NCT00525330

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P75+ for phase_2 type-2-diabetes

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_2 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

August 22, 2013

Status Verified

August 1, 2013

Enrollment Period

11 months

First QC Date

September 3, 2007

Last Update Submit

August 14, 2013

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • 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

  • To compare effects of once daily (QD) dosing versus twice daily (BID) dosing of KRP-104 on HbA1c and FPG

    12 weeks

  • 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)

    12 weeks

  • To assess the safety and tolerability of KRP-104;

    Daily for 12 weeks to 2 weeks post-treatment

Study Arms (3)

KRP-104 120 mg QD

EXPERIMENTAL
Drug: KRP-104 QD Drug: Placebo Drug: Metformin

KRP-104 60 mg BID

EXPERIMENTAL
Drug: KRP-104 BID Drug: Placebo Drug: Metformin

Placebo

PLACEBO COMPARATOR
Drug: Placebo Drug: Metformin

Interventions

KRP-104 QD Drug: Placebo Drug: MetforminDRUG

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-104 120 mg QD
Placebo Drug: MetforminDRUG

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

Placebo
KRP-104 BID Drug: Placebo Drug: MetforminDRUG

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.

KRP-104 60 mg BID

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 70 years, inclusive;
  • Males and females of non-childbearing potential;
  • Diagnosis of type 2 diabetes mellitus according; and
  • On a stable dose of metformin monotherapy at randomization (can be on other oral therapies or naive at study entry

You may not qualify if:

  • History of type 1 diabetes mellitus or history of diabetic ketoacidosis or persistent hypoglycemia;
  • History or presence of alcoholism or drug abuse
  • Typical consumption of ≥10 drinks of alcohol weekly;
  • 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;
  • Uncontrolled high blood pressure;
  • History or evidence of cardiovascular or pulmonary disease
  • Must meet other laboratory and Medical History clinical criteria. Please contact recruitment center for referrals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

San Diego, California, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • David Orloff

    Medpace, Inc.

    STUDY CHAIR

  • Tufail Syed

    Medpace India

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2007

First Posted

September 5, 2007

Study Start

September 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

August 22, 2013

Record last verified: 2013-08

Locations

US(1)