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

NCT02987751 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-09-10

No results posted yet for this study

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.

Conditions

  • Type2 Diabetes

Interventions

DRUG

Glargine + Glulisine

Glargine should be taken 30 minutes before breakfast/dinner, the dose is adjusted as per fasting blood glucose during each visit and Glulisine should be taken 20 minutes before breakfast/dinner, the dose is adjusted as per postprandial blood glucose during each visit

DRUG

Premixed analogue insulin (70/30)

Premixed analogue insulin should be taken 30 minutes before breakfast/dinner, the dose is adjusted as per fasting blood glucose during each visit.

Sponsors & Collaborators

  • India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

    lead OTHER

Principal Investigators

  • Ambady Ramachandran, MD,Ph.D,D.Sc · President, India Diabetes Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-29
Primary Completion
2018-09-30
Completion
2019-06-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02987751 on ClinicalTrials.gov