NCT00458016

Brief Summary

The purpose of this study is to collect important information regarding the safety, tolerability, and efficacy of MB07803 when administered for 28 days in patients with type 2 diabetes mellitus

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P25-P50 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

25 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

March 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 5, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 9, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

October 3, 2011

Status Verified

September 1, 2011

Enrollment Period

1 year

First QC Date

April 5, 2007

Last Update Submit

September 29, 2011

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Fasting Plasma Glucose Concentration

    Change from baseline to Day 28

Secondary Outcomes (1)

  • Fasting serum triglycerides and free fatty acids, fasting serum insulin.

    Change from baseline to Day 28

Study Arms (5)

1

EXPERIMENTAL
Drug: MB07803

2

EXPERIMENTAL
Drug: MB07803

3

EXPERIMENTAL
Drug: MB07803

4

EXPERIMENTAL
Drug: MB07803

5

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MB07803DRUG

Daily oral administration

1234
PlaceboDRUG

Daily oral administration

5

Eligibility Criteria

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

You may qualify if:

  • Fasting plasma glucose between 120 - 270 mg/dL at screening
  • HbA1c measurements between 6.0 - 10% at screening
  • Females who are surgically sterile (i.e. women who have had a hysterectomy or tubal ligation). Females who are postmenopausal for at least 12 consecutive months and documented by blood follicular stimulating hormone (FSH) greater than or equal to 40 mlU/mL.Females of childbearing potential must be willing to use an approved double-barrier method of birth control (e.g. condom plus spermicide ;IUD plus spermicide) from the time of signing the informed consent form through 4 weeks following the last dose of study drug.
  • Body mass index (BMI) in the range of 18.5 - 37 kg/m2 Patients with a BMI in the range of 37.5 - 40 kg/m2 who in the Investigator's opinion, are in good health and satisfy the eligibility criteria, will be considered on a case-by case basis
  • Written informed consent

You may not qualify if:

  • Type 1 diabetes mellitus
  • Type 2 diabetes mellitus with a history of diabetic ketoacidosis or ketosis-prone
  • Use of thiazolidinediones (TZDs)
  • Currently on more than two oral hypoglycemic agent
  • History of outpatient insulin use
  • Clinically significant history of cardiac disease within 6 months of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Unknown Facility

Los Angeles, California, 90057, United States

Location

Unknown Facility

Walnut Creek, California, 94598, United States

Location

Unknown Facility

Miami, Florida, 33169, United States

Location

Unknown Facility

Miami Gardens, Florida, 33169, United States

Location

Unknown Facility

Chicago, Illinois, 60607, United States

Location

Unknown Facility

Chicago, Illinois, 60611, United States

Location

Unknown Facility

Indianapolis, Indiana, 46254, United States

Location

Unknown Facility

Indianapolis, Indiana, 46260, United States

Location

Unknown Facility

Butte, Montana, 59701, United States

Location

Unknown Facility

Las Vegas, Nevada, 89123, United States

Location

Unknown Facility

Charlotte, North Carolina, 28209, United States

Location

Unknown Facility

Statesville, North Carolina, 28677, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27103, United States

Location

Unknown Facility

Cincinnati, Ohio, 45246, United States

Location

Unknown Facility

Delaware, Ohio, 43015, United States

Location

Unknown Facility

Marion, Ohio, 43302, United States

Location

Unknown Facility

Willoughby Hills, Ohio, 44094, United States

Location

Unknown Facility

Tulsa, Oklahoma, 74104, United States

Location

Unknown Facility

Charleston, South Carolina, 29407, United States

Location

Unknown Facility

Bristol, Tennessee, 37620, United States

Location

Unknown Facility

Corpus Christi, Texas, 78404, United States

Location

Unknown Facility

Dallas, Texas, 75231, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

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

Study Record Dates

First Submitted

April 5, 2007

First Posted

April 9, 2007

Study Start

March 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

October 3, 2011

Record last verified: 2011-09

Locations

US(25)