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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03226210

Enrollment

110

Registered

2017-07-21

Start date

2015-02-01

Completion date

2016-07-01

Last updated

2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Rapid-acting insulin analogues, Continuous glucose monitoring system (CGMS), Continuous subcutaneous insulin infusion (CSII)

Brief 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).

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.

Interventions

DRUGaspart 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.).

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026