Health Condition 1: null- Type 2 Diabetes Mellitus
Conditions
Interventions
Intervention1: Dutogliptin: 400 mg once daily
Control Intervention1: Placebo: Placebo given QD
Sponsors
Phenomix Corporation
5930 Cornerstone Court West, Suite 230
San Diego, CA 92121
Forest Laboratories, Inc.
Harborside Financial Center, Plaza V
New Jersey City, NJ 07311, USA
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Type 2 diabetes mellitus, diagnosed at least 4 months prior to Screening (Visit 1). 2. Male and female subjects with a BMI of 20 to 48 kg/m2, inclusive. Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of  2000 mg (or the highest tolerated dose; reason for intolerance must be documented) used in accordance with product labeling for at least 6 weeks prior to Screening (Visit 1). 3. Fasting plasma C-peptide greater than 0.26 nmol/L (> 0.8 ng/mL; > 281 pmol/L) at Screening (Visit 1). 4. HbA1c 7.0% ? 10.0%, inclusive, at Screening (Visit 1) and Visit 4 (lab results from Visit 3). 5. Stable weight, with no more than a 5 kg weight gain or loss in the 3 months prior to Screening (Visit 1) (by history). 6. Age 18 to 85 years, inclusive. 7. Subjects receiving medication(s) other than anti-diabetic medication that might affect the maintenance or measurement of plasma glucose must be on a stable dose for 4 weeks prior to Screening (Visit 1). All herbal medication taken for the treatment of diabetes must be discontinued for the duration of the study. 8. TSH results must be within normal limits. If taking thyroid hormone, the dose must have been stable for at least 6 weeks prior to Screening (Visit 1). 9. If taking medication(s) for hypertension (including diuretics), the dose(s) must have been stable for at least 4 weeks prior to Screening (Visit 1). 10. Male and non-pregnant, non-lactating (and not planning to become pregnant during the course of the study) female subjects. For men and women of childbearing potential, willingness to use adequate contraception and not become pregnant (or have their partner[s] become pregnant) during the full course of the study. Adequate contraceptive measures include oral contraceptives (stable use for 2 or more cycles prior to ScreeningVisit 1); IUD; Depo Provera; Norplant System implants; bilateral tubal ligation; vasectomy; condom or diaphragm plus either contraceptive sponge, foam, or jelly; and abstinence. 11. Willing to return for all clinic visits and complete all study-related procedures, including self-monitoring of blood glucose. 12. Able to understand and provide informed consent.
Exclusion criteria
Exclusion criteria: Exclusion Criteria at Study Entry (Screen, Visit 1) 1. Currently on anti-diabetic drugs other than metformin. 2. Type 1 diabetes mellitus, mature onset diabetes of the young (MODY), insulin requiring Type 2 diabetes mellitus, or other unusual or rare forms of diabetes mellitus. 3. Elevated blood glucose due to medical treatment or due to a concurrent medical condition other than Type 2 diabetes mellitus. 4. Skin lesions, edema states, diabetic foot, or epilepsy. 5. History of diabetic coma or hypoglycemic episode requiring help in the form of glucose, glucagon, orange juice, etc, from a second person during the 6 months prior to Screening (Visit 1). 6. History of stroke, myocardial infarction, symptomatic coronary artery disease, angina, or arrhythmia within 4 weeks prior to Screening (Visit 1) or any history of congestive heart failure Class III or IV according to the New York Heart Association functional classification system (NYHA, The Stages of Heart Failure). 7. History of or risk for acute pancreatitis or exacerbation of pancreatitis. 8. Inadequately controlled hypertension: systolic blood pressure &#61619; 160 mmHg and/or diastolic blood pressure &#61619; 100 mmHg at Visit 1 or Visit 2. The measurement at Visit 1 or 2 may be repeated if the initial read-out is felt to be inaccurate. 9. Gastrointestinal surgery for obesity (including bypass, gastroplasty, and banding procedures) within the last year prior to Screening (Visit 1) or plans to have such surgery or procedures for removal of excess fatty tissue (e.g., liposuction, breast reduction or augmentation) during the course of the study. 10. Current efforts to lose weight either by participation in a commercial behavior modification/diet program (e.g., Jenny Craig&#61650;, Weight Watchers&#61650;) or attempting to lose weight outside of such a program with or without drugs. 11. Current administration of antipsychotic medications (except for PRN use of prochlorperazine for nausea), administration within the past 2 weeks of systemic glucocorticoids at a dose greater than 5 mg of prednisone or equivalent daily, or current administration of products intended to stimulate appetite (e.g., Megace&#61650;). 12. Except for Type 2 diabetes mellitus, any other uncontrolled, serious pulmonary, cardiovascular, hematologic, renal, gastrointestinal, endocrine, neurological, immunosuppressive, psychiatric, or urogenital disorder; or diseases of skin and its appendages, the eyes, ears, nose, or throat. 13. History or presence of malignancy within the past year. Subjects who have been successfully treated (for 3 months or longer) with no recurrence of basal cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled. 14. HIV, Hepatitis B, or Hepatitis C virus positive (by history only). 15. History of alcohol or substance abuse in the past 2 years or eating disorder diagnosed in the past 5 years. 16. Use of any investigational drug or participation in any investigational study within 30 days prior to Screening (Visit 1). 17. Total bilirubin above the upper limit of normal; creatinine &#8805; 1.5 mg/dL (&#8805; 133 µmol/L) (for males) or creatinine &#8805; 1.4 mg/dL (&#8805; 124 µmol/L) (for females); AST (SGOT) or ALT (SGPT) > 2.5 × the upper limit of normal; alkaline phosphatase > 1.5 × the upper limit of normal; or hemoglobin < 11 g/dL (< 110 g/L). 18. At Visit 4 only, subjects with a fasting plas
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the efficacy of dutogliptin over 26 weeks, as evidenced by placebo- corrected changes in HbA1cTimepoint: At week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| ? To demonstrate safety and tolerability of dutogliptin. ? To demonstrate changes in fasting plasma glucose over 26 weeks. Timepoint: On completion of patient participation | — |
Countries
India
Contacts
Public ContactMandar Vaidya
Employee of DiagnoSearch
Outcome results
None listed