Status:
COMPLETED
Safety and Efficacy of Once-Daily KRP-104 in Type 2 Diabetics With Inadequate Glycemic Control on Metformin Alone
Lead Sponsor:
ActivX Biosciences, Inc.
Collaborating Sponsors:
Kyorin Pharmaceutical Co.,Ltd
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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
- Patients meeting the following criteria at the screening visit (Visit 1) will be eligible to participate in the trial:
- Signed written informed consent;
- Males and females 18 to 75 years of age, inclusive;
- 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;
- 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
- History of type 1 diabetes mellitus or history of diabetic ketoacidosis or persistent hypoglycemia;
- History or presence of alcoholism or drug abuse within the 2 years prior to dosing;
- Typical consumption of greater than or equal to 10 drinks of alcohol weekly;
- 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;
- Fasting plasma glucose/blood glucose greater than 240 mg/dL (13.3 mmol/L) at Visit 3 (Week -2) (1 laboratory retest permitted);
- Body mass index less than or equal to 20 kg/m2 and greater than or equal to 48 kg/m2;
- Systolic blood pressure \<100 mmHg or \>160 mmHg and diastolic blood pressure \<50 mmHg or \>100 mmHg at Visit 3 (Note: medication to control blood pressure is allowed and should be optimized and stabilized prior to Visit 3);
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2 X the upper limit of normal (ULN) (1 laboratory retest permitted);
- Creatine phosphokinase (CPK) greater than 2 X the ULN (if not explained by muscular trauma or exercise) (1 laboratory retest permitted);
- Serum creatinine \>1.5 mg/dL for males (132.6 μmol/L) and 1.4 mg/dL for females (123.8 μmol/L);
- 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);
- 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);
- Treatment with any type of insulin (ie, injected or inhaled) within the previous 3 months;
- Must meet other laboratory and Medical History clinical criteria. Please contact recruitment center for referrals
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
403 Patients enrolled
Trial Details
Trial ID
NCT00995345
Start Date
October 1 2009
End Date
January 1 2011
Last Update
June 26 2014
Active Locations (45)
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Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Los Angeles, California, United States
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Valley Village, California, United States