| CTRI Number |
CTRI/2021/10/037325 [Registered on: 14/10/2021] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
observation |
| Study Design |
Other |
|
Public Title of Study
|
observational survey to validate Glycemic HaPPiness scale Patient PhYsician Component in patients with Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
HAPPY
A prospective Multicentric cross-sectional non-interventional observational survey to validate Glycemic HaPPiness scale Patient PhYsician Component in patients with Type 2 Diabetes Mellitus |
| Trial Acronym |
Diabetes Mellitus` |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrDevesh Kumar |
| Designation |
Director Clinical Trial Operations |
| Affiliation |
IR Innovate research Pvt Ltd |
| Address |
B1 Building D 13 Sector 3 Noida 201301 NA
Gautam Buddha Nagar
UTTAR PRADESH
201301
India
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9971169602 |
| Fax |
|
| Email |
Devesh.kumar@innovate-research.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDevesh Kumar |
| Designation |
Director Clinical Trial Operations |
| Affiliation |
IR Innovate research Pvt Ltd |
| Address |
B1 Building D 13 Sector 3 Noida 201301 NA
Gautam Buddha Nagar
UTTAR PRADESH
201301
India
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9971169602 |
| Fax |
|
| Email |
Devesh.kumar@innovate-research.com |
|
Details of Contact Person
Public Query
|
| Name |
DrDevesh Kumar |
| Designation |
Director Clinical Trial Operations |
| Affiliation |
IR Innovate research Pvt Ltd |
| Address |
B1 Building D 13 Sector 3 Noida 201301 NA
Gautam Buddha Nagar
UTTAR PRADESH
201301
India
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9971169602 |
| Fax |
|
| Email |
Devesh.kumar@innovate-research.com |
|
|
Source of Monetary or Material Support
|
| Dr Reddys Laboratories Ltd |
|
|
Primary Sponsor
|
| Name |
Dr Reddys Laboratories Ltd |
| Address |
7-1-27, Ameerpet, Hyderabad – 500016 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrPooja Khosla |
Dr. Pooja Khosla Clinic |
20/4 old rajinder nagar new delhi 110060
New Delhi
DELHI |
8826628182
drpoojakhoslamedicine@gmail.com |
| DrHarsh Mittal |
Panchsheel Hospital |
C3, 64/A Block C Yamuna Vihar Shahdara Delhi 110053
New Delhi
DELHI |
9560506410
harshmittal86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Royal Pune independent ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1-Patients of either sex aged 18 years and above.
2-Willing and able to sign Data Disclosure consent form.
3-Patients with clinical diagnosis of Type 2 Diabetes Mellitus |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To validate Glycemic Happiness scale Patient & Physician Component in patients with Type 2 Diabetes Mellitus. |
Baseline Only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate Type 2 Diabetes Mellitus patient demographics, diagnosis and clinical presentation in India.
2. To evaluate the association of various chronic diseases like Heart Disease, Dyslipidemia, Hypertension and Liver disease with Type 2 Diabetes Mellitus and its various presentations.
3. To understand the pattern of usage of different Oral Hypoglycemic Agents as Monotherapy or combination therapy in Type 2 Diabetes Mellitus, factors influencing the choice of different Anti diabetic Medication(like comorbid conditions, drug interactions, attributes of various Anti-diabetic medications)
4. To understand the patient compliance in using Anti diabetic Medication and the satisfaction levels in terms of symptomatic improvement with different Anti diabetic medications. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/10/2021 |
| 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="21"
Months="11"
Days="5" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Data Would Be Published Once Study Is Complete |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This survey is a multi-centric, non- interventional, cross-sectional survey to understand the patient profile, disease profile and treatment pattern of patients suffering from Type 2 Diabetes Mellitus in India. Patients with clinical diagnosis of Type 2 Diabetes Mellitus will be invited to take part in the survey. All participants will sign an Informed Consent Form to get enrolled in the survey. Investigator will collect all required data from the participants and complete the Case record form with available information. |