Type 2 diabetes mellitus (T2DM) MedDRA version: 12.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Sponsors
Forest Research Institute, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able to understand and provide written informed consent before the initiation of any study-related procedures 2. Male or female outpatients aged 40 to 85 years, inclusive 3. Diagnosis of T2DM for at least 3 months 4. Treatment naive or receiving stable treatment for T2DM (see also exclusion criterion #1) ? Treatment naive is defined as no treatment with oral hypoglycemic agents, insulin, or other diabetes medication for a minimum of 4 weeks ? Stable treatment for oral hypoglycemic agents is defined as the same dosage for at least 4 weeks, except for pioglitazone, for which stable dose means the same dose for at least 12 weeks ? Stable treatment for insulin means that the total number of units of insulin (short, intermediate, and long-acting) has not changed by more than 15% in the 4 weeks preceding Visit 1 5. HbA1c value of 6.5% to 10%, inclusive 6. Fasting Plasma Glucose (FPG) value = 270 mg/dL (15 mmol/L) 7. Stable weight, with no more than a 7% weight gain or loss in the last 3 months (by history) 8. Body mass index (BMI) of 20 to 48 kg/m2, inclusive 9. Having (A) a history of previously demonstrated CV disease OR (B) the presence of multiple risk factors for CV disease A. History of previously demonstrated CV disease includes any of the following: 1) Any previous clinical CV events: myocardial infarction, unstable angina pectoris with diagnostic ischemic ST-T wave changes on electrocardiogram (ECG), or stroke but not within 2 months of Visit 1 for these clinical events), OR 2) Positive diagnostic tests: ankle-brachial index 30 µg/mg) on two or more occasions including on the Visit 1 assessment - Current cigarette smoking or having quit within the 3 months before screening Note: If patient
Exclusion criteria
Exclusion criteria: 1. Taken a GLP-1 agonist (eg, exenatide, liraglutide), rosiglitazone, or a DPP-4 inhibitor (eg, Januvia [sitagliptin], Galvus [vildagliptin], Onglyza [saxagliptin], alogliptin) in the past 3 months 2. Type 1 diabetes mellitus, maturity-onset diabetes of the young, or any unusual or rare form of diabetes mellitus 3. Elevated blood glucose resulting from medical treatment or from a concurrent medical condition other than T2DM, eg, hyperadrenocorticalism caused by Cushing syndrome (or Cushing disease), pheochromocytoma, acromegaly, and hyperthyroidism 4. Skin lesions (eg, discoloration, swelling, atrophy, ulceration) or edema states that are considered medically important by the Investigator 5. Current diabetic foot ulcer or a foot ulcer that healed within the month before screening 6. History of epilepsy, not including childhood febrile seizures 7. History of hypoglycemic episode requiring the assistance of a second person to administer glucose, glucagon, orange juice, etc, during the 6 months before screening 8. History of diabetic ketoacidosis ever, or hyperosmolar, hyperglycemic, nonketotic syndrome during the 6 months before screening 9. Congestive heart failure class III or IV (according to the New York Heart Association functional classification system) at screening or during the month before screening 10. History of or risk factors for acute pancreatitis (eg, alcohol abuse, extreme hypertriglyceridemia [> 1000 mg/dL], multiple small gallstones [unless cholecystectomy subsequently performed]), or risk factors for exacerbation of chronic pancreatitis 11. Systolic blood pressure (SBP) = 160 mm Hg or 5 mg of prednisone or equivalent daily within the 2 weeks before screening. See study reference manual for prednisone equivalence of other glucocorticoids 13. History of cancer, other than treated basal cell or squamous cell carcinoma of the skin, unless the malignancy has been in complete remission for at least 3 years. (Complete remission is defined as the disappearance of all signs of cancer in response to treatment) 14. History of infection with or history of serologic evidence of previous infection with human immunodeficiency virus, hepatitis B, or hepatitis C virus 15. History of alcohol or cocaine abuse in the past 2 years or current use of other illicit drugs that, in the judgment of the PI, would negatively affect the patient’s ability to participate in the study 16. Total bilirubin level above the upper limit of normal (ULN), unless associated with an elevated indirect total bilirubin typical of Gilbert syndrome; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × ULN; or alkaline phosphatase > 1.5 × ULN 17. eGFR as assessed by the MDRD study equation < 35 mL/min/1.73 m2 18. Treatment with any IP or participation in any investigational study within 30 days or 5 half-lives of the IP before screening 19. Randomized in a previous investigational study of dutogliptin 20. Employee or relative of an employee of the investigational study center or of anyone associated with the conduct of the study 21. History of hypersensitivity reaction to dutogliptin or other DPP-4 inhibitor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to obtain safety information regarding patients with T2DM who are at high risk for MACEs while they are receiving treatment with dutogliptin or placebo in addition to a background of antidiabetic therapy.;Secondary Objective: -;Primary end point(s): The primary endpoint is the incidence rate of major adverse cardiovascular events occurring while on IMP treatment or during the 30 days following the last dose of IMP. | — |
Countries
Estonia, Latvia, Lithuania
Outcome results
None listed