Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes

Phase 2CompletedNCT00612040

Novo Nordisk A/S178 enrolled

Overview

This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of this trial is to compare two NN1250 (insulin degludec) formulations with each other and with insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

178

Conditions

Diabetes Diabetes Mellitus, Type 1

Interventions

insulin degludecDRUG

Formulation 1: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily

insulin degludecDRUG

Formulation 2: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily

insulin glargineDRUG

Treat-to-target dose titration scheme, injection s.c., once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 1 diabetes for at least one year * HbA1c 7-11% (both inclusive) * Treated with insulin for at least six months - any regimen Exclusion Criteria: * Any systemic treatment with products which in the Investigator's opinion could interfere with glucose or lipid metabolism (eg systemic corticosteroids) 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 that, in the opinion of the Investigator, may confound the results of the trial or pose additional risk in administering trial product

Locations (33)

Outcomes

Primary Outcomes

Change in Glycosylated Haemoglobin (HbA1c)

Change from baseline in HbA1c after 16 weeks of treatment

Time frame: Week 0, Week 16

Secondary Outcomes

Change in Fasting Plasma Glucose (FPG)

Change from baseline in FPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) after 16 weeks of treatment

Time frame: Week 0, Week 16

Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)

Estimate of the overall mean of SMPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) 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, bedtime, at 4 am and before breakfast.

Time frame: Week 16

Rate of Major and Minor Hypoglycaemic Episodes

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.

Time frame: Week 0 to Week 16 + 5 days follow up

Rate of Nocturnal Major and Minor Hypoglycaemic Episodes

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 06:00 (excluded).

Time frame: Week 0 to Week 16 + 5 days follow up

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.

Data from ClinicalTrials.gov

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