Clinical Trial Details
| Trial ID: | L3680 |
| Source ID: | NCT00495469 |
| Associated Drug: | Gsk189075 |
| Title: | Dose-Ranging Study In Subjects With Type 2 Diabetes Mellitus Who Are Treatment-Naive |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00495469/results |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: GSK189075|DRUG: Placebo |
| Outcome Measures: | Primary: Mean Change From Baseline in Hemoglobin A1c (Glycosylated Hemoglobin) (HbA1c) at Week 12, The blood samples were collected at Baseline, Week 4, Week 8 and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the Intent-to-Treat (ITT) Population with Last observation carried forward (LOCF). Adjusted mean is presented as least square (LS) mean., Baseline (Week 0) and at Week 12 | Secondary: Mean Change From Baseline in HbA1c at Weeks 4 and 8, The blood samples were collected at Baseline, Week 4, Week 8 and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 4 and 8 minus Baseline value. The primary analysis was performed on the ITT Population with LOCF., Baseline (Week 0) and at Week 4 nad 8|Mean Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG), The samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and Week 14 (follow up). Participants were asked to be on fast for at least 8 hours prior to each study visits and collection of lab samples. Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the ITT Population with LOCF. Adjusted mean is presented as LS mean., Baseline (Week 0) and at Week 12|Mean Change From Baseline to Week 12 in Fructosamine (Corrected), The blood samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and Week 14 (follow up). Participants were asked to be on fast for at least 8 hours prior to each study visits and collection of lab samples. Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the ITT Population with LOCF. Adjusted mean is presented as LS mean., Baseline (Week 0) and at Week 12|Number of Participants Who Were HbA1c Responders at Week 12, Differences between treatment groups in the proportion of participants who achieved HbA1c targets of \<=6.5% and \<7% at Week 12 in the ITT population with LOCF were assessed based on a logistic regression model with terms included for treatment and Baseline HbA1c. Differences between treatment groups in the proportion of participants who achieved a clinically meaningful decreases from Baseline in HbA1c (\>=0.7%) at Week 12 were assessed in the same manner., Week 12|Number of Participants Who Were Fasting Plasma Glucose (FPG) Responders at Week 12, Differences between treatment groups in the proportion of participants who achieved FPG targets of \<7.0 millimoles per liter (mmol/L) (126 milligrams per deciliter \[mg/dL\]) and \<7.8 mmol/L (140 mg/dL) at Week 12 in the ITT population with LOCF were assessed based on a logistic regression model with terms included for treatment and Baseline FPG. The proportion of participants who achieved the target of \<5.5 mmol/L (100 mg/dL) at Week 12 within each treatment group were summarized only. Differences between treatment groups in the proportion of participants who achieved a clinically meaningful decreases from Baseline in FPG (1.7 mmol/L \[\>=30 mg/dL\]) at Week 12 were assessed in the same manner., Week 12|Mean Change From Baseline to Week 12 in Triglycerides, Samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean., Baseline (Week 0) and at Week 12|Mean Change From Baseline to Week 12 in Total Cholesterol, Samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean., Baseline (Week 0) and at Week 12|Mean Change From Baseline to Week 12 in Low Density Lipoprotein Cholesterol (LDL-c), Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean., Baseline (Week 0) and Week 12|Mean Change From Baseline to Week 12 in High Density Lipoprotein Cholesterol (HDL-c), Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean., Baseline (Week 0) and Week 12|Mean Change From Baseline to Week 12 in LDL-c/HDL-c Ratio, Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean., Baseline (Week 0) and Week 12|Mean Change From Baseline to Week 12 in Total Cholesterol/HDL-c Ratio, Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean., Baseline (Week 0) and Week 12|Mean Change From Baseline to Week 12 in Body Weight, Body weight measurement was taken at Baseline, Week 2, Week 4, Week 8, Week 12 and at Week 14 (follow up). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean., Baseline (Week 0) and Week 12|Number of Participants With Any On-therapy Adverse Events (AEs) and Serious Adverse Events (SAEs), AE was defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment., Up to Week 12|Number of Participants With On-therapy Hypoglycemia, Participants were provided with a Daily Glucose Monitoring Log to record glucose meter readings and to record symptoms of hypoglycemia. A separate electronic case report form (eCRF) page was provided to capture events of hypoglycemia., Up to Week 12|Number of Participants With Vital Signs of Potential Clinical Importance (PCI) at Any Time on Therapy, Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) were measured pre-dose in duplicate, after the participant has been lying quietly for 5 minutes, and then in duplicate 3 minutes after standing up. Participants were asked to refrain from smoking for at least 30 minutes prior to vital sign measurements., Up to Week 12|Number of Participants With Abnormal Electrocardiogram (ECG) Findings at Any Time Post-Baseline, Full 12-lead ECGs were recorded at Randomization (Week 0), Week 4, and Week 12 or early withdrawal. If the QTc was \>500 milliseconds on the locally read ECG recording, an additional 2 ECG recordings at 10 minute intervals were made at that visit. If the average QTc for the 3 recordings was \>500 milliseconds, the participant was withdrawn from the study., Up to Week 12|Number of Participants With Abnormal Chemistry Value of PCI at Any Time on Therapy, Chemistry parameters: Albumin, Alkaline phosphatase, Alanine animotransferase, Aspartate aminotransferase, Total billirubin, Calcium, Carbon dioxide/Bicarbonate, Glucose, Potassium, Sodium, Phosphorus and Total protein were assessed for abnormal PCI values. Participants were instructed to fast for at least 8 hours prior to all study visits for the collection of laboratory samples. Samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and at Week 14 (follow up)., Up to Week 12|Number of Participants With Abnormal Hematology Value of PCI at Any Time on Therapy, Hematology parameters: Hemoglobin, Hematocrit, Platelet count and White blood cells were assessed for abnormal PCI values. Participants were instructed to fast for at least 8 hours prior to all study visits for the collection of laboratory samples. Samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and at Week 14 (follow up)., Up to Week 12 |
| Sponsor/Collaborators: | Sponsor: GlaxoSmithKline |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 250 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2007-08-17 |
| Completion Date: | 2008-06-05 |
| Results First Posted: | 2017-10-30 |
| Last Update Posted: | 2017-10-30 |
| Locations: | GSK Investigational Site, Mesa, Arizona, 85206, United States|GSK Investigational Site, Artesia, California, 90701, United States|GSK Investigational Site, Buena Park, California, 90620, United States|GSK Investigational Site, Fresno, California, 93720, United States|GSK Investigational Site, Greenbrae, California, 94904, United States|GSK Investigational Site, La Jolla, California, 92037, United States|GSK Investigational Site, Norwalk, California, 90650, United States|GSK Investigational Site, Petaluma, California, 94954, United States|GSK Investigational Site, Sacramento, California, 95823, United States|GSK Investigational Site, San Mateo, California, 94401, United States|GSK Investigational Site, Santa Ana, California, 92701, United States|GSK Investigational Site, Tarzana, California, 91356, United States|GSK Investigational Site, Torrance, California, 90505, United States|GSK Investigational Site, Deland/Florida, Florida, 32720, United States|GSK Investigational Site, Hollywood, Florida, 33023, United States|GSK Investigational Site, Jacksonville/Florida, Florida, 32223, United States|GSK Investigational Site, Miami, Florida, 33156, United States|GSK Investigational Site, Miami, Florida, 33169, United States|GSK Investigational Site, Ocoee/Florida, Florida, 34761, United States|GSK Investigational Site, Saint Cloud, Florida, 34769, United States|GSK Investigational Site, Atlanta, Georgia, 30322, United States|GSK Investigational Site, Atlanta, Georgia, 30342, United States|GSK Investigational Site, Bloomingdale, Illinois, 60108, United States|GSK Investigational Site, Chicago, Illinois, 60616, United States|GSK Investigational Site, Oak Brook, Illinois, 60523, United States|GSK Investigational Site, South Bend, Indiana, 46614, United States|GSK Investigational Site, Lafayette, Louisiana, 70503, United States|GSK Investigational Site, Lake Charles, Louisiana, 70601, United States|GSK Investigational Site, Oxon Hill, Maryland, 20745, United States|GSK Investigational Site, Boston, Massachusetts, 02118, United States|GSK Investigational Site, Gulfport, Mississippi, 39501, United States|GSK Investigational Site, Jackson, Mississippi, 39202, United States|GSK Investigational Site, Kosciusko, Mississippi, 39090, United States|GSK Investigational Site, Rolling Fork, Mississippi, 39159, United States|GSK Investigational Site, Chesterfield, Missouri, 63017, United States|GSK Investigational Site, St. Louis/Missouri, Missouri, 63118, United States|GSK Investigational Site, Henderson, Nevada, 89014, United States|GSK Investigational Site, Las Vegas, Nevada, 89016, 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, Clifton, New Jersey, 7011, United States|GSK Investigational Site, Albuquerque, New Mexico, 87102, United States|GSK Investigational Site, Commack, New York, 11725, United States|GSK Investigational Site, Ithaca, New York, 14850, United States|GSK Investigational Site, New York, New York, 10032, United States|GSK Investigational Site, Asheboro/North Carolina, North Carolina, 27203, United States|GSK Investigational Site, Canal Fulton, Ohio, 44614, United States|GSK Investigational Site, Bensalem/Pennsylvania, Pennsylvania, 19020, United States|GSK Investigational Site, West Chester, Pennsylvania, 19382, United States|GSK Investigational Site, Manning, South Carolina, 29102, United States|GSK Investigational Site, Simpsonville, South Carolina, 29681, United States|GSK Investigational Site, Athens/Tennessee, Tennessee, 37303, United States|GSK Investigational Site, Corpus Christi, Texas, 78404, United States|GSK Investigational Site, Dallas, Texas, 75230, United States|GSK Investigational Site, Dallas, Texas, 75235, United States|GSK Investigational Site, Harlingen/Texas, Texas, 78550, United States|GSK Investigational Site, Houston, Texas, 77030, United States|GSK Investigational Site, Houston, Texas, 77074, United States|GSK Investigational Site, Houston, Texas, 77081, United States|GSK Investigational Site, Midland, Texas, 79705, United States|GSK Investigational Site, San Anonio, Texas, 78221, United States|GSK Investigational Site, San Antonio, Texas, 78229, United States|GSK Investigational Site, Burke, Virginia, 22015, United States|GSK Investigational Site, Bellevue, Washington, 98004, United States|GSK Investigational Site, Langley, British Columbia, V3A 4H9, Canada|GSK Investigational Site, Bathurst, New Brunswick, E2A 4X7, Canada|GSK Investigational Site, Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada|GSK Investigational Site, Brampton, Ontario, L6T 3T1, Canada|GSK Investigational Site, Mississauga, Ontario, L5A 3V4, Canada|GSK Investigational Site, Oakville, Ontario, L6H 3P1, Canada|GSK Investigational Site, Ottawa, Ontario, K1K 4K4, Canada|GSK Investigational Site, Thornhill, Ontario, L4J 8L7, Canada|GSK Investigational Site, Toronto, Ontario, M3H 5S4, Canada|GSK Investigational Site, Toronto, Ontario, M4R 2G4, Canada|GSK Investigational Site, L'ancienne-Lorette, Quebec, G2E 2X1, Canada|GSK Investigational Site, Québec, G1V 4G5, Canada|GSK Investigational Site, Brno, 624 00, Czechia|GSK Investigational Site, Brno, 636 00, Czechia|GSK Investigational Site, Praha 10, 100 00, Czechia|GSK Investigational Site, Praha 5, 158 00, Czechia|GSK Investigational Site, Parnu, 80018, Estonia|GSK Investigational Site, Tallinn, 13415, Estonia|GSK Investigational Site, Tallin, 13419, Estonia|GSK Investigational Site, Tartu, 51014, Estonia|GSK Investigational Site, Allmendingen, Baden-Wuerttemberg, 89604, Germany|GSK Investigational Site, Wangen, Baden-Wuerttemberg, 88239, Germany|GSK Investigational Site, Grossheirath, Bayern, 96269, Germany|GSK Investigational Site, Hohenau, Bayern, 94545, Germany|GSK Investigational Site, Kuenzing, Bayern, 94550, Germany|GSK Investigational Site, Muenchen, Bayern, 80339, Germany|GSK Investigational Site, Muenchen, Bayern, 80469, Germany|GSK Investigational Site, Parsberg, Bayern, 92331, Germany|GSK Investigational Site, Ruhmannsfelden, Bayern, 94239, Germany|GSK Investigational Site, Sulzbach-Rosenberg, Bayern, 92237, Germany|GSK Investigational Site, Falkensee, Brandenburg, 14612, Germany|GSK Investigational Site, Brinkum/Stuhr, Niedersachsen, 28816, Germany|GSK Investigational Site, Einbeck, Niedersachsen, 37574, Germany|GSK Investigational Site, Hannover, Niedersachsen, 30159, Germany|GSK Investigational Site, Lueneburg, Niedersachsen, 21339, Germany|GSK Investigational Site, Tostedt, Niedersachsen, 21255, Germany|GSK Investigational Site, Hassloch, Rheinland-Pfalz, 67454, Germany|GSK Investigational Site, Ingelheim, Rheinland-Pfalz, 55218, Germany|GSK Investigational Site, Wolmirstedt, Sachsen-Anhalt, 39326, Germany|GSK Investigational Site, Dresden, Sachsen, 01129, Germany|GSK Investigational Site, Freital, Sachsen, 01705, Germany|GSK Investigational Site, Schmiedeberg, Sachsen, 01762, Germany|GSK Investigational Site, Luebeck, Schleswig-Holstein, 23568, Germany|GSK Investigational Site, Berlin, 10115, Germany|GSK Investigational Site, Berlin, 10249, Germany|GSK Investigational Site, Berlin, 12524, Germany|GSK Investigational Site, Berlin, 13347, Germany|GSK Investigational Site, Athens, 115 27, Greece|GSK Investigational Site, Athens, 11528, Greece|GSK Investigational Site, Thessaloniki,, 56429, Greece|GSK Investigational Site, Thessaloniki, 564 29, Greece|GSK Investigational Site, Bangalore, 560034, India|GSK Investigational Site, Bangalore, 560043, India|GSK Investigational Site, Chennai, 600010, India|GSK Investigational Site, Mumbai, 400007, India|GSK Investigational Site, Pune, 411004, India|GSK Investigational Site, Kaunas, LT-48259, Lithuania|GSK Investigational Site, Kaunas, LT-50009, Lithuania|GSK Investigational Site, Kaunas, LT-51270, Lithuania|GSK Investigational Site, Vilnius, LT-08661, Lithuania|GSK Investigational Site, Guadalajara, Jalisco, 44150, Mexico|GSK Investigational Site, Cuernavaca, Morelos, 62250, Mexico|GSK Investigational Site, Mérida, Yucatán, 97129, Mexico|GSK Investigational Site, Durango, 34070, Mexico|GSK Investigational Site, Rotorua, 3201, New Zealand|GSK Investigational Site, Bydgoszcz, 85-021, Poland|GSK Investigational Site, Porabka, 43-353, Poland|GSK Investigational Site, Siemianowice Slaskie, 41-103, Poland|GSK Investigational Site, Wroclaw, 50-349, Poland|GSK Investigational Site, Aibonito/Puerto Rico, 00705, Puerto Rico|GSK Investigational Site, Caguas, 00725, Puerto Rico|GSK Investigational Site, Carolina, 00983, Puerto Rico|GSK Investigational Site, Ponce, 00717, Puerto Rico|GSK Investigational Site, Rio Piedras, 00921, Puerto Rico|GSK Investigational Site, Trujillo Alto/Puerto Rico, 00976, Puerto Rico|GSK Investigational Site, Arad, 310011, Romania|GSK Investigational Site, Brasov, 500365, Romania|GSK Investigational Site, Sfantu Gheorghe, 520064, Romania|GSK Investigational Site, Timisoara, 300736, Romania|GSK Investigational Site, Moscow, 129110, Russian Federation|GSK Investigational Site, Saint-Peterburgh, 197022, Russian Federation|GSK Investigational Site, St.Petersburg, 191025, Russian Federation|GSK Investigational Site, Tomsk, 634 050, Russian Federation|GSK Investigational Site, Tumen, 625023, Russian Federation|GSK Investigational Site, Lenasia South, Gauteng, 01827, South Africa|GSK Investigational Site, Bellville, 7530, South Africa|GSK Investigational Site, Gauteng, 1459, South Africa|GSK Investigational Site, Parow, 7505, South Africa|GSK Investigational Site, Roodepoort, 1709, South Africa|GSK Investigational Site, Dnipropetrovsk, 49027, Ukraine|GSK Investigational Site, Kyiv, 02091, Ukraine|GSK Investigational Site, Vinnitsa, 21010, Ukraine |
| URL: | https://clinicaltrials.gov/show/NCT00495469 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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