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)

NCT ID: NCT01868542

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-05-31

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).

Conditions

Diabetes; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

3-0-3 Algorithm

A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values, the following insulin detemir dose adjustments were done : \>6.1 mmol/L (\>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, \< 4.4 mmol/L (\<80 mg/dL) -3U insulin detemir.

Group Type: EXPERIMENTAL

insulin detemir

Intervention Type: DRUG

Insulin detemir was administered once daily to the subjects. The dose was titrated based on the previous breakfast SMPG values.

2-4-6-8 Algorithm

A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial. During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : \>10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, \<3.1 mmol/L (\<56 mg/dL) -4U insulin detemir.

Group Type: EXPERIMENTAL

insulin detemir

Intervention Type: DRUG

Insulin detemir was administered once daily to the subjects. The dose was titrated based on the previous breakfast SMPG values.

Interventions

insulin detemir

Insulin detemir was administered once daily to the subjects. The dose was titrated based on the previous breakfast SMPG values.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Daejeon, , South Korea

Novo Nordisk Investigational Site

Daejeon, , South Korea

Novo Nordisk Investigational Site

Daejeon, , South Korea

Novo Nordisk Investigational Site

Daejeon, , South Korea

Novo Nordisk Investigational Site

Daejeon, , South Korea

Novo Nordisk Investigational Site

Daejeon, , South Korea

Countries

South Korea

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

U1111-1132-9267

Identifier Type: OTHER

Identifier Source: secondary_id

NN304-3994

Identifier Type: -

Identifier Source: org_study_id