| CTRI Number |
CTRI/2010/091/000044 [Registered on: 11/06/2010] |
| Last Modified On: |
13/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of NN5401 versus insulin glargine, both with metformin treatment, in subjects with type 2 diabetes |
Scientific Title of Study
Modification(s)
|
A Trial Comparing Efficacy and Safety of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOSTâ„¢ : START 1) / NN5401-3726: An Extension Trial Comparing Safety and Efficacy of NN5401 With Insulin Glargine in Subjects With Type 2 Diabetes |
| Trial Acronym |
(BOOSTâ„¢: START 1) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2009-011271-78 |
EudraCT |
| NCT01045707 |
ClinicalTrials.gov |
| NN5401-3590 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Ajay Kumar |
| Designation |
Prinicipal Investigator |
| Affiliation |
Diabetes Care & Research Centre |
| Address |
Diabetes Care & Research Centre
G.C -1B, Near Overbridge
Not Applicable
N/A
800020
India |
| Phone |
06122350434 |
| Fax |
06122357332 |
| Email |
drajaykr@yahoo.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Raman Shetty |
| Designation |
Clinical ,medical and Regulatory Director |
| Affiliation |
Novo Nordisk India Private Limited. |
| Address |
Novo Nordisk India Private Ltd.
Plot No.32, 47 - 50,EPIP Area, Whitefield,
Bangalore
KARNATAKA
560 066
India |
| Phone |
918041123518 |
| Fax |
918041119026 |
| Email |
rasy@novonordisk.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Mr Avik Kumar Ghosh |
| Designation |
Senior Clinical Operations Manager |
| Affiliation |
Novo Nordisk India Private Ltd. |
| Address |
Novo Nordisk India Private Ltd.
Plot No.32, 47 - 50,EPIP Area, Whitefield,
Bangalore
KARNATAKA
560 066
India |
| Phone |
918030713446 |
| Fax |
918041119026 |
| Email |
avkg@novonordisk.com |
|
|
Source of Monetary or Material Support
|
|
Primary Sponsor
Modification(s)
|
| Name |
Novo Nordisk AS |
| Address |
c/oNovo Nordisk India Private Ltd.
Plot No.32, 47 - 50,
EPIP Area, Whitefield,
Bangalore - 560 066
India
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Unnikrishnan A.G. |
Amrita Institute of Medical Sciences |
Elamakkara (P.O),-682036
|
0484-2802084
0484 2802084
unnikrishnanag@aims.amrita.edu |
| Dr Ajay Kumar |
Diabetes Care & Research Centre |
G.C -1B, Near Overbridge,Kankarbagh,-800020
Patna
BIHAR |
0612-2350434
0612-2357332
drajaykr@yahoo.com |
| Dr S K Sharma |
Diabetes, Thyroid & Research Centre |
11, Shivaji Nagar,Civil lines-302016
Jaipur
RAJASTHAN |
0141-2229202
0141-2221598
sksharma7@gmail.com |
| Dr Manoj Chawla |
Lina Diabetes Care Centre |
003/, Yashodan Appartments,Four Bunglows Jn., J.P. Road, Andheri (W)-400053
Mumbai
MAHARASHTRA |
022-26302288
022-26302623
dr_manoj@hotmail.com |
| Dr Arpandev Bhattacharyya |
Lotus Diagnostic Centre |
No 493, CMH Road,Indiranagar-560038
Bangalore
KARNATAKA |
080-25284000
080-25257500
arpan@diabetesendocrinology.in |
| Dr Nallaperumal |
Swamy Diabetes Centre |
No 174, RK Mutt Road,Mandeveli-600028
Chennai
TAMIL NADU |
044-24615115
044-24684462
swamydiabetes@gmail.com |
| Dr M. Shunmugavelu |
Trichy Diabetes Speciality Centre |
B-37, Shastri Road ,7th Cross Thillai nagar-620018
|
0431-2742091
0431-4021782
msv_diab@sify.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Clinicom, "Bhooma", No 7, 17 A Cross, Malleshwaram west, Bangalore- 560055 ( Dr Ajay Kumar) |
Approved |
| Clinicom, "Bhooma", No 7, 17 A Cross, Malleshwaram west, Bangalore- 560055 ( Dr M Shunmugavelu) |
Approved |
| Clinicom, "Bhooma", No 7, 17 A Cross, Malleshwaram west, Bangalore- 560055 ( Dr Manoj Chawla) |
Approved |
| Clinicom, "Bhooma", No 7, 17 A Cross, Malleshwaram west, Bangalore- 560055 ( Dr Nallaperumal S) |
Approved |
| Clinicom, "Bhooma", No 7, 17 A Cross, Malleshwaram west, Bangalore- 560055( Dr SK Sharma) |
Approved |
| Clinicom, "Bhooma", No 7, 17 A Cross, Malleshwaram west, Bangalore- 560055 ( Dr Arpandev Bhattacharyya) |
Approved |
| Institutional Ethics Committee, Amrita Institute of Medical Sciences & Research Center, Amrita Lane, Elamakkara, P.O. Kochi- 682036(Dr Unnikrishnan A G) |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E08-E13||Diabetes mellitus, Diabetes Mellitus, Type 2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Insulin Glargine. |
Insulin glargine injected s.c. (under the skin) once daily. Dose will be individually adjusted.
|
| Intervention |
NN5401 |
NN5401 injected s.c. (under the skin) once daily with the breakfast meal. Dose will be individually adjusted |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of type 2 diabetes mellitus for at least 6 months
Insulin naïve subjects
Treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start
HbA1c between 7.5 ? 11.0% (both inclusive)
BMI (Body Mass Index) no higher than 40.0 kg/m2
Age 18 and older
|
|
| ExclusionCriteria |
| Details |
Treatment with GLP-1 receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start
Cardiovascular disease diagnosed within 6 months before trial start
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HbA1c change |
From baseline after 26 weeks of treatment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plasma glucose profiles |
After 26 weeks of treatment
|
|
Target Sample Size
Modification(s)
|
Total Sample Size="526"
Sample Size from India="86"
Final Enrollment numbers achieved (Total)= "530"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
20/10/2010 |
| Date of First Enrollment (Global) |
11/01/2010 |
| Date of Study Completion (Global) |
26/10/2010 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None YEt |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of this clinical trial is to compare NN5401 with insulin glargine, as add-on to subject's ongoing treatment with metformin + at least one OAD (oral anti-diabetic drug) in subjects with type 2 diabetes.
Trial Start Date in India:28 Jan 2010
Subjects Enrolled in India:71
Duration of trial: 26 weeks |