Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes

Novo Nordisk A/S296 enrolled

Overview

This trial is conducted in Europe, Africa and the United States of America (USA). The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment in type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

296

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

insulin detemirDRUG

Treat-to-target dose titration scheme (individually adjusted dose) for a once daily injection s.c. (under the skin)

insulin aspartDRUG

Administered 1 - 3 times daily, at largest prandial increment, injection s.c. (under the skin)

insulin aspartDRUG

Administered 1 - 3 times daily, at largest meals, injection s.c. (under the skin)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes mellitus for more than 6 months * HbA1c (glycosylated haemoglobin A1c) between 7.5 % and 10.0% at trial initiation (screening) * BMI (Body Mass Index) less than 40 kg/m2 * Basal insulin treatment for at least 3 months (NPH once or twice daily, insulin glargine or detemir once daily) * Treatment with one to 3 OADs Exclusion Criteria: * Known or suspected allergy to trial products or related products * Women who are pregnant, are breast-feeding or intend to become pregnant within the next 48 weeks * Previous participation in any trial including this for the last 6 months * Use of more than 1 U/kg of basal insulin daily at trial initiation (screening)

Locations (69)

Outcomes

Primary Outcomes

Glycosylated Haemoglobin A1c (HbA1c)

Analysed for the full analysis set.

Time frame: week 36

Glycosylated Haemoglobin A1c (HbA1c)

Measured for the Per Protocol analysis set.

Time frame: week 36

Secondary Outcomes

Hypoglycaemic Episodes

Number of hypoglycaemic episodes from Week 0 to Week 36, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Time frame: Weeks 0-36

Biochemistry: Serum Alanine Aminotransferase

Alanine aminotransferase was measured in serum at week 36. Serum samples were analysed at a central laboratory.

Time frame: week 36

Haematology: Haemoglobin Measured in Blood

Haemoglobin was measured in blood samples at week 36. Blood samples were analysed at a central laboratory.

Time frame: week 36

Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide

High-sensitivity C-reactive peptide was measured in serum at week 36. Serum samples were analysed at a central laboratory.

Time frame: week 36

Data from ClinicalTrials.gov

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