NCT01035879

Brief Summary

To define the relative efficacy, safety and tolerability profiles of oral daily MBX-2982 at three different daily doses vs. placebo and sitagliptin 100 mg when administered for up to 4 weeks in patients that are treatment-naive or taking a single anti-diabetic medication (non-TZD, non-injectable).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2 diabetes

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_2 diabetes

Geographic Reach
3 countries

14 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

December 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

April 17, 2015

Status Verified

March 1, 2015

Enrollment Period

8 months

First QC Date

December 17, 2009

Last Update Submit

March 30, 2015

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Evaluate the effect of MBX-2982 on the absolute and percent change from baseline and placebo in mean weighted average of 14-point blood glucose levels associated with a standardized breakfast and lunch

    4 weeks

Secondary Outcomes (1)

  • Evaluate the effect of MBX-2982 on additional glycemic parameters.

    4 weeks

Study Arms (5)

MBX-2982 25 mg

EXPERIMENTAL
Drug: MBX-2982

MBX-2982 100 mg

EXPERIMENTAL
Drug: MBX-2982

MBX-2982 300 mg

EXPERIMENTAL
Drug: MBX-2982

Sitagliptin 100 mg

ACTIVE COMPARATOR
Drug: Sitagliptin

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

MBX-2982DRUG

tablets and capsule once daily

MBX-2982 25 mg
SitagliptinDRUG

tablets and capsule once daily

Sitagliptin 100 mg
placeboDRUG

tablets and capsule once daily

Placebo

Eligibility Criteria

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

You may qualify if:

  • History of type 2 diabetes of at least 3 months duration
  • Treatment-naïve (not on any anti-diabetic medication) or treated with a single anti-diabetic agent (excluding insulin, exenatide or other GLP-1 analogs, pioglitazone or rosiglitazone)
  • HbA1c 7.0-8.5% (inclusive) at screening
  • BMI ≥ 26 kg/m2 for patients recruited from U.S or Georgia or ≥ 22 kg/m2 for patients recruited from India

You may not qualify if:

  • Any history of type 1 diabetes or diabetic ketoacidosis
  • History of major upper GI surgery
  • Evidence or history of clinically significant GI illness including dyspepsia, PUD, nausea, diarrhea, malabsorption, etc.
  • History of outpatient insulin use within last 1 year (insulin use while hospitalized is acceptable)
  • Weight loss \> 10 pounds (4.5 kg) in the 3 months prior to screening visit or use of weight loss medications (prescription or OTC) within 30 days of screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Impact Clinical Trials

Los Angeles, California, 90036, United States

Location

Nevada Alliance Against Diabetes

Las Vegas, Nevada, 89101, United States

Location

United Medical Associates

Binghamton, New York, 13901, United States

Location

dgd Research, Inc., a Cetero Research Co.

San Antonio, Texas, 78229, United States

Location

Healthy Life Clinical Diagnostic Center

Tbilisi, 0144, Georgia

Location

Georgian Diabetes Center

Tbilisi, 0159, Georgia

Location

Medulla Chemotherapy and Immunotherapy Clinic

Tbilisi, 0186, Georgia

Location

Bharti Research Institute of Diabetes and Endocrinology

Karnāl, Haryana, 132001, India

Location

Diabetes Thyroid Hormone Research Institute Pvt Ltd

Indore, M.p., 452001, India

Location

Gandhi Endocrinology & Diabetes Centre

Rāmdaspeth, Nagpur, 10, India

Location

Gokula Metropolis Research, MS Ramaiah Memorial Hospital

Bangalore, 560 054, India

Location

Medisys Clinisearch India Pvt Ltd

Bangalore, 560043, India

Location

Hormone Care Research Centre

Ghaziabad, 201002, India

Location

Bangalore Endocrinology & Diabetes Research Centre

Malleshwaram, 560 003, India

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

MBX-2982Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Officials

  • Brian Roberts, MD

    Metabolex, Inc.

    STUDY DIRECTOR

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

December 17, 2009

First Posted

December 21, 2009

Study Start

December 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

April 17, 2015

Record last verified: 2015-03

Locations

IN(7)GE(3)US(4)