| Trial ID: | L7364 |
| Source ID: | NCT02987751
|
| Associated Drug: |
Glargine + Glulisine
|
| Title: |
A Study on Comparison of Glargine Plus Glulisine With Premixed Insulin in Type 2 Diabetes Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type2 Diabetes
|
| Interventions: |
DRUG: Glargine + Glulisine|DRUG: Premixed analogue insulin (70/30)
|
| Outcome Measures: |
Primary: Changes in HbA1c, 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, Baseline and 24 weeks | Secondary: Changes in Fasting Blood Glucose, Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of changes in fasting blood glucose, Baseline and 24 weeks|Changes in postprandial blood glucose, Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of changes in postprandial blood glucose, Baseline and 24 weeks|Changes in 7 point self monitored blood glucose profile, Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of changes in 7 point self monitored blood glucose profile, Baseline and 24 weeks|Percentage reduction of HbA1c < 7%, Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of percentage reduction of HbA1c \< 7%, Baseline and 24 weeks|Changes in Insulin dose, Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of changes in Insulin dose, Baseline and 24 weeks|Number of events of symptomatic hypoglycemia, Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of number of events of symptomatic hypoglycemia, Baseline and 24 weeks|Number of events of severe hypoglycemia, Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of number of events of severe hypoglycemia, Baseline and 24 weeks|Changes in weight, Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of changes in Weight, Baseline and 24 weeks|Changes in Body mass index, Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of changes in body mass index, Baseline and 24 weeks|Changes in blood pressure, Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of changes in blood pressure, Baseline and 24 weeks|Number of participants treated related to adverse events, Number of adverse event observed in both Glargine + Glulisine and Premixed analogue Insulin group will be assessed, Baseline and 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
200
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2016-12-29
|
| Completion Date: |
2019-06
|
| Results First Posted: |
|
| Last Update Posted: |
2019-09-10
|
| Locations: |
Dr.Mallikarjnn Jali, Belgaum, Karnataka, 590010, India|Singhvi Health Centre, Chennai, Tamil Nadu, 600 019, India|MedWay Hospitals, Chennai, Tamil Nadu, 600024, India|Kovai Diabetes Speciality Center and Hospital, Coimbatore, Tamil Nadu, 641009, India|Arthur Asirvatham Hospital, Madurai, Tamil Nadu, 625 020, India|M.G.Diabetes Speciality and Research Center, Salem, Tamil Nadu, 636016, India|Ramana Maharishi Rangammal Hospital, Tiruvannamalai, Tamil Nadu, 606 603, India|Trichy Diabetes Speciality Center (P) Ltd, Trichy, Tamil Nadu, 620018, India
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| URL: |
https://clinicaltrials.gov/show/NCT02987751
|
