Trial of short and extended period insulin treatment for newly detected type-2 diabetes patients

Effect of short term versus extended period early intensive conventional insulin therapy on beta cell function, insulin resistance, glycemic control and long term remission rate in newly diagnosed type 2 diabetes: a randomized parallel group trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/01/002379

Enrollment

220

Registered

2012-01-25

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- Newly diagnosed type 2 Diabetes Mellitus

Interventions

Intervention1: split mixed human insulin: 2 weeks of insulin treatment Control Intervention1: split mixed human insulin: 12 weeks of insulin treatment

Eligibility

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed T2DM patients (treatment naÃ¯ve, less than six months since diagnosis) of both sexes aged 25-65 years who have failed to diet and exercise therapy alone (diagnosis would be based on American Diabetes Association recommendations) 2. Willing to give informed consent after explaining the purpose, nature and potential risks of the study

Exclusion criteria

Exclusion criteria: 1. Acute or severe chronic diabetic complications 2. Severe intercurrent illness(the condition or the treatment there of is likely to affect the study outcomes) 3. Impaired renal functions (S. Creatinine 1.5 mg% in males and 1.4 mg% in females) 4. Impaired hepatic functions (Serum bilirubin, SGOT, SGPT, and Alkaline phosphatase 1.5 times the upper limit of normal) 5. Tested positive for glutamic acid decarboxylase antibody 6. Maturity onset diabetes in youth (exclusion by history) 7. Patients requiring 1.3U/kg body weight of insulin at the end of titration phase. 8. Pregnancy / lactation 9. Malignancy (previously documented) 10. Ischemic heart disease (previously documented)

Design outcomes

Primary

Measure	Time frame
1. Proportion of patients achieving remission at 12 months in both the groups and glycemic control in both the groups over 12 months post intensive insulin treatment.Timepoint: 0 day, 7 days, 1 month, 2, 3, 6, 9 and 12 months	—

Secondary

Measure	Time frame
1. Time to relapse of hyperglycemia and addition of first OAD i.e. metformin in both the groups 2. Time to addition of second OAD. 3. Beta cell function in both the treatment groups at 12 months of follow-up compared to end of insulin treatment. Timepoint: 0 day, 7 days, 1 month, 2, 3, 6, 9 and 12 months	—

Countries

Argentina, India

Contacts

Public ContactDr Smita Pattanaik

PGIMER, Chandigarh

drs_pattanaik@yahoo.com0172-2755240

Outcome results

None listed

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