Efficacy and safety of EGT0001442 compared with placebo in patients with type 2 diabetes mellitus
Scientific Title of Study
Efficacy and safety of EGT0001442 compared with placebo in patients with type 2 diabetes mellitus inadequately controlled by diet and exercise and up to one oral anti-diabetes agent
Trial Acronym
none
Secondary IDs if Any
Secondary ID
Identifier
THR-1442-C-418
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Dr Sumbul Siddiqui
Designation
Medical Monitor
Affiliation
Max Neeman International
Address
Max Neeman International
Max House, 1st Floor
1, Dr. Jha Marg, Okhla Phase-III
New Delhi-110020
South DELHI 110020 India
Phone
91-8130666357
Fax
011-41001945
Email
ssiddiqui@neemanasia.com
Details of Contact Person Public Query
Name
Dr Shariq Anwar
Designation
Director Operations
Affiliation
Max Neeman International
Address
Max Neeman International
Max House, 1, Dr. Jha Marg, Okhla Phase III
New Delhi - 110020, India
South DELHI 110020 India
Phone
09810979215
Fax
91-11-40548168
Email
sanwar@neemanasia.com
Source of Monetary or Material Support
Theracos, Inc.
225 Cedar Hill Street,
Suite 200,
Marlborough, MA 01752, U.S.A
Primary Sponsor
Name
Theracos Inc
Address
225 Cedar Hill Street,
Suite 200
Marlborough, MA 01752, U.S.A
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
Colombia India Mexico United States of America
Sites of Study
No of Sites = 11
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Paramesh Shamanna
Bangalore Clinisearch
Dept. of Endocrinology Bangalore Clinisearch,
Bangalore Medical Center, No. 426, 4th Cross, 2nd Block, Kalyan Nagar,
Bangalore-560043
Bangalore KARNATAKA
9845010610 080-25459006 drparamesh2@gmail.com
DrShreejith N Kumar
DEA Diabetes Care Centre
Dept. of Endocrinology
IDEA Diabetes Care Centre,
K5, Kochar Road,
Sasthamangalam,
Trivendrum-2311174
Thiruvananthapuram KERALA
9847204360 0471-2726939 drsnkumar@yahoo.com
Dr R BalamurganKovai
Diabetes Speciality Center & Hospital
Diabetologist
Dept. of Endocrinology Diabetes Speciality Center & Hospital,
15, Vivekananda Road,
Ramnagar, Coimbatore-641009
Coimbatore TAMIL NADU
Consultant Diabetologist
Dept. of Endocrinology
PACE Clinical Research Center,
(Pranav Diabetes Center)
# 57/1, Nanda Complex,
Banaswadi, Ramamurthy Nagar Main Road, Bangalore-560043.
Bangalore KARNATAKA
9731911630 080-41626643 drgmprasad@gmail.com
Dr Ganapathi B
St. Johns Medical College & Hospital
Endocrinologist& Diabetologist
Dept. of Endocrinology
St. Johns Medical College & Hospital,
Sarjapur Road, Koramangala,
Bangalore- 560034
Bangalore KARNATAKA
Bangalore Central Ethics Committee, no.1423, Kullappa Layout, Kullappa Circle, St. Thomas town, P.O.Bangalore-560084
Approved
Central India Medical research Ethics Committee, Dr. S.M.Patil Hospital, Yugdharma complex, Ramdaspeth, Nagpur-440010, MH
Submittted/Under Review
Ethics committee for Research on Human Subjects, Old hospital Building, 2nd Floor, Room No.46, Near Seminar Hall, Shri GS Medical College & KEM hospital, Acharya Dhonde Marg, Parel, Mumbai-400012
Submittted/Under Review
Global Health Concern Ethics Committee, Maratha Samaj Building, Sakkardara, Nagpur-440009.M.H.
Approved
Global Health Ethics Committee, Maratha Samaj Building, Sakkardara, Nagpur-440009.M.H.
Submittted/Under Review
Independent Human Ethics Committee,Navarangam Lane, North 2 Medical College, Trivandrum, Kerala.
Submittted/Under Review
Institutional Ethics Committee of Kovai Diabetes Speciality Centre & Hospital,15, Vivekananda Road, Ramnagar, Coimbatore-641009. Tamilnadu.
Submittted/Under Review
The Ethics Committee, SUT Group of Hospitals, Pattom, P.O., Trivandrum-695004
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Type 2 Diabetes Mellitus
,
Intervention / Comparator Agent
Type
Name
Details
Intervention
EGT0001442
20 mg Capsules OD for 98 weeks
Comparator Agent
Placebo
OD for 98 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1.Male/female subjects ≥18 years old
2.Diagnosed with type 2 diabetes
3.Body mass index(BMI)≤ 45 Kg/m2
4.HbA1c between 7 and 10%(Inclusive) as screening
5.FPG <250 mg/dL at screening for subjects not treated with oral anti-diabetic therapies or FPG <240 mg/dL at screening for subjects treated with anti-diabetic therapies
6.Diabetes currently treated with diet and exercise only or diet and exercise along with one approved oral anti-diabetic agent.
7.If taking anti-diabetic medication, dose and regimen must be stable for past 3 months
8.If taking anti-hypertensive medication, dose and regimen must be stable for past 3 months
9.If taking lipid modifying therapy, dose and regimen must be stable for past 3 months
10.Blood glucose level <250 mg/dL based on finger stick blood glucose for all subjects at randomization
ExclusionCriteria
Details
1.Hemoglobinopathy that affects HbA1c measurement
2.Current use of injected therapy for treatment of diabetes(insulin or GLP-1 receptor based therapy)
3.Genitourinary tract infection within 6 weeks of screening
4.Greater than 2 episodes of genitourinary tract infection in the past year
5.History of kidney stones, bladder malfunctioning or other significant risk factor for urinary tract infections
6.eGFR, as calculated by the modification of diet in renal disease study equation(MDRD), <50 mL/min/1.73 m2
7.Abnormal tests of liver function ALT, AST or bilirubin ≥ 3x ULN
8.Diagnosis of retinopathy or significant nephropathy (eGFR <50 mL/min/1.73 m2)
9.Uncontrolled hypertension (systolic BP >160 or diastolic BP >95)
10.Not willing to use effective birth control, if female with child bearing potential
11.Life expectancy< 2 years
12.New York Heart Association(NYHA) class 4 heart failure
13.Sera positive of HCV, HIV, or positive on drug screen
14.Currently participating in another interventional trial
15.Previous treatment with EGT0001442 or EGT0001474
16.Not able to comply with the study scheduled visits
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
On-site computer system
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
The primary objective of this trial study is to assess the efficacy of EGT0001442 on lowering HbA1c
at week 24 compared with Placebo.
Secondary Outcome
Outcome
TimePoints
To assess the efficacy of EGT0001442 in lowering FPG
at weeks 2 and 24 compared with placebo
To assess the efficacy of EGT0001442 based on the proportion of subjects who reach the American Diabetes Association(ADA) target HbA1c of 7% in the EGT0001442 group compared with placebo
from week 1 to week 96
To assess the effect of EGT0001442 on systolic and diastolic BP
at screening, run in period, and from week 1 to week 96
To assess the effect of EGT0001442 on body weight compared with placebo
at screening, run in period, week 1, 6, 8,10,12,14 and 15.
To assess the change from baseline in HbA1c over time
from week 1 to week 96
To assess the safety of EGT0001442 in patients with T2DM
from week 1 to week 96
Target Sample Size
Total Sample Size="300" Sample Size from India="90" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 2
Date of First Enrollment (India)
12/12/2011
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
13/07/2011
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="2" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Other (Terminated)
Publication Details
none as now.
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This
study is a multinational, 2 arm parallel group, randomized, double-blind
placebo-controlled study to compare treatment with once daily EGT0001442, 20 mg
capsules to matching placebo in either treatment-naïve type 2 diabetic patients
(i.e. those not taking an anti-hyperglycemic agent for ≥16 weeks prior to study
entry) or patients treatedwith one oral
anti-diabetes drug. The study is already being conducted in 12 sites in US and
7 sites in Mexico and will be conducted in Eleven centers in India. The primary
outcome measure is to assess the efficacy of EGT0001442 in lowering HbA1c at
week 24 compared with Placebo.
The
Primary Outcome Measure is:
To assess
efficacy of EGT0001442 in lowering HbA1c at week 24 compared with placebo.
The Secondary Outcome measures are:
To
assess the efficacy of EGT0001442 in lowering FPG at weeks 2 and 24 compared
with placebo. To assess the efficacy of EGT0001442 based on the proportion of
subjects who reach the American Diabetes Association (ADA) target HbA1c of
<7% in the EGT0001442 group compared with placebo.To assess the effect of
EGT0001442 on systolic and diastolic blood pressure compared with placebo. To
assess the effect of EGT0001442 on body weight compared with placebo. To assess
the change in HbA1c change over time, week 1 to week 96.To assess the safety of
EGT0001442 in patients with T2DM