safety and efficacy of once-daily krp-104 in type 2 diabetics with inadequate glycemic control on metformin alone

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to assess the safety and effectiveness of krp-104 on glycemic control in patients with type 2 diabetes inadequately controlled on metformin alone.


Eligibility criteria:
inclusion criteria: patients meeting the following criteria at the screening visit (visit 1) will be eligible to participate in the trial: 1. signed written informed consent; 2. males and females 18 to 75 years of age, inclusive; 3. females of childbearing potential must agree to use 2 adequate forms of barrier method contraception (eg, latex condom and intrauterine device or a diaphragm) to avoid pregnancy while in the study; 4. on a stable dose (greater than or equal to 10 weeks at the same dose) of metformin monotherapy (less than or equal to 1500 mg/day or maximum tolerated dose), have an hba1c greater than or equal to 7.0% and less than or equal to 10.5%; or * on metformin (less than or equal to 1500 mg/day) and 1 other antidiabetic agent (excluding tzd, insulin, or incretin therapies \[dpp-4 inhibitors and glp-1 analogues\]) and have an hba1c greater than or equal to 6.8% and less than or equal to 10.0%; or * not on antidiabetic therapy (for at least 3 months prior to visit 1) or have not been on a stable dose of metformin monotherapy for 10 weeks and have an hba1c greater than or equal to 8.0% and less than or equal to 11.0%. exclusion criteria: 1. history of type 1 diabetes mellitus or history of diabetic ketoacidosis or persistent hypoglycemia; 2. history or presence of alcoholism or drug abuse within the 2 years prior to dosing; 3. typical consumption of greater than or equal to 10 drinks of alcohol weekly; 4. presence of any of the following conditions: * significant renal impairment (glomerular filtration rate less than 60 ml/min); * diabetic gastroparesis; * active liver disease (other than asymptomatic nonalcoholic fatty liver disease), cirrhosis, or symptomatic gallbladder disease; 5. fasting plasma glucose/blood glucose greater than 240 mg/dl (13.3 mmol/l) at visit 3 (week -2) (1 laboratory retest permitted); 6. body mass index less than or equal to 20 kg/m2 and greater than or equal to 48 kg/m2; 7. systolic blood pressure \ 160 mmhg and diastolic blood pressure \ 100 mmhg at visit 3 (note: medication to control blood pressure is allowed and should be optimized and stabilized prior to visit 3); 8. aspartate aminotransferase (ast) or alanine aminotransferase (alt) \>2 x the upper limit of normal (uln) (1 laboratory retest permitted); 9. creatine phosphokinase (cpk) greater than 2 x the uln (if not explained by muscular trauma or exercise) (1 laboratory retest permitted); 10. serum creatinine \>1.5 mg/dl for males (132.6 μmol/l) and 1.4 mg/dl for females (123.8 μmol/l); 11. fasting triglycerides (tg) \>600 mg/dl (6.78 mmol/l) at visit 3 (week -2) (note: diet/exercise and lipid-lowering medication to control elevated tg is allowed; medications should be optimized and stabilized prior to visit 3); 12. treatment with pioglitazone or rosiglitazone within the previous 10 weeks (visit 1); treatment with incretin therapy (dpp-4 inhibitors or glp-1 analogues) within the previous 4 weeks (visit 1); 13. treatment with any type of insulin (ie, injected or inhaled) within the previous 3 months; 14. must meet other laboratory and medical history clinical criteria. please contact recruitment center for referrals

Keywords: type 2 diabetes metformin