None listed
Conditions
Interventions
Group 1 Type of group
Dutogliptin 400mg oral administration once daily on background of glimepiride with or without metformin
Group name:Group 2 Type of group
Placebo, oral administration once daily on background of glimepiride with or without metformin
Sponsors
Forest Research Institute, Inc,
Eligibility
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: • Able to understand and grant informed written consent before performing any study procedure. • Outpatients of both sexes from 18 to 85 years of age, inclusive, in the Selection Visit (Visit 1). • Diagnosis of T2DM according to the criteria of the ADA (1997) and the World Health Organization (1998) at least 3 months before the Selection Visit (Visit 1). • Present a body mass index of 20 to 48 kg / m2 at the Selection Visit (Visit 1). • Have received a stable dose of glimepiride of 4 to 6 mg / d alone or in combination with a stable dose of metformin> 1500 mg / d (or maximum tolerated dose) for at least 6 weeks before the Selection Visit (Visit 1 ). (Note; if the patient is taking 6 mg / d of glimepiride, the dose should be reduced to 6 mg / d in the Selection Visit ([Visit 1]) • Have received a stable dose of glimepiride of 4 to 6 mg / d alone or in combination with a stable dose of metformin> 1500 mg / d (or the maximum tolerated dose) for at least 2 weeks at the time of Visit 2. (Note: if the patient is taking 7% and 7% to 7% and 0.26 nmol / L (> 0.8 ng / mL;> 260 pmol / L) on the Selection Visit (Visit 1). • Have a stable weight, without an increase or decrease of more than 7% in the last months before the Selection Visit (Visit 1) (according to your background). • If they take medication, in addition to an antidiabetic medication, which could affect blood glucose, they must have been receiving a stable dose for at least 4 weeks before the Selection Visit (Visit 1). • Be willing, on the Selection Visit (Visit 1) and throughout the study, to discontinue all herbal medications taken for the treatment of diabetes. • Have a thyroid stimulating hormone level since the Selection Visit (Visit 1) that is within normal limits. If the patient receives thyroid hormones, the dose should be stable for at least 6 weeks before the Selection Visit (Visit 1). • If you take medication for hypertension (including diuretics), you must have taken a stable dose for at least 4 weeks before the Selection Visit (Visit • If you are a woman, you should not be pregnant, or planning to become pregnant during the study, or breastfeeding. Potentially fertile women must have a negative serum p-hCG test at the Selection Visit (Visit 1). • Potentially fertile patients should be willing to use an appropriate contraceptive method; Do not get pregnant (or th
Exclusion criteria
Exclusion criteria: • Be currently taking more than two hypoglycemic agents (OHA). • Having been treated with insulin or with a GLP-1 analog, on an outpatient basis, within 6 weeks of the Selection Visit (Visit 1). • Having type 1 diabetes mellitus, juvenile onset diabetes at maturity, T2DM that requires insulin, other rare or unusual fornias of diabetes mellitus, or a history of diabetic ketoacidosis. • Having high blood glucose due to medical treatment or a concurrent medical condition other than T2DM (eg, hyperadrenocorticalism due to Cusliing Syndrome [or Cushing´s disease], pheochromocytoma, acromegaly, hyperthyroidism, another endocrine disorder that raises blood glucose). • Present skin lesions fco / wo dyschromia, inflammation, atrophy, ulceration), edematous states, diabetic foot ulcers. • Have a history of epilepsy, excluding childhood febrile seizures. • Have a history of a hypoglycemic episode that required glucose, glucagon, orange juice, etc., provided by another person during the 6 months prior to the Selection Visit (Visit 1). • Have a history of hyperglycemic syndrome, hyperosmolar, or non-ketosic syndrome during the 6 months prior to the Selection Visit (Visit 1). • Having had a stroke, myocardial infarction, symptomatic coronary artery disease, angina or arrhythmia within 4 weeks prior to the Selection Visit (Visit 1) or a history of congestive heart failure class III or class IV (according to the system of functional classification of the New York Heart Association). • Have a history of or risk factors for acute pancreatitis (such as alcoholism, small and multiple gallstones, hypertriglyceridemia) or exacerbation of chronic pancreatitis. • Have a systolic blood pressure (SBP)> 160 mmHg or 100 mmHg or <50 mmHg on the Selection Visit (Visit 1). The measurement can be repeated at the Selection Visit (Visit 1) if there is a suspicion that the initial reading is not accurate or is not representative of the patient´s usual blood pressure. • Have undergone obesity gastrointestinal surgery (including bypass, gastroplasty and cerclage procedures) within the year prior to the Selection Visit (Visit 1) or have plans to have surgery or a procedure for the removal of adipose tissue (eg .. liposuction or breast reduction) during the course of the study. • Have started a weight loss regimen within 4 weeks of the Selection Visit (Visit 1), both on their own account and by participation in a commercial diet / habits change program (eg, Jermy Craig, Weight Watchers ) or by taking medication to lose weight (eg, phentermine, sibutramine, Xenical / AUi [orlistat]). • Be currently taking an antipsychotic medication (except prochlorperazine on demand for nausea), having taken systemic glucocorticoids at a dose greater than 5 mg daily of prednisone or equivalent within 2 weeks prior to the Selection Visit (Visit 1), or be currently taking products to stimulate appetite (eg, megestrol acetate [Megace]). See the Study Reference Manual for the equivalence of prednisone or other glucocorticoids. • History of cancer other than squamous cell carcinoma or treated basal cell. (Note: the inclusion of patients with a history of cancer is allowed as long as it is in complete remission for at least 5 years before the Selection Visit [Visit 1]. A complete remission is defined as the disappearance of all cancer signs in response to treatment). • Having been inf
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of serum hemoglobin A1c values by laboratory tests during the study. Measure:Changes in Hemoglobin A1c values 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), Visit 8 (Week 26). | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of serum Fasting Plasma Glucose values by laboratory tests during the study. Measure:Changes in fasting plasma glucose values 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), Visit 8 (Week 26). | — |
Countries
Belarus, Colombia, Hungaria, India, Lithuania, Peru, Romania, United States
Contacts
Public ContactYngrid Saldarriaga
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed