Clinical trial NCT03363594: Indian Phenotype Registry
Official title: A Non-interventional Nationwide Registry to Identify Indian Phenotype Characteristics in Diabetes Mellitus Patients in India.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Diabetes, T2D
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2017-12-06
Enrollment: 40000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetes Mellitus patients

Brief summary: This study is a non-interventional, multicentre observational study to be conducted at 1000 sites in India. The study targets to enrol approx. 50000 patients with approx. 50 patients per site. The study would enrol Diabetes Mellitus patients who provides written informed consent. No study medication will be prescribed or administered as a part of study procedure. Patients, who have been treated as per Investigators' routine clinical practice will be screened for enrolment in study. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).

Detailed description: This study is a non-interventional, multicentre observational study to be conducted at 1000 sites in India. The study targets to enrol approx. 50000 patients with approx. 50 patients per site. The study would enrol Diabetes Mellitus patients who provides written informed consent. No study medication will be prescribed or administered as a part of study procedure. Patients, who have been treated as per Investigators' routine clinical practice will be screened for enrolment in study. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).

This is a single visit cross sectional study however during site feasibility visit, probability of follow-up of these patients will be evaluated. If feasible protocol will be amended to continue data collection prospectively for appropriate duration

Eligibility criteria: Inclusion Criteria

1. Male or female patients with 18 years and above.
2. Patients who provide written informed consent.
3. Patients with previously diagnosed with Diabetes Mellitus
4. HbA1C report available within past 3 months

Exclusion Criteria- None

Primary outcomes:
measure: To evaluate total body fat content across various BMI categories in the study population
timeFrame: 1 day
Secondary outcomes:
measure: To analyse different characteristics of Diabetes Mellitus patient in study population
timeFrame: 1 day
measure: To correlate HbA1C level with various BMI categories
timeFrame: 1 day
Other outcomes:
Locations:
city: Guntur
country: India
facility: Research Site
state: Andhra Pradesh
city: Kakinada
country: India
facility: Research Site
state: Andhra Pradesh
city: Madanapalle
country: India
facility: Research Site
state: Andhra Pradesh
city: Nellore
country: India
facility: Research Site
state: Andhra Pradesh
city: Rajahmundry
country: India
facility: Research Site
state: Andhra Pradesh
city: Vijaywada
country: India
facility: Research Site
state: Andhra Pradesh
city: Visakhapatnam
country: India
facility: Research Site
state: Andhra Pradesh
city: Dibrugarh
country: India
facility: Research Site
state: Assam
city: Guwahati
country: India
facility: Research Site
state: Assam
city: Nagaon
country: India
facility: Research Site
state: Assam
city: Silchar
country: India
facility: Research Site
state: Assam
city: Tinsukia
country: India
facility: Research Site
state: Assam
city: Bhagalpur
country: India
facility: Research Site
state: Bihar
city: Gaya
country: India
facility: Research Site
state: Bihar
city: Patna
country: India
facility: Research Site
state: Bihar
city: Samastipur
country: India
facility: Research Site
state: Bihar
city: Samstipur
country: India
facility: Research Site
state: Bihar
city: Bhilai
country: India
facility: Research Site
state: Chhattisgarh
city: Durg
country: India
facility: Research Site
state: Chhattisgarh
city: Raipur
country: India
facility: Research Site
state: Chhattisgarh
city: Rohtak
country: India
facility: Research Site
state: Chhattisgarh
city: New Delhi
country: India
facility: Research Site
state: Delhi
city: Ahmedabad
country: India
facility: Research Site
state: Gujarat
city: Amreli
country: India
facility: Research Site
state: Gujarat
city: Anand
country: India
facility: Research Site
state: Gujarat
city: Bharuch
country: India
facility: Research Site
state: Gujarat
city: Bhavnagar
country: India
facility: Research Site
state: Gujarat
city: Bhuj
country: India
facility: Research Site
state: Gujarat
city: Borsad
country: India
facility: Research Site
state: Gujarat
city: Botad
country: India
facility: Research Site
state: Gujarat
city: Chaibasa
country: India
facility: Research Site
state: Gujarat
city: Dahod
country: India
facility: Research Site
state: Gujarat
city: Himatnagar
country: India
facility: Research Site
state: Gujarat
city: Jamnagar
country: India
facility: Research Site
state: Gujarat
city: Junagadh
country: India
facility: Research Site
state: Gujarat
city: Kutch
country: India
facility: Research Site
state: Gujarat
city: Morbi
country: India
facility: Research Site
state: Gujarat
city: Nadiad
country: India
facility: Research Site
state: Gujarat
city: Navsari
country: India
facility: Research Site
state: Gujarat
city: Patan
country: India
facility: Research Site
state: Gujarat
city: Porbandar
country: India
facility: Research Site
state: Gujarat
city: Rajkot
country: India
facility: Research Site
state: Gujarat
city: Surat
country: India
facility: Research Site
state: Gujarat
city: Unnao
country: India
facility: Research Site
state: Gujarat
city: Vadodara
country: India
facility: Research Site
state: Gujarat
city: Valsad
country: India
facility: Research Site
state: Gujarat
city: Vapi
country: India
facility: Research Site
state: Gujarat
city: Bangalore
country: India
facility: Research Site
state: Haryana
city: Faridabad
country: India
facility: Research Site
state: Haryana
city: Gurugram
country: India
facility: Research Site
state: Haryana
city: Hisar
country: India
facility: Research Site
state: Haryana
city: Panchkula
country: India
facility: Research Site
state: Haryana
city: Panipat
country: India
facility: Research Site
state: Haryana
city: Rohtak
country: India
facility: Research Site
state: Haryana
city: Sonipat
country: India
facility: Research Site
state: Haryana
city: Yamunanagar
country: India
facility: Research Site
state: Haryana
city: Mandi
country: India
facility: Research Site
state: Himachal Pradesh
city: Srinagar
country: India
facility: Research Site
state: Jammu And Kashmir
city: Jamshedpur
country: India
facility: Research Site
state: Jharkhand
city: Ranchi
country: India
facility: Research Site
state: Jharkhand
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Belgaum
country: India
facility: Research Site
state: Karnataka
city: Gulbarga
country: India
facility: Research Site
state: Karnataka
city: Angamaly
country: India
facility: Research Site
state: Kerala
city: Chengannur
country: India
facility: Research Site
state: Kerala
city: Edappally
country: India
facility: Research Site
state: Kerala
city: Ernakulam
country: India
facility: Research Site
state: Kerala
city: Idukki
country: India
facility: Research Site
state: Kerala
city: Kochi
country: India
facility: Research Site
state: Kerala
city: Kollam
country: India
facility: Research Site
state: Kerala
city: Kottayam
country: India
facility: Research Site
state: Kerala
city: Malappuram
country: India
facility: Research Site
state: Kerala
city: Nedumangad
country: India
facility: Research Site
state: Kerala
city: Palakkad
country: India
facility: Research Site
state: Kerala
city: Pezhakkappilly
country: India
facility: Research Site
state: Kerala
city: Thalassery
country: India
facility: Research Site
state: Kerala
city: Thiruvananthapuram
country: India
facility: Research Site
state: Kerala
city: Thrissur
country: India
facility: Research Site
state: Kerala
city: Trivandrum
country: India
facility: Research Site
state: Kerala
city: Bhopal
country: India
facility: Research Site
state: Madhya Pradesh
city: Guna
country: India
facility: Research Site
state: Madhya Pradesh
city: Gwalior
country: India
facility: Research Site
state: Madhya Pradesh
city: Indore
country: India
facility: Research Site
state: Madhya Pradesh
city: Jabalpur
country: India
facility: Research Site
state: Madhya Pradesh
city: Mandsaur
country: India
facility: Research Site
state: Madhya Pradesh
city: Ujjain
country: India
facility: Research Site
state: Madhya Pradesh
city: Ahmednagar
country: India
facility: Research Site
state: Maharastra
city: Aurangabad
country: India
facility: Research Site
state: Maharastra
city: Bhiwandi
country: India
facility: Research Site
state: Maharastra
city: Kalyan
country: India
facility: Research Site
state: Maharastra
city: Kolhapur
country: India
facility: Research Site
state: Maharastra
city: Mumbai
country: India
facility: Research Site
state: Maharastra
city: Nagpur
country: India
facility: Research Site
state: Maharastra
city: Nasik
country: India
facility: Research Site
state: Maharastra
city: Navi Mumbai
country: India
facility: Research Site
state: Maharastra
city: Palanpur
country: India
facility: Research Site
state: Maharastra
city: Palghar
country: India
facility: Research Site
state: Maharastra
city: Pune
country: India
facility: Research Site
state: Maharastra
city: Raigad
country: India
facility: Research Site
state: Maharastra
city: Rajkot
country: India
facility: Research Site
state: Maharastra
city: Sangli
country: India
facility: Research Site
state: Maharastra
city: Satara
country: India
facility: Research Site
state: Maharastra
city: Sindhudurg
country: India
facility: Research Site
state: Maharastra
city: Solapur
country: India
facility: Research Site
state: Maharastra
city: Thane
country: India
facility: Research Site
state: Maharastra
city: Vasai
country: India
facility: Research Site
state: Maharastra
city: Imphal
country: India
facility: Research Site
state: Manipur
city: Shillong
country: India
facility: Research Site
state: Meghalaya
city: Berhampur
country: India
facility: Research Site
state: Odisha
city: Bhubaneswar
country: India
facility: Research Site
state: Odisha
city: Bhubneshwar
country: India
facility: Research Site
state: Odisha
city: Bhuvaneshwar
country: India
facility: Research Site
state: Odisha
city: Cuttack
country: India
facility: Research Site
state: Odisha
city: Cuttuck
country: India
facility: Research Site
state: Odisha
city: Paradip
country: India
facility: Research Site
state: Odisha
city: Puri
country: India
facility: Research Site
state: Odisha
city: Rourkela
country: India
facility: Research Site
state: Odisha
city: Sambalpur
country: India
facility: Research Site
state: Odisha
city: Amritsar
country: India
facility: Research Site
state: Panjab
city: Jalandhar
country: India
facility: Research Site
state: Panjab
city: Khanna
country: India
facility: Research Site
state: Panjab
city: Kharar
country: India
facility: Research Site
state: Panjab
city: Ludhiana
country: India
facility: Research Site
state: Panjab
city: Moga
country: India
facility: Research Site
state: Panjab
city: Patiala
country: India
facility: Research Site
state: Panjab
city: Ajmer
country: India
facility: Research Site
state: Rajasthan
city: Ambala
country: India
facility: Research Site
state: Rajasthan
city: Bikaner
country: India
facility: Research Site
state: Rajasthan
city: Hanumangarh
country: India
facility: Research Site
state: Rajasthan
city: Jaipur
country: India
facility: Research Site
state: Rajasthan
city: Jamshedpur
country: India
facility: Research Site
state: Rajasthan
city: Jodhpur
country: India
facility: Research Site
state: Rajasthan
city: Kota
country: India
facility: Research Site
state: Rajasthan
city: Udaipur
country: India
facility: Research Site
state: Rajasthan
city: Chennai
country: India
facility: Research Site
state: Tamil Nadu
city: Coimbatore
country: India
facility: Research Site
state: Tamil Nadu
city: Erode
country: India
facility: Research Site
state: Tamil Nadu
city: Hosur
country: India
facility: Research Site
state: Tamil Nadu
city: Kanchipuram
country: India
facility: Research Site
state: Tamil Nadu
city: Kochi
country: India
facility: Research Site
state: Tamil Nadu
city: Kumbakonam
country: India
facility: Research Site
state: Tamil Nadu
city: Madurai
country: India
facility: Research Site
state: Tamil Nadu
city: Nagerkoil
country: India
facility: Research Site
state: Tamil Nadu
city: Pattukottai
country: India
facility: Research Site
state: Tamil Nadu
city: Pondicherry
country: India
facility: Research Site
state: Tamil Nadu
city: Ranipet
country: India
facility: Research Site
state: Tamil Nadu
city: Salem
country: India
facility: Research Site
state: Tamil Nadu
city: Thanjavur
country: India
facility: Research Site
state: Tamil Nadu
city: Thiruvannamalai
country: India
facility: Research Site
state: Tamil Nadu
city: Thiruvarur
country: India
facility: Research Site
state: Tamil Nadu
city: Trichy
country: India
facility: Research Site
state: Tamil Nadu
city: Vellore
country: India
facility: Research Site
state: Tamil Nadu
city: Hyderabad
country: India
facility: Research Site
state: Telangana
city: Karimnagar
country: India
facility: Research Site
state: Telangana
city: Secunderabad
country: India
facility: Research Site
state: Telangana
city: Agra
country: India
facility: Research Site
state: Uttar Pradesh
city: Aligarh
country: India
facility: Research Site
state: Uttar Pradesh
city: Allahabad
country: India
facility: Research Site
state: Uttar Pradesh
city: Bareilly
country: India
facility: Research Site
state: Uttar Pradesh
city: Bareli
country: India
facility: Research Site
state: Uttar Pradesh
city: Bulandshahr
country: India
facility: Research Site
state: Uttar Pradesh
city: Etawah
country: India
facility: Research Site
state: Uttar Pradesh
city: Faizabad
country: India
facility: Research Site
state: Uttar Pradesh
city: Firozabad
country: India
facility: Research Site
state: Uttar Pradesh
city: Ghaziabad
country: India
facility: Research Site
state: Uttar Pradesh
city: Gorakhpur
country: India
facility: Research Site
state: Uttar Pradesh
city: Hathras
country: India
facility: Research Site
state: Uttar Pradesh
city: Jhansi
country: India
facility: Research Site
state: Uttar Pradesh
city: Kanpur
country: India
facility: Research Site
state: Uttar Pradesh
city: Karnal
country: India
facility: Research Site
state: Uttar Pradesh
city: Lucknow
country: India
facility: Research Site
state: Uttar Pradesh
city: Meerut
country: India
facility: Research Site
state: Uttar Pradesh
city: Moradabad
country: India
facility: Research Site
state: Uttar Pradesh
city: Noida
country: India
facility: Research Site
state: Uttar Pradesh
city: Piliphit
country: India
facility: Research Site
state: Uttar Pradesh
city: Rampur
country: India
facility: Research Site
state: Uttar Pradesh
city: Varanasi
country: India
facility: Research Site
state: Uttar Pradesh
city: Dehradun
country: India
facility: Research Site
state: Uttarakhand
city: Haldwani
country: India
facility: Research Site
state: Uttarakhand
city: Baguihati
country: India
facility: Research Site
state: West Bengal
city: Basirhat
country: India
facility: Research Site
state: West Bengal
city: Bolapur
country: India
facility: Research Site
state: West Bengal
city: Burdwan
country: India
facility: Research Site
state: West Bengal
city: Durgapur
country: India
facility: Research Site
state: West Bengal
city: Guwahati
country: India
facility: Research Site
state: West Bengal
city: Habra
country: India
facility: Research Site
state: West Bengal
city: Hooghly
country: India
facility: Research Site
state: West Bengal
city: Howrah
country: India
facility: Research Site
state: West Bengal
city: Hubli
country: India
facility: Research Site
state: West Bengal
city: Jalpaiguri
country: India
facility: Research Site
state: West Bengal
city: Kharagpur
country: India
facility: Research Site
state: West Bengal
city: Kolkata
country: India
facility: Research Site
state: West Bengal
city: Malda
country: India
facility: Research Site
state: West Bengal
city: Nadia
country: India
facility: Research Site
state: West Bengal
city: Siliguri
country: India
facility: Research Site
state: West Bengal
city: Chandigarh
country: India
facility: Research Site
city: Goa
country: India
facility: Research Site
Study officials:
References: