DiabetesSTART-INDIANCT02208921
An Observational, Cross Sectional Study to Assess the Prevalence of Chronic Kidney Disease (CKD) in Type 2 Diabetes Patients
An observational study of Diabetes, run by AstraZeneca at 18 sites in India.
Trial summary
This non-interventional, multi-centric, cross-sectional study is aimed to determine the prevalence of Chronic Kidney Disease in Indian patients with Type 2 Diabetes (T2DM). 3000 patients will be enrolled from 30 investigative sites all over the country. Each investigative site will be expected to enrol 100 subjects. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes
- How many people
- 3,000 participants
- Where
- 18 sitesIndia
- Study dates
- Sep 2014to May 2015
- How long will I take part?
- 1 Day
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A total of 3000 T2DM patients of either gender with age of 18 years and more will be enrolled in the study after the Informed Consent Process.
Who may be able to join
- Known cases of T2DM.
- Male and female patients aged 18 years and above.
- Must provide written Informed consent.
Who cannot join
- Patients with known type-1 diabetes.
- Patients with any form of acute kidney injury based on investigator's discretion.
- Patients on maintenance dialysis or known renal transplant patients.
- Patients who have participated in any interventional study within past 3 months prior to entry in this study.
- Pregnant women.
- Patients with symptomatic Urinary Tract Infection (UTI) or with history of hematuria.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
India18 sites
Research Site
Ahmedabad
Research Site
Bangalore
Research Site
Chandigarh
Research Site
Chennai
Research Site
Coimbatore
Research Site
Delhi
Research Site
Ghaziabad
Research Site
Hyderabad
Research Site
Jaipur
Research Site
Kanpur
Research Site
Karnāl
Research Site
Kolkata
Research Site
Ludhiana
Research Site
Mumbai
Research Site
Noida
Research Site
Pune
Research Site
Rohtak
Research Site
Trivandrum
About this study
Official title: An Observational, Cross Sectional Study to Assess the Prevalence of Chronic Kidney Disease in Type 2 Diabetes Patients in India
This non-interventional, multi-centric, cross-sectional study is aimed to determine the prevalence of Chronic Kidney Disease in Indian patients with Type 2 Diabetes (T2DM). 3000 patients will be enrolled from 30 investigative sites all over the country. Each investigative site will be expected to enrol 100 subjects. All the procedures will be completed in a single day.
Read the detailed description
This is an observational, multicenter, cross-sectional study to be conducted at 30 sites in India. Endocrinologist/ Diabetologist from multiple private clinics will evaluate the Type 2 Diabetes patients. The study will be conducted over 9-10 months and will be started after obtaining written approval of Independent Ethics Committee (IEC) and written Informed consent of the patient. . Each investigative site will be expected to enrol 100 subjects. All the procedures will be completed in a single day.
- Conditions
- Diabetes
- Keywords
- Type 2 Diabetes
- 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 group | Role | What they receive |
|---|---|---|
| T2DM patients with Chronic Kidney Disease | T2DM patients with Chronic Kidney Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of T2DM patients with Chronic Kidney Disease (CKD)
The proportion of T2DM patients with CKD as per GFR (Glomerular Filtration Rate)criteria. GFR below 90 ml/min/1.73 m2 is defined as CKD. we will also classify CKD into various groups as per the KDIGO 2013.
Measured: 1 day
Secondary outcomes (3)
Frequency of T2DM patients in various stages of CKD
The proportion of T2DM patients with CKD as per GFR (Glomerular Filtration Rate)criteria. We will also classify CKD into various groups as per the KDIGO (KIDNEY DISEASE IMPROVING GLOBAL OUTCOMES) 2013.
Measured: 1 day
Frequency of T2DM patients with CKD in patients with different duration of T2DM
The proportion of T2DM patients with CKD as per GFR (Glomerular Filtration Rate)criteria.we will also classify CKD into various groups as per the KDIGO 2013.
Measured: 1 day
Frequency of patients with HbA1C less than 7% in T2DM patients with and without CKD
Frequency of patients with HbA1C (Glycated Haemoglobin) less than 7% in T2DM patients with and without CKD. we will correlate prevalence of CKD with HbA1C level.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Prasanna Kumar K.M, DM, Study chair, Endocrinology Center for Diabetes and Endocrine Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208921
- Sponsor's protocol ID
- D1843R00050
- Other IDs
- NIS-DIN-XXX-2014/1
- Acronym
- START-INDIA
- Status last verified
- Mar 2016
- First submitted
- 4 Aug 2014
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Cross Sectional Study to Assess the Prevalence of Chronic Kidney Disease in Type 2 Diabetes Patients in India
- ClinicalTrials.gov ID
- NCT02208921
- Acronym / sponsor ID
- START-INDIA / D1843R00050
- Conditions
- Diabetes
- Keywords
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 5 Aug 2014 (estimated)
- 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.
This non-interventional, multi-centric, cross-sectional study is aimed to determine the prevalence of Chronic Kidney Disease in Indian patients with Type 2 Diabetes (T2DM). 3000 patients will be enrolled from 30 investigative sites all over the country. Each investigative site will be expected to enrol 100 subjects. All the procedures will be completed in a single day.
Detailed description
This is an observational, multicenter, cross-sectional study to be conducted at 30 sites in India. Endocrinologist/ Diabetologist from multiple private clinics will evaluate the Type 2 Diabetes patients. The study will be conducted over 9-10 months and will be started after obtaining written approval of Independent Ethics Committee (IEC) and written Informed consent of the patient. . Each investigative site will be expected to enrol 100 subjects. All the procedures will be completed in a single day.
Study design
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T2DM patients with Chronic Kidney Disease | – | –T2DM patients with Chronic Kidney Disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 3000 T2DM patients of either gender with age of 18 years and more will be enrolled in the study after the Informed Consent Process.
Key inclusion criteria (3 listed)
- Known cases of T2DM.
- Male and female patients aged 18 years and above.
- Must provide written Informed consent.
Key exclusion criteria (6 listed)
- Patients with known type-1 diabetes.
- Patients with any form of acute kidney injury based on investigator's discretion.
- Patients on maintenance dialysis or known renal transplant patients.
- Patients who have participated in any interventional study within past 3 months prior to entry in this study.
- Pregnant women.
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
The proportion of T2DM patients with Chronic Kidney Disease (CKD)
Time frame: 1 day
The proportion of T2DM patients with CKD as per GFR (Glomerular Filtration Rate)criteria. GFR below 90 ml/min/1.73 m2 is defined as CKD. we will also classify CKD into various groups as per the KDIGO 2013.
3 secondary outcomes
Frequency of T2DM patients in various stages of CKD
Time frame: 1 day
Frequency of T2DM patients with CKD in patients with different duration of T2DM
Time frame: 1 day
Frequency of patients with HbA1C less than 7% in T2DM patients with and without CKD
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 25 Mar 2016.
- CSR\_SynopsisLink provided by the sponsor.
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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.
Dr. Prasanna Kumar K.M, DM study chair
Endocrinology Center for Diabetes and Endocrine Care
18 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, run by AstraZeneca at 18 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 3 inclusion and 6 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 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
The proportion of T2DM patients with Chronic Kidney Disease (CKD) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2016.