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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00525330
• Other study ID #: 0104-003
• Status: Completed
• Phase: Phase 2
• First received: September 3, 2007
• Last updated: August 14, 2013
• Start date: September 2007
• Est. completion date: August 2008

Study information

• Verified date: August 2013
• Source: ActivX Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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
• Placebo Drug: Metformin
Two tablets 15 to 30 minutes before each meal, morning and evening.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ActivX Biosciences, Inc.	Kyorin Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	No
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	No
Secondary	To compare effects of once daily (QD) dosing versus twice daily (BID) dosing of KRP-104 on HbA1c and FPG		12 weeks	No
Secondary	To assess the effects of KRP-104 on post-prandial glucose dynamics and insulin sensitivity (homeostasis model index [HOMA-ß]) 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	No
Secondary	To assess the safety and tolerability of KRP-104;		Daily for 12 weeks to 2 weeks post-treatment	Yes