| CTRI Number |
CTRI/2026/01/100054 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A single visit study multicentre study to study the diabetes related medical conditions among 10000 patients with no intervention |
|
Scientific Title of Study
|
Cross-sectional observational multicentre pan India real-world study in patients living with T2DM to understand the prevalence of key diabetes associated comorbidities and to analyze the characteristics of such patients (INSIGHTS) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CP1225 Version 1 Dated 27.10.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bipin Sethi |
| Designation |
Consultant |
| Affiliation |
Cipla House |
| Address |
Cipla House Peninsula Business Park
Ganpatrao Kadam Marg Lower Parel Mumbai 400013 Maharashtra India
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9848021482 |
| Fax |
|
| Email |
sethibipin54@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandesh Sawant |
| Designation |
Head Clinical Trials |
| Affiliation |
Cipla House |
| Address |
Cipla House 289 Bellasis Rd Opposite Sahil Hotel Navjeevan Society Dalal Estate Mumbai Central Mumbai Maharashtra
Mumbai
MAHARASHTRA
400008
India |
| Phone |
7738384694 |
| Fax |
|
| Email |
sandesh.sawant3@cipla.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Senthilnathan Mohanasundaram |
| Designation |
Head Medical Affairs |
| Affiliation |
Cipla House |
| Address |
Cipla House, 289, Bellasis Rd, Opposite Sahil Hotel, Navjeevan Society, Dalal Estate, Mumbai Central, Mumbai, Maharashtra
Postal code: 400008
State: Maharashtra
Phone:
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9920378123 |
| Fax |
|
| Email |
senthilnathan.m@Cipla.com |
|
|
Source of Monetary or Material Support
|
| Cipla Limited Cipla House, 289, Bellasis Rd, Opposite Sahil Hotel, Navjeevan Society, Dalal Estate, Mumbai Central, Mumbai MAHARASHTRA 400008 India |
|
|
Primary Sponsor
|
| Name |
Cipla Limited |
| Address |
Cipla House Peninsula Business Park
Ganpatrao Kadam Marg Lower Parel Mumbai 400013 Maharashtra India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bipin Sethi |
Cipla Limited |
Cipla House Peninsula Business Park
Ganpatrao Kadam Marg Lower Parel Mumbai 400013 Maharashtra India
Mumbai
MAHARASHTRA |
9848021482
sethibipin54@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethicare Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
Patients more than or equal to 18 years of age
Previously diagnosed with T2DM and under the treating doctor’s care for at least 3 months coming for follow-up and undergoing treatment
Willing to provide written informed consent and comply with the study procedures
|
|
| ExclusionCriteria |
| Details |
Patients with T1DM and/or Gestational diabetes mellitus
Pregnant or lactating women or those planning pregnancy during the study period
Participants in another clinical trial |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To understand the prevalence of key diabetes associated comorbidities such as ASCVD Heart Failure CKD Obesity in patients with T2DM
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To understand the patient demographics personal or clinical history clinical parameter or biochemistry drug therapy diabetes and comorbidities of the study population |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="10000"
Sample Size from India="10000"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The increasing burden of T2DM in India is closely linked with rising cases of comorbidities like ASCVD heart failure CKD and obesity all of which significantly influence clinical outcomes and management strategies Despite this limited real-world data exists on how these comorbidities manifest and co-exist in patients with T2DM in the Indian population There is a clear need to bridge this evidence gap through real-world studies that capture the prevalence and patient characteristics of these conditions Such insights can help enable more informed and personalized care approaches for Indian patients with T2DM |