A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of KRP-104 in Patients With Type 2 Diabetes Inadequately Controlled on Metformin Alone

Phase 2

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT00525330
• Lead Sponsor: ActivX Biosciences, Inc.

Brief Summary

To assess the safety and efficacy of chronic therapy with KRP-104, a novel DPP-IV inhibitor, in patients with Type 2 Diabetes on stable metformin therapy. In addition, an estimate of how much of the HbA1c response is attributable to nocturnal coverage will be explored.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-03
• Study First Submitted QC: 2007-09-04
• Study First Posted: 2007-09-05
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Disposition First Submitted: 2011-06-07
• Disposition First Submitted QC: 2011-06-07
• Disposition First Posted: 2011-06-21
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-14
• Last Update Posted: 2013-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

Inclusion Criteria

1. Age 18 to 70 years, inclusive;
2. Males and females of non-childbearing potential;
3. Diagnosis of type 2 diabetes mellitus according; and
4. On a stable dose of metformin monotherapy at randomization (can be on other oral therapies or naive at study entry

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

3. Typical consumption of ≥10 drinks of alcohol weekly;

4. Presence of any of the following conditions:

   • Significant renal impairment (glomerular filtration rate <60 mL/min [to be calculated by the central laboratory]);
   • Diabetic retinopathy;
   • Diabetic gastroparesis;
   • Active liver disease (other than asymptomatic nonalcoholic fatty liver disease), cirrhosis, or symptomatic gallbladder disease;

5. Uncontrolled high blood pressure;

6. History or evidence of cardiovascular or pulmonary disease

7. Must meet other laboratory and Medical History clinical criteria. Please contact recruitment center for referrals

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary objective of this trial is to demonstrate the hemoglobin A1c (HbA1c)-lowering effects of KRP-104 in patients with type 2 diabetes inadequately controlled on metformin alone.	12-weeks

Secondary Outcome Measures

Name	Time	Method
To assess the fasting plasma glucose (FPG)-lowering effect of KRP-104 in patients with type 2 diabetes inadequately controlled on metformin alone;	12-weeks
To compare effects of once daily (QD) dosing versus twice daily (BID) dosing of KRP-104 on HbA1c and FPG	12 weeks
To assess the effects of KRP-104 on post-prandial glucose dynamics and insulin sensitivity (homeostasis model index [HOMA-β]) in the setting of a Meal Tolerance Test(MTT)	12 weeks	Changes from pre-prandial to 2-hour post-prandial glucose, active GLP-1, insulin summarized by treatment group from Week 0 to Week 5 and Week 12. Percent change in 2-hour post-prandial glucose summarized by treatment group from Week 0 to Week 5 and Week 12.
To assess the safety and tolerability of KRP-104;	Daily for 12 weeks to 2 weeks post-treatment