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

This study has been completed.
Sponsor:
Collaborator:
Kyorin Pharmaceutical Co.,Ltd
Information provided by (Responsible Party):
ActivX Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT00525330
First received: September 3, 2007
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: KRP-104 QD Drug: Placebo Drug: Metformin
Drug: Placebo Drug: Metformin
Drug: KRP-104 BID Drug: Placebo Drug: Metformin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by ActivX Biosciences, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To compare effects of once daily (QD) dosing versus twice daily (BID) dosing of KRP-104 on HbA1c and FPG [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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; [ Time Frame: Daily for 12 weeks to 2 weeks post-treatment ] [ Designated as safety issue: Yes ]

Enrollment: 213
Study Start Date: September 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KRP-104 120 mg QD Drug: KRP-104 QD 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
Experimental: KRP-104 60 mg BID Drug: KRP-104 BID Drug: Placebo Drug: Metformin
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.
Placebo Comparator: Placebo Drug: Placebo Drug: Metformin
Two tablets 15 to 30 minutes before each meal, morning and evening.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525330

Locations
United States, California
San Diego, California, United States
Sponsors and Collaborators
ActivX Biosciences, Inc.
Kyorin Pharmaceutical Co.,Ltd
Investigators
Study Chair: David Orloff Medpace, Inc.
Study Chair: Tufail Syed Medpace India
  More Information

No publications provided

Responsible Party: ActivX Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00525330     History of Changes
Other Study ID Numbers: 0104-003
Study First Received: September 3, 2007
Last Updated: August 14, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014