A study on comparison of glargine plus glulisine with premixed insulin in type 2 diabetes patients

Phase 4

Completed

Conditions: Health Condition 1: null- TYPE 2 DIABETES MELLITUS

Registration Number: CTRI/2017/02/007861

Lead Sponsor: India Diabetes Research Foundation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Insulin naÃ¯ve men and women with T2DM on stable dose of 2 or 3 OHAs for at least 3 months

2. Both men and women of age more than or equal to 18 and less than or equal to 65 years

3. Have an HbA1c more than or equal to 7.5% and less than or equal to 10.5% with fasting blood glucose more than or equal to 150 mg/dl and/or Postprandial blood glucose more than or equal to 200 mg/dl

4. Body mass index less than or equal to 40 kg/m2

5. Have given written informed consent to participate in this study in accordance with local regulations

6. Subject must have access to telephone for calling into the clinical center as part of test product compliance

Exclusion Criteria

1. Type 1 diabetes

2. BMI more than 40 kg/m2

3. Subject is being treated for severe active infection of any type

4. Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study

5. Planned surgery in the next 6 months

6. Any event forecasted to require a temporary need to switch to insulin

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the change in HbA1c from baseline to week 24 between Glargine OD + Glulisine in comparison with Premixed insulin initiation in insulin naÃ¯ve patients with T2DMTimepoint: 24 weeks

Secondary Outcome Measures

Name	Time	Method
7-point self-monitored blood glucose (SMBG) profilesTimepoint: 24 weeks;Blood pressureTimepoint: 24 weeks;Body Mass IndexTimepoint: 24 weeks;Fasting plasma glucoseTimepoint: 24 weeks;Insulin DoseTimepoint: 24 weeks;Overall adverse eventsTimepoint: 24 weeks;Percentage of participants with HbA1c less than 7%Timepoint: 24 weeks;Postprandial glucoseTimepoint: 24 weeks;Severe HypoglycemiaTimepoint: 24 weeks;Symptomatic HypoglycemiaTimepoint: 24 weeks;WeightTimepoint: 24 weeks