Diabetes Mellitus Clinical Trial
— IP RegistryOfficial title:
A Non-interventional Nationwide Registry to Identify Indian Phenotype Characteristics in Diabetes Mellitus Patients in India.
| NCT number | NCT03363594 |
| Other study ID # | D1843R00282 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | December 11, 2017 |
| Est. completion date | June 14, 2019 |
| Verified date | June 2020 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 40000 |
| Est. completion date | June 14, 2019 |
| Est. primary completion date | June 14, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| India | Research Site | Agra | Uttar Pradesh |
| India | Research Site | Ahmedabad | Gujarat |
| India | Research Site | Ahmednagar | Maharastra |
| India | Research Site | Ajmer | Rajasthan |
| India | Research Site | Aligarh | Uttar Pradesh |
| India | Research Site | Allahabad | Uttar Pradesh |
| India | Research Site | Ambala | Rajasthan |
| India | Research Site | Amreli | Gujarat |
| India | Research Site | Amritsar | Panjab |
| India | Research Site | Anand | Gujarat |
| India | Research Site | Angamaly | Kerala |
| India | Research Site | Aurangabad | Maharastra |
| India | Research Site | Baguihati | West Bengal |
| India | Research Site | Bangalore | Karnataka |
| India | Research Site | Bangalore | Haryana |
| India | Research Site | Bareilly | Uttar Pradesh |
| India | Research Site | Bareli | Uttar Pradesh |
| India | Research Site | Basirhat | West Bengal |
| India | Research Site | Belgaum | Karnataka |
| India | Research Site | Berhampur | Odisha |
| India | Research Site | Bhagalpur | Bihar |
| India | Research Site | Bharuch | Gujarat |
| India | Research Site | Bhavnagar | Gujarat |
| India | Research Site | Bhilai | Chhattisgarh |
| India | Research Site | Bhiwandi | Maharastra |
| India | Research Site | Bhopal | Madhya Pradesh |
| India | Research Site | Bhubaneswar | Odisha |
| India | Research Site | Bhubneshwar | Odisha |
| India | Research Site | Bhuj | Gujarat |
| India | Research Site | Bhuvaneshwar | Odisha |
| India | Research Site | Bikaner | Rajasthan |
| India | Research Site | Bolapur | West Bengal |
| India | Research Site | Borsad | Gujarat |
| India | Research Site | Botad | Gujarat |
| India | Research Site | Bulandshahr | Uttar Pradesh |
| India | Research Site | Burdwan | West Bengal |
| India | Research Site | Chaibasa | Gujarat |
| India | Research Site | Chandigarh | |
| India | Research Site | Chengannur | Kerala |
| India | Research Site | Chennai | Tamil Nadu |
| India | Research Site | Coimbatore | Tamil Nadu |
| India | Research Site | Cuttack | Odisha |
| India | Research Site | Cuttuck | Odisha |
| India | Research Site | Dahod | Gujarat |
| India | Research Site | Dehradun | Uttarakhand |
| India | Research Site | Dibrugarh | Assam |
| India | Research Site | Durg | Chhattisgarh |
| India | Research Site | Durgapur | West Bengal |
| India | Research Site | Edappally | Kerala |
| India | Research Site | Ernakulam | Kerala |
| India | Research Site | Erode | Tamil Nadu |
| India | Research Site | Etawah | Uttar Pradesh |
| India | Research Site | Faizabad | Uttar Pradesh |
| India | Research Site | Faridabad | Haryana |
| India | Research Site | Firozabad | Uttar Pradesh |
| India | Research Site | Gaya | Bihar |
| India | Research Site | Ghaziabad | Uttar Pradesh |
| India | Research Site | Goa | |
| India | Research Site | Gorakhpur | Uttar Pradesh |
| India | Research Site | Gulbarga | Karnataka |
| India | Research Site | Guna | Madhya Pradesh |
| India | Research Site | Guntur | Andhra Pradesh |
| India | Research Site | Gurugram | Haryana |
| India | Research Site | Guwahati | Assam |
| India | Research Site | Guwahati | West Bengal |
| India | Research Site | Gwalior | Madhya Pradesh |
| India | Research Site | Habra | West Bengal |
| India | Research Site | Haldwani | Uttarakhand |
| India | Research Site | Hanumangarh | Rajasthan |
| India | Research Site | Hathras | Uttar Pradesh |
| India | Research Site | Himatnagar | Gujarat |
| India | Research Site | Hisar | Haryana |
| India | Research Site | Hooghly | West Bengal |
| India | Research Site | Hosur | Tamil Nadu |
| India | Research Site | Howrah | West Bengal |
| India | Research Site | Hubli | West Bengal |
| India | Research Site | Hyderabad | Telangana |
| India | Research Site | Idukki | Kerala |
| India | Research Site | Imphal | Manipur |
| India | Research Site | Indore | Madhya Pradesh |
| India | Research Site | Jabalpur | Madhya Pradesh |
| India | Research Site | Jaipur | Rajasthan |
| India | Research Site | Jalandhar | Panjab |
| India | Research Site | Jalpaiguri | West Bengal |
| India | Research Site | Jamnagar | Gujarat |
| India | Research Site | Jamshedpur | Jharkhand |
| India | Research Site | Jamshedpur | Rajasthan |
| India | Research Site | Jhansi | Uttar Pradesh |
| India | Research Site | Jodhpur | Rajasthan |
| India | Research Site | Junagadh | Gujarat |
| India | Research Site | Kakinada | Andhra Pradesh |
| India | Research Site | Kalyan | Maharastra |
| India | Research Site | Kanchipuram | Tamil Nadu |
| India | Research Site | Kanpur | Uttar Pradesh |
| India | Research Site | Karimnagar | Telangana |
| India | Research Site | Karnal | Uttar Pradesh |
| India | Research Site | Khanna | Panjab |
| India | Research Site | Kharagpur | West Bengal |
| India | Research Site | Kharar | Panjab |
| India | Research Site | Kochi | Tamil Nadu |
| India | Research Site | Kochi | Kerala |
| India | Research Site | Kolhapur | Maharastra |
| India | Research Site | Kolkata | West Bengal |
| India | Research Site | Kollam | Kerala |
| India | Research Site | Kota | Rajasthan |
| India | Research Site | Kottayam | Kerala |
| India | Research Site | Kumbakonam | Tamil Nadu |
| India | Research Site | Kutch | Gujarat |
| India | Research Site | Lucknow | Uttar Pradesh |
| India | Research Site | Ludhiana | Panjab |
| India | Research Site | Madanapalle | Andhra Pradesh |
| India | Research Site | Madurai | Tamil Nadu |
| India | Research Site | Malappuram | Kerala |
| India | Research Site | Malda | West Bengal |
| India | Research Site | Mandi | Himachal Pradesh |
| India | Research Site | Mandsaur | Madhya Pradesh |
| India | Research Site | Meerut | Uttar Pradesh |
| India | Research Site | Moga | Panjab |
| India | Research Site | Moradabad | Uttar Pradesh |
| India | Research Site | Morbi | Gujarat |
| India | Research Site | Mumbai | Maharastra |
| India | Research Site | Nadia | West Bengal |
| India | Research Site | Nadiad | Gujarat |
| India | Research Site | Nagaon | Assam |
| India | Research Site | Nagerkoil | Tamil Nadu |
| India | Research Site | Nagpur | Maharastra |
| India | Research Site | Nasik | Maharastra |
| India | Research Site | Navi Mumbai | Maharastra |
| India | Research Site | Navsari | Gujarat |
| India | Research Site | Nedumangad | Kerala |
| India | Research Site | Nellore | Andhra Pradesh |
| India | Research Site | New Delhi | Delhi |
| India | Research Site | Noida | Uttar Pradesh |
| India | Research Site | Palakkad | Kerala |
| India | Research Site | Palanpur | Maharastra |
| India | Research Site | Palghar | Maharastra |
| India | Research Site | Panchkula | Haryana |
| India | Research Site | Panipat | Haryana |
| India | Research Site | Paradip | Odisha |
| India | Research Site | Patan | Gujarat |
| India | Research Site | Patiala | Panjab |
| India | Research Site | Patna | Bihar |
| India | Research Site | Pattukottai | Tamil Nadu |
| India | Research Site | Pezhakkappilly | Kerala |
| India | Research Site | Piliphit | Uttar Pradesh |
| India | Research Site | Pondicherry | Tamil Nadu |
| India | Research Site | Porbandar | Gujarat |
| India | Research Site | Pune | Maharastra |
| India | Research Site | Puri | Odisha |
| India | Research Site | Raigad | Maharastra |
| India | Research Site | Raipur | Chhattisgarh |
| India | Research Site | Rajahmundry | Andhra Pradesh |
| India | Research Site | Rajkot | Gujarat |
| India | Research Site | Rajkot | Maharastra |
| India | Research Site | Rampur | Uttar Pradesh |
| India | Research Site | Ranchi | Jharkhand |
| India | Research Site | Ranipet | Tamil Nadu |
| India | Research Site | Rohtak | Haryana |
| India | Research Site | Rohtak | Chhattisgarh |
| India | Research Site | Rourkela | Odisha |
| India | Research Site | Salem | Tamil Nadu |
| India | Research Site | Samastipur | Bihar |
| India | Research Site | Sambalpur | Odisha |
| India | Research Site | Samstipur | Bihar |
| India | Research Site | Sangli | Maharastra |
| India | Research Site | Satara | Maharastra |
| India | Research Site | Secunderabad | Telangana |
| India | Research Site | Shillong | Meghalaya |
| India | Research Site | Silchar | Assam |
| India | Research Site | Siliguri | West Bengal |
| India | Research Site | Sindhudurg | Maharastra |
| India | Research Site | Solapur | Maharastra |
| India | Research Site | Sonipat | Haryana |
| India | Research Site | Srinagar | Jammu And Kashmir |
| India | Research Site | Surat | Gujarat |
| India | Research Site | Thalassery | Kerala |
| India | Research Site | Thane | Maharastra |
| India | Research Site | Thanjavur | Tamil Nadu |
| India | Research Site | Thiruvananthapuram | Kerala |
| India | Research Site | Thiruvannamalai | Tamil Nadu |
| India | Research Site | Thiruvarur | Tamil Nadu |
| India | Research Site | Thrissur | Kerala |
| India | Research Site | Tinsukia | Assam |
| India | Research Site | Trichy | Tamil Nadu |
| India | Research Site | Trivandrum | Kerala |
| India | Research Site | Udaipur | Rajasthan |
| India | Research Site | Ujjain | Madhya Pradesh |
| India | Research Site | Unnao | Gujarat |
| India | Research Site | Vadodara | Gujarat |
| India | Research Site | Valsad | Gujarat |
| India | Research Site | Vapi | Gujarat |
| India | Research Site | Varanasi | Uttar Pradesh |
| India | Research Site | Vasai | Maharastra |
| India | Research Site | Vellore | Tamil Nadu |
| India | Research Site | Vijaywada | Andhra Pradesh |
| India | Research Site | Visakhapatnam | Andhra Pradesh |
| India | Research Site | Yamunanagar | Haryana |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |
1 day | |
| Secondary | To analyse different characteristics of Diabetes Mellitus patient in study population | patient characteristics like age, gender | 1 day | |
| Secondary | 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 | 1 day |
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