EUCTR2009-012597-13-HUActive, not recruitingPhase 1
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study toEvaluate the Safety and Efficacy of Dutogliptin in Patients with Type 2 DiabetesMellitus on Background Treatment with Glimepiride with or without Metformin
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 650
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 according to the ADA (1997) and World Health Organization (1998) criteria at least 3 months before the Screening Visit (Visit 1)
- •- FPG = 126 mg/dL (7.0 mmol/L)
- •- Plasma glucose = 200 mg/dL (11.1 mmol/L) at 2 hours following the ingestion of
- •75 g of anhydrous glucose in an oral glucose tolerance test
- •- Random plasma glucose > 200 mg/dL (11.1 mmol/L) in a person with symptoms
- •of 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). (Note: If the patient is taking
- •< 1500 mg/d of metformin because of intolerance, the reason for intolerance must be
- •documented. If the patient is taking > 6 mg/d of glimepiride, the dosage should be
- •reduced to 6 mg/d at the Screening Visit [Visit 1])
- •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). See Appendix III and Section 9.4.7.1 for the recommended
- •switch algorithm
- •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. (Note: If the patient is taking < 1500 mg/d of metformin
- •because of intolerance, the reason for intolerance must be documented)
- •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. See Appendix III for further details on HbA1c levels and glimepiride dose modification
- •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. See Appendix III and Section 9.5.1.1 for further details
- •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 takin
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 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, diabetic foot ulcers
- •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
- •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 < 90 mm Hg and/or diastolic blood pressure (DBP) = 100 mm Hg or < 50 mm Hg at the Screening Visit (Visit 1). The measurement at the Screening Visit (Visit 1) can be repeated if the initial reading is felt to be inaccurate or unrepresentative of the patient’s usual blood pressure
- •12. Have had gastrointestinal surgery for obesity (including bypass, gastroplasty, and banding procedures) within the year before the Screening Visit (Visit 1) or have plans to have such surgery or procedures for the removal of excess fatty tissue during the course of the study
- •13. Have started a weight-loss regimen within 4 weeks of the Screening Visit (Visit 1)
- •either on one’s own or by participating in a commercial behavior modification/diet
- •program or by taking a medication for weight reduction
- •14. Be currently taking an antipsychotic medication (except prochlorperazine as needed for nausea), have taken systemic glucocorticoids at a dose greater than 5 mg of prednisone or equivalent daily within the 2 weeks before the Screening Visit (Visit 1), or be currently taking products intended to stimulate appetite. See the Study Reference Manual for prednisone equivalence of other glucocorticoids
- •15. Have a history of cancer other than treated basal-cell or squamous-cell carcinoma of the skin
- •16. Have been infected with or have serologic evidence of previous infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus (by history only)
- •17. Have a history of alcohol or substance abuse in the past 2 years or an eating disorder diagnosed in the past 5 years
- •18. Have total bilirubin above the upper limit of normal (ULN) (unless associated with an elevated indirect bilirubin typical of Gilbert syndrome), aspartate aminotransferase
- •(AST) or alanine aminotransferase (ALT) > 2.5 times the ULN, or alkaline phosphatase > 1.5 times the ULN from the Screening Visit (Visit 1) clinical laboratory results
- •19. Have hemoglobin of < 11 g/dL (< 110 g/L) from the Screening Visit (Visit 1) clinical
- •laboratory results
- •20. Have ser
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