A Study on Comparison of Glargine Plus Glulisine With Premixed Insulin in Type 2 Diabetes Patients

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a multicentre, randomized, open label on comparison of a Long-Acting Basal Insulin Analog Glargine plus Glulisine with Premixed Insulin in Adult Patients with Type 2 Diabetes Mellitus in 200 patients that will be conducted in seven centers in Tamil Nadu. The primary outcome measures will be to compare the change in HbA1c from baseline to week 24 between Glargine OD + Glulisine in comparison with Premixed insulin initiation in insulin naïve patients with T2DM. The secondary outcomes is to compare the following in the two arms between baseline and 24 weeks Fasting plasma glucose, Postprandial glucose, 7-point self-monitored blood glucose (SMBG) profiles, Percentage of participants with HbA1c < 7%, Insulin dose, Overall adverse events, Symptomatic Hypoglycemia, Severe hypoglycemic, Weight, BMI and Blood pressure.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

1. Insulin naïve 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 ≥ 18 and ≤ 65 years.

3. Have an HbA1c ≥ 7.5% and ≤ 10.5% with fasting blood glucose ≥ 150 mg/dl, and/or Postprandial blood glucose ≥ 200 mg/dl

4. Body mass index (BMI) ≤ 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 > 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