ClinicalTrials.gg
CompletedNCT03363594IP RegistryUpdated Jun 16, 2020

Indian Phenotype Registry

An observational study in Diabetes Mellitus, sponsored by AstraZeneca. Completed at 197 sites in India. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-06-16.

Sponsored by AstraZeneca · Observational

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Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
40,000
Ages
18 Years to 99 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 122 studies in Diabetes Mellitus by AstraZeneca — none open to participants now, none under way, none of them phase 3. Diabetes Mellitus · AstraZeneca.

Enrollment
2nd of 30
40,000 · median 1,267
Started
2017
with 2 others
Observational
31 of 122
none open now
Registered
114th of 122
by date

Among the 122 studies in Diabetes Mellitus by AstraZeneca, this one is the 2nd largest by enrollment of the 30 observational ones that give a count, is one of 3 that started in 2017, is one of 31 observational ones, and was the 114th registered.

Diabetes Mellitus

8,292 studies on the registry are indexed under Diabetes Mellitus; 1,074 are open to participants now.

Browse Diabetes Mellitus studies →

Open to participants now

None of the 122 studies in Diabetes Mellitus by AstraZeneca is open now. The open studies under Diabetes Mellitus, anywhere →

Who these studies take

Of the 650 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 197 (30%) stop at 75 or younger; 88 take children under 18; 183 take healthy volunteers.

This study: 18 Years to 99 Years · all sexes · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 122 studies in Diabetes Mellitus by AstraZeneca as a file.
02

Study 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).

Read the 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

03

Conditions studied

  • Diabetes Mellitus

Keywords

  • Diabetes, T2D
04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Diabetes Mellitus patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria- None

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
40,000 participants (actual)
Patient registry
No

Groups and cohorts

  • 1

    Diabetes Mellitus

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

Secondary outcomes

  1. To analyse different characteristics of Diabetes Mellitus patient in study population

    patient characteristics like age, gender

    Time frame: 1 day

  2. 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

    Time frame: 1 day

07

Study locations

197 sites
  • Research Site
    Guntur, Andhra Pradesh D1843R00282, India
  • Research Site
    Kakinada, Andhra Pradesh D1843R00282, India
  • Research Site
    Madanapalle, Andhra Pradesh D1843R00282, India
  • Research Site
    Nellore, Andhra Pradesh D1843R00282, India
  • Research Site
    Rajahmundry, Andhra Pradesh D1843R00282, India
  • Research Site
    Vijaywada, Andhra Pradesh D1843R00282, India
  • Research Site
    Visakhapatnam, Andhra Pradesh D1843R00282, India
  • Research Site
    Dibrugarh, Assam D1843R00282, India
  • Research Site
    Guwahati, Assam D1843R00282, India
  • Research Site
    Nagaon, Assam D1843R00282, India
  • Research Site
    Silchar, Assam D1843R00282, India
  • Research Site
    Tinsukia, Assam D1843R00282, India
  • Research Site
    Bhagalpur, Bihar D1843R00282, India
  • Research Site
    Gaya, Bihar D1843R00282, India
  • Research Site
    Patna, Bihar D1843R00282, India
  • Research Site
    Samastipur, Bihar D1843R00282, India
  • Research Site
    Samstipur, Bihar D1843R00282, India
  • Research Site
    Bhilai, Chhattisgarh D1843R00282, India
  • Research Site
    Durg, Chhattisgarh D1843R00282, India
  • Research Site
    Raipur, Chhattisgarh D1843R00282, India
  • Research Site
    Rohtak, Chhattisgarh D1843R00282, India
  • Research Site
    New Delhi, Delhi D1843R00282, India
  • Research Site
    Ahmedabad, Gujarat D1843R00282, India
  • Research Site
    Amreli, Gujarat D1843R00282, India
  • Research Site
    Anand, Gujarat D1843R00282, India
  • Research Site
    Bharuch, Gujarat D1843R00282, India
  • Research Site
    Bhavnagar, Gujarat D1843R00282, India
  • Research Site
    Bhuj, Gujarat D1843R00282, India
  • Research Site
    Borsad, Gujarat D1843R00282, India
  • Research Site
    Botad, Gujarat D1843R00282, India
  • Research Site
    Chaibasa, Gujarat D1843R00282, India
  • Research Site
    Dahod, Gujarat D1843R00282, India
  • Research Site
    Himatnagar, Gujarat D1843R00282, India
  • Research Site
    Jamnagar, Gujarat D1843R00282, India
  • Research Site
    Junagadh, Gujarat D1843R00282, India
  • Research Site
    Kutch, Gujarat D1843R00282, India
  • Research Site
    Morbi, Gujarat D1843R00282, India
  • Research Site
    Nadiad, Gujarat D1843R00282, India
  • Research Site
    Navsari, Gujarat D1843R00282, India
  • Research Site
    Patan, Gujarat D1843R00282, India
  • Research Site
    Porbandar, Gujarat D1843R00282, India
  • Research Site
    Rajkot, Gujarat D1843R00282, India
  • Research Site
    Surat, Gujarat D1843R00282, India
  • Research Site
    Unnao, Gujarat D1843R00282, India
  • Research Site
    Vadodara, Gujarat D1843R00282, India
  • Research Site
    Valsad, Gujarat D1843R00282, India
  • Research Site
    Vapi, Gujarat D1843R00282, India
  • Research Site
    Bangalore, Haryana D1843R00282, India
  • Research Site
    Faridabad, Haryana D1843R00282, India
  • Research Site
    Gurugram, Haryana D1843R00282, India
  • Research Site
    Hisar, Haryana D1843R00282, India
  • Research Site
    Panchkula, Haryana D1843R00282, India
  • Research Site
    Panipat, Haryana D1843R00282, India
  • Research Site
    Rohtak, Haryana D1843R00282, India
  • Research Site
    Sonipat, Haryana D1843R00282, India
  • Research Site
    Yamunanagar, Haryana D1843R00282, India
  • Research Site
    Mandi, Himachal Pradesh D1843R00282, India
  • Research Site
    Srinagar, Jammu And Kashmir D1843R00282, India
  • Research Site
    Jamshedpur, Jharkhand D1843R00282, India
  • Research Site
    Ranchi, Jharkhand D1843R00282, India
  • Research Site
    Bangalore, Karnataka D1843R00282, India
  • Research Site
    Belgaum, Karnataka D1843R00282, India
  • Research Site
    Gulbarga, Karnataka D1843R00282, India
  • Research Site
    Angamaly, Kerala D1843R00282, India
  • Research Site
    Chengannur, Kerala D1843R00282, India
  • Research Site
    Edappally, Kerala D1843R00282, India
  • Research Site
    Ernakulam, Kerala D1843R00282, India
  • Research Site
    Idukki, Kerala D1843R00282, India
  • Research Site
    Kochi, Kerala D1843R00282, India
  • Research Site
    Kollam, Kerala D1843R00282, India
  • Research Site
    Kottayam, Kerala D1843R00282, India
  • Research Site
    Malappuram, Kerala D1843R00282, India
  • Research Site
    Nedumangad, Kerala D1843R00282, India
  • Research Site
    Palakkad, Kerala D1843R00282, India
  • Research Site
    Pezhakkappilly, Kerala D1843R00282, India
  • Research Site
    Thalassery, Kerala D1843R00282, India
  • Research Site
    Thiruvananthapuram, Kerala D1843R00282, India
  • Research Site
    Thrissur, Kerala D1843R00282, India
  • Research Site
    Trivandrum, Kerala D1843R00282, India
  • Research Site
    Bhopal, Madhya Pradesh D1843R00282, India
  • Research Site
    Guna, Madhya Pradesh D1843R00282, India
  • Research Site
    Gwalior, Madhya Pradesh D1843R00282, India
  • Research Site
    Indore, Madhya Pradesh D1843R00282, India
  • Research Site
    Jabalpur, Madhya Pradesh D1843R00282, India
  • Research Site
    Mandsaur, Madhya Pradesh D1843R00282, India
  • Research Site
    Ujjain, Madhya Pradesh D1843R00282, India
  • Research Site
    Ahmednagar, Maharastra D1843R00282, India
  • Research Site
    Aurangabad, Maharastra D1843R00282, India
  • Research Site
    Bhiwandi, Maharastra D1843R00282, India
  • Research Site
    Kalyan, Maharastra D1843R00282, India
  • Research Site
    Kolhapur, Maharastra D1843R00282, India
  • Research Site
    Mumbai, Maharastra D1843R00282, India
  • Research Site
    Nagpur, Maharastra D1843R00282, India
  • Research Site
    Nasik, Maharastra D1843R00282, India
  • Research Site
    Navi Mumbai, Maharastra D1843R00282, India
  • Research Site
    Palanpur, Maharastra D1843R00282, India
  • Research Site
    Palghar, Maharastra D1843R00282, India
  • Research Site
    Pune, Maharastra D1843R00282, India
  • Research Site
    Raigad, Maharastra D1843R00282, India
  • Research Site
    Rajkot, Maharastra D1843R00282, India

Showing the first 100 of 197 sites. Choose a country and city above to see the rest.

08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2017 to primary completion in Jun 2019, 18 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 20, 2017
First posted
Dec 6, 2017
StartActual
Dec 11, 2017
Primary completionActual
Jun 14, 2019
CompletionActual
Jun 14, 2019
Last update
Jun 16, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03363594
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Dec 6, 2017
Start date
Dec 11, 2017
Primary completion
Jun 14, 2019
Completion
Jun 14, 2019
Last update
Jun 16, 2020
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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