A Phase 2 interventional study of KRP-104 QD Drug: Placebo Drug: Metformin and Placebo Drug: Metformin in Type 2 Diabetes, sponsored by ActivX Biosciences, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-08-22.
Sponsored by ActivX Biosciences, Inc. · Phase 2, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 213 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →ActivX Biosciences, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Presence of any of the following conditions:
Drug: KRP-104 QD Drug: Placebo Drug: Metformin
Drug: KRP-104 BID Drug: Placebo Drug: Metformin
Drug: Placebo Drug: Metformin
KRP-104 120 mg: KRP-104 two 50 mg tablets and two 10 mg tablets 15 to 30 minutes before morning meal and 2 placebo tablets 15 to 30 minutes before evening meal
Two tablets 15 to 30 minutes before each meal, morning and evening.
KRP-104 60 mg: KRP-104 one 50 mg tablet plus one 10 mg tablet 15 to 30 minutes before each meal, morning and evening.
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.
Time frame: 12-weeks
To assess the fasting plasma glucose (FPG)-lowering effect of KRP-104 in patients with type 2 diabetes inadequately controlled on metformin alone;
Time frame: 12-weeks
To compare effects of once daily (QD) dosing versus twice daily (BID) dosing of KRP-104 on HbA1c and FPG
Time frame: 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.
Time frame: 12 weeks
To assess the safety and tolerability of KRP-104;
Time frame: Daily for 12 weeks to 2 weeks post-treatment
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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ActivX Biosciences, Inc.