Type II Diabetes MellitusINSIGHTNCT01523405
A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In T2DM
An observational study of Type II Diabetes Mellitus, run by AstraZeneca at 70 sites in India.
Trial summary
This is a non-interventional, cross sectional, multicentric study in T2DM patients which will involve a single visit for study related procedures. This study will be conducted in approximately 5,000 patients at around 300 hospitals/primary care clinics across India. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type II Diabetes Mellitus
- How many people
- 4,911 participants
- Where
- 70 sitesIndia
- Study dates
- Mar 2012to Feb 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 5,000 adult patients (≥ 18 years) diagnosed with T2DM will be randomly selected from around 300 hospitals/primary care clinics across India to participate in this study.
Who may be able to join
- Patients with diagnosis of T2DM for > 1 year prior to entry in the study willing and able to complete the questionnaire and on pharmacotherapy
- Patients who are currently treated with a single or combination of injectable/oral antidiabetic drugs with or without insulin therapy
- Treatment type must be unchanged in the previous 3 months. However, dose modifications are allowed
- Patients who agree to participate in the study and give their written informed consent
Who cannot join
- Patients with type 1 diabetes
- Patients with diabetic ketoacidosis and/or hyperosmolar hyperglycaemic state
- Patients with secondary diabetes (including disease of the exocrine pancreas, endocrinopathies)
- Patients with concurrent treatment involving systemic glucocorticoids. However, inhaled, locally injected and topical use of glucocorticoids is allowed
- Patients suffering from severe cardiac, hepatic, renal diseases as judged by the investigator
- Any condition of the patient which may have an impact on objective and outcome of the trial example: patients currently undergoing major/ minor surgical
Trial locations and contacts
70 sites in 1 country.
70 sites in 1 country
India70 sites
Research Site
Ahemdabad, Gujarat
Research Site
Ahmedabad, Gujarat
Research Site
Anand, Gujarat
Research Site
Bangalore, Karnataka
Research Site
Bhilāi, Uttar Pradesh
Research Site
Bhopal, Madhya Pradesh
Research Site
Bhubaneswar, Odisha
Research Site
Bilāspur, Chhattisgarh
Research Site
Chennai, Gujarat
Research Site
Chennai, Tamil Nadu
Research Site
Coimbatore, Tamil Nadu
Research Site
Cuddlore, Tamil Nadu
Research Site
Delhi, National Capital Territory of Delhi
Research Site
Delhi, New Delhi
Research Site
Dhanbad, Jharkhand
Research Site
Fatepur, Uttar Pradesh
Research Site
Ghaziabad, Uttar Pradesh
Research Site
Gorakhpur, Uttar Pradesh
Research Site
Guwahati, Assam
Research Site
Gwalior, Madhya Pradesh
Research Site
Hanamkoda, Andhra Pradesh
Research Site
Hubli, Karnatka
Research Site
Hyderabad, Andhra Pradesh
Research Site
Indore, Madhya Pradesh
Research Site
Indore(MP), Madhya Pradesh
Research Site
Jaipur, Rajasthan
Research Site
Jodhpur, Rajasthan
Research Site
Kammam, Andhra Pradesh
Research Site
Kanchipuram, Tamil Nadu
Research Site
Kannur, Kerala
Research Site
Kanpur, Karnataka
Research Site
Kanpur, Uttar Pradesh
Research Site
Karaikal, Tamil Nadu
Research Site
Karnāl, Haryana
Research Site
Khammam, Andhra Pradesh
Research Site
Kolkata, West Bangal
Research Site
Kolkata, West Bengal
Research Site
Kota, Rajasthan
Research Site
Kurnool, Andhra Pradesh
Research Site
Lucknow, Uttar Pradesh
Research Site
Ludhiana, Punjab
Research Site
Madurai, Tamil Nadu
Research Site
Mangalore, Karnataka
Research Site
Mangalore, Karnatka
Research Site
Mapusa, Goa
Research Site
Mumbai, Maharashtra
Research Site
Mysore, Bangalore
Research Site
Mysore, Karnataka
Research Site
Mysore, Karnatka
Research Site
Nadiād, Gujarat
Research Site
Nellore, Andhra Pradesh
Research Site
New Delh, New Delhi
Research Site
New Delhi, New Delhi
Research Site
Noida, Uttar Pradesh
Research Site
Panchkula, Haryana
Research Site
Puducherry, Puducherry
Research Site
Pune, Maharashtra
Research Site
Pune, Mahrastra
Research Site
Pushkar, Rajasthan
Research Site
Raipur, Chhattisgarh
Research Site
Ranchi, Jharkhand
Research Site
Thuckalay, Tamil Nadu
Research Site
Trichy, Karnataka
Research Site
Trichy, Tamil Nadu
Research Site
Ujjain, Madhya Pradesh
Research Site
Vadodara, Gujarat
Research Site
Vellore, Tamil Nadu
Research Site
Vijayawada, Andhara Pradesh
Research Site
Vijayawada, Andhra Pradesh
Research Site
Visakhapatnam, Andhra Pradesh
About this study
Official title: A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In Type 2 Diabetes Patients On Pharmacotherapy (INSIGHT)
This is a non-interventional, cross sectional, multicentric study in T2DM patients which will involve a single visit for study related procedures. This study will be conducted in approximately 5,000 patients at around 300 hospitals/primary care clinics across India. Approximately 18-20 patients per site will be enrolled. This study has been designed to evaluate diabetes related quality of life (DQoL), frequency and impact of hypoglycaemia in relation to HbA1c control and to assess disease modifying variables-BMI and BP in T2DM patients on oral / injectable anti-diabetic drugs with/without insulin therapy.
Read the detailed description
A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In Type 2 Diabetes Patients On Pharmacotherapy (INSIGHT)
- Conditions
- Type II Diabetes Mellitus
- Keywords
- Non Interventional Study, Type II Diabetes Mellitus, Quality of Life
- Medical subject headings
- 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 |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetic Quality of Life using Modified 15 item DQoL (MDQoL) questionnaire
Measured: 2nd February 2012 - 2nd August 2012
Secondary outcomes (3)
HbA1c and its correlation with frequency of hypoglycemia
Measured: 2nd February 2012 - 2nd August 2012
Frequency and impact of hypoglycemia using HFS-II (worry subscale)
Measured: 2nd February 2012 - 2nd August 2012
Disease modifying variables Body Mass Index (BMI) and Blood Pressure (BP)
Measured: 2nd February 2012 - 2nd August 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 4,911 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abhay Raut, MD, Principal investigator, Prashanti Clinic,Sashi Kumar, MBBS, Principal investigator, Dianova Diabetes CentreSubodh Chandra, MD, Principal investigator, Chandra Medicals Pvt. LtdDebashish Maji, MD, DM, Principal investigator, Calcutta Diabetes and endocrine Foundation,Mayur Patel, MD, Principal investigator, Swasthya (All India Institute of Diabetes and Research)Nallaperumal Sivagnam, MBBS, Principal investigator, Swamy Diabetes Centre,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523405
- Sponsor's protocol ID
- NIS-CIN-XXX-2011/3
- Acronym
- INSIGHT
- Status last verified
- Sep 2014
- First submitted
- 30 Jan 2012
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In Type 2 Diabetes Patients On Pharmacotherapy (INSIGHT)
- ClinicalTrials.gov ID
- NCT01523405
- Acronym / sponsor ID
- INSIGHT / NIS-CIN-XXX-2011/3
- Conditions
- Type II Diabetes Mellitus
- Keywords
- Non Interventional Study, Type II Diabetes Mellitus, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,911 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 1 Feb 2012 (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 is a non-interventional, cross sectional, multicentric study in T2DM patients which will involve a single visit for study related procedures. This study will be conducted in approximately 5,000 patients at around 300 hospitals/primary care clinics across India. Approximately 18-20 patients per site will be enrolled. This study has been designed to evaluate diabetes related quality of life (DQoL), frequency and impact of hypoglycaemia in relation to HbA1c control and to assess disease modifying variables-BMI and BP in T2DM patients on oral / injectable anti-diabetic drugs with/without insulin therapy.
Detailed description
A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In Type 2 Diabetes Patients On Pharmacotherapy (INSIGHT)
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 5,000 adult patients (≥ 18 years) diagnosed with T2DM will be randomly selected from around 300 hospitals/primary care clinics across India to participate in this study.
Key inclusion criteria (4 listed)
- Patients with diagnosis of T2DM for > 1 year prior to entry in the study willing and able to complete the questionnaire and on pharmacotherapy
- Patients who are currently treated with a single or combination of injectable/oral antidiabetic drugs with or without insulin therapy
- Treatment type must be unchanged in the previous 3 months. However, dose modifications are allowed
- Patients who agree to participate in the study and give their written informed consent
Key exclusion criteria (6 listed)
- Patients with type 1 diabetes
- Patients with diabetic ketoacidosis and/or hyperosmolar hyperglycaemic state
- Patients with secondary diabetes (including disease of the exocrine pancreas, endocrinopathies)
- Patients with concurrent treatment involving systemic glucocorticoids. However, inhaled, locally injected and topical use of glucocorticoids is allowed
- Patients suffering from severe cardiac, hepatic, renal diseases as judged by the investigator
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
Diabetic Quality of Life using Modified 15 item DQoL (MDQoL) questionnaire
Time frame: 2nd February 2012 - 2nd August 2012
3 secondary outcomes
HbA1c and its correlation with frequency of hypoglycemia
Time frame: 2nd February 2012 - 2nd August 2012
Frequency and impact of hypoglycemia using HFS-II (worry subscale)
Time frame: 2nd February 2012 - 2nd August 2012
Disease modifying variables Body Mass Index (BMI) and Blood Pressure (BP)
Time frame: 2nd February 2012 - 2nd August 2012
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 8 Sep 2014.
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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.
Abhay Raut, MD principal investigator
Prashanti Clinic,
Sashi Kumar, MBBS principal investigator
Dianova Diabetes Centre
Subodh Chandra, MD principal investigator
Chandra Medicals Pvt. Ltd
70 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type II Diabetes Mellitus, run by AstraZeneca at 70 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 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 8 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 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?
Diabetic Quality of Life using Modified 15 item DQoL (MDQoL) questionnaire (time frame: 2nd February 2012 - 2nd August 2012). 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 8 Sep 2014; AzTrials last refreshed its copy on 2 Nov 2026.