NCT00995345

Brief Summary

The purpose of this study is to assess the safety and effectiveness of KRP-104 on glycemic control in patients with type 2 diabetes inadequately controlled on metformin alone.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
403

participants targeted

Target at P75+ for phase_2 type-2-diabetes

Timeline
Completed

Started Oct 2009

Geographic Reach
7 countries

45 active sites

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

October 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 15, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

June 26, 2014

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2014

Enrollment Period

1.3 years

First QC Date

October 12, 2009

Results QC Date

August 14, 2013

Last Update Submit

June 23, 2014

Conditions

Type 2 Diabetes

Keywords

Type 2 DiabetesMetformin

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c From Baseline (Week 0) to Week 24

    Mean Change in HbA1c (%) from Baseline to Week 24 with LOCF, ITT population LS mean (SE)

    Week 24

Secondary Outcomes (3)

  • Change in Body Weight

    24 weeks

  • Percentage of Patients Achieving HbA1c Less Than 7%

    24 weeks

  • Percentage of Patients Requiring Rescue Therapy for Elevated Glucose

    24 weeks of treatment.

Study Arms (5)

Dose 1: KRP-104 40 mg

EXPERIMENTAL

Tablet, once-daily for 24 weeks

Drug: KRP-104

Dose 2: KRP-104 80 mg

EXPERIMENTAL

Tablet, once-daily for 24 weeks

Drug: KRP-104

Dose 3: KRP-104 100 mg

EXPERIMENTAL

Tablet, once-daily for 24 weeks

Drug: KRP-104

Dose 4: KRP-104 20/120mg

EXPERIMENTAL

Tablet, once-daily for 24 weeks (dose switch from 20 to 120 mg at week 12)

Drug: KRP-104

Placebo

PLACEBO COMPARATOR

Tablet, once-daily for 24 weeks

Drug: Placebo

Interventions

KRP-104DRUG

Tablet

Dose 1: KRP-104 40 mgDose 2: KRP-104 80 mgDose 3: KRP-104 100 mgDose 4: KRP-104 20/120mg
PlaceboDRUG

Tablet

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients meeting the following criteria at the screening visit (Visit 1) will be eligible to participate in the trial:
  • Signed written informed consent;
  • Males and females 18 to 75 years of age, inclusive;
  • Females of childbearing potential must agree to use 2 adequate forms of barrier method contraception (eg, latex condom AND intrauterine device or a diaphragm) to avoid pregnancy while in the study;
  • On a stable dose (Greater than or equal to 10 weeks at the same dose) of metformin monotherapy (Less than or equal to 1500 mg/day or maximum tolerated dose), have an HbA1c greater than or equal to 7.0% and less than or equal to 10.5%; or
  • On metformin (less than or equal to 1500 mg/day) and 1 other antidiabetic agent (excluding TZD, insulin, or incretin therapies \[DPP-4 inhibitors and GLP-1 analogues\]) and have an HbA1c greater than or equal to 6.8% and less than or equal to 10.0%; or
  • Not on antidiabetic therapy (for at least 3 months prior to Visit 1) or have not been on a stable dose of metformin monotherapy for 10 weeks and have an HbA1c greater than or equal to 8.0% and less than or equal to 11.0%.

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 within the 2 years prior to dosing;
  • Typical consumption of greater than or equal to 10 drinks of alcohol weekly;
  • Presence of any of the following conditions:
  • Significant renal impairment (glomerular filtration rate less than 60 mL/min);
  • Diabetic gastroparesis;
  • Active liver disease (other than asymptomatic nonalcoholic fatty liver disease), cirrhosis, or symptomatic gallbladder disease;
  • Fasting plasma glucose/blood glucose greater than 240 mg/dL (13.3 mmol/L) at Visit 3 (Week -2) (1 laboratory retest permitted);
  • Body mass index less than or equal to 20 kg/m2 and greater than or equal to 48 kg/m2;
  • Systolic blood pressure \<100 mmHg or \>160 mmHg and diastolic blood pressure \<50 mmHg or \>100 mmHg at Visit 3 (Note: medication to control blood pressure is allowed and should be optimized and stabilized prior to Visit 3);
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2 X the upper limit of normal (ULN) (1 laboratory retest permitted);
  • Creatine phosphokinase (CPK) greater than 2 X the ULN (if not explained by muscular trauma or exercise) (1 laboratory retest permitted);
  • Serum creatinine \>1.5 mg/dL for males (132.6 μmol/L) and 1.4 mg/dL for females (123.8 μmol/L);
  • Fasting triglycerides (TG) \>600 mg/dL (6.78 mmol/L) at Visit 3 (Week -2) (Note: diet/exercise and lipid-lowering medication to control elevated TG is allowed; medications should be optimized and stabilized prior to Visit 3);
  • Treatment with pioglitazone or rosiglitazone within the previous 10 weeks (Visit 1); treatment with incretin therapy (DPP-4 inhibitors or GLP-1 analogues) within the previous 4 weeks (Visit 1);
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (45)

Unknown Facility

Birmingham, Alabama, United States

Location

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Phoenix, Arizona, United States

Location

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Los Angeles, California, United States

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Valley Village, California, United States

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Honolulu, Hawaii, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Delaware, Ohio, United States

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Marion, Ohio, United States

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Beaver, Pennsylvania, United States

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Jenkintown, Pennsylvania, United States

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Greer, South Carolina, United States

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Austin, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Sandy City, Utah, United States

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West Jordan, Utah, United States

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Buenos Aires, Argentina

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Córdoba, Argentina

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Loma Hermos Buenos Aires, Argentina

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Chrudim III, Czechia

Location

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Holešov, Czechia

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Mělník, Czechia

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Ostrava, Czechia

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Prague, Czechia

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Guatemala City, Guatemala

Location

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Bialystok, Poland

Location

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Gdansk, Poland

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Krakow, Poland

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Lodz, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Arkhangelsk, Russia

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Kemerovo, Russia

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Moscow, Russia

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Novosibirsk, Russia

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Saint Petersburg, Russia

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Port Elizabeth, Eastern Cape, South Africa

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Bloemfontein, Free State, South Africa

Location

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Johannesburg, Gauteng, South Africa

Location

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Soweto, Gauteng, South Africa

Location

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Durban, Kwazula-Natal, South Africa

Location

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Cape Town, Western Cape, South Africa

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Paarl, Western Cape, South Africa

Location

Unknown Facility

Somerset West, Western Cape, South Africa

Location

Related Publications (1)

  • Plotkin DJ, Lewin A, Logan D, Kato T, Kozarich J, Wei X, Vest J, Orloff D. KRP-104, A Uniquely Prandial-Targeted DPP-4 Inhibitor. Abstract and Poster # 822, Presented at: European Association for the Study of Diabetes 38th Annual Meeting, Berlin Germany, October 1-5, 2012.

    RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Dr. Diane Plotkin, Sr. Director Clinical Development
Organization
ActivX Biosciences
dianep@activx.com
858-558-5558

Study Officials

  • Diane J Plotkin, PhD

    ActivX Biosciences, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

October 12, 2009

First Posted

October 15, 2009

Study Start

October 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

June 26, 2014

Results First Posted

June 26, 2014

Record last verified: 2014-06

Locations

US(17)AR(3)GU(1)CZ(5)PL(6)RU(5)ZA(8)