Comparison of NN1250 Plus Insulin Aspart With Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes

Novo Nordisk A/S629 enrolled

Overview

This trial is conducted in Africa, Europe and the United States of America (USA). The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients with type 1 diabetes. The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension period is registered as NN1250-3644.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

629

Conditions

Diabetes Diabetes Mellitus, Type 1

Interventions

insulin degludecDRUG

Injected subcutaneously once daily. Dose was individually adjusted.

insulin glargineDRUG

Injected subcutaneously once daily. Dose individually adjusted.

insulin aspartDRUG

Injected subcutaneously as mealtime insulin. Dose was individually adjusted.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 1 diabetes mellitus for at least 12 months * Current treatment with any basal bolus insulin for at least 12 months * HbA1c below or equal to 10.0% * BMI (Body Mass Index) below or equal to 35.0 kg/m\^2 * For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3583 (NCT00982228) Exclusion Criteria: * Use of any other antidiabetic drug than insulin within the last 3 months * Cardiovascular disease within the last 6 months * Uncontrolled treated/untreated severe hypertension * Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months * Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements * Cancer and medical history of cancer

Locations (91)

Outcomes

Primary Outcomes

Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment

Change from baseline in HbA1c after 52 weeks of treatment

Time frame: Week 0, Week 52

Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)

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.

Time frame: Week 0 to Week 104 + 7 days follow up

Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.

Time frame: Week 0 to Week 104 + 7 days follow up

Extension Trial (Primary Endpoint): Cross-reacting Antibodies to Human Insulin

The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing and after a 1-week wash-out period.

Time frame: Week 0, Week 106

Secondary Outcomes

Data from ClinicalTrials.gov

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