Clinical trial NCT00525330: 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: ActivX Biosciences, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Kyorin Pharmaceutical Co.,Ltd
First posted: 2007-09-05
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 12-weeks
Secondary outcomes:
measure: To assess the fasting plasma glucose (FPG)-lowering effect of KRP-104 in patients with type 2 diabetes inadequately controlled on metformin alone;
timeFrame: 12-weeks
measure: To compare effects of once daily (QD) dosing versus twice daily (BID) dosing of KRP-104 on HbA1c and FPG
timeFrame: 12 weeks
measure: 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)
timeFrame: 12 weeks
measure: To assess the safety and tolerability of KRP-104;
timeFrame: Daily for 12 weeks to 2 weeks post-treatment
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
Study officials:
affiliation: Medpace, Inc.
name: David Orloff
role: STUDY_CHAIR
affiliation: Medpace India
name: Tufail Syed
role: STUDY_CHAIR
References: