Diabetes MellitusIP RegistryNCT03363594

Indian Phenotype Registry

An observational study of Diabetes Mellitus, run by AstraZeneca at 197 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Diabetes Mellitus
How many people: 40,000 participants
Where: 197 sitesIndia
Study dates: 11 Dec 2017to 14 Jun 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Diabetes Mellitus patients

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

197 sites in 1 country.

City, postcode or hospital

197 sites in 1 country

India197 sites

Research Site
Agra, Uttar Pradesh, D1843R00282
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Ahilyanagar, Maharashtra, D1843R00282
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Ahmedabad, Gujarat, D1843R00282
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Ajmer, Rajasthan, D1843R00282
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Aligarh, Uttar Pradesh, D1843R00282
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Allahābād, Uttar Pradesh, D1843R00282
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Ambala, Rajasthan, D1843R00282
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Amreli, Gujarat, D1843R00282
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Amritsar, Punjab, D1843R00282
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Anand, Gujarat, D1843R00282
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Angamaly, Kerala, D1843R00282
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Baguihati, West Bengal, D1843R00282
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Bangalore, Haryana, D1843R00282
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Bangalore, Karnataka, D1843R00282
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Bareilly, Uttar Pradesh, D1843R00282
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Bareli, Uttar Pradesh, D1843R00282
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Basirhat City, West Bengal, D1843R00282
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Belagavi, Karnataka, D1843R00282
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Berhampur, Odisha, D1843R00282
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Bhagalpur, Bihar, D1843R00282
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Bharūch, Gujarat, D1843R00282
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Bhavnagar, Gujarat, D1843R00282
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Bhilai, Chhattisgarh, D1843R00282
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Bhiwandi, Maharashtra, D1843R00282
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Bhopal, Madhya Pradesh, D1843R00282
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Bhubaneswar, Odisha, D1843R00282
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Bhubneshwar, Odisha, D1843R00282
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Bhuj, Gujarat, D1843R00282
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Bhuvaneshwar, Odisha, D1843R00282
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Bikaner, Rajasthan, D1843R00282
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Bolapur, West Bengal, D1843R00282
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Borsad, Gujarat, D1843R00282
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Botad, Gujarat, D1843R00282
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Bulandshahr, Uttar Pradesh, D1843R00282
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Burdwan, West Bengal, D1843R00282
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Chaibasa, Gujarat, D1843R00282
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Chandigarh, D1843R00282
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Chengannūr, Kerala, D1843R00282
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Chennai, Tamil Nadu, D1843R00282
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Chhatrapati Sambhajinagar, Maharashtra, D1843R00282
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Coimbatore, Tamil Nadu, D1843R00282
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Cuttack, Odisha, D1843R00282
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Cuttuck, Odisha, D1843R00282
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Dehradun, Uttarakhand, D1843R00282
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Dibrugarh, Assam, D1843R00282
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Dohad, Gujarat, D1843R00282
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Durg, Chhattisgarh, D1843R00282
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Durgapur, West Bengal, D1843R00282
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Edappally, Kerala, D1843R00282
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Ernākulam, Kerala, D1843R00282
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Erode, Tamil Nadu, D1843R00282
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Etāwah, Uttar Pradesh, D1843R00282
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Faizabad, Uttar Pradesh, D1843R00282
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Faridabad, Haryana, D1843R00282
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Firozabad, Uttar Pradesh, D1843R00282
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Gaya, Bihar, D1843R00282
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Ghaziabad, Uttar Pradesh, D1843R00282
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Goa, D1843R00282
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Gorakhpur, Uttar Pradesh, D1843R00282
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Guna, Madhya Pradesh, D1843R00282
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Guntur, Andhra Pradesh, D1843R00282
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Gurugram, Haryana, D1843R00282
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Guwahati, Assam, D1843R00282
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Guwahati, West Bengal, D1843R00282
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Gwalior, Madhya Pradesh, D1843R00282
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Hābra, West Bengal, D1843R00282
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Haldwani, Uttarakhand, D1843R00282
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Hanumāngarh, Rajasthan, D1843R00282
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Hāthras, Uttar Pradesh, D1843R00282
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Himatnagar, Gujarat, D1843R00282
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Hisar, Haryana, D1843R00282
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Hosūr, Tamil Nadu, D1843R00282
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Howrah, West Bengal, D1843R00282
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Hubli, West Bengal, D1843R00282
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Hugli, West Bengal, D1843R00282
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Hyderabad, Telangana, D1843R00282
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Idukki, Kerala, D1843R00282
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Imphal, Manipur, D1843R00282
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Indore, Madhya Pradesh, D1843R00282
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Jabalpur, Madhya Pradesh, D1843R00282
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Jaipur, Rajasthan, D1843R00282
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Jalandhar, Punjab, D1843R00282
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Jalpāiguri, West Bengal, D1843R00282
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Jamnagar, Gujarat, D1843R00282
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Jamshedpur, Jharkhand, D1843R00282
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Jamshedpur, Rajasthan, D1843R00282
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Jhānsi, Uttar Pradesh, D1843R00282
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Jodhpur, Rajasthan, D1843R00282
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Jūnāgadh, Gujarat, D1843R00282
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Kākināda, Andhra Pradesh, D1843R00282
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Kalaburagi, Karnataka, D1843R00282
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Kalyān, Maharashtra, D1843R00282
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Kanchipuram, Tamil Nadu, D1843R00282
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Kanpur, Uttar Pradesh, D1843R00282
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Karīmnagar, Telangana, D1843R00282
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Karnal, Uttar Pradesh, D1843R00282
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Khanna, Punjab, D1843R00282
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Kharagpur, West Bengal, D1843R00282
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Kharar, Punjab, D1843R00282
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Kochi, Kerala, D1843R00282
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Kochi, Tamil Nadu, D1843R00282
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Kolhāpur, Maharashtra, D1843R00282
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Kolkata, West Bengal, D1843R00282
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Kollam, Kerala, D1843R00282
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Kota, Rajasthan, D1843R00282
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Kottayam, Kerala, D1843R00282
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Kumbakonam, Tamil Nadu, D1843R00282
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Kutch, Gujarat, D1843R00282
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Lucknow, Uttar Pradesh, D1843R00282
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Ludhiana, Punjab, D1843R00282
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Madanapalle, Andhra Pradesh, D1843R00282
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Madurai, Tamil Nadu, D1843R00282
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Malappuram, Kerala, D1843R00282
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Malda, West Bengal, D1843R00282
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Mandi, Himachal Pradesh, D1843R00282
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Mandsaur, Madhya Pradesh, D1843R00282
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Meerut, Uttar Pradesh, D1843R00282
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Moga, Punjab, D1843R00282
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Morādābād, Uttar Pradesh, D1843R00282
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Morvi, Gujarat, D1843R00282
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Mumbai, Maharashtra, D1843R00282
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Nabadwip, West Bengal, D1843R00282
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Nadiād, Gujarat, D1843R00282
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Nagaon, Assam, D1843R00282
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Nagerkoil, Tamil Nadu, D1843R00282
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Nagpur, Maharashtra, D1843R00282
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Nashik, Maharashtra, D1843R00282
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Navi Mumbai, Maharashtra, D1843R00282
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Navsari, Gujarat, D1843R00282
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Nedumangād, Kerala, D1843R00282
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Nellore, Andhra Pradesh, D1843R00282
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New Delhi, National Capital Territory of Delhi, D1843R00282
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Noida, Uttar Pradesh, D1843R00282
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Palakkad, Kerala, D1843R00282
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Palanpur, Maharashtra, D1843R00282
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Pālghar, Maharashtra, D1843R00282
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Panchkula, Haryana, D1843R00282
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Panipat, Haryana, D1843R00282
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Paradip, Odisha, D1843R00282
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Pātan, Gujarat, D1843R00282
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Patiāla, Punjab, D1843R00282
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Patna, Bihar, D1843R00282
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Pattukkottai, Tamil Nadu, D1843R00282
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Pezhakkappilly, Kerala, D1843R00282
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Piliphit, Uttar Pradesh, D1843R00282
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Pondicherry, Tamil Nadu, D1843R00282
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Porbandar, Gujarat, D1843R00282
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Pune, Maharashtra, D1843R00282
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Puri, Odisha, D1843R00282
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Raigad, Maharashtra, D1843R00282
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Raipur, Chhattisgarh, D1843R00282
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Rajahmundry, Andhra Pradesh, D1843R00282
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Rajkot, Gujarat, D1843R00282
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Rajkot, Maharashtra, D1843R00282
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Rāmpur, Uttar Pradesh, D1843R00282
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Ranchi, Jharkhand, D1843R00282
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Ranipet, Tamil Nadu, D1843R00282
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Rohtak, Chhattisgarh, D1843R00282
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Rohtak, Haryana, D1843R00282
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Rourkela, Odisha, D1843R00282
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Salem, Tamil Nadu, D1843R00282
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Samāstipur, Bihar, D1843R00282
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Sambalpur, Odisha, D1843R00282
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Samstipur, Bihar, D1843R00282
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Sangli, Maharashtra, D1843R00282
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Satara, Maharashtra, D1843R00282
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Secunderabad, Telangana, D1843R00282
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Shillong, Meghālaya, D1843R00282
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Silchar, Assam, D1843R00282
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Siliguri, West Bengal, D1843R00282
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Sindhudurg, Maharashtra, D1843R00282
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Solapur, Maharashtra, D1843R00282
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Sonīpat, Haryana, D1843R00282
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Srinagar, Jammu and Kashmir, D1843R00282
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Surat, Gujarat, D1843R00282
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Thalassery, Kerala, D1843R00282
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Thane, Maharashtra, D1843R00282
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Thanjavur, Tamil Nadu, D1843R00282
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Thiruvananthapuram, Kerala, D1843R00282
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Thiruvannamalai, Tamil Nadu, D1843R00282
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Thiruvarur, Tamil Nadu, D1843R00282
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Thrissur, Kerala, D1843R00282
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Tinsukia, Assam, D1843R00282
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Trichy, Tamil Nadu, D1843R00282
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Trivandrum, Kerala, D1843R00282
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Udaipur, Rajasthan, D1843R00282
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Ujjain, Madhya Pradesh, D1843R00282
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Unnao, Gujarat, D1843R00282
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Vadodara, Gujarat, D1843R00282
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Valsād, Gujarat, D1843R00282
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Vapi, Gujarat, D1843R00282
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Varanasi, Uttar Pradesh, D1843R00282
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Vasai, Maharashtra, D1843R00282
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Vellore, Tamil Nadu, D1843R00282
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Vijaywada, Andhra Pradesh, D1843R00282
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Visakhapatnam, Andhra Pradesh, D1843R00282
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Yamuna Nagar, Haryana, D1843R00282

Other trials in India

About this study

Official title: A Non-interventional Nationwide Registry to Identify Indian Phenotype Characteristics in Diabetes Mellitus Patients in India.

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).

Read the detailed description

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

Conditions: Diabetes Mellitus
Keywords: Diabetes, T2D
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03363594
Study group	Role	What they receive
1		Diabetes Mellitus

What is being measured

The primary outcome is the main question the study is designed to answer.

To evaluate total body fat content across various BMI categories in the study population
Bioelectrical impedance will be used to estimate how much % body fat in terms of weight compared to total body weight.
Since it is a ratio (weight of fat/total body weight) so no unit is required. The ratio will be multiplied by 100 to get Fat percentage.
Measured: 1 day

Secondary outcomes (2)

To analyse different characteristics of Diabetes Mellitus patient in study population
patient characteristics like age, gender
Measured: 1 day
To correlate HbA1C level with various BMI categories
Weight in kilogram, height in meter will be combined to report BMI in kg/m2. then HbA1c in percentage and BMI in kg/m2 will be aggregated to get correlation
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Dec 201714 Jun 2019

First posted6 Dec 2017
Study start11 Dec 2017
Primary completion14 Jun 2019
Study completion14 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Cross-sectional
Enrolment: 40,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03363594
Sponsor's protocol ID: D1843R00282
Acronym: IP Registry
Status last verified: Jun 2020
First submitted: 20 Nov 2017
Last updated: 16 Jun 2020
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Genetics of Type 2 Diabetes in West Africans
Hypertension, Diabetes
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
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A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin
Diabetes Mellitus, Type 2
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Active, not recruiting
Adapting FAMS to Optimize CGM Use Among Emerging Adults With Type 1 Diabetes
Type 1 Diabetes

All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Non-interventional Nationwide Registry to Identify Indian Phenotype Characteristics in Diabetes Mellitus Patients in India.
ClinicalTrials.gov ID: NCT03363594
Acronym / sponsor ID: IP Registry / D1843R00282
Conditions: Diabetes Mellitus
Keywords: Diabetes, T2D
Study type: Observational
Recruitment status: Completed
Enrolment: 40,000 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 11 Dec 2017 (actual)
Primary completion: 14 Jun 2019 (actual)
Study completion: 14 Jun 2019 (actual)
First posted: 6 Dec 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
1	–	–Diabetes Mellitus

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Diabetes Mellitus patients

Key inclusion criteria (4 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

To evaluate total body fat content across various BMI categories in the study population
Time frame: 1 day
Bioelectrical impedance will be used to estimate how much % body fat in terms of weight compared to total body weight. Since it is a ratio (weight of fat/total body weight) so no unit is required. The ratio will be multiplied by 100 to get Fat percentage.

2 secondary outcomes

To analyse different characteristics of Diabetes Mellitus patient in study population
Time frame: 1 day
To correlate HbA1C level with various BMI categories
Time frame: 1 day

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
redacted CSR synopsisLink provided by the sponsor.

Related trials for Diabetes Mellitus

RecruitingObservational study
Genetics of Type 2 Diabetes in West Africans
Hypertension, Diabetes
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Not yet recruitingPhase 3
A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin
Diabetes Mellitus, Type 2
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Active, not recruiting
Adapting FAMS to Optimize CGM Use Among Emerging Adults With Type 1 Diabetes
Type 1 Diabetes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

197 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, run by AstraZeneca at 197 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 197 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate total body fat content across various BMI categories in the study population (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03363594.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.