Type 2 diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Product Name: SYR-322 (SYR110322)
Product Code: SYR-322_301
Pharmaceutical Form: Tablet
Current Sponsor code: SYR-322_301
Other descriptive name: SYR-322 (SYR110322)
Concentration unit: mg milligram
Sponsors
Takeda Global Research & Development Centre (Europe) Ltd.,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject eligibility is determined according to the following criteria: 1. The subject is male or female, with a historical diagnosis of type 2 diabetes, and must be aged 18 to 70 years, inclusive. 2. A female subject of childbearing potential who is sexually active agrees to use adequate contraception from screening throughout the duration of the study. Women NOT of child bearing potential are defined as those who have been surgically sterilized (hysterectomy, oophorectomy, tubal ligation) or who are post-menopausal (defined as at least 2 years since last regular menses). Acceptable methods of contraception are defined in Section 9.1.11 Contraception and Pregnancy Avoidance Procedure. 3. The subject is capable of understanding and complying with the protocol requirements. 4. The subject has either failed treatment with diet and exercise for 3 months prior to Screening or has been receiving a stable dose of metformin, sulfonylurea, nataglinide, or repaglinide for more than 3 months prior to Screening. 5. The subject has inadequate glycemic control as defined by A1C concentration between 6.5 and 9.0%, inclusive. 6. The subject has a fasting plasma glucose 23 kg/m2 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any subject who meets any of the following criteria will not qualify for entry into the study: 1. The subject has a history of type 1 diabetes. 2. The subject has a history of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within the past 2 years. 3. The subject has a diastolic blood pressure greater than 100 mm Hg or a systolic blood pressure of greater than 160 mm Hg. 4. The subject has a previous history of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study medication. (This criterion does not include those subjects with basal cell or Stage 1 squamous cell carcinoma of the skin.) 5. The subject has a hemoglobin 133 µmol/L. 8. The subject has a fasting total cholesterol >6.5 mmol/L. 9. The subject has New York Heart Association heart failure of any Class (I-IV) regardless of therapy. 10. The subject has a history of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months prior to Screening. 11. The subject has a history of acute metabolic diabetic complications. 12. The subject has a history of any hemoglobinopathy that may affect determination of A1C. 13. The subject has a history of infection with human immunodeficiency virus. 14. The subject has a history of diabetic gastro paresis. 15. The subject has a history of gastric bypass surgery. 16. The subject is unwilling or unable to comply with the protocol or scheduled appointments. 17. The subject has a history of hypersensitivity or allergies to SYR-322, pioglitazone or any related compounds. 18. The subject is pregnant, intends to become pregnant during the course of the study, or is lactating. 19. The subject is currently participating in another investigational study or has participated in an investigational study within the past 30 days. 20. The subject has any other serious disease or condition at Screening or at randomization that might affect life expectancy or make it difficult to successfully manage and follow the subject according to the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effects of SYR-322 alone and SYR-322 coadministered with pioglitazone HC1 versus placebo on postprandial triglycerides in subjects with type 2 diabetes. ;Secondary Objective: To evaluate the effect of SYR-322 and SYR-322 coadministered with pioglitazone HC1 versus placebo on postprandial lipid parameters, postprandial lipoprotein parameters, postprandial GLP-1, postprandial glucagon, postprandial glucose, postprandial insulin, measurements of glycemic control (ie, A1C, fasting plasma glucose, C-peptide, insulin, proinsulin), inflammatory markers (ie, adiponectin and high-sensitivity C-reactive protein), cardiovascular markers (ie, VCAM, ICAM, and e-selectin), and endothelial function (pulse wave tonometry). Safety variables will include incidence of treatment emergent adverse events (AEs), clinical laboratory evaluations, physical examinations, vital signs, and 12-lead ECG readings. In addition markers of oxidative stress and short term glycaemic control will be evaluated as exploratory variables.;Primary end point(s): The primary endpoint is the change from Baseline in postprandial incremental area under the curve (AUC) for triglycerides at Week 16. | — |
Countries
Netherlands, Sweden
Outcome results
None listed