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Long term observational study to check how the patients with Diabetes are managed by doctors and what are the results of different treatments on health effects (on heart, kidney & other organs) on patients over a period

A Prospective observational study of a pan-India cohort of patients with type 2 diabetes mellitus for macrovascular and microvascular complications, glycemic control, and time to treatment adaptation over 3 years. - LANDMARC

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/05/008452
Enrollment
6300
Registered
2017-05-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Type 2 Diabetes Mellitus

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Sanofi India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female patients with type 2 diabetes 2. Patient age at diagnosis of T2DM should be more than 25 years and less than years 3.At the time of inclusion in the study, the duration of T2DM since diagnosis should be at least 2 years 4.Patients currently on 2 or more anti-diabetic agents (with or without glycemic control) 5.Signed Informed Consent before inclusion in the study

Exclusion criteria

Exclusion criteria: 1. Known type 1 diabetes mellitus and secondary diabetes (Eg. Gestational diabetes, fibrocalculus pancreatic diabetes). 2. Limited life expectancy due to terminal diseases such as (but not limited to) end stage renal disease (ESRD), cirrhosis of liver, congestive heart failure and active malignancy. 3. Patients on investigational drug or who have participated in a clinical trial in the previous 3 months.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with macrovascular disease over 36 months [Cumulative incidence]: cardiovascular (non-fatal myocardial infarction, non-fatal stroke and cardiovascular death) and peripheral vascular disease (will be defined by Edinburgh Claudication Questionnaire).Timepoint: Every Year

Secondary

MeasureTime frame
1. Composite renal and retinal microvascular outcome that included the first occurrence of any of the following: Initiation of retinal photocoagulation, vitreous hemorrhage, diabetes-related blindness, or incident or worsening nephropathy.Timepoint: Every Year

Countries

India

Contacts

Public ContactMs Vaishali Kanade

Sanofi India Limited

Deepa.Chodankar@sanofi.com91-9096867313

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 1, 2026