| Trial ID: | L2373 |
| Source ID: | NCT00525330
|
| Associated Drug: |
Krp-104 Qd Drug: Placebo Drug: Metformin
|
| Title: |
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
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: KRP-104 QD Drug: Placebo Drug: Metformin|DRUG: Placebo Drug: Metformin|DRUG: KRP-104 BID Drug: Placebo Drug: Metformin
|
| Outcome Measures: |
Primary: 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: 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), 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., 12 weeks|To assess the safety and tolerability of KRP-104;, Daily for 12 weeks to 2 weeks post-treatment
|
| Sponsor/Collaborators: |
Sponsor: ActivX Biosciences, Inc. | Collaborators: Kyorin Pharmaceutical Co.,Ltd
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
213
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-09
|
| Completion Date: |
2008-08
|
| Results First Posted: |
|
| Last Update Posted: |
2013-08-22
|
| Locations: |
San Diego, California, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00525330
|
