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

PHASE2CompletedINTERVENTIONAL
Enrollment

213

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

August 31, 2008

Study Completion Date

August 31, 2008

Conditions
Type 2 Diabetes
Interventions
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.

Trial Locations (1)

Unknown

San Diego

Sponsors
All Listed Sponsors
collaborator

Kyorin Pharmaceutical Co.,Ltd

INDUSTRY

lead

ActivX Biosciences, Inc.

INDUSTRY

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 | Biotech Hunter | Biotech Hunter