AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 2NCT00196989

Study In People With Type 2 Diabetes

A Phase 2 study testing Pioglitazone and GW677954 in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 143 sites in 13 countries.

Completed

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

Official record
Search all trials

Trial summary

This Phase 2 dose-ranging study will evaluate the efficacy, safety and tolerability of a range of doses of GW677954 compared with placebo over sixteen weeks of treatment in subjects with T2DM (Type 2 Diabetes Mellitus). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Pioglitazone and GW677954
How many people
448 participants
Where
143 sitesin 13 countries
Study dates
Sep 2005to Apr 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

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

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with T2DM as defined by the criteria of the ADA and/or recognized by WHO Expert Committee on the Diagnosis and Classification of Diabetes Mellitus [American Diabetes Association, 2004], for at least 3 months preceding screening (see Section 15.3, Appendix 3:, "Diagnosis and Classification of Diabetes Mellitus").
  • To be eligible for Randomization into the trial, a subject must satisfy all of the following glycemic criteria:
  • HbA1c level via central laboratory at the pre-screening visit
  • If HbA1c ≥ 8.0% but ≤ 10.0%: subject may proceed to Randomization;
  • If HbA1c ≥ 7.8% but < 8.0%, subject not eligible to proceed, but may be retested once to establish eligibility (or lack thereof). If HbA1c level ≥ 8.0% upon retest, subject is eligible to proceed; otherwise they should be withdrawn.
  • If HbA1c < 7.8%, subject not eligible to proceed (no retest allowed).
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  • FPG level via central laboratory at the pre-screening visit must be < 270 mg/dL (15.0 mmol/L). FPG may be retested within a week to confirm eligibility (or lack thereof).
  • Concurrent T2DM therapy:
  • Diet and/or exercise treated: Must not have taken antidiabetic medication for at least 2 months prior to the pre-screening visit, OR
  • Metformin monotherapy: Subjects entering the study on metformin must be on the same dose, formulation and regimen of metformin for at least 2 months prior to the pre-screening visit, AND
  • TZDs and insulin are excluded in the 3 months prior to the Screening visit for all subjects.
  • Males and females who are 18 to 70 years of age inclusive at the time of Screening.
  • If female, eligible to enter and participate in this study:
  • If of non-childbearing potential (i.e., physiologically incapable of becoming pregnant (tubal ligation), including any female who is post-menopausal [>1 year without menstrual period]); or,
  • If of child-bearing potential, has a negative pregnancy test at Screening (serum), at Randomization (urine) and:
  • Has a male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject, or
  • Uses double-barrier methods of contraception; condoms with the use of caps (with spermicide) and IUDs are acceptable, or
  • Uses hormonal contraceptives (oral, depots, patches etc) with double- barrier methods of contraception as outlined above, or
  • Abstains from sexual intercourse, or
  • Is with a same sex partner and does not participate in bisexual activities where there is any risk of pregnancy.
  • Body Mass Index (BMI): ≥25 and ≤40 kg/m² and weigh at least 50 kg at Screening.
  • If subject is a smoker, must be able to abstain while in clinic at each visit.
  • Subject has given full written informed consent prior to any study related procedures are performed.

Who cannot join

  • Metabolic Disease including:
  • Diagnosis of Type 1 diabetes mellitus
  • Uncorrected thyroid dysfunction. (NOTE: subjects with hypothyroidism on a stable dose of thyroid replacement therapy for at least 1 month prior to Screening, and who have a screening thyroid stimulating hormone (TSH) within the upper limit of normal may participate).
  • Significant weight gain or loss (defined as > 5% of total body weight) within the 3 months prior to Screening.
  • Previous use of insulin for treatment of hyperglycemia within 3 months of Screening.
  • History of recent clinically significant cardiovascular disease including:
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  • History or ECG evidence of prior myocardial infarction within 6 months prior to Screening.
  • Current unstable angina or history of unstable angina in past 6 months.
  • Coronary revascularization including percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery that is either planned or occurred in the 6 months prior to Screening.
  • Clinically significant arrhythmia or valvular heart disease.
  • Congestive heart failure (CHF) with New York Heart Association (NYHA) Class II-IV symptoms (see Section 15.4, Appendix 4).
  • Blood pressure > 160/100 mmHg or resting heart rate > 100 bpm. Note: subjects using antihypertensives [e.g., beta blockers, angiotensin converting enzyme (ACE) inhibitors, angiotensin II antagonists, calcium channel blockers and diuretics] must be on stable doses during the 30 days prior to Screening and during the trial.
  • Has a QTc interval (Bazett's) > 440 msec in males and > 450 msec in females at Screening.
  • Clinically significant ECG abnormalities which, in the opinion of the Investigator, may affect the interpretation of safety data, or which otherwise, contraindicates participation in a clinical trial with a new chemical entity.
  • History of chronic pancreatitis.
  • Familial hypercholesterolemia.
  • TGs ≥800 mg/dL (8.96 mmol/L) at Screening.
  • Serum creatinine at screening > 1.4 mg/dL (124 µmol/L) for women, or > 1.5 mg/dL (133 µmol/L) for men.
  • Clinically significant anemia defined by hemoglobin concentrations <12.0 g/dL or < 120.0 g/L for males and < 11.0 g/dL or < 110.0 g/L for females.
  • History of significant co-morbid diseases (e.g., cholelithiasis, gastrointestinal disease, etc.) that would preclude participation in the study.
  • Documented history of hepato-biliary disease including a history of, or positive laboratory results for hepatitis (hepatitis B surface antigen and/or hepatitis C antibody) at Screening, and/or clinically significant hepatic enzyme elevation including:
  • •Any one of the following enzymes greater than 2.5 times the upper limit of normal (ULN) value at Screening:
  • Alanine aminotransferase (ALT)
  • Aspartate aminotransferase (AST)
  • Alkaline phosphatase (ALP)
  • Total or direct bilirubin > 1.5 times the ULN at Screening, unless consistent with presumed or diagnosed Gilbert's disease.
  • History of metabolic acidosis, rhabdomyolysis, myalgia, myositis or myopathy after taking statins or fibrates.
  • Any subject who has withdrawn therapy due to AEs after taking a PPARγ or a PPARα/γ dual agonist, either marketed (e.g., troglitazone, rosiglitazone or pioglitazone) or under current or previous clinical investigation.
  • Signs or symptoms of myositis at Screening (or upon 1 repeat test), and/or creatinine phosphokinase (CPK)≥3.0 times ULN
  • Is currently taking or has taken any of the following medications in the 3 months prior to the pre-screening visit:
  • Anti-obesity agents (including fat absorption blocking agents)
  • St. John's Wort
  • Warfarin and other oral anticoagulants (excluding aspirin and non-steroidal anti-inflammatory drugs)
  • Digoxin
  • Oral or injectable corticosteroids (inhaled and intranasal steroids are acceptable)
  • Use of antidiabetic agents (other than metformin) in the 2 months prior to the pre-screening visit.
  • Use of TZDs in the 3 months prior to the pre-screening visit.
  • Methotrexate, cyclosporine or monoclonal antibodies (e.g., alemtuzumab, gemtuzumab ozogamicin, rituximab, trastuzumab, ibritumomab, tiuxetan) for rheumatoid arthritis or psoriasis.
  • Atypical antipsychotic medications [e.g., aripiprazole (Abilify), risperidone (Risperdal), clozapine (Clozaril), olanzapine (Zyprexa), quetiapine (Seroquel), and ziprasidone (Geodon)].
  • Antiretroviral drugs
  • Use of lipid lowering agents within 3 months prior to the pre-screening visit. This includes statins, fibrates, ezetimibe (Zetia), niacin and bile acid sequestrants.
  • Monoamine oxidase inhibitors
  • History of cancer except for the following:
  • Basal cell carcinoma or superficial squamous cell carcinoma treated by local excision.
  • Cervical cancer in situ treated definitively more than 6 months prior to screening.
  • Women who are lactating, pregnant, or planning to become pregnant.
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to any drug chemically related to the study drug.
  • Known allergy to any of the capsule excipients, or history of drug or other allergy, which, in the opinion of the responsible study physician, contradicts participation. Hypersensitivity to metformin or any of its components (for subjects entering on metformin).
  • Has a history of substance and/or alcohol abuse within the past year as determined by the Investigator at screening or during treatment:
  • Unwilling to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.
  • History of alcohol abuse defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint of beer or 1 measure of spirits or 1 glass of wine.
  • Received treatment with a new molecular entity (investigational drug) during the previous 4 months or participated in any other trial during the previous 3 months, or has participated in a previous study with GW677954. A new molecular entity is defined as any compound not in Phase 3. (The washout is from last dose of investigational product in the previous study until the first dose of investigational product.)
  • Likely to be non-compliant, in the investigator's opinion, with respect to the protocol and related scheduled visits.
  • Subject has any concomitant medical condition which in the opinion of the investigator makes them unsuitable to participate in the study.
  • Subject is either an immediate family member of a participating investigator, study coordinator, employee of an investigator; or is a member of the staff conducting the study.

Trial locations and contacts

143 sites in 13 countries.

143 sites in 13 countries

United States69 sites

  • GSK Investigational Site

    Albuquerque, New Mexico, 87102

  • GSK Investigational Site

    Alhambra, California, 91801

  • GSK Investigational Site

    Artesia, California, 90701

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Birmingham, Alabama, 35205

  • GSK Investigational Site

    Chandler, Arizona, 85224

  • GSK Investigational Site

    Cite, Tennessee, 37604

  • GSK Investigational Site

    Cleveland, Ohio, 44195

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Denver, Colorado, 80220

  • GSK Investigational Site

    Duluth, Georgia, 30097

  • GSK Investigational Site

    East Providence, Rhode Island, 02914

  • GSK Investigational Site

    Edmonds, Washington, 98026

  • GSK Investigational Site

    Everett, Washington, 98208

  • GSK Investigational Site

    Franklin, Ohio, 45005

  • GSK Investigational Site

    Greensboro, North Carolina, 27401

  • GSK Investigational Site

    Greer, South Carolina, 29651

  • GSK Investigational Site

    Henderson, Nevada, 89014

  • GSK Investigational Site

    Henderson, Nevada, 89015

  • GSK Investigational Site

    Hollywood, Florida, 33021

  • GSK Investigational Site

    Hollywood, Florida, 33023

  • GSK Investigational Site

    Honolulu, Hawaii, 96813

  • GSK Investigational Site

    Huntington Beach, California, 92648

  • GSK Investigational Site

    Indianapolis, Indiana, 46260

  • GSK Investigational Site

    Inglewood, California, 90301

  • GSK Investigational Site

    Irvine, California, 92618

  • GSK Investigational Site

    Kingsport, Tennessee, 37660

  • GSK Investigational Site

    La Jolla, California, 92037

  • GSK Investigational Site

    Largo, Florida, 33773

  • GSK Investigational Site

    Las Vegas, Nevada, 89106

  • GSK Investigational Site

    Las Vegas, Nevada, 89119

  • GSK Investigational Site

    Las Vegas, Nevada, 89128

  • GSK Investigational Site

    Long Beach, California, 90806

  • GSK Investigational Site

    Los Angeles, California, 90057

  • GSK Investigational Site

    Los Angeles, California, 90095

  • GSK Investigational Site

    Miami, Florida, 33156

  • GSK Investigational Site

    Monroe, Washington, 98272

  • GSK Investigational Site

    New York, New York, 10024

  • GSK Investigational Site

    New York, New York, 10032

  • GSK Investigational Site

    Northport, Alabama, 35476

  • GSK Investigational Site

    Northridge, California, 91325

  • GSK Investigational Site

    Norwalk, California, 90650

  • GSK Investigational Site

    Norwich, Connecticut, 06360

  • GSK Investigational Site

    Pahrump, Nevada, 89048

  • GSK Investigational Site

    Pasadena, California, 91105

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19107

  • GSK Investigational Site

    Phoenix, Arizona, 85006

  • GSK Investigational Site

    Phoenix, Arizona, 85032

  • GSK Investigational Site

    Sacramento, California, 95825

  • GSK Investigational Site

    Saint Cloud, Florida, 34769

  • GSK Investigational Site

    Salt Lake City, Utah, 84109

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Diego, California, 92128

  • GSK Investigational Site

    San Diego, California, 92177

  • GSK Investigational Site

    Santa Fe, New Mexico, 87505

  • GSK Investigational Site

    Santa Monica, California, 90404

  • GSK Investigational Site

    Sarasota, Florida, 34239

  • GSK Investigational Site

    Simpsonville, South Carolina, 29681

  • GSK Investigational Site

    Springfield, Illinois, 62701

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Tustin, California, 92780

  • GSK Investigational Site

    Tyler, Texas, 75708

  • GSK Investigational Site

    Virginia Beach, Virginia, 23451

  • GSK Investigational Site

    Vista, California, 92084

  • GSK Investigational Site

    Wauwatosa, Wisconsin, 53226

  • GSK Investigational Site

    West Hills, California, 91307

  • GSK Investigational Site

    West Jordan, Utah, 84084

  • GSK Investigational Site

    West Yarmouth, Massachusetts, 02673

Other trials in United States

Canada25 sites

  • GSK Investigational Site

    Bonaventure, Quebec, G0C 1E0

  • GSK Investigational Site

    Brampton, Ontario, L6T 3J1

  • GSK Investigational Site

    Granby, Quebec, J2G 8Z9

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3A 1Y8

  • GSK Investigational Site

    Halifax, Nova Scotia, B3K 5R3

  • GSK Investigational Site

    Langley, British Columbia, V3A 4H9

  • GSK Investigational Site

    Laval, Quebec, H7T 2P5

  • GSK Investigational Site

    London, Ontario, N5W 6A2

  • GSK Investigational Site

    Longueuil, Quebec, J4N 1L6

  • GSK Investigational Site

    Mississauga, Ontario, L5A 1N1

  • GSK Investigational Site

    Montreal, Quebec, H4N 2W2

  • GSK Investigational Site

    Ottawa, Ontario, K1H 1A2

  • GSK Investigational Site

    Québec, Quebec, G1W 4R4

  • GSK Investigational Site

    Saint-Marc-des-Carrieres, Quebec, G0A 4B0

  • GSK Investigational Site

    Sainte-Foy, Quebec, G1V 1V6

  • GSK Investigational Site

    Sainte-Foy, Quebec, G1V 4G2

  • GSK Investigational Site

    Sainte-Foy, Quebec, G1V 4G5

  • GSK Investigational Site

    Sherbrooke, Quebec, J1G 5K2

  • GSK Investigational Site

    Smiths Falls, Ontario, K7A 4W8

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1E 2C2

  • GSK Investigational Site

    Thornhill, Ontario, L4J 8L7

  • GSK Investigational Site

    Toronto, Ontario, M4R 2G4

  • GSK Investigational Site

    Toronto, Ontario, M9W 4L6

  • GSK Investigational Site

    Waterloo, Ontario, N2J 1C4

  • GSK Investigational Site

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Australia8 sites

  • GSK Investigational Site

    Adelaide, South Australia, 5000

  • GSK Investigational Site

    Box Hill, Victoria, 3128

  • GSK Investigational Site

    Carina Heights, Queensland, 4152

  • GSK Investigational Site

    Keswick, South Australia, 5035

  • GSK Investigational Site

    Miranda, New South Wales, 2228

  • GSK Investigational Site

    Port Lincoln, South Australia, 5606

  • GSK Investigational Site

    Ringwood East, Victoria, 3135

  • GSK Investigational Site

    Spring Hill, Queensland, 4000

Other trials in Australia

Czechia7 sites

  • GSK Investigational Site

    České Budějovice, 370 87

  • GSK Investigational Site

    Cheb, 350 02

  • GSK Investigational Site

    Olomouc, 779 00

  • GSK Investigational Site

    Prague, 10000

  • GSK Investigational Site

    Prague, 128 08

  • GSK Investigational Site

    Prague, 15030

  • GSK Investigational Site

    Prague, 158 00

Other trials in Czechia

Mexico6 sites

  • GSK Investigational Site

    Cuernavaca, Morelos, 62420

  • GSK Investigational Site

    Durango, Durango, 3400

  • GSK Investigational Site

    Mexico City, 11650

  • GSK Investigational Site

    Monterrey, Nuevo León, 64570

  • GSK Investigational Site

    Pachuca, Hidalgo, 42039

  • GSK Investigational Site

    Tijuana, Baja California Norte, 22320

Other trials in Mexico

Russia6 sites

  • GSK Investigational Site

    Moscow, 117 036

  • GSK Investigational Site

    Perm, 614600

  • GSK Investigational Site

    Samara, 443067

  • GSK Investigational Site

    Tyumen, 625023

  • GSK Investigational Site

    Ufa, 450000

  • GSK Investigational Site

    Yaroslavl, 150062

Other trials in Russia

Argentina5 sites

  • GSK Investigational Site

    Buenos Aires, Buenos Aires, 1425

  • GSK Investigational Site

    Capital Federal, Buenos Aires, 1181

  • GSK Investigational Site

    Capital Federal, Buenos Aires, C1221ACI

  • GSK Investigational Site

    Córdoba, Córdoba Province, 5000

  • GSK Investigational Site

    San Juan, 5400

Other trials in Argentina

Latvia5 sites

  • GSK Investigational Site

    Cēsis, LV4100

  • GSK Investigational Site

    Daugavpils, LV5417

  • GSK Investigational Site

    Riga, LV 1002

  • GSK Investigational Site

    Riga, LV1024

  • GSK Investigational Site

    Tukums, LV 3100

Other trials in Latvia

New Zealand5 sites

  • GSK Investigational Site

    Auckland, 1309

  • GSK Investigational Site

    Auckland, 1311

  • GSK Investigational Site

    Christchurch, 8001

  • GSK Investigational Site

    Rotorua, 3201

  • GSK Investigational Site

    Tauranga, 3001

Other trials in New Zealand

Peru4 sites

  • GSK Investigational Site

    Lima, Lima Province, Lima 14

  • GSK Investigational Site

    Lima, Lima Province, Lima 27

  • GSK Investigational Site

    Lima, Lima 1

  • GSK Investigational Site

    San Isidro, Lima region, Lima 27

Other trials in Peru

Colombia1 site

  • GSK Investigational Site

    Bogotá

Other trials in Colombia

Costa Rica1 site

  • GSK Investigational Site

    San José, Provincia de San José

Other trials in Costa Rica

Ecuador1 site

  • GSK Investigational Site

    Quito

Other trials in Ecuador

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of Oral GW677954 as a Monotherapy for 12 Weeks Duration in Patients With Type 2 Diabetes Mellitus

This Phase 2 dose-ranging study will evaluate the efficacy, safety and tolerability of a range of doses of GW677954 compared with placebo over sixteen weeks of treatment in subjects with T2DM (Type 2 Diabetes Mellitus).

Read the detailed description

A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Placebo-Controlled, Study To Evaluate Efficacy, Safety And Tolerability Of Oral GW677954 Capsules (2.5, 5, 10, 15 And 20 Mg Once A Day) As A Monotherapy (Diet and/or exercise treated) Or As An Add-On To Metformin For 16 Weeks Duration In Subjects With Type 2 Diabetes Mellitus

Being tested
Pioglitazone, GW677954
Keywords
Efficacy, PPARpan, Type 2 Diabetes Mellitus, Phase IIb, Safety, Pharmacokinetics, GW677954, Pharmacodynamics, Tolerability, Dose-Ranging
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

What is being measured

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

  1. Percentage change from Baseline (Day 1) in glycated hemoglobin (HbA1c) levels at Week 16 as a measure of improvement in glucose control

    Improvement in glucose control was measured by means of reduction in glycated hemoglobin (Hb) levels in blood.

    Measured: Week (W) 16

Secondary outcomes (27)

  1. Percentage change from Baseline (Day 1) in fasting HbA1c levels at Weeks 4, 8 and 12

    Improvement in glucose control was measured by means of reduction in glycated hemoglobin (HbA1c) levels in blood. Change from Baseline is the value at indicated time point minus the value at Baseline.

    Measured: Weeks 4, 8, and 12

  2. Change from Baseline (Day 1) in fasting plasma glucose (FPG) at Weeks 1, 2, 4, 6, 8, 12 and 16

    Change from Baseline is the value at indicated time point minus the value at Baseline.

    Measured: W1, W2, W4, W6, W8, W12, and W16

  3. Change from Baseline (Day 1) in fasting fructosamine at Weeks 2 and 4

    Change from Baseline is the value at indicated time point minus the value at Baseline.

    Measured: Baseline (Day 1), W2, W4

  4. Percentage of participants achieving target HbA1c levels at Weeks 4, 8, 12, and 16

    Improvement in glucose control was measured by means of reduction in glycated hemoglobin (HbA1c) levels in blood. The ideal concentration of HbA1c was desired to be less than or equal to 7%.

    Measured: Weeks 4, 8, 12, and 16

  5. Percentage of participants achieving a decrease in HbA1c of >= 0.7% from Baseline (Day 1) at Weeks 4, 8, 12 and 16

    Improvement in glucose control was measured by means of reduction in glycated hemoglobin (HbA1c) levels in blood.

    Measured: Baseline (Day 1), Weeks 4, 8, 12, and 16

  6. Percentage of participants achieving target range of FPG at Weeks 1, 2, 4, 6, 8, 12 and 16

    The target range for FPG was <=126 milligrams per deciliter (mg/dL) or 7.0 millimoles per liter (mmol/L) to <=140 mg/dL or 7.8 mmol/L

    Measured: Weeks 1,2, 4, 6, 8, 12, and 16

  7. Percentage of participants achieving a decrease from Baseline (Day 1) of >=30 mg/dL [1.66 mmol/L] in FPG at Weeks 1, 2, 4, 6, 8, 12 and 16

    Change from Baseline is the value at indicated time point minus the value at Baseline.

    Measured: Weeks 1, 2, 4, 6, 8, 12, and 16

  8. Ratio to the Baseline (percentage change) of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and free fatty acids (FFA) at Weeks 2, 4, 8, 12, and 16

    This data analysis was based on log-transformed data.

    Measured: Baseline (Day 1), Weeks 2, 4, 8, 12, and 16

  9. Percentage change from Baseline (Day 1) in non-HDL-C based on log-transformed data at Week 16

    Change from Baseline is the value at indicated time point minus the value at Baseline.

    Measured: At Week 16

  10. Percentage change from Baseline (Day 1) in very low density lipoprotein-cholesterol (VLDL-C), apolipoprotein AI (Apo AI), AII, and B at Week 16.

    Change from Baseline is the value at indicated time point minus the value at Baseline.

    Measured: At Week 16

  11. Change from Baseline (Day 1) in Apo B/TC, TC/HDL-C, and LDL-C/Apo B ratio at Week 16

    Change from Baseline is the value at indicated time point minus the value at Baseline.

    Measured: At Week 16

  12. Change from Baseline (Day 1) in hemoglobin at Week 16

    This analysis was performed in sitting position. Change from Baseline is the value at indicated time point minus the value at Baseline.

    Measured: At Week 16

  13. Change from Baseline (Day 1) in hematocrit at Week 16

    Change from Baseline is the value at indicated time point minus the value at Baseline.

    Measured: Wekk 16

  14. Change from Baseline (Day 1) in systolic and diastolic blood pressure (SBP and DBP) at Week 16

    Systolic blood pressure )SBP) and diastolic blood pressure (DBP) were measured in sitting position. Change from Baseline is the value at indicated time point minus the value at Baseline.

    Measured: At Week 16

  15. Change from Baseline (Day 1) in heart rate at Week 16

    Heart rate was measured in sitting position. Change from Baseline is the value at indicated time point minus the value at Baseline.

    Measured: Week 16

  16. Change from Baseline (Day 1) in body weight at Week 16

    Change from Baseline is the value at indicated time point minus the value at Baseline.

    Measured: Week 16

  17. Change from Baseline (Day 1) in 12 lead electrocardiogram (ECG) measures including PR interval, QT interval, QTc interval and QRS duration at Week 16

    QT(c) interval calculations were done by Bazett's method (QTc[B]) as well as by Fridericia's correction (QTc[F]). Change from Baseline is the value at indicated time point minus the Baseline value.

    Measured: Week 16

  18. Number of participants with clinical hematology, chemistry, urinalysis, exploratory cardiac parameters of potential clinical concern (PCC) along with serum pregnancy test over period

    Participants were analyzed for any abnormality for laboratory parameters either higher or lower than the potential clinical concern range.

    Measured: Upto 16 weeks

  19. Number of participants with hypoglycemic events as a measure of ophthalmic assessment

    Participants received a glucose log for reading for routine recording of glucometer readings. Glucose values were recorded on timely basis.

    Measured: Up to 16 weeks

  20. Number of participants with intensity of hypoglycemic events as a measure of ophthalmic assessment

    Participants received a glucose log for reading for routine recording of glucometer readings. Glucose values were recorded on timely basis.

    Measured: Up to 16 weeks

  21. Number of participants with adverse events (AEs) and serious adverse events (SAEs) over period

    Adverse event (AE) is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.

    Measured: Up to 16 weeks

  22. Change from Baseline (Day 1) in phosphocreatine kinase (Creatine kinase-MB) over period

    CK-MB is a cardiac biomarker.

    Measured: Up to 16 weeks

  23. Number of participants with absolute Troponin-I (cTnI) levels over period

    Troponin-I (cTnI) is a cardiac biomarker.

    Measured: Up to 16 weeks

  24. Change from Baseline (Day 1) in fasting insulin at Week 8 and 16

    Change from Baseline is the value at indicated time point minus the value at Baseline.

    Measured: Week 8 and 16

  25. Change from Baseline (Day 1) in C-peptide at Week 8 and 16

    Measured: Week 8 and 16

  26. Change from Baseline (Day 1) in HOMA-S at Week 16

    Measured: Week 16

  27. Change from Baseline (Day 1) in QUICKI at Week 16

    Measured: Week 16

Timeline

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

  1. First posted20 Sep 2005 (estimated)
  2. Study startSep 2005
  3. Primary completionApr 2007
  4. Study completionApr 2007

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
448 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00196989
Sponsor's protocol ID
ADG20001
Status last verified
Mar 2017
First submitted
13 Sep 2005
Last updated
23 Mar 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pioglitazone and GW677954 in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 143 sites in 13 countries.

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

Who may be eligible to take part?

The sponsor lists 23 inclusion and 55 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 143 sites in United States, Canada, Australia, Czechia, Mexico and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

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

What does the primary outcome measure?

Percentage change from Baseline (Day 1) in glycated hemoglobin (HbA1c) levels at Week 16 as a measure of improvement in glucose control (time frame: Week (W) 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00196989.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.

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