None listed
Conditions
Interventions
Group 1 Type of group
dutogliptin, oral tablet administered once daily on background of pioglitazone
Group name:Group 2 Type of group
placebo, oral tablet administered once daily on background of pioglitazone
Sponsors
Forest Research Institute, Inc,
Eligibility
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: • Be able to understand and provide written informed consent before participating in any study-related procedures • Be male or female outpatients 18 to 85 years of age, inclusive • Be willing to return for all clinic visits and complete all study-related procedures, including self-monitoring of blood glucose • Have a body mass index of 20 to 48 kg/m2 • Have stable weight, with no more than a 7% gain or loss in the previous 3 months • Be diagnosed with T2DM at least 3 months before the Screening Visit (Visit 1). Verification of diagnosis should be made by obtaining documentation or written confirmation from the physician treating the patient’s diabetes • If taking a medication(s) for hypertension (including a diuretic), be taking a stable dose for at least 4 weeks before study start • If taking a medication(s) other than an antidiabetic that might affect blood glucose level, be taking a stable dose for at least 4 weeks before study start • Have a thyroid-stimulating hormone level on laboratory testing at screening that is within the reference range provided by the central laboratory. If the patient is taking thyroid hormone, the dose must have been stable for at least 6 weeks before study start • Be willing to discontinue, for the duration of the study, all herbal medication taken for the treatment of diabetes • Have a fasting serum C-peptide > 0.26 nmol/L (> 0.8 ng/mL; > 260 pmol/L) on laboratory testing at screening • Female patients must not be pregnant, not planning to become pregnant during the course of the study, and not lactating. Women of childbearing potential must have a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test on laboratory testing at screening • If of childbearing potential (or having partner[s] of childbearing potential), must be willing to use an adequate method of contraception and not become pregnant (or have partner[s] become pregnant) for the duration of the study. Adequate contraceptive methods include, but are not limited to, oral contraceptives (stable use for 2 or more cycles before screening); intrauterine devices; Depo-Provera; Norplant System implants; bilateral tubal ligation; vasectomy; condom or diaphragm plus either contraceptive sponge, foam, or jelly; and abstinence • Have an HbA1c level = 7.0% and = 10.0% • Be drug-treatment naïve, or treated with a stable dose of pioglitazone or rosiglitazone, or treated with a stable dose of any other oral hypoglycemic agent (OHA) as monotherapy at the time of the Screening Visit (Visit 1): - Drug-treatment naïve means never having received an OHA or parenteral medication (insulin or GLP-1 analogue) or, if having received an OHA or parenteral medication, been off said OHA or parenteral medication for a minimum of 6 weeks (12 weeks for pioglitazone or rosiglitazone) before Visit 1 - Stable dose of pioglitazone or rosiglitazone means a minimum of 12 weeks - Stable dose of any other OHA as monotherapy means a minimum of 6 weeks • Be willing to refrain from donating blood during the study and for up to 1 month after completing the study Between Visits 1 and 2: • Patients who switch to pioglitazone or whose dosage of pioglitazone is increased during the screening period must have an FPG level = 270 mg/dL (15 mmol/L) before Visit 2
Exclusion criteria
Exclusion criteria: • Currently taking more than one OHA • Have been treated as an outpatient with insulin, a GLP-1 analogue, or a DPP4 inhibitor within 6 weeks of the Screening Visit (Visit 1) • Have type 1 diabetes mellitus, maturity-onset diabetes of the young, insulin-requiring T2DM, other unusual or rare forms of diabetes mellitus, or history of diabetic ketoacidosis • Have elevated blood glucose levels owing to medical treatment or to a concurrent medical condition other than T2DM • Have skin lesions (eg, discoloration, swelling, atrophy, ulceration), edema states, or diabetic foot ulcers considered medically important by the Investigator • Have a history of epilepsy, not including childhood febrile seizures • Have a history of hypoglycemic episode requiring glucose, glucagon, orange juice, etc administered by a second person during the 6 months before the Screening Visit (Visit 1) • Have a history of hyperosmolar, hyperglycemic, or nonketotic syndrome during the 6 months before the Screening Visit (Visit 1) • Have had a stroke, myocardial infarction, symptomatic coronary artery disease, angina, or arrhythmia within 4 weeks before the Screening Visit (Visit 1) or a history of class III or class IV congestive heart failure (according to the New York Heart Association functional classification system) • Have a history of or risk factors for acute pancreatitis or exacerbation of chronic pancreatitis • Have a systolic blood pressure (SBP) = 160 mm Hg or 5 mg of prednisone or equivalent daily within the 2 weeks before the Screening Visit (Visit 1), or currently taking products intended to stimulate appetite. (See the Study Reference Manual for prednisone equivalence of other glucocorticoids) • Have a history of cancer other than treated basal-cell or squamous-cell carcinoma of the skin. (Note: Patients with a history of cancer are allowed to participate provided that the malignancy has been in complete remission for at least 5 years before the Screening Visit [Visit 1]. Complete remission is defined as the disappearance of all signs of cancer in response to treatment) • Have been infected with or have serologic evidence of previous infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus (as determined by the central laboratory) • Have a history of alcohol or substance abuse in the prior 2 years or an eating disorder diagnosed in the prior 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Laboratory tests performed during the study Measure:Hemoglobin A1c Level (HbA1c) Timepoints:HbA1c is drawn at Visit 1 (Week -16 to -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Week 8 (Week 26) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Laboratory tests performed during the study Measure:Fasting Plasma Glucose Level (FPG) Timepoints:FPG is drawn at Visit 1 (Week -16 to -4), Visit 2 (Week -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Visit 8 (Week 26) | — |
Countries
Belarus, Germany, India, Lithuania, Peru, Romania, United States
Contacts
Public ContactYngrid Rossana Saldarriaga
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed