| CTRI Number |
CTRI/2009/091/000161 [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, Active Controlled Trial |
|
Public Title of Study
|
Effect of insulin detemir and insulin glargine on blood glucose control in subjects with type 2 diabetes |
|
Scientific Title of Study
|
A 26 week randomised, multinational, open labelled, 2 armed, parallel group, treat-to-target once daily treatment trial with insulin detemir versus insulin glargine, both in combination with metformin in subjects with type 2 diabetes
|
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NCT00909480 |
ClinicalTrials.gov |
| NN304-1768 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Nallaperumal |
| Designation |
Principal Investigator |
| Affiliation |
Swamy Diabetes Centre |
| Address |
175, R.K Mutt Road,
Mandeveli
Chennai
TAMIL NADU
600028
India |
| Phone |
04424615115 |
| Fax |
91-44-24614465 |
| Email |
swamydiabetes@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 37 , 47 -50
EPIP area, Whitefield
Bangalore
KARNATAKA
560066
India |
| Phone |
918030713358 |
| 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 Limited, |
| Address |
Plot no 37 , 47 -50
EPIP area, Whitefield
Bangalore
KARNATAKA
560066
India |
| Phone |
918030713446 |
| Fax |
918041119026 |
| Email |
avkg@novonordisk.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Novo Nordisk A/S
c/oNovo Nordisk India Private Ltd.
Plot No.32, 47 - 50,
EPIP Area, Whitefield,
Bangalore - 560 066
India
|
|
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
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India
Argentina
Democratic People's Republic of Korea
Thailand
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jothydev |
Jothydev Diabetes and Research Centre |
ground floor,JDC Junction, Konkalam Road ,Mudavanmugal -695032
Thiruvananthapuram
KERALA |
0471-2356200
0471-2356666
Jothydev@asianet.com |
| Dr Nallaperumal |
Swamy Diabetes Centre |
175, R.K Mutt Road, Mandeveli,Opposite to Canara bank -600028
Chennai
TAMIL NADU |
+91-9940050344
+91- 44- 26414465
swamydiabetes@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Independant Ethics committee, MumbaiDr Jyothydev |
Approved |
| Independant Ethics committee, Mumbai_Dr Nallaperumal |
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
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Insulin Detemir |
Treat-to-target(individually adjusted dose) titration according to titration algorithm. S.c. injection once daily.
Duration 26 Weeks |
| Comparator Agent |
Insulin Glargine |
Treat-to-target(individually adjusted dose) titration according to titration algorithm. S.c. injection once daily.
Duration 26 Weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with type 2 diabetes for at least 6 months
Stable treatment with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) with or without one other OAD (sulphonylureas, meglitinides, thiazolidinediones or DPP-4 inhibitors) for at least 3 months
Subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed)
HbA1c 7.0-9.0 % (both inclusive) by central laboratory analysis (one re-test within one week is allowed)
Body Mass Index (BMI) less than or equal to 35.0 kg/m2
Age 18 years and above |
|
| ExclusionCriteria |
| Details |
Any contraindication to insulin detemir or insulin glargine according to the local labelling
Receipt of any investigational product within 4 weeks
Anticipated change of dose of any systemic treatment with products, which in the Investigator's opinion could interfere with glucose metabolism (e.g. systemic corticosteroids)
Clinically significant diseases which, in the Investigator's opinion may confound the results of the trial or pose additional risk in administering trial product
Any other condition that the Investigator feels would interfere with trial participation or evaluation of results |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
On-site computer system |
Blinding/Masking
Modification(s)
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in HbA1C from baseline after 26 weeks of treatment |
26 weeks of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects achieving HbA1c of 7.0% or less |
after 26 weeks of treatment |
| Proportion of subjects achieving HbA1c of 6.5% or less |
after 26 weeks of treatment |
| Glycaemic control as measured by fasting plasma glucose (FPG) (central laboratory values) |
after 26 weeks of treatment
|
| Within-subject variation of self measured plasma glucose (SMPG) before breakfast during the trial |
after 26 weeks of treatment
|
| Glycaemic control as measured by 9-point plasma glucose profile (self-measured) |
after 26 weeks of treatment
|
| Incidence of hypoglycaemic episodes during the trial: nocturnal and over 24 hours |
after 26 weeks of treatment
|
| Change in body weight |
26 weeks of treatment
|
|
Target Sample Size
Modification(s)
|
Total Sample Size="444"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "458"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
13/07/2009 |
| Date of Study Completion (India) |
07/06/2010 |
| Date of First Enrollment (Global) |
20/05/2009 |
| Date of Study Completion (Global) |
11/06/2010 |
|
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)
|
The scientific Trial Publication details are as below
•Meneghini L, Kesavadev J, Demissie M, Nazeri A, Hollander P. Once-daily initiation of basal insulin as add-on to metformin: a 26-week, randomized, treat-to-target trial comparing insulin detemir with insulin glargine in patients with type 2 diabetes. Diabetes, obesity & metabolism 2013;
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The aim of this clinical trial is to determine whether two insulin treatments given once daily are equally effective with respect to the blood glucose lowering effect in type 2 diabetics inadequately controlled on metformin treatment with or without an additional anti-diabetic drug (OAD). 30 patients are proposed to be enrolled from India Total No of Subjects Enrolled In India:52 Trial ID:NN304-1768 Date of First Enrolment in India:13 Jul 2009
The study is completed globally |