Clinical trial NCT01486966: Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin With or Without Metformin in Chinese Patients With Type 2 Diabetes
Official title: A 2-week, Randomised, Controlled, Open-label, Two-group Parallel, Multi-centre Trial Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin Both in a Basal Bolus Regimen With or Without Metformin in Chinese Inpatients With Type 2 Diabetes Currently Treated With Insulin Qualifying for Intensified Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-07
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of insulin detemir plus insulin aspart and NPH insulin plus human soluble insulin both in a basal bolus regimen with or without metformin in Chinese patients with type 2 diabetes.

The trial adopts a group sequential design, where the analysis of the primary efficacy endpoint will be performed at the interim analysis, in addition to the final formal analysis. The decision to continue or stop the trial will be based on the result of the interim analysis.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus (diagnosed clinically) for at 12 months or longer
* Currently treated with basal insulin once daily or premixed insulin twice daily for at least 3 months with or without OAD(s), and total daily insulin dose less than 1.4 IU (U)/kg (If treated with metformin, unchanged total daily dose of at least 1000 mg for at least 3 months)
* Body Mass Index (BMI) equal to 40 kg/m\^2 or below
* HbA1c (glycosylated haemoglobin A1c) between 7.0% and 10.0% by central laboratory analysis
* Plan to be admitted for optimising glycaemic control at least 2 days prior to the randomisation

Exclusion Criteria:

* Treatment with thiazolidinediones (TZD) or Glucagon-Like Peptide-1 (GLP-1) receptor agonists within the last 3 months prior to the screening
* Anticipated change after the randomisation in concomitant medication known to interfere with glucose metabolism, such as systemic corticosteroids, beta-blockers and mono amine oxidase (MAO) inhibitors
* Previous participation in this trial (participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period.)

Primary outcomes:
measure: Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment
timeFrame: Week 0, week 2
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment
timeFrame: Week 0, week 2
measure: Change From Baseline in Mean 2-hour Post Prandial Plasma Glucose (2hPPG) of 3 Meals After Two Weeks of Treatment
timeFrame: Week 0, week 2
measure: Change From Baseline in Mean Value of Pre-lunch, Pre-dinner and Bedtime PG After Two Weeks of Treatment
timeFrame: Week 0, week 2
measure: Percentage of Subjects Achieving FPG < 6.0 mmol / L After Two Weeks of Treatment
timeFrame: Week 2
measure: Percentage of Subjects Achieving Mean 2hPPG of 3 Meals < 8.0 mmol / L After Two Weeks of Treatment
timeFrame: Week 2
measure: Percentage of Subjects Achieving Both FPG and 2hPPG Targets After Two Weeks of Treatment
timeFrame: Week 2
measure: Percentage of Subjects Achieving FPG Target Without Nocturnal Hypoglycaemia After Two Weeks of Treatment
timeFrame: Week 2
measure: Change From Baseline in Fructosamine After Two Weeks of Treatment
timeFrame: Week 0, week 2
measure: Incidence of Hypoglycaemic Episodes
timeFrame: Weeks 0-2
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Chongqing
country: China
facility: Novo Nordisk Investigational Site
state: Chongqing
city: Wuxi
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Nanchang
country: China
facility: Novo Nordisk Investigational Site
state: Jiangxi
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Guo X, Li Q, Shi Y, Bu R, Liu J, Qu S, Gao Y. Efficacy and safety of insulin detemir plus insulin aspart versus NPH insulin plus human soluble insulin with or without metformin in Chinese type 2 diabetes. Chinese J Diabetes 2014; 22 (1)