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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4
Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4
Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4
Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4
For subjects previously treated with metformin, the dosage and frequency will be kept unchanged
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, China
Novo Nordisk Investigational Site
Chongqing, Chongqing Municipality, China
Novo Nordisk Investigational Site
Wuxi, Jiangsu, China
Novo Nordisk Investigational Site
Nanchang, Jiangxi, China
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, China
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, China
Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment
Mean value of 8-point PG was the arithmetic mean of all 8 time-instant PG values of the 8-point PG profile.
Time frame: Week 0, week 2
Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment
The FPG referred to pre-breakfast plasma glucose.
Time frame: Week 0, week 2
Change From Baseline in Mean 2-hour Post Prandial Plasma Glucose (2hPPG) of 3 Meals After Two Weeks of Treatment
The mean 2hPPG was derived from the 8-point PG profile as the mean value of the available 120 minutes after each meal.
Time frame: Week 0, week 2
Change From Baseline in Mean Value of Pre-lunch, Pre-dinner and Bedtime PG After Two Weeks of Treatment
The mean value of pre-lunch, pre-dinner and bedtime PG was derived from the 8-point PG profile measured before lunch, dinner and bedtime.
Time frame: Week 0, week 2
Percentage of Subjects Achieving FPG < 6.0 mmol / L After Two Weeks of Treatment
Time frame: Week 2
Percentage of Subjects Achieving Mean 2hPPG of 3 Meals < 8.0 mmol / L After Two Weeks of Treatment
Time frame: Week 2
Percentage of Subjects Achieving Both FPG and 2hPPG Targets After Two Weeks of Treatment
FPG target was \< 6.0 mmol / L, 2hPPG target was \< 8.0 mmol / L.
Time frame: Week 2
Percentage of Subjects Achieving FPG Target Without Nocturnal Hypoglycaemia After Two Weeks of Treatment
FPG target was \< 6.0 mmol / L. Nocturnal hypoglycaemia was defined as a hypoglycaemic episode happened between 00:01 and 05:59 a.m. (both included).
Time frame: Week 2
Change From Baseline in Fructosamine After Two Weeks of Treatment
Time frame: Week 0, week 2
Incidence of Hypoglycaemic Episodes
All events summarized were treatment emergent hypoglycaemic events. Hypoglycaemic episodes were summarized based on the ADA classification and also according to an additional definition. Severe hypoglycemia: ADA definition. Minor hypoglycaemic episode: an episode with symptoms with confirmation by plasma glucose (PG) \< 3.1 mmol/l (56 mg/dl) and was handled by the subject himself/herself, or any asymptomatic PG value \< 3.1 mmol/l (56 mg/dl). A hypoglycaemia episode was defined as nocturnal if the time of onset was between 00:01 and 05:59 a.m. (both included), otherwise it was diurnal.
Time frame: Weeks 0-2
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