Type 2 diabetes mellitus (T2DM) MedDRA version: 12.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Sponsors
Forest Research Institute, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible to participate in the study, patients must meet the following criteria: 1. Be able to understand and provide written informed consent before the conduct of any study-related procedures 2. Be male or female outpatients 18 to 85 years of age, inclusive, at the Screening Visit (Visit 1) 3. Be diagnosed with T2DM at least 3 months before the Screening Visit (Visit 1). Verification of T2DM diagnosis should be made by obtaining documentation or written confirmation from the physician treating the patient’s diabetes 4. Have a body mass index of 20 to 48 kg/m2 at the Screening Visit (Visit 1) 5. Have received a stable dosage of glimepiride 4 to 6 mg/d alone or in combination with a stable dosage of metformin = 1500 mg/d (or maximally tolerated dose) for at least 6 weeks before the Screening Visit (Visit 1) OR Be willing to switch to glimepiride if receiving a stable dose that is at least half the maximal labeled dose of another SU alone or in combination with a stable dosage of metformin = 1500 mg/d (or maximally tolerated dose) for at least 6 weeks before the Screening Visit (Visit 1) OR Be willing to switch to glimepiride if receiving a stable dose of any OHA other than an SU as monotherapy at the time of the Screening Visit (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 OR Be drug treatment naive, meaning 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 Screening Visit (Visit 1) 6. Have received a stable dosage of glimepiride 4 to 6 mg/d alone or in combination with a stable dosage of metformin = 1500 mg/d (or maximally tolerated dose) for at least 2 weeks by Visit 2 7. Have an HbA1c value of = 7% and = 10% at the Screening Visit (Visit 1), except for (1) patients who have been taking glimepiride 4 mg/d alone or in combination with metformin and (2) patients who have been taking half the maximal dose of another SU alone or in combination with metformin, in which cases HbA1c can be = 7% to = 10.5%. These patients must be willing to switch to glimepiride and uptitrate the glimepiride dose if necessary 8. Have an HbA1c value of = 7% and = 10% at Visit 4 (value taken at Visit 3) 9. Have an FPG = 270 mg/dL (15 mmol/L) before Visit 2 for patients whose dose of glimepiride is being modified, or who are being switched to glimepiride, during the Screening period 10. Have a fasting plasma C-peptide > 0.26 nmol/L (> 0.8 ng/mL; > 260 pmol/L) at the Screening Visit (Visit 1) 11. Have stable weight, with no more than a 7% gain or loss in the 3 months before the Screening Visit (Visit 1) (by history) 12. If taking a medication(s), other than an antidiabetic, that might affect blood glucose, must have been receiving a stable dose for at least 4 weeks before the Screening Visit (Visit 1) 13. Be willing at the Screening Visit (Visit 1) to discontinue for the duration of the study all herbal medication taken for the treatment of diabetes 14. Have a thyroid-stimulating hormone level from the Screening Visit (Visit 1) that is within normal limits. If the patient is taking thyroid hormone, the dose must have been stable for at least 6 weeks before the Screening Visit (Visit 1) 15. If taking a medication(s) for
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will not be eligible to participate in the study: 1. Currently taking more than two oral hypoglycemic agents (OHA) 2. Have been treated with insulin or a GLP-1 analogue or a DPP4 inhibitor as an outpatient within 6 weeks of the Screening Visit (Visit 1) 3. 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 4. Have elevated blood glucose due to medical treatment or to a concurrent medical condition other than T2DM 5. Have skin lesions, edema states, or diabetic foot ulcers considered medically important by the Investigator 6. Have a history of epilepsy, not including childhood febrile seizures 7. 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) 8. Have a history of hyperosmolar, hyperglycemic, or nonketotic syndrome during the 6 months before Screening Visit (Visit 1) 9. 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 congestive heart failure class III or class IV (according to the New York Heart Association functional classification system) 10. Have a history of or risk factors for acute pancreatitis or exacerbation of chronic pancreatitis 11. Have a systolic blood pressure (SBP) = 160 mm Hg or 2.5 times the ULN, or alkaline phosphatase > 1.5 times the ULN from the Screening Visit (Visit 1) clinical laboratory results 19.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background therapy with glimepiride with or without metformin.;Secondary Objective: There no secondary objectives in the trial.;Primary end point(s): HbA1c | — |
Countries
Hungary, Lithuania
Outcome results
None listed