CTRI

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CTRI Number

CTRI/2017/02/007861 [Registered on: 14/02/2017] Trial Registered Retrospectively

Last Modified On:

18/11/2019

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A study on comparison of glargine plus glulisine with premixed insulin in type 2 diabetes patients

Scientific Title of Study

A Prospective, Multicentric, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog Glargine plus Glulisine with Premixed Insulin in Adult Patients with Type 2 Diabetes Mellitus

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
IDRFARH007/Version 1.1/01 Sep 2016	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr A Ramachandran
Designation	President
Affiliation	India Diabetes Research Foundation
Address	No 28 Marshalls Road Egmore Chennai Chennai TAMIL NADU 600008 India
Phone	04428414311
Fax
Email	research@ardiabetes.org

Details of Contact Person
Scientific Query

Name	Dr Arun Raghavan
Designation	Consultant Diabetologist
Affiliation	Dr.A.Ramachandrans Diabetes Hospitals
Address	No 28 Marshalls Road Egmore Chennai Chennai TAMIL NADU 600008 India
Phone	04428414311
Fax
Email	arun34@yahoo.com

Details of Contact Person
Public Query

Name	Dr K Satheesh
Designation	Senior Research Officer
Affiliation	India Diabetes Research Foundation
Address	No 28 Marshalls Road Egmore Chennai Chennai TAMIL NADU 600008 India
Phone	04428414311
Fax
Email	satresearch01@gmail.com

Source of Monetary or Material Support

India Diabetes Research Foundation No 28 Marshalls Road Egmore Chennai 600008

Primary Sponsor

Name	India Diabetes Research Foundation
Address	No 28 Marshalls Road Egmore Chennai
Type of Sponsor	Research institution

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 7
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Arthur Joseph Asirvatham	Arthur Asirvatham Hospital	Department of Diabetology Room No 1 42 A Kuruvikaran Salai Near Anna bus stand Madurai Madurai TAMIL NADU	04522535266 ajasirvathamresearch@yahoo.in
Dr Mallikarjnn Jali	KLES Dr Prabhakar Kore Hospital & MRC	Department of Diabetology Room No 1, NehruNagar, Belagavi-590010, Karnataka India Belgaum KARNATAKA	8722594892 drmvjali@gmail.com
Dr Balamurugan Ramanathan	Kovai Diabetes Speciality Center and Hospital	Department of Diabetology Room No 1 No 15 Vivekananda Road Ram Nagar Coimbatore Coimbatore TAMIL NADU	04224377732 balamurugan_dr@hotmail.com
Dr M G Uvaraj	M G Diabetes Speciality and Research Center	Department of Diabetology Room No 1 No 255 a Saradha College Road Fair Lands Salem Salem TAMIL NADU	9442317474 drmgu@hotmail.com
Dr Abraham Oomman	Ramana Maharishi Rangammal Hospital	Department of Diabetology Room No 1 Athiyandal Tiruvannamalai Tiruvanamalai TAMIL NADU	04175236108 drabrahamoomman@gmail.com
Dr Sunil Singhvi	Singhvi Health Center	Department of Diabetology Room No 1 No 127 Mint street Sowcarpet Chennai Chennai TAMIL NADU	04425296464 drsunilsinghvi@gmail.com
Dr Minakshisundaram Shunmugavelu	Trichy Diabetes Speciality Center (P) Ltd	Department of Diabetology Room No 1 B 37 Sasthri Road 7th cross East Thillainagar Tiruchirappali Tiruchirappalli TAMIL NADU	04312742091 msv_diab@yahoo.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 7
Name of Committee	Approval Status
Ethics Committee of India Diabetes Research Foundation and Dr A Ramachandran s Diabetes Hospitals	Approved
Ethics Committee of India Diabetes Research Foundation and Dr A Ramachandran s Diabetes Hospitals	Approved
Ethics Committee of India Diabetes Research Foundation and Dr A Ramachandran s Diabetes Hospitals	Approved
Ethics Committee of India Diabetes Research Foundation and Dr A Ramachandran s Diabetes Hospitals	Approved
Ethics Committee of India Diabetes Research Foundation and Dr A Ramachandran s Diabetes Hospitals	Approved
Ethics Committee of India Diabetes Research Foundation and Dr A Ramachandran s Diabetes Hospitals	Approved
KLE University	Approved

Regulatory Clearance Status from DCGI
Modification(s)

Status

Notified

Health Condition / Problems Studied

Health Type	Condition
Patients	TYPE 2 DIABETES MELLITUS,

Intervention / Comparator Agent

Type	Name	Details
Intervention	GLARGINE, GLULISINE	Insulin Glargine and Insulin Glulisine administrated at pre-breakfast/dinner
Comparator Agent	Premixed Analogue Insulin 70/30	Premixed analogue insulin administered at pre-breakfast/dinner

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1. Insulin naÃ¯ve men and women with T2DM on stable dose of 2 or 3 OHAs for at least 3 months 2. Both men and women of age more than or equal to 18 and less than or equal to 65 years 3. Have an HbA1c more than or equal to 7.5% and less than or equal to 10.5% with fasting blood glucose more than or equal to 150 mg/dl and/or Postprandial blood glucose more than or equal to 200 mg/dl 4. Body mass index less than or equal to 40 kg/m2 5. Have given written informed consent to participate in this study in accordance with local regulations 6. Subject must have access to telephone for calling into the clinical center as part of test product compliance

ExclusionCriteria

Details

1. Type 1 diabetes

2. BMI more than 40 kg/m2

3. Subject is being treated for severe active infection of any type

4. Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study

5. Planned surgery in the next 6 months

6. Any event forecasted to require a temporary need to switch to insulin

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Centralized

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
To compare the change in HbA1c from baseline to week 24 between Glargine OD + Glulisine in comparison with Premixed insulin initiation in insulin naÃ¯ve patients with T2DM	24 weeks

Secondary Outcome

Outcome	TimePoints
Fasting plasma glucose	24 weeks
Postprandial glucose	24 weeks
7-point self-monitored blood glucose (SMBG) profiles	24 weeks
Percentage of participants with HbA1c less than 7%	24 weeks
Insulin Dose	24 weeks
Overall adverse events	24 weeks
Symptomatic Hypoglycemia	24 weeks
Severe Hypoglycemia	24 weeks
Weight	24 weeks
Body Mass Index	24 weeks
Blood pressure	24 weeks

Target Sample Size

Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0"

Phase of Trial

Phase 4

Date of First Enrollment (India)

29/12/2016

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="2"
Months="6"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

None Yet

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary

This is a multicentre, randomized, open label study on comparison of change in HbA1c between Glargine OD + Glulisine and Premixed insulin in insulin naÃ¯ve patients for 24 weeks in 200 patients with T2DM. This study will be conducted in seven centres in Chennai. The primary outcome measures will be to compare the effects of Glargine OD + Glulisine versus Premixed insulin on changes in HbA1c in insulin naÃ¯ve T2DM patients at 24 weeks. The secondary outcomes will be effect of Glargine OD + Glulisine versus Premixed insulin based treatment on fasting blood glucose, postprandial blood glucose, 7-point self-monitored blood glucose (SMBG) profiles, Percentage of participants with HbA1c < 7%, Insulin dose, Overall adverse events, Weight, BMI, Blood pressure, Symptomatic Hypoglycemia and Severe hypoglycemic at 24 weeks.