladivostok, , Russia

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Volgograd, , Russia

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Voronezh, , Russia

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Yaroslavl, , Russia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Nitra, , Slovakia

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Port Elizabeth, Eastern Cape, South Africa

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Meyerspark, Gauteng, South Africa

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Parktown, Gauteng, South Africa

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Chatsworth, KwaZulu-Natal, South Africa

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Umhlanga, KwaZulu-Natal, South Africa

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Bellville, , South Africa

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Benoni, , South Africa

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Bloemfontein, , South Africa

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Cape Town, , South Africa

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Cape Town, , South Africa

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Durban, , South Africa

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Newton, , South Africa

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Observatory, , South Africa

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Parktown, , South Africa

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Pretoria, , South Africa

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Somerset West, , South Africa

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Soweto, , South Africa

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Soweto, , South Africa

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Worcester, , South Africa

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Eksjö, , Sweden

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Gothenburg, , Sweden

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Gothenburg, , Sweden

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Gothenburg, , Sweden

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Härnösand, , Sweden

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Karlshamn, , Sweden

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Kristianstad, , Sweden

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Ljungby, , Sweden

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Malmo, , Sweden

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Malmo, , Sweden

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Oskarshamn, , Sweden

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Skene, , Sweden

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Stockholm, , Sweden

GSK Investigational Site

Stockholm, , Sweden

GSK Investigational Site

Vaxjo, , Sweden

GSK Investigational Site

Vällingby, , Sweden

GSK Investigational Site

Bangkok, , Thailand

GSK Investigational Site

Bath, Somerset, United Kingdom

GSK Investigational Site

Chippenham, , United Kingdom

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Doncaster, , United Kingdom

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Harrogate, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Sheffield, , United Kingdom

Countries

United States; Argentina; Canada; Chile; Colombia; Czechia; Denmark; Finland; Germany; India; Italy; Latvia; Mexico; Netherlands; Norway; Pakistan; Peru; Philippines; Romania; Russia; Slovakia; South Africa; Sweden; Thailand; United Kingdom

References

Punthakee Z, Bosch J, Gerstein HC. Setting the record straight on TIDE: a lost opportunity for patients with diabetes. Diabetologia. 2013 Sep;56(9):1884-7. doi: 10.1007/s00125-013-2959-0. Epub 2013 Jun 6.

Reference Type: DERIVED

PMID: 23740195 (View on PubMed)

Punthakee Z, Bosch J, Dagenais G, Diaz R, Holman R, Probstfield J, Ramachandran A, Riddle M, Ryden LE, Zinman B, Afzal R, Yusuf S, Gerstein H; TIDE Trial Investigators. Design, history and results of the Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) randomised controlled trial. Diabetologia. 2012 Jan;55(1):36-45. doi: 10.1007/s00125-011-2357-4. Epub 2011 Oct 29.

Reference Type: DERIVED

PMID: 22038523 (View on PubMed)

Study Documents

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

111960

Identifier Type: -

Identifier Source: org_study_id