None listed
Conditions
Interventions
Group 1 Type of group
32 mg of TAK-559 daily for a period of up to 26 weeks
Group name:Group 2 Type of group
Daily placebo dose for a period of up to 26 weeks
Sponsors
TAKEDA PHARMACEUTICALS,
Eligibility
Inclusion criteria
Inclusion criteria: Patients diagnosed with diabetes mellitus type 2, from 25 to 75 years of age, inclusive. The patient must have a self-monitoring level (SMBG) of stable or worsening blood glucose and a controlled diet and exercise level. The patient must have a glycosylated hemoglobin level (HbAlc) greater than or equal to 8.0% and less than or equal to 10.0% and a fasting plasma glucose level (FPG) greater than or equal to 126 mg / dL ( 7.0 mmoi / 1) in Selection B. In addition to type 2 diabetes mellitus, patients must be in good health according to the doctor´s criteria, be willing to sign the informed consent form and meet all criteria of inclusion specified in the protocol before being included in the study.
Exclusion criteria
Exclusion criteria: Patients who are hypersensitive to TAK-559 or related compounds, who have clinically significant abnormal results on physical examinations (PE), electrocardiograms (ECG), clinical evaluations of the laboratory or who have received any of the following, will be excluded from the study. medications not allowed as detailed in the protocol. Patients must not comply with any other exclusion criteria specified in the protocol before being incorporated into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:HbA1c level after 26 weeks of treatment Measure:Change in HbA1c level after 26 weeks of treatment Timepoints:26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:level of HbA1c, FPG, Insulin in serum, Peptide C Measure:Change in the level of HbA1c, FPG, Insulin in serum, Peptide C Timepoints:26 weeks ; Outcome name:Lipid levels (triglycerides, total cholesterol, high density lipoproteins [HDL], low density lipoproteins [LDL], very low density lipoproteins [VLDL], apolipoproteins [AIyv B100]). Measure:Change in lipid levels (triglycerides, total cholesterol, high density lipoproteins [HDL], low density lipoproteins [LDL], very low density lipoproteins [VLDL], apolipoproteins [AIyv B100]). Timepoints:After treatment ; Outcome name:Levels of thrombosis markers (plasminogen activator inhibitor 1 [lAP-1], fibrinogens). Measure:Change in levels of thrombosis markers (plasminogen activator inhibitor 1 [lAP-1], fibrinogens). Timepoints:During treatment ; Outcome name:Levels of inflammation markers (interleukin-6 [IL-6], C-reactive protein [CRP]). Measure:Change in the levels of inflammation markers (interleukin-6 [IL-6], C-reactive protein [CRP]). Timepoints:During treatment ; Outcome name:albumin / creatinine ratio in urine Measure:Change in albumin / creatinine ratio in urine Timepoints:During treatment | — |
Outcome results
None listed