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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

NCT ID: NCT00525330

Last Updated: 2013-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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KRP-104 120 mg QD

Group Type EXPERIMENTAL

KRP-104 QD Drug: Placebo Drug: Metformin

Intervention Type DRUG

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

KRP-104 60 mg BID

Group Type EXPERIMENTAL

KRP-104 BID Drug: Placebo Drug: Metformin

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo Drug: Metformin

Intervention Type DRUG

Two tablets 15 to 30 minutes before each meal, morning and evening.

Interventions

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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

Intervention Type DRUG

Placebo Drug: Metformin

Two tablets 15 to 30 minutes before each meal, morning and evening.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyorin Pharmaceutical Co.,Ltd

INDUSTRY

Sponsor Role collaborator

ActivX Biosciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Orloff

Role: STUDY_CHAIR

Medpace, Inc.

Tufail Syed

Role: STUDY_CHAIR

Medpace India

Locations

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San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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0104-003

Identifier Type: -

Identifier Source: org_study_id