None listed
Conditions
Interventions
Group 1 Type of group
Subjects will take 2 placebo tablets concomitantly at any time of the day but at approximately the same time every day, with or without food.
Group name:Group 3 Type of group
Subjects will take 2 tablets (400 mg of PHX1149T and one placebo tablet) concomitantly at any time of the day but at approximately the same time every day, with or without food.
Sponsors
PHENOMIX CORPORATION,
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • Subjects with type 2 diabetes mellitus: who do not currently receive an antidiabetic medication regimen (who have not received prior treatment), or who have a diagnosis at least 4 months prior to selection and who are currently in a medication regimen antidiabetics (1 or 2 antidiabetic medications administered orally) and are willing to undergo a drug wash. • BMI of 25 to 48 kg / m2, inclusive. For subjects from India and the Asia Pacific region, the accepted range is 23 to 48 kg / m2. • Plasma peptide C fasting greater than 0.26 nmol / 1 (> 0.8 ng / ml). • Those who have not received prior treatment: HbAlc 7.0% —10.0%, inclusive. Those who are willing to do the drug wash: HbAlc of <8.5% (no minimum value). • Stable weight, without weight gain or loss greater than 5 kg in the 3 months prior to the study (by background). • From 18 to 75 years old, inclusive. • Subjects who receive medication that is not for the treatment of diabetes but that could affect the maintenance or measurement of blood glucose should maintain a stable dose for 4 weeks before selection. All herbal medication for the treatment of diabetes should be discontinued during the course of the study. • If you are taking thyroid hormone, the dose should be stable for at least 4 weeks before selection (Visit 1). • If you take medication to treat hypertension (including diuretics), the dose should remain stable for at least 4 weeks before selection (Visit 1). • Men and women who are not pregnant or breastfeeding and do not plan to become pregnant during the study. For men and women with reproductive potential, willingness to use an appropriate contraceptive method and not to get pregnant (or get pregnant with their partner (s)) throughout the course of the study. Suitable contraceptive measures include oral contraceptives (stable use for 2 cycles or more before pre-selection); IUD; Depo-Provera®; Norplant® System implants; bilateral tubal ligation; vasectomy; condom or diaphragm in addition to sponge, foam or contraceptive gel; and abstinence). • Are willing to return for clinical visits and complete all procedures related to the study, including self-monitoring of blood glucose. • That they are able to understand and grant informed consent.
Exclusion criteria
Exclusion criteria: • Currently under treatment with 3 or more oral antidiabetic medications or insulin. • Diagnosis of type 1 diabetes mellitus, late-onset juvenile diabetes (MODY), insulin-dependent type 2 diabetes mellitus or other unusual forms of diabetes mellitus. • High blood glucose level due to medical treatment or a concurrent medical condition other than type 2 diabetes mellitus. • Marked diabetic complications: severe autonomic or sensory neuropathies, such as gastroparesis, nephropathy or proliferative retinopathy (laser treatment with stable retinopathy will be acceptable). • Skin lesions, edematous conditions, diabetic foot, peripheral arterial disease or epilepsy • History of diabetic coma or hypoglycemic episodes that require the administration of glucose, glucagon, consumption of orange juice, etc. by a third party during the 6 months prior to the selection. • History of stroke, myocardial infarction, symptomatic coronary disease, angina or arrhythmia during the 4 months prior to selection or any history of congestive heart failure. • History or risks of acute pancreatitis or exacerbation of pancreatitis. • Hypertension without adequate control: Average value of systolic pressure for Visit 1 and Visit 2 of> 160 mmHg and / or diastolic pressure of> 100 mmHg. The measurement in Visit 1 or 2 may be repeated once if the first result is not considered correct. • Gastrointestinal surgery for obesity (including bypass, gastroplasty and gastric band placement procedures) during the year prior to selection (Visit 1) or plans to perform this type of surgery or procedures to remove excess adipose tissue (for example, lipoaspiration, breast reduction or augmentation) during the study. • Current efforts to lose weight either by participating in a commercial diet or behavior modification program (such as Jenny Craig®, Weight Watchers®) or attempting to lose weight outside such programs with or without medications. • Current administration of antipsychotic medication (except for PRN the use of prochlorperazine for nausea), administration in the last two weeks of systemic glucocorticoids with a dose greater than 5 mg of prednisone or the equivalent per day or current administration of appetite stimulating products (such as Megace®). • With the exception of type 2 diabetes, and at the discretion of the investigator any other pulmonary, cardiovascular, hematological, renal, gastrointestinal, endocrine, neurological, immunosuppressive, psychiatric or urogenital disorder of serious uncontrolled nature, or skin diseases and their appendages, eyes, ears, nose or throat. • Background or presence of malignant disease in the last year. Subjects who have been successfully treated (for 3 months or more) may be enrolled without recurrence of basal cell carcinoma of the skin or carcinoma in situ in the cervix. • HIV, hepatitis B or hepatitis C positive (by background only). • History of alcohol or other substance abuse in the last 2 years or diagnosis of eating disorders in the last 5 years. • Use of any investigational medication or participation in any research study within 30 days prior to selection (Visit 1). • Total bilirubin> to the normal upper limit; creatinine> 1.6 mgdl (> 142 pmol / l) (for men) or creatinine> 1.5 mg / dl (> 133 (oneVl) (for women); AST. (SGOT) or ALT (SGPT)> 2, 5 times the normal upper limit, alkaline phosphatase> to 1.5 times the normal upper limit or hemoglobin <11
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Change in the value of HbA1c from Day 98 (baseline) to Day 196 or change until the last visit of subjects who retire prematurely. Measure:Change in HbA1c from Day 28 to Day 196 Timepoints:from Day 28 to Day 196 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Postprandial blood glucose levels on Days 28 and 196 will be assessed by calculating the area under the curve (AUC) with the blood glucose values obtained after the standard food test (starting with the value taken immediately before the standard food test ) as the time value since the food intake as the value x. Measure:Changes in fasting blood glucose from Day 28 to Day 196 Timepoints:from Day 28 to Day 196 ; Outcome name:Change in the value of HbA1c from Day 98 (baseline) to Day 196 or change until the last visit of subjects who retire prematurely. Measure:Percentage of subjects that reach the treatment objective of a HbA1c level <7.0% on Day 196. Timepoints:Day 196 ; Outcome name:The AUC will be determined by means of the linear trapezoidal rule. The change in AUC values from Day 28 to Day 196 will be calculated. On Days 28 and 196, the maximum blood glucose value will also be determined after food intake. Measure:Change in AUC and maximum postprandial blood glucose value after standard meal tests on Days 28 and 196 of the study (maximum postprandial blood glucose level minus baseline level). Timepoints:Days 28 and 196 ; Outcome name:On Day 196, blood samples will be taken to determine the pharmacokinetics of PHX1149. Samples taken during the 3 hours after the administration of the dose and, if possible, the samples taken 8 ± 1 hours after the administration of the dose (7 ± 1 hour after the food test) will be analyzed. The values of Cmax, Tmax and AUC of 0-3 hours will be determined. Measure:The plasma levels of PHX1149 obtained before and after the dose of the medication and the standard food test on Day 196. Timepoints:Day 196. ; Outcome name:On Day 196, samples will be taken to determine DPP4 inhibition in all subjects. The samples collected will be analyzed within three hours after the administration of the dose and, if possible, 8 hours after the dose is received. The change from the | — |
Countries
Argentina, Australia, India, Malasya, Romania, Thailand, Ukraine, United States
Contacts
Public ContactNicolas Emilio Sandoval
INC Research Peru S.A.C
Outcome results
None listed