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)

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868542
• Other study ID #: NN304-3994
• Secondary ID: U1111-1132-9267
• Status: Completed
• Phase: Phase 4
• First received: May 30, 2013
• Last updated: April 27, 2016
• Start date: June 2013
• Est. completion date: May 2015

Study information

• Verified date: April 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods

• - 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin detemir
The subjects will have insulin detemir administered once daily. The dose will be titrated based on the previous breakfast SMPG values.
• insulin detemir
The subjects will have insulin detemir administered once daily. The dose will be titrated based on the previous breakfast SMPG values.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline		Week 0, week 20	No
Secondary	Change in HbA1c		Week -2, week 12	No
Secondary	Proportion of subjects achieving HbA1c below 7.0%		Week 20	No
Secondary	Change in fasting plasma glucose from baseline		week 0, week 12	No
Secondary	Incidence of nocturnal hypoglycaemic episodes (23:00-05:59)		At 20 weeks of treatment and over 24 hours	No
Secondary	Change in fasting plasma glucose from baseline		Week 0, week 20	No
Secondary	Incidence of adverse events		Week 20	No

External Links

•   Clinical Trials at Novo Nordisk