Type II Diabetes Mellitus in subjects with Moderate and Severe Renal Impairment including subjects on Hemodialysis MedDRA version: 12.0 Level: LLT Classification code 10045250 Term: Type II diabetes mellitus with renal manifestations
Conditions
Interventions
Product Name: Dutogliptin
Pharmaceutical Form: Tablet
INN or Proposed INN: Dutogliptin Tartrate
CAS Number: 890402-81-0
Current Sponsor code: PHX1149T
Other descriptive name: PHX1149
Concentration uni
Sponsors
Phenomix Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Type 2 diabetes mellitus diagnosed at least 4 months prior to screening; age 18 to 85 years, inclusive. • Renal impairment as determined by MDRD formula calculation of GFR estimate = 59 mL/min/1.73m2 at screening. • Hemodialysis subjects must have stable renal status for at least 6 months, with a functional, mature, A-V shunt. • HbA1c 7.0% – 10.5%, inclusive. • Male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects. • Subjects can be on any combination of a sulfonylurea, TZD, meglitinide, acarbose, or insulin as background medications (or no antidiabetic drugs at all). Metformin, GLP-1 analogues, or DPP4 inhibitors are not permitted. • No Type 1 diabetes mellitus or history of diabetic ketoacidosis. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes mellitus or history of diabetic ketoacidosis, mature onset diabetes of the young (MODY), or other unusual or rare forms of diabetes mellitus. 2. Peritoneal dialysis. 3. Kidney transplant subject 4. Use of metformin (for the past 4 weeks prior to randomization). 5. Elevated blood glucose due to medical treatment or due to a concurrent medical condition other than Type 2 diabetes mellitus. 6. Current or prior (within 1 per month) requiring emergency intervention and help in the form of glucose or glucagon from a second person during the 6 months prior to screening. 9. History of stroke, myocardial infarction, symptomatic coronary artery disease, clinically significant/unstable angina or clinically significant/unstable arrhythmia during the 4 weeks prior to screening (Visit 1). 10. History of congestive heart failure Class III or IV 11. History of or risks for acute pancreatitis or exacerbation of pancreatitis. 12. Inadequately controlled hypertension: systolic blood pressure = 160 mmHg (in severe and ESRD subjects: systolic 180 mmHg), diastolic blood pressure 100 mmHg at Visit 1 or Visit 2. The measurement at Visit 1 or 2 can be repeated once if the initial assessment is felt to be incorrect. 13. Except for Type 2 diabetes and chronic kidney disease, any other uncontrolled, , serious pulmonary, cardiovascular, hematologic, gastrointestinal, endocrine, neurological, immunosuppressive, psychiatric, or urogenital disorder; or diseases of skin and its appendages, the eyes, ears, nose, or throat. 14. History or presence of malignancy within the past 5 years. 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. 15. HIV or Hepatitis B or C (by history only). 16. History of alcohol or substance abuse in the past 2 years or eating disorder diagnosed in the past 5 years. 17. Use of any investigational drug or participation in any investigational study within 30 days prior to screening (Visit 1) or less than 4 half-lives in the case of prior use of monoclonal antibodies or similar agents. 18. Total bilirubin > 1.5 × above the upper limit of normal; AST (SGOT) or ALT (SGPT) > 2.5 × the upper limit of normal; alkaline phosphatase > 1.5 × the upper limit of normal; or hemoglobin < 8 g/dL (<80 g/L). 19. Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the subject’s appropriate participation in this study or obscure the effects of treatment. Additional Exclusion Criteria Specific to Hemodialysis Subjects at Study Entry: 1. Dialysis required secondary to acute renal failure. 2. Patients on dialysis immediately prior to renal transplant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess safety and tolerability of dutogliptin in Type 2 diabetic subjects with moderate or severe renal impairment;Secondary Objective: To assess changes in HbA1c. To assess changes in fasting plasma glucose. To collect PK and PD (ex vivo inhibition of DPP4) information on dutogliptin in a subset of subjects.;Primary end point(s): Safety, tolerability, HbA1c, and fasting plasma glucose. Additional endpoints include PK and PD (DPP4 inhibition) in a subset of subjects | — |
Countries
Czech Republic, Hungary
Outcome results
None listed