NCT01029704

Brief Summary

The purpose of this study was to assess the effect of EGT0001442 on fasting plasma glucose after 28 days of treatment in subjects with type 2 diabetes. The study also assessed the pharmacokinetics, safety and tolerability of EGT0001442, the effect on weight and HbA1c as well as the effect EGT0001442 has on the amount of glucose produced in the body by the urine.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
151

participants targeted

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

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_2 diabetes-mellitus-type-2

Geographic Reach
2 countries

12 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
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 10, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 20, 2011

Completed
Last Updated

June 16, 2021

Status Verified

June 1, 2021

Enrollment Period

7 months

First QC Date

December 9, 2009

Results QC Date

June 21, 2011

Last Update Submit

June 15, 2021

Conditions

Diabetes Mellitus Type 2

Keywords

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (3)

  • Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study

    Fasting glucose levels were measured at four time points; At day -2, day 1, day 27 and day 29 (24-h after the last dose). Baseline is defined as the mean of FPG values on day -2 and day 1. End of treatment is defined as the mean of FPG values on day 27 and day 29. Changes in the FPG during the study period was calculated by subtracting the Baseline FPG from End of Treatment FPG.

    Baseline; Day -2 and Day 1. End of Treatment: Day 27 and Day 29

  • Pharmacokinetics of EGT0001442 (Cmax) at 4 Dose Levels at Week 4

    Blood samples were collected during Segment 1 at pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12 and 24 h (day 2), and 48 h (day 3) post dose for the determination of EGT0001442. Plasma concentrations of EGT0001442 were measured using a validated HPLC/MS-MS method and PK parameters were calculated by standard noncompartmental methods.

    Pre-dose to 48 h post-dose

  • Pharmacokinetics of EGT0001442 (AUC 0-t and 0-24) at 4 Dose Levels at Week 4

    Blood samples were collected during Segment 1 at pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12 and 24 h (day 2), and 48 h (day 3) post dose for the determination of EGT0001442. Plasma concentrations of EGT0001442 were measured using a validated HPLC/MS-MS method and PK parameters were calculated by standard noncompartmental methods.

    Pre-dose to 48 h post-dose

Secondary Outcomes (4)

  • Change in the Body Weight From Baseline at Week 4

    Baseline and Day 29

  • Changes in Hemoglobin A1c (HbA1c) From Baseline at Week 4

    Baseline and Day 29

  • Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28

    Baseline, Day 1 and Day 28

  • Change in FPG Following Cessation of Treatment

    Days 27/29 to Days 41/43

Study Arms (2)

EGT0001442

EXPERIMENTAL
Drug: EGT0001442

Placebo

PLACEBO COMPARATOR
Drug: Placebo capsules to match EGT0001442

Interventions

EGT0001442DRUG

Segment 1 is a single center, open labeled, ascending dose study in diabetic subjects who will receive 5, 10, 20, or 50 mg of EGT0001442 capsules orally once daily for 28 days. Segment 2 is a multi-center, double-blind, placebo-controlled parallel group study. Diabetic subjects will be randomly assigned to receive oral EGT0001442 at 5, 10, 20, or 50 mg/day for 28 days.

Also known as: Human SGLT2 inhibitor
EGT0001442
Placebo capsules to match EGT0001442DRUG

Segment 1: Not applicable. Segment 2: Diabetic subjects will be randomly assigned to receive oral placebo once daily for 28 days.

Also known as: Human SGLT2 inhibitor
Placebo

Eligibility Criteria

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

You may qualify if:

  • Male or female between the ages of 18 and 70 years diagnosed with type 2 diabetes.
  • Body mass index (BMI) between 18 kg/m2 and 37 kg/m2 (inclusive).
  • HbA1c levels between 6.5 and 9.5 (inclusive) where the upper limit of normal for the HbA1c assay is 6.4% or HbA1c levels between 6.2 and 9.5% (inclusive) where the upper limit of normal for the HbA1c assay is 6.1%.
  • Fasting plasma glucose levels between 126 and 270 mg/dL (7 - 15 mmol/L, inclusive) while on diabetic medications.
  • Treatment naïve subjects with HbA1c between 6.5 and 9.5 and fasting plasma glucose between 126 and 270 mg/dL (7 - 15 mmol/L).
  • If taking drugs for diabetes, must be medically able and willing to discontinue diabetic medications for the duration of the study.
  • Female subjects must be surgically sterilized or postmenopausal.

You may not qualify if:

  • Type 1 diabetes or diabetes treated with insulin injection.
  • Insulin therapy or oral antidiabetic medication other than metformin, sitagliptin, saxagliptin, a sulfonylurea or combination of these.
  • Sitting blood pressure above 150/95 mmHg on two evaluations at least 10 minutes apart at screening.
  • Positive results on screen for drugs of abuse.
  • Previous treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer.
  • Previous treatment with EGT0001474 or EGT0001442.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Research Site #10

Birmingham, Alabama, United States

Location

Research Site #04

National City, California, United States

Location

Research Site #12

Denver, Colorado, United States

Location

Research Site #07

Miami, Florida, United States

Location

Research Site #08

Miami, Florida, United States

Location

Research Site #06

Reading, Pennsylvania, United States

Location

Research Site #11

DeSoto, Texas, United States

Location

Research Site #01

San Antonio, Texas, United States

Location

Research Site #15

San Antonio, Texas, United States

Location

Research Site #03

Brampton, Ontario, Canada

Location

Research Site #13

London, Ontario, Canada

Location

Research Site #02

Mississauga, Ontario, Canada

Location

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
Albert Collinson
Organization
Theracos, Inc.
acollinson@theracos.com
(508) 630-2129

Study Officials

  • Mason W Freeman, M.D.

    Massachusetts General Hospital

    STUDY CHAIR

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

December 9, 2009

First Posted

December 10, 2009

Study Start

December 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

June 16, 2021

Results First Posted

July 20, 2011

Record last verified: 2021-06

Locations

CA(3)US(9)