NCT02537470

Brief Summary

This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of doses of a biphasic formulation of remogliflozin etabonate compared to placebo, administered over 12 weeks in subjects with type 2 diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
191

participants targeted

Target at P50-P75 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

19 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

July 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

1.1 years

First QC Date

August 25, 2015

Last Update Submit

January 16, 2018

Conditions

Type 2 Diabetes MellitusDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Glycosylated haemoglobin A1c (HbA1c) at Week 12

    12 weeks

Secondary Outcomes (12)

  • HbA1c

    at weeks 4, 8 and 12

  • Fasting plasma glucose (FPG)

    at Weeks 4, 8 and 12

  • Insulin

    at Weeks 4, 8 and 12

  • C-peptide

    at Weeks 4, 8 and 12

  • Total Cholesterol

    at Weeks 4, 8 and 12

  • +7 more secondary outcomes

Study Arms (2)

Arm 1

OTHER

Placebo

Other: Placebo

Arm 2

EXPERIMENTAL

Biphasic remogliflozin etabonate

Drug: Biphasic Remogliflozin Etabonate

Interventions

Biphasic Remogliflozin EtabonateDRUG

Experimental Drug

Arm 2
PlaceboOTHER

Placebo Comparator

Arm 1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to provide written informed consent
  • Subject with clinical diagnosis of type 2 diabetes
  • HbA1c 7.0 - 10.5% inclusive at Visit 1.

You may not qualify if:

  • History of metabolic acidosis or ketoacidosis.
  • Current active renal disease that is not related to hypertension or type 2 diabetes (e.g. non-diabetic glomerulonephritis, interstitial nephritis, symptomatic nephrolithiasis, etc.)
  • Use of an investigational device or investigational drug within 30 days or 5 half-lives (whichever is longer) prior to Visit 1.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Advanced Arizona Clinical Research

Tucson, Arizona, 85712, United States

Location

Long Beach Clinical Trials

Long Beach, California, 90806, United States

Location

Long Beach Center for Clinical Research

Long Beach, California, 90807, United States

Location

National Research Institute

Los Angeles, California, 90057, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Chase Medical Research

Waterbury, Connecticut, 06708, United States

Location

Medical Research Unlimited

Hialeah, Florida, 33012, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Meridien Research

Tampa, Florida, 33634, United States

Location

eStudySite, Las Vegas

Las Vegas, Nevada, 89109, United States

Location

Comprehensive Clinical Research

Berlin, New Jersey, 08009, United States

Location

Albuquerque Clinical Trials, Inc

Albuquerque, New Mexico, 87102, United States

Location

Mountain View Clinical Research

Greer, South Carolina, 29651, United States

Location

New Phase Research & Development

Knoxville, Tennessee, 37909, United States

Location

Austin Center for Clinical Research

Austin, Texas, 78756, United States

Location

Padre Coast Clinical Research

Corpus Christi, Texas, 78404, United States

Location

Juno Research, LLC

Houston, Texas, 77074, United States

Location

Wasatch Clinical Research

Salt Lake City, Utah, 84107, 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

  • Joel M Neutel, MD

    Orange County Research Center

    PRINCIPAL INVESTIGATOR

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

August 25, 2015

First Posted

September 1, 2015

Study Start

July 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

January 18, 2018

Record last verified: 2018-01

Locations

US(19)