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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

NCT00525330 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2013-08-22

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Kyorin Pharmaceutical Co.,Ltd

    collaborator INDUSTRY

  • ActivX Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • David Orloff · Medpace, Inc.

  • Tufail Syed · Medpace India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00525330 on ClinicalTrials.gov