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

September 3, 2007
August 14, 2013
September 2007
August 2008   (final data collection date for primary outcome 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. [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00525330 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To assess the fasting plasma glucose (FPG)-lowering effect of KRP-104 in patients with type 2 diabetes inadequately controlled on metformin alone;
  • To compare effects of once daily (QD) dosing versus twice daily (BID) dosing of KRP-104 on HbA1c and FPG
  • 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)
  • To assess the safety and tolerability of KRP-104;
  • To evaluate the pharmacokinetics (PK) of KRP-104 and metformin at trough and 2 post-dosing timepoints to assess the drug-drug interaction in a subset of US patients;
  • To assess the effect of KRP-104 on body weight.
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
  • 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
  • Drug: Placebo Drug: Metformin
    Two tablets 15 to 30 minutes before each meal, morning and evening.
  • 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.
  • Experimental: KRP-104 120 mg QD
    Intervention: Drug: KRP-104 QD Drug: Placebo Drug: Metformin
  • Experimental: KRP-104 60 mg BID
    Intervention: Drug: KRP-104 BID Drug: Placebo Drug: Metformin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
213
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00525330
0104-003
Not Provided
ActivX Biosciences, Inc.
ActivX Biosciences, Inc.
Kyorin Pharmaceutical Co.,Ltd
Study Chair: David Orloff Medpace, Inc.
Study Chair: Tufail Syed Medpace India
ActivX Biosciences, Inc.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP