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

Phase 3

Conditions: Health Condition 1: null- Newly diagnosed type 2 Diabetes Mellitus

Registration Number: CTRI/2012/01/002379

Lead Sponsor: CSIR NewDelhi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 220

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

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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