Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 Diabetes
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00613951
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble Insulin Analogue Combination \[SIAC\], insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive subjects with type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 182
- Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
- Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximum 14 days within the last 3 months)
- Treatment with one or two oral anti-diabetic drugs (OADs): metformin, sulfonylurea, other insulin secretagogue (e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 months at a stable maximally tolerated dose or at least half maximally allowed dose according to locally approved summary of product characteristics (SPC)
- HbA1c, 7.0-11.0 % (both inclusive)
- Body Mass Index (BMI), 25.0-37.0 kg/m^2 (both inclusive)
- Metformin contraindication according to local practice
- Thiazolidinedione (TZD) treatment within previous 3 months prior to Visit 1
- Any systemic treatment with products, which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) within 3 months prior to randomisation
- Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system (except for conditions associated with type 2 diabetes) that, in the opinion of the investigator, may confound the results of the trial or pose additional risk in administering trial product
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SIAC 30 (B) metformin - SIAC 45 (B) metformin - BIAsp 30 metformin - SIAC 30 (B) insulin degludec/insulin aspart - SIAC 45 (B) insulin degludec/insulin aspart - BIAsp 30 biphasic insulin aspart -
- Primary Outcome Measures
Name Time Method Change in Glycosylated Haemoglobin (HbA1c) Week 0, Week 16 Change from baseline in HbA1c after 16 weeks of treatment
- Secondary Outcome Measures
Name Time Method Vital Signs: Systolic Blood Pressure (BP) Week 0, Week 16 Values at baseline (Week 0) and at Week 16
Vital Signs: Pulse Week 0, Week 16 Values at baseline (Week 0) and at Week 16
Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) Week -4, Week 16 Laboratory values at screening (Week -4) and at Week 16
Vital Signs: Diastolic Blood Pressure (BP) Week 0, Week 16 Values at baseline (Week 0) and at Week 16
Rate of Major and Minor Hypoglycaemic Episodes Week 0 to Week 16 + 5 days follow up Observed rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) Week 16 Estimate of the overall mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, before bedtime, at 4 am and before breakfast.
Rate of Treatment Emergent Adverse Events (AEs) Week 0 to Week 16 + 5 days follow up Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes Week 0 to Week 16 + 5 days follow up Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 05:59 (included).
Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) Week -4, Week 16 Laboratory values at screening (Week -4) and at Week 16
Physical Examination Week -4, Week 8, Week 16 Physical examination was performed at screening (week -4), and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.
Laboratory Safety Parameters (Biochemistry): Serum Creatinine Week -4, Week 16 Laboratory values at screening (Week -4) and at Week 16
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇪🇸San Juan, Spain