Clinical trial NCT01868542: A Trial Comparing the Glycaemic Control of Levemir® Administered Once Daily According to Two Insulin Detemir Titration Algorithms After 20 Weeks in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Treatment With or Without Other Anti-diabetic Drugs (OADs)
Official title: A 20-week, Randomised, Multi-centre, Open-labelled Trial Comparing the Glycaemic Control of Levemir® Administered Once Daily According to Two Titration Algorithms (3-0-3 Algorithm and 2-4-6-8 Algorithm) After 20 Weeks in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Treatment in Korea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-06-04
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The aim of the trial is to compare the glycaemic control of Levemir® (insulin detemir) administered once daily according to two titration algorithms after 20 weeks in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without other anti-diabetic drugs (OADs).


Eligibility criteria: Inclusion Criteria:

* - Diagnosed with type 2 diabetes mellitus at least 3 months prior to Visit 1 (week -2)
* - Treatment with at least 1000 mg metformin per day with/without other OADs at a stable dose (at either the maximal tolerated dose or at least half of the maximum recommended dose according to the package insert) for at least 3 months prior to Visit 1
* - Insulin-naïve subjects
* - HbA1c above or equal to 7.5% by central laboratory analysis
* - Body mass index (BMI) below or equal to 35.0 kg/m\^2

Exclusion Criteria:

* - Female who is breast-feeding
* - The receipt of any investigational product within 4 weeks prior to Visit 1
* - Any contraindication to insulin detemir according to the domestic labelling
* - Anticipated change of dose of any systemic treatment with products, which in the investigator's opinion could interfere with glucose metabolism (such as systemic corticosteroids, beta-blockers, monoamine oxidase \[MAO\] inhibitors)
* - Clinically significant diseases which, in the investigator's opinion, may confound the results of the trial or pose additional risk in administering trial product
* - Any conditions that the investigator judges would interfere with trial participation or evaluation of the results

Primary outcomes:
measure: Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline.
timeFrame: Week 0, week 20
Secondary outcomes:
measure: Change in HbA1c
timeFrame: Week 0, week 12
measure: Proportion of Subjects Achieving HbA1c Below 7.0%
timeFrame: Week 20
measure: Change in Fasting Plasma Glucose From Baseline
timeFrame: week 0, week 12
measure: Incidence of Hypoglycaemic Episodes : Nocturnal (23:00-05:59) and Over 24 Hours.
timeFrame: For 20 weeks of treatment and over 24 hours
measure: Change in Fasting Plasma Glucose From Baseline
timeFrame: Week 0, week 20
measure: Incidence of Adverse Events
timeFrame: Week 20
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Daejeon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Daejeon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Daejeon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Daejeon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Daejeon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: