Study In People With Type 2 Diabetes
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
1 other identifier
interventional
448
12 countries
142
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 diabetes-mellitus-type-2
Started Sep 2005
Typical duration for phase_2 diabetes-mellitus-type-2
142 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedMarch 23, 2017
March 1, 2017
1.6 years
September 13, 2005
March 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Week (W) 16
Secondary Outcomes (27)
Percentage change from Baseline (Day 1) in fasting HbA1c levels at Weeks 4, 8 and 12
Weeks 4, 8, and 12
Change from Baseline (Day 1) in fasting plasma glucose (FPG) at Weeks 1, 2, 4, 6, 8, 12 and 16
W1, W2, W4, W6, W8, W12, and W16
Change from Baseline (Day 1) in fasting fructosamine at Weeks 2 and 4
Baseline (Day 1), W2, W4
Percentage of participants achieving target HbA1c levels at Weeks 4, 8, 12, and 16
Weeks 4, 8, 12, and 16
Percentage of participants achieving a decrease in HbA1c of >= 0.7% from Baseline (Day 1) at Weeks 4, 8, 12 and 16
Baseline (Day 1), Weeks 4, 8, 12, and 16
- +22 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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).
- 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:
- +8 more criteria
You may not qualify if:
- 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:
- 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.
- +40 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (143)
GSK Investigational Site
Birmingham, Alabama, 35205, United States
GSK Investigational Site
Northport, Alabama, 35476, United States
GSK Investigational Site
Chandler, Arizona, 85224, United States
GSK Investigational Site
Phoenix, Arizona, 85006, United States
GSK Investigational Site
Phoenix, Arizona, 85032, United States
GSK Investigational Site
Alhambra, California, 91801, United States
GSK Investigational Site
Artesia, California, 90701, United States
GSK Investigational Site
Huntington Beach, California, 92648, United States
GSK Investigational Site
Inglewood, California, 90301, United States
GSK Investigational Site
Irvine, California, 92618, United States
GSK Investigational Site
La Jolla, California, 92037, United States
GSK Investigational Site
Long Beach, California, 90806, United States
GSK Investigational Site
Los Angeles, California, 90057, United States
GSK Investigational Site
Los Angeles, California, 90095, United States
GSK Investigational Site
Northridge, California, 91325, United States
GSK Investigational Site
Norwalk, California, 90650, United States
GSK Investigational Site
Pasadena, California, 91105, United States
GSK Investigational Site
Sacramento, California, 95825, United States
GSK Investigational Site
San Diego, California, 92128, United States
GSK Investigational Site
San Diego, California, 92177, United States
GSK Investigational Site
Santa Monica, California, 90404, United States
GSK Investigational Site
Tustin, California, 92780, United States
GSK Investigational Site
Vista, California, 92084, United States
GSK Investigational Site
West Hills, California, 91307, United States
GSK Investigational Site
Denver, Colorado, 80220, United States
GSK Investigational Site
Norwich, Connecticut, 06360, United States
GSK Investigational Site
Hollywood, Florida, 33021, United States
GSK Investigational Site
Hollywood, Florida, 33023, United States
GSK Investigational Site
Largo, Florida, 33773, United States
GSK Investigational Site
Miami, Florida, 33156, United States
GSK Investigational Site
Saint Cloud, Florida, 34769, United States
GSK Investigational Site
Sarasota, Florida, 34239, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Duluth, Georgia, 30097, United States
GSK Investigational Site
Honolulu, Hawaii, 96813, United States
GSK Investigational Site
Springfield, Illinois, 62701, United States
GSK Investigational Site
Indianapolis, Indiana, 46260, United States
GSK Investigational Site
West Yarmouth, Massachusetts, 02673, United States
GSK Investigational Site
St Louis, Missouri, 63110, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Henderson, Nevada, 89014, United States
GSK Investigational Site
Henderson, Nevada, 89015, United States
GSK Investigational Site
Las Vegas, Nevada, 89106, United States
GSK Investigational Site
Las Vegas, Nevada, 89119, United States
GSK Investigational Site
Las Vegas, Nevada, 89128, United States
GSK Investigational Site
Pahrump, Nevada, 89048, United States
GSK Investigational Site
Albuquerque, New Mexico, 87102, United States
GSK Investigational Site
Santa Fe, New Mexico, 87505, United States
GSK Investigational Site
New York, New York, 10024, United States
GSK Investigational Site
New York, New York, 10032, United States
GSK Investigational Site
Greensboro, North Carolina, 27401, United States
GSK Investigational Site
Cleveland, Ohio, 44195, United States
GSK Investigational Site
Franklin, Ohio, 45005, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107, United States
GSK Investigational Site
East Providence, Rhode Island, 02914, United States
GSK Investigational Site
Greer, South Carolina, 29651, United States
GSK Investigational Site
Simpsonville, South Carolina, 29681, United States
GSK Investigational Site
Cite, Tennessee, 37604, United States
GSK Investigational Site
Kingsport, Tennessee, 37660, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Tyler, Texas, 75708, United States
GSK Investigational Site
Salt Lake City, Utah, 84109, United States
GSK Investigational Site
West Jordan, Utah, 84084, United States
GSK Investigational Site
Virginia Beach, Virginia, 23451, United States
GSK Investigational Site
Edmonds, Washington, 98026, United States
GSK Investigational Site
Everett, Washington, 98208, United States
GSK Investigational Site
Monroe, Washington, 98272, United States
GSK Investigational Site
Wauwatosa, Wisconsin, 53226, United States
GSK Investigational Site
Buenos Aires, Buenos Aires, 1425, Argentina
GSK Investigational Site
Capital Federal, Buenos Aires, 1181, Argentina
GSK Investigational Site
Capital Federal, Buenos Aires, C1221ACI, Argentina
GSK Investigational Site
Córdoba, Córdoba Province, 5000, Argentina
GSK Investigational Site
San Juan, 5400, Argentina
GSK Investigational Site
Miranda, New South Wales, 2228, Australia
GSK Investigational Site
Carina Heights, Queensland, 4152, Australia
GSK Investigational Site
Spring Hill, Queensland, 4000, Australia
GSK Investigational Site
Adelaide, South Australia, 5000, Australia
GSK Investigational Site
Keswick, South Australia, 5035, Australia
GSK Investigational Site
Port Lincoln, South Australia, 5606, Australia
GSK Investigational Site
Box Hill, Victoria, 3128, Australia
GSK Investigational Site
Ringwood East, Victoria, 3135, Australia
GSK Investigational Site
Langley, British Columbia, V3A 4H9, Canada
GSK Investigational Site
Winnipeg, Manitoba, R3E 3P4, Canada
GSK Investigational Site
St. John's, Newfoundland and Labrador, A1E 2C2, Canada
GSK Investigational Site
Halifax, Nova Scotia, B3K 5R3, Canada
GSK Investigational Site
Brampton, Ontario, L6T 3J1, Canada
GSK Investigational Site
Greater Sudbury, Ontario, P3A 1Y8, Canada
GSK Investigational Site
London, Ontario, N5W 6A2, Canada
GSK Investigational Site
Mississauga, Ontario, L5A 1N1, Canada
GSK Investigational Site
Ottawa, Ontario, K1H 1A2, Canada
GSK Investigational Site
Smiths Falls, Ontario, K7A 4W8, Canada
GSK Investigational Site
Thornhill, Ontario, L4J 8L7, Canada
GSK Investigational Site
Toronto, Ontario, M4R 2G4, Canada
GSK Investigational Site
Toronto, Ontario, M9W 4L6, Canada
GSK Investigational Site
Waterloo, Ontario, N2J 1C4, Canada
GSK Investigational Site
Bonaventure, Quebec, G0C 1E0, Canada
GSK Investigational Site
Granby, Quebec, J2G 8Z9, Canada
GSK Investigational Site
Laval, Quebec, H7T 2P5, Canada
GSK Investigational Site
Longueuil, Quebec, J4N 1L6, Canada
GSK Investigational Site
Montreal, Quebec, H4N 2W2, Canada
GSK Investigational Site
Québec, Quebec, G1W 4R4, Canada
GSK Investigational Site
Saint-Marc-des-Carrieres, Quebec, G0A 4B0, Canada
GSK Investigational Site
Sainte-Foy, Quebec, G1V 1V6, Canada
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G2, Canada
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G5, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1G 5K2, Canada
GSK Investigational Site
Bogotá, Colombia
GSK Investigational Site
San José, Provincia de San José, Costa Rica
GSK Investigational Site
Cheb, 350 02, Czechia
GSK Investigational Site
České Budějovice, 370 87, Czechia
GSK Investigational Site
Olomouc, 779 00, Czechia
GSK Investigational Site
Prague, 10000, Czechia
GSK Investigational Site
Prague, 128 08, Czechia
GSK Investigational Site
Prague, 15030, Czechia
GSK Investigational Site
Prague, 158 00, Czechia
GSK Investigational Site
Quito, Ecuador
GSK Investigational Site
Cēsis, LV4100, Latvia
GSK Investigational Site
Daugavpils, LV5417, Latvia
GSK Investigational Site
Riga, LV 1002, Latvia
GSK Investigational Site
Riga, LV1024, Latvia
GSK Investigational Site
Tukums, LV 3100, Latvia
GSK Investigational Site
Tijuana, Baja California Norte, 22320, Mexico
GSK Investigational Site
Durango, Durango, 3400, Mexico
GSK Investigational Site
Pachuca, Hidalgo, 42039, Mexico
GSK Investigational Site
Cuernavaca, Morelos, 62420, Mexico
GSK Investigational Site
Monterrey, Nuevo León, 64570, Mexico
GSK Investigational Site
Mexico City, 11650, Mexico
GSK Investigational Site
Auckland, 1309, New Zealand
GSK Investigational Site
Auckland, 1311, New Zealand
GSK Investigational Site
Christchurch, 8001, New Zealand
GSK Investigational Site
Rotorua, 3201, New Zealand
GSK Investigational Site
Tauranga, 3001, New Zealand
GSK Investigational Site
Lima, Lima Province, Lima 14, Peru
GSK Investigational Site
Lima, Lima Province, Lima 27, Peru
GSK Investigational Site
San Isidro, Lima region, Lima 27, Peru
GSK Investigational Site
Lima, Lima 1, Peru
GSK Investigational Site
Moscow, 117 036, Russia
GSK Investigational Site
Perm, 614600, Russia
GSK Investigational Site
Samara, 443067, Russia
GSK Investigational Site
Tyumen, 625023, Russia
GSK Investigational Site
Ufa, 450000, Russia
GSK Investigational Site
Yaroslavl, 150062, Russia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
September 1, 2005
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
March 23, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.