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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03226210
• Other study ID #: DIA-THY-2
• Status: Completed
• Phase: Phase 4
• First received: July 19, 2017
• Last updated: July 19, 2017
• Start date: February 1, 2015
• Est. completion date: July 1, 2016

Study information

• Verified date: July 2017
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 1, 2016
• Est. primary completion date: May 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
China	Nanjing First Hostital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint was the between-group difference of MAGE	the 24-h mean amplitude of glycemic excursions (MAGE)	14 days