None listed
Conditions
Interventions
Group 1 Type of group
PHX1149T 400 mg orally once daily with or without food.
Group name:Group 2 Type of group
Placebo tablets orally once daily with or without food.
Sponsors
PHENOMIX CORPORATION,
Eligibility
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: • Type 2 diabetes mellitus, diagnosed at least 4 months before the Selection (Visit 1). • Men and women with an IMG of 20 to 48 kg / m ^, inclusive. Current treatment of type 2 diabetes mellitus with a stable dose of metformin of> 2000 mg (or the maximum tolerated dose; the reason for the intolerance should be documented) used according to the product label for at least 6 weeks before Selection (Visit 1). • Fasting plasma peptide C greater than 0.26 nmol / 1 (> 0.8 ng / ml;> 281 pmol / 1) in the Selection (Visit 1). • HbA1c of 7.0% - 10.0%, inclusive, in the Selection (Visit 1) and Visit 4 (results of the Visit 3 laboratory). • Stable weight, with weight gain or loss not exceeding 5 kg in the 3 months prior to the Selection (Visit 1) (depending on the background). • From 18 to 85 years old, inclusive. • Subjects who receive medication other than antidiabetic medication that could affect maintenance or measurement of plasma glucose should be at a stable dose for 4 weeks prior to Selection (Visit 1). All herbal medication that is being taken to treat diabetes during the study should be discontinued. • TSH results must be within normal limits. If you are taking thyroid hormone, the dose must have been stable for at least • 6 weeks prior to the Selection (Visit 1). • If you take medications 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 of childbearing age, willingness to use an appropriate contraceptive method and not to become pregnant (or to get pregnant with their partner (s)) throughout the course of the study. Appropriate contraceptive measures include oral contraceptives (stable for 2 or more cycles before Selection / Visit 1); IUD, Depo-Provera®; Norplant® System implants; bilateral tubal ligation; vasectomy; condom or diaphragm plus sponge, foam or contraceptive gel, and withdrawal. • 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 antidiabetic medications other than metformin. • Type 1 diabetes mellitus, late-onset juvenile diabetes (MODY), type 2 diabetes mellitus requiring insulin or other unusual or rare forms of diabetes mellitus. • High blood glucose level due to medical treatment or a concurrent medical condition other than type 2 diabetes mellitus, • Skin lesions, edematous conditions, diabetic foot or epilepsy. • History of diabetic coma or hypoglycemic episode that require the administration of glucose, glucagon, orange juice, etc. by a third party during the 6 months prior to the Selection (Visit 1). • History of stroke, myocardial infarction, symptomatic coronary artery disease, angina or arrhythmia within 4 weeks prior to Selection (Visit 1) or any history of congestive heart failure class III or IV according to the New York functional classification Heart Association (NYHA) (NYHA, The Stages of Heart Failure). • History of or risk of acute pancreatitis or exacerbation of pancreatitis. • Hypertension without adequate control: systolic blood pressure> 100mmHg and / or diastolic blood pressure> 100mmHg at Visit 1 or 2. The measurement at 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 (for example, Jenny Craig, Weight Watchers®) or attempt to lose weight outside such programs with or without medications. • Current administration of antipsychotic medication (except for the use of prochlorperazine for nausea, as necessary), 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 products appetite stimulators (for example, Megace). • With the exception of type 2 diabetes mellitus, any other pulmonary, cardiovascular, hematological, renal, gastrointestinal, endocrine, neurological, immunosuppressive, psychiatric or urogenital disorder of a serious uncontrolled nature, or diseases of the skin and its appendages, the 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 the Selection (Visit 1). • Total bilirubin above the normal upper limit; creatinine> 1.5mg / dl (> 142 | amol / l) (for men) or creatinine> 1.4 mg / dl (> 133 nmol / l) (for women); AST (SGOT) or ALT (SGPT)> 2.5 times the normal upper limit; alkaline phosphatase> 1.5 times the normal upper limit; or hemoglobin <11 g / dl (<110g / l). • Any clinically relevant laboratory condition, disease, disorder or abnormality that, at the investig
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The last available value for subjects who finish the study in advance before the end of the 26 weeks of double-blind treatment (ie, the LOCF). This variable will be analyzed by means of a covariance analysis model (ANCOVA), with the treatment group and the country as factors and the baseline value of HbA1c as a covariate. Measure:Change in HbA1c with respect to baseline (Visit 4 [Day 28]) to Visit 8 (Day 210) Timepoints:Visit 4 [Day 28] to Visit 8 (Day 210) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:They will be analyzed using all available data with the last observation method considered (LOCF). The change with respect to the baseline value (Visit 4 [Day 28]) at each visit will be analyzed through a covariance analysis model (ANCOVA) that includes the effects of the treatment group, the country and the corresponding baseline value. Measure:Change with respect to baseline HbA1c value in all other visits and change with respect to baseline fasting blood glucose value in all visits Timepoints:all other visits ; Outcome name:It will be analyzed through the Cochran-Mantel-Haenszel procedure, stratified by country. For all subjects who do not complete Visit 8 (Day 210), the last value will be considered before starting rescue medication. Measure:Proportion of subjects that reach a HbA1c value <7% on Visit 8 (Day 210) Timepoints:Visit 8 (Day 210) | — |
Countries
Argentina, Chile, Czech Republic, India, Peru, Poland, United States
Contacts
Public ContactPierina Alexandra Benavente
INC Research Peru S.A.C
Outcome results
None listed