Comparison of Efficacy and Safety of Prandilin and NovoRapid in Newly Diagnosed Type 2 Diabetes

Comparison of Efficacy and Safety of Prandilin and NovoRapid Evaluated by Continuous Glucose Monitoring System in Newly Diagnosed Type 2 Diabetes

To compare the effect of the rapid-acting insulin analogues (RAIAs) NovoRapid (aspart) and Prandilin (lispro) on glycemic variations by Continuous glucose monitoring system (CGMS) in continuous subcutaneous insulin infusion (CSII) with metformin intensive therapy in newly diagnosed type 2 diabetes mellitus (T2DM).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: aspart insulin or lipro insulin

Detailed Description

The study was designed as a single blind randomized control trial. A total of 110 newly type 2 diabetic diagnosed patients with hemoglobin A1c (HbA1c%) above 9% were hospitalized, and were randomly divided into two groups: NovoRapid group (group Asp) and Prandilin group (group Lis) in CSII, combined with metformin therapy. Treatments were maintained for 2-3 weeks after the glycaemic target was reached. To complete the assessment of general information, fasting C-peptide (C-P0), 2-h postprandial C-peptide (C-P2h), fasting insulin (Ins0), 2-h postprandial insulin (Ins2h), HbA1c% and fructosamine on the baseline and endpoint. 4 days continuous glucose monitoring (CGM) was performed on after three days stable glucose.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Nanjing First Hostital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. voluntary to attend this study signed the informed consent; 2. between 18 and 75 years of age; 3. according to the who standards, the subjects should be newly diagnosed as type 2 diabetes; 4. BMI between 19 and 35kg/m2; 5.HbA1c>9%; 6. using enough contraception and not pregnancy; 7. The patients do not attend any medical subjectsin in the last 3 months before enrollment; 8. the subjects agreed to maintain the original diet and exercise habits throughout the study period.

Exclusion Criteria:

1. Patients with severe cardiopulmonary disease; 2. Patients with acute complications (diabetic ketoacidosis, diabetic ketosis hypertonic coma, diabetes lactic acidosis, etc.); 3. Patients with intolerance to metformin allergy to metformin 4. Patients with history of mental disease, and not suitable for the use of insulin pump; 5. Researchers think that the patients does not fit for this research (such as alcoholism, drug abuse, etc.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NovoRapid group (group Asp)	Drug: aspart insulin or lipro insulin; After completing OGTTS, enrolled subjects (new diagnosed T2DM) were randomly assigned into two groups: NovoRapid group (group Asp, Novo Nordisk, Bagsvaerd, Denmark) and Prandilin group (group Lis, Gan & Lee pharmaceuticals, Beijing, China) in CSII, combined with metformin (Bristol-Myers Squibb, USA) therapy. During insulin intensive therapy, every patient general use 1.5g metformin per day. If the patient is unable to tolerate the side effects of metformin, such as diarrhea, nausea, vomiting, allergies, etc., the daily dose of metformin is reduced to 1.0g. If the patients are still unable to tolerate the daily 1.0g of metformin, exit from this study.
Experimental: Prandilin group (group Lis)	Drug: aspart insulin or lipro insulin; After completing OGTTS, enrolled subjects (new diagnosed T2DM) were randomly assigned into two groups: NovoRapid group (group Asp, Novo Nordisk, Bagsvaerd, Denmark) and Prandilin group (group Lis, Gan & Lee pharmaceuticals, Beijing, China) in CSII, combined with metformin (Bristol-Myers Squibb, USA) therapy. During insulin intensive therapy, every patient general use 1.5g metformin per day. If the patient is unable to tolerate the side effects of metformin, such as diarrhea, nausea, vomiting, allergies, etc., the daily dose of metformin is reduced to 1.0g. If the patients are still unable to tolerate the daily 1.0g of metformin, exit from this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary endpoint was the between-group difference of MAGE	the 24-h mean amplitude of glycemic excursions (MAGE)	14 days

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Study Director: Bingli Liu, Doctor, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: July 19, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Continuous glucose monitoring system (CGMS); Continuous subcutaneous insulin infusion (CSII); Rapid-acting insulin analogues
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin Aspart
• Other Study ID Numbers: DIA-THY-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No