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To compare the effect of oral drugs for Type 2 diabetes mellitus with insulin therapy in two randomised groups,to see remission of diabetes in two arms.

Conventional vs low dose insulin therapy for management of Type2 Diabetes Mellitus : A Randomised Open label Study of newly diagnosed Type 2 Diabetes Mellitus patients - ROLIDM

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/07/002816
Enrollment
80
Registered
2012-07-20
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- Diabetes Mellitus type 2.

Interventions

Intervention1: Insulin premixed 30/70,twice dosing 8 -15 units per day.: . Patients will be randomised in to 2 groups and followed up every 4 weeks. At each of these visits one of the study physician

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Newly diagnosed type 2 diabetics. • Drug/insulin naïve. • T2DM as per WHO criteria

Exclusion criteria

Exclusion criteria: • Previous pharmacological treatment for diabetes. • Type 1 diabetes. • Diabetes with pregnancy • Secondary diabetes. • Acute complications.

Design outcomes

Primary

MeasureTime frame
To study the effect of treatment in insulin and the conventional treatment group for achievement of normoglycaemia.Timepoint: 1)At start of treatment.2)At 15 days of treatment.3) 1month of treatment. 4)2 months of treatment.5) 3 months of treatment.6) After 6 months of treatment 3 times.

Secondary

MeasureTime frame
To assess effect of low dose insulin therapy on development / progression of complications in newly diagnosed patients with T2DMTimepoint: Every 6 monthly for 18 months

Countries

India

Contacts

Public ContactDr A C Ammini

AIIMS

aca433@yahoo.com09868397600

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026