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

NCT02987751 | Completed Phase 4 DMC

• 1 other identifier: IDRFARH007
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 8

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Changes in Fasting Blood Glucose

  Baseline and 24 weeks

• Changes in postprandial blood glucose

  Baseline and 24 weeks

• Changes in 7 point self monitored blood glucose profile

  Baseline and 24 weeks

• Percentage reduction of HbA1c < 7%

  Baseline and 24 weeks

• Changes in Insulin dose

  Baseline and 24 weeks

Study Arms (2)

Glargine + Glulisine

EXPERIMENTAL

Insulin Glargine + Glulisine (12U/day + 4U/day) at pre-breakfast/dinner for 24 weeks

Drug: Glargine + Glulisine

Premixed Analogue Insulin (70/30)

ACTIVE COMPARATOR

Premixed analogue Insulin (70/30) 16U/day at pre-breakfast/dinner for 24 weeks

Drug: Premixed analogue insulin (70/30)

Interventions

Glargine + Glulisine DRUG

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

Also known as: Lantus + Apidra

Glargine + Glulisine

Premixed analogue insulin (70/30) DRUG

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

Also known as: Novomix

Premixed Analogue Insulin (70/30)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Insulin naïve men and women with T2DM on stable dose of 2 or 3 OHAs for at least 3 months.
• Both men and women of age ≥ 18 and ≤ 65 years.
• Have an HbA1c ≥ 7.5% and ≤ 10.5% with fasting blood glucose ≥ 150 mg/dl, and/or Postprandial blood glucose ≥ 200 mg/dl
• Body mass index (BMI) ≤ 40 kg/m2.
• Have given written informed consent to participate in this study in accordance with local regulations.
• Subject must have access to telephone for calling into the clinical center as part of test product compliance.

You may not qualify if:

• Type 1 diabetes
• BMI \> 40 kg/m2
• Subject is being treated for severe active infection of any type
• Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.
• Planned surgery in the next 6 months
• Any event forecasted to require a temporary need to switch to insulin

Sponsors & Collaborators

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

Study Sites (8)

Dr.Mallikarjnn Jali

Belagavi, Karnataka, 590010, India

Location

Singhvi Health Centre

Chennai, Tamil Nadu, 600 019, India

Location

MedWay Hospitals

Chennai, Tamil Nadu, 600024, India

Location

Kovai Diabetes Speciality Center and Hospital

Coimbatore, Tamil Nadu, 641009, India

Location

Arthur Asirvatham Hospital

Madurai, Tamil Nadu, 625 020, India

Location

M.G.Diabetes Speciality and Research Center

Salem, Tamil Nadu, 636016, India

Location

Ramana Maharishi Rangammal Hospital

Tiruvannamalai, Tamil Nadu, 606 603, India

Location

Trichy Diabetes Speciality Center (P) Ltd

Trichy, Tamil Nadu, 620018, India

Location

MeSH Terms

Interventions

Insulin Glargine; insulin glulisine; Insulin Aspart

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Officials

• Ambady Ramachandran, MD,Ph.D,D.Sc

  President, India Diabetes Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 9, 2016
• Study Start: December 29, 2016
• Primary Completion: September 1, 2018
• Study Completion: June 1, 2019
• Last Updated: September 10, 2019

Record last verified: 2019-09

Locations

IN (8)