| CTRI Number |
CTRI/2011/11/002102 [Registered on: 02/11/2011] Trial Registered Prospectively |
| Last Modified On: |
08/07/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A 2 staged clinical trial to evaluate the efficacy, safety, tolerability and pharmacokinetics of P2202 over 12 week treatment period in overweight/obese Patients of Type 2 Diabetes Mellitus Inadequately Controlled on Metformin, Sulphonylurea, or Both. |
|
Scientific Title of Study
|
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Two-Staged, Fixed Design Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of P2202 in Overweight/Obese Patients of Type 2 Diabetes Mellitus Inadequately Controlled on Metformin, Sulphonylurea, or Both. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| P2202/47/10 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajesh Nair |
| Designation |
Consultant |
| Affiliation |
Mar Augustine Golden Jubilee Hospital |
| Address |
Dept. of General Medicine, Mookkannoor (PO) Angamaly Ernakulam District
Ernakulam
KERALA
683577
India |
| Phone |
0484-2616869 |
| Fax |
|
| Email |
rnairdr@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purvi Chawla |
| Designation |
Clinical Leader |
| Affiliation |
Piramal Life sciences Ltd Mumbai |
| Address |
1, Nirlon Complex,
Off western express highway,
Goregaon (E),
Mumbai, Maharashtra
Mumbai (Suburban)
MAHARASHTRA
400 063
India |
| Phone |
02230818087 |
| Fax |
|
| Email |
purvi.chawla@piramal.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Purvi Chawla |
| Designation |
Clinical Leader |
| Affiliation |
Piramal Life Sciences Ltd Mumbai |
| Address |
1, Nirlon Complex,
Off western express highway,
Goregaon (E),
Mumbai, Maharashtra
Mumbai (Suburban)
MAHARASHTRA
400 063
India |
| Phone |
02230818087 |
| Fax |
|
| Email |
purvi.chawla@piramal.com |
|
|
Source of Monetary or Material Support
|
| Piramal Life Sciences Limited
1, Nirlon Complex,
Off. WE Highway, Near Hub mall,
Goregaon East,
Mumbai, Maharashtra 400 063
India |
|
|
Primary Sponsor
|
| Name |
Piramal Life Sciences Limited |
| Address |
1, Nirlon Complex,
Off western express highway,
Goregaon (E),
Mumbai, Maharashtra 400 063
India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Canada
India |
Sites of Study
Modification(s)
|
| No of Sites = 14 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrTVDevarajan |
Apollo First Med Hospitals |
#154, P.H.Road,
Kilpauk, Chennai, 600010,
Tamil Nadu
Chennai
TAMIL NADU |
044-28211111
drtvd@rediffmail.com |
| Dr AJ Ashirvatham |
Arthur Asirvatham Hospital |
Arthur Asirvatham Hospital,
Kuruvukaran Salai,
Anna Bus Stand,
Madurai – 625020
Madurai
TAMIL NADU |
0452-2535266
drajasirvatham@yahoo.co.in |
| Dr Nikhil Bhagwat |
B.Y L Nair Hospital |
Endocrinology Department, Mumbai Central, Mumbai - 400007
Mumbai
MAHARASHTRA |
022-23027163
bhagwatnik@yahoo.co.in |
| Dr Parmesh Shamanna |
Bangalore Clinisearch |
No.416, 4th Cross, 2nd Block,
Kalyan Nagar, Bangalore-560043
Karnataka
Bangalore
KARNATAKA |
080-25459001
drparamesh2@gmail.com |
| Dr KM Prasanna Kumar |
Bangalore Diabetes Hospital |
16/M Millers Tank Bed Area,Thimmaiah Road, Vasanthnagar-560052, Bangalore
Bangalore
KARNATAKA |
080-22372980
dr.kmpk@gmail.com |
| Dr Shailaja Kale |
Clinical Research Unit, Orange Diabetes Speciality Clinic |
Plot No. 9, Adwait Appartment, vasant baag Society, Bibewadi Road, Pune
Pune
MAHARASHTRA |
020-24432601
orangediabetes@yahoo.com |
| Dr Vaishali Deshmukh |
Deshmukh Clinic & Research Center |
Mulay Arcade 2nd & 4th Floor, Near Maharashtra Mandal School, Tilak Road. Pune - 411030
Pune
MAHARASHTRA |
020-65214388
deshmukhclinic@rediffmail.com |
| Dr Abhay Mutha |
Diabetes Care & Research Centre |
B/5, Mittal Court,
478 - Rastapeth,
Pune - 411011
Pune
MAHARASHTRA |
020-26124232
drabhaymutha@gmail.com |
| Dr S R Aravind |
Diacon Hospital |
No 359-360, 19th Main, Ist Block,
Rajajinagar, Bangalore
Bangalore
KARNATAKA |
080-23131166
080-23130553
draravind@hotmail.com |
| Dr C S Yajnik |
KEM Hospital Research Centre |
6th Fl, Banoo Coyaji Bldg, KEM Hospital Research Centre, Sardar Moodliar Rd, Rasta Peth, Pune
Pune
MAHARASHTRA |
020-66405731
csyajnik@hotmail.com |
| Dr Thomas Paul |
Madonna Hospital and Research Center |
Angamaly – 683572,
Ernakulam (Dt), Kerala
Ernakulam
KERALA |
0484-2453466
madonna.research@gmail.com |
| Dr Rajesh Nair |
Mar Augustine Golden Jubilee Hospital |
Dept. of General Medicine,
Mookkannoor (PO)
Angamaly -683 577,
Ernakulam District
Ernakulam
KERALA |
0484-2616869
0484-2616869
rnairdr@yahoo.co.in |
| Dr Rakesh Kumar Sahay |
Osmania General Hospital |
Afzal Gunz, Hyderabad,
Andhra Pradesh - 500012
Hyderabad
ANDHRA PRADESH |
040-24651667
sahayrk@gmail.com |
| Dr B Bala Raju |
Yashoda Hospital |
Raj Bhavan Road,Somajiguda,Hyderabad-500 004
Hyderabad
ANDHRA PRADESH |
040-23319999
drbalaraju@yahodahospitals.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| Bangalore Central Ethics Committee |
Approved |
| Bangalore Diabetes Hospital Ethics committee |
Approved |
| Diabetes Care and Research Centre Ethics Committee |
Approved |
| Diacon Hospital Ethics committee |
Approved |
| Ethics committee- Apollo Hospitals |
Approved |
| IEC, Yashoda academy of medical education and research |
Approved |
| Institutional Ethics Committee B.Y.L.Nair Ch.Hospital and T.N.Medical College |
Approved |
| Institutional Ethics Committee, MAGJ Hospital |
Approved |
| Institutional Ethics Committee,Madonna Hospital and Research centre |
Approved |
| Institutional review board |
Approved |
| Institutional Review Borad,Arthur Asirvatham Hospital |
Approved |
| KEM Hospital Research Centre Ethics Committee |
Approved |
| Manavata Clinical Research Institute |
Approved |
| Osmania Medical college Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
P2202 |
In Stage I, P2202 will be administered at 1000 mg once in aday for a period of 12 weeks.
After the Stage I analysis, dose levels for Stage II will be selected based on the PK-PD modeling and simulation. |
| Comparator Agent |
Placebo |
It will be administered in similar fashion like P2202. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult male and females between 18 years to 65 years of age with a BMI more than or equal to 27 kg/m2 but less than or equal to 40 kg/m2, inclusively.
Subjects with established type 2 diabetes mellitus
Subjects with HbA1c level more than or equal to 7.5% and less than 10% at screening.
Subjects who are on a stable dose of Metformin and/or Sulfonylurea
Subjects with fasting plasma glucose of less than or equal to 14.4 mmol/L and at least 5.5 mmol/L prior to randomization
Subjects with a C-peptide value of > 0.299 nmol/L (0.9 ng/mL) at the screening visit
Subjects with serum LDL-C more than or equal to 3.10 mmol/L and less than or equal to 4.89 mmol/L
Subjects with serum triglycerides more than or equal to1.69 mmol/L and less than or equal to 6.76 mmol/L.
Non-surgically sterile male subjects with partner(s) of childbearing potential who must be must be willing to use contraception throughout the study and ensure that their partner(s) will use simultaneously effective means of contraception during this period.
Non-childbearing potential female subjects who have sexual intercourse with a non-sterile male partner will be advised to use an acceptable method of contraception throughout the study
Negative pregnancy test at screening |
|
| ExclusionCriteria |
| Details |
Subjects with type 1 diabetes mellitus, maturity-onset diabetes of the young or any rare form of diabetes. Subjects with hyperglycemia due to secondary causes or frequent hypoglycemic events
Subjects with a history of acute diabetic complications prior to screening
Subjects treated with insulin or other anti-diabetic agents prior to screening
Subjects who received systemic glucocorticoids prior to screening
Subjects with a history of clinically significant disease other than type 2 diabetes, which in the investigator’s opinion will disallow him/her from completing the current study
Subjects with a history of uncontrolled hypertension or secondary hypertension
Subjects with abnormal renal and hepatic function
Subjects who have received any investigational new drug prior to screening. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HbA1c |
baseline and end of study visit. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| fasting serum lipids |
baseline and end of study |
| serum adiponectin and serum leptin |
baseline and end of study visit. |
| serum hsCRP |
baseline and end of study |
| fasting plasma glucose, fasting serum insulin and fasting serum C-peptide |
baseline and end of study visit. |
|
|
Target Sample Size
|
Total Sample Size="698"
Sample Size from India="600"
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)
|
02/12/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
13/04/2011 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Type 2 diabetes mellitus, the commonest form of diabetes, is an increasing global health burden and affects 285 million people globally, between 20 and 79 years of age and 50.8 million people in the same age group in India. This incidence is projected to increase to 438 million globally and to 87.0 million in India by the year 2030. It is characterized by insulin secretory dysfunction and peripheral tissue insulin resistance, which lead to increased hepatic glucose output and decreased glucose uptake in skeletal muscle and adipose tissues. Treatment of type 2 diabetes mellitus is primarily aimed at lowering insulin resistance and increasing the function of beta cells. Diabetic patients are prone to suffer from increased cardiovascular mortality due to attendant risk factors of dyslipidemia, hypertension and obesity. Oral agents are often used with or without insulin therapy to achieve good metabolic control, assessed from the measurement of glycated hemoglobin (HbA1c), fasting and post-prandial plasma glucose.
P2202 is a novel oral drug with potent and selective 11 beta-hydroxysteroid dehydrogenase type 1 (11 beta HSD1) inhibitory properties, being developed for the management of type 2 diabetes mellitus and possibly metabolic syndrome. A battery of in vitro and in vivo tests has been performed with P2202 to study its pharmacological, pharmacokinetic (PK) and toxicity profiles. |