A Study Of BRL49653C For The Treatment Of Type 2 Diabetes
Trial overview
Number of participants with adverse events (AE) and serious adverse events (SAE)
Timeframe: Up to 52 weeks
Change from Baseline in White blood cell (WBC) count at Week 12 and Week 52
Timeframe: Baseline (Week 0) and Week 12 and Week 52
Change from Baseline in Red blood cell (RBC) count and platelets at Week 12 and Week 52
Timeframe: Baseline (Week 0) and Week 12 and Week 52
Change from Baseline in hemoglobin at Week 12 and Week 52
Timeframe: Baseline (Week 0) and Week 12 and Week 52
Change from Baseline in Mean corpuscular volume (MCV) at Week 12 and Week 52
Timeframe: Baseline (Week 0) and Week 12 and Week 52
Change from Baseline in mean corpuscular hemoglobin (MCH) at Week 12 and Week 52
Timeframe: Baseline (Week 0) and Week 12 and Week 52
Change from Baseline in hematocrit, mean corpuscular hemoglobin concentration (MCHC), eosinophils, basophils, neutrophils, lymphocytes and monocytes
Timeframe: Baseline (Week 0) and Week 12 and Week 52
Change from Baseline in alanine amino transferase-glutamic-pyruvic transaminase (ALT [GPT)], aspartate aminotransferase-glutamic oxaloacetic transaminase (AST [GOT]), lactate dehydrogenase (LDH) and alkaline phosphatase test (Al-P) at Week 12 and Week 52
Timeframe: Baseline (Week 0) and Week 12 and Week 52
Change from Baseline in gamma glutamyl transpeptidase (Gamma-GTP) and creatine phosphokinase at Week 12 and Week 52
Timeframe: Baseline (Week 0) and Week 12 and Week 52
Change from Baseline in blood urea nitrogen (BUN), creatinine, uric acid, total bilirubin, direct bilirubin, calcium, total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol and triglycerides
Timeframe: Baseline (Week 0) and Week 12 and Week 52
Change from Baseline in Total protein and albumin at Week 12 and Week 52
Timeframe: Baseline (Week 0) and Week 12 and Week 52
Change from Baseline in sodium, chloride and potassium at Week 12 and Week 52
Timeframe: Baseline (Week 0) and Week 12 and Week 52
Change from Baseline in brain natriuretic peptide at Week 12 and Week 52
Timeframe: Baseline (Week 0) and Week 12 and Week 52
Change from Baseline in LDL particle size
Timeframe: Baseline (Week 0) and Week 12 and Week 52
Change from Baseline in LDH isozyme-LDH1, LDH isozyme-LDH2, LDH isozyme-LDH3, LDH isozyme-LDH4, LDH isozyme-LDH5, CK isozyme-MB, CK isozyme-MM and CK isozyme-BB at Week 12 and Week 52
Timeframe: Baseline (Week 0) and Week 12 and Week 52
Number of participants with abnormalities in urine protein, occult blood and ketone bodies
Timeframe: Up to Week 52
Change from Baseline in vital signs- chest X-ray (cardiothoracic ratio [CTR])
Timeframe: Baseline (Week 0) and Week 12 and Week 52
Change from Baseline in vital signs- Body weight
Timeframe: Baseline (Week 0) and Week 12 and Week 52
Change from Baseline in vital signs- systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Timeframe: Baseline (Week 0) and Week 12 and Week 52
Change from Baseline in vital signs- pulse rate
Timeframe: Baseline (Week 0) and Week 12 and Week 52
Number of participants with abnormal electrocardiogram (ECG) findings
Timeframe: Up to Week 52
Change from Baseline in hemoglobin A1c (HbA1c) and HbA1c profile
Timeframe: Baseline (Week 0) and Week 12 and Week 52
Change from Baseline in fasting plasma glucose (FPG)
Timeframe: Baseline (Week 0) and Week 12 and Week 52
Change from Baseline in insulin
Timeframe: Baseline (Week 0) to Week 52
Change from Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Timeframe: Baseline (Week 0) to Week 52
Change from Baseline in Homeostasis Model Assessment of β-cell Function (HOMA-β)
Timeframe: Baseline (Week 0) to Week 52
Participation criteria
- Patients with type 2 diabetes mellitus managed by diet therapy or one antidiabetic agent (sulfonylurea or alpha glucosidase inhibitor) will be candidates for this study. These candidates will be checked up on their clinical laboratory data, and must have adequate blood, liver and kidney function.
- Patient with serious cardiovascular disease or serious hepatic disease will not be eligible.
- Patients with type 2 diabetes mellitus managed by diet therapy or one antidiabetic agent (sulfonylurea or alpha glucosidase inhibitor) will be candidates for this study. These candidates will be checked up on their clinical laboratory data, and must have adequate blood, liver and kidney function.
- Patient with serious cardiovascular disease or serious hepatic disease will not be eligible.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.