| CTRI Number |
CTRI/2010/091/000022 [Registered on: 09/06/2010] |
| 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 with insulin glargine, both in combination with oral antidiabetic drugs, in subjects with type 2 diabetes |
|
Scientific Title of Study
|
A trial comparing efficacy and safety of NN5401 with insulin glargine, both in combination with oral antidiabetic drugs in subjects with type 2 diabetes (BOOST? : INTENSIFY BASAL)
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2008-005767-34 |
EudraCT |
| NCT01045447 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
DrRakesh Sahay |
| Designation |
Principal Investigator |
| Affiliation |
Osmania General Hospital |
| Address |
2nd Floor, Golden Jubilee Block,
Afzalgunj,
Hyderabad
ANDHRA PRADESH
500012
India |
| Phone |
919849597507 |
| Fax |
914024616687 |
| Email |
sahayrk@gmail.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 |
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 |
Plot No.32, 47 - 50,EPIP Area,
Whitefield,
Bangalore
KARNATAKA
560066
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/o
Novo 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
Modification(s)
|
India
Croatia
France
Poland
Republic of Korea
South Africa
Sweden
Turkey
United States of America |
|
Sites of Study
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.Neetha Deshpande |
Belgaum Diabetes Centre |
Belgaum Diabetes Centre,Maruthi Galli-590 001
Belgaum
KARNATAKA |
+919880271313
+91831242268
neetarohit@gmail.com |
| Dr.Rishi Shukla |
Centre for Diabetes and Endocrine Diseases |
113/14,Shahi darbar apartment,Swaroop Nagar-208005
|
+915122541696
+915123068279
drrishishukla@gmail.com |
| Dr.Banshi Saboo |
Dia Care |
#2,Gandhi Park,Nr.Nehrunagar Char Rasta, Ambawadi,-380015
Ahmadabad
GUJARAT |
+917926302104
+917926302104
banshisaboo@hotmail.com |
| Dr. Sreejith Kumar |
Diabetes Care Centre |
Diabetes Care Centre, Kochar Road,,Sasthamangalam-695 010
Thiruvananthapuram
KERALA |
+919847204360
+914712726939
drsnkumar@yahoo.com |
| Dr.Alok Kunango |
Kanungo Institute of Diabetes Specialities Pvt Ltd, |
Plot No:1120,,Dumduma,-751019
|
+919437055740
+916742471299
kanungokids@gmail.com |
| Dr. Prabha Adhikari |
KMC Hospital |
V Floor, New MCODS Building,,Attavar-575001
Bangalore
KARNATAKA |
+919880991290
+918242425092
adhikari_pmr@yahoo.com |
| Dr.Srinivas Murthy |
Life Care Clinic & Research Centre |
#2253, M.C.N Complex,,Kodegehalli Main Road,Sahakarnagar-560 092
Bangalore
KARNATAKA |
+919448051046
+918023630055
lifecareclinic@rediffmail.com |
| Dr.Rakesh Sahay |
Osmania General Hospital, |
2nd Floor, Golden Jubilee Block, Afzalgunj, ,2nd Floor, Golden Jubilee Block, Afzalgunj, -500012
Hyderabad
ANDHRA PRADESH |
+91 9849597507
+914024616687
sahayrk@gmail.com |
| Dr.Shailaja Kale |
Sahyadri Hospital |
Plot No: 13, Sno. 573,City No: 281,Swami Vivekananda Marg, Bibwewadi-411 037
Pune
MAHARASHTRA |
+919325217275
+912024463796
drshailaja@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Clinicom (Dr.Banshi Saboo) |
Approved |
| Clinicom (Dr.Neetha Deshpande) |
Approved |
| Clinicom (Dr.Sreenivasa Murthy) |
Approved |
| Cuttack Diabetes Research Foundation (Dr.Alok Kanungo) |
Approved |
| Independent Human Ethics Committee (Dr.Sreejith Kumar) |
Approved |
| Manipal University Ethics Committee (Dr.Prabha Adhikari) |
Approved |
| Osmania Medical College Ethics Committee (Dr.Rakesh Sahay) |
Approved |
| Regency Hospital Ethics Committee (Dr.Rishi Shukla) |
Approved |
| Sahyadri Ethics Committee (Dr.Shailaja Kale) |
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 subcutaneously (under the skin) once daily. The dose will be individually adjusted
|
| Intervention |
NN5401 |
NN5401 injected subcutaneously (under the skin) once daily with main meal. The dose will be individually adjusted.
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 diabetes mellitus for at least 6 months
Ongoing daily treatment with a basal insulin (insulin detemir, insulin glargine, or insulin NPH) once daily for at least 3 months
Ongoing treatment with metformin with our without other OADs (oral anti-diabetic drugs) for at least 3 months
HbA1c 7.0 ? 10.0 % (both inclusive)
BMI (Body Mass Index) at most 40.0 kg/m2
Age 18 Years and older
|
|
| ExclusionCriteria |
| Details |
Treatment with other insulin regimens than those listed in key inclusion criterion within the last 3 months
Treatment with rosiglitazone, or GLP-1 receptor agonists within the last 3 months
Significant cardiovascular disease within the last 6 months
Uncontrolled treated/untreated severe hypertension
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
Impaired liver or renal function
Cancer and medical history of cancer |
|
|
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="450"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
11/01/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
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
|
|
|
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 in patients with type 2 diabetes inadequately controlled with insulin and oral antidiabetic drugs (OADs). Subjects will continue their ongoing treatment with OADs (oral anti-diabetic drugs) in the trial.
Trial ID: NN5401-3593
No of subjects enrolled in India: Randomised: 108
First patient first Visit:04 Mar 2010 |