Back to resultsA 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)
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
insulin detemir
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
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
Sites / Locations
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
3-0-3 Algorithm
2-4-6-8 Algorithm
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline.
Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 20 weeks of treatment. Only the subjects in the full analysis set with HbA1c values after 20 weeks of treatment were included.
Secondary Outcome Measures
Change in HbA1c
Change in HbA1c at 12 weeks of treatment from visit 2.
Proportion of Subjects Achieving HbA1c Below 7.0%
Responder was a dichotomous endpoint (responder/non-responder) that was defined based on whether a subject had met the ADA HbA1c target at end of trial (HbA1c < 7.0% at end of trial) during 20 weeks of treatment.
Change in Fasting Plasma Glucose From Baseline
Change in fasting plasma glucose from baseline.
Incidence of Hypoglycaemic Episodes : Nocturnal (23:00-05:59) and Over 24 Hours.
A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of the investigational medicinal product (IMP), and no later than the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 inclusive. All plasma glucose values: · equal or below 3.9 mmol/L (70 mg/dL) or · higher than 3.9 mmol/L (70 mg/dL) when they occur in conjunction with hypoglycaemic symptoms.
Change in Fasting Plasma Glucose From Baseline
Change in fasting plasma glucose from baseline.
Incidence of Adverse Events
A treatment emergent adverse event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the day of visit 22.(week 20)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01868542
Brief Title
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
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3-0-3 Algorithm
Arm Type
Experimental
Arm Description
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.
Arm Title
2-4-6-8 Algorithm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Description
Insulin detemir was administered once daily to the subjects. The dose was titrated based on the previous breakfast SMPG values.
Primary Outcome Measure Information:
Title
Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline.
Description
Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 20 weeks of treatment. Only the subjects in the full analysis set with HbA1c values after 20 weeks of treatment were included.
Time Frame
Week 0, week 20
Secondary Outcome Measure Information:
Title
Change in HbA1c
Description
Change in HbA1c at 12 weeks of treatment from visit 2.
Time Frame
Week 0, week 12
Title
Proportion of Subjects Achieving HbA1c Below 7.0%
Description
Responder was a dichotomous endpoint (responder/non-responder) that was defined based on whether a subject had met the ADA HbA1c target at end of trial (HbA1c < 7.0% at end of trial) during 20 weeks of treatment.
Time Frame
Week 20
Title
Change in Fasting Plasma Glucose From Baseline
Description
Change in fasting plasma glucose from baseline.
Time Frame
week 0, week 12
Title
Incidence of Hypoglycaemic Episodes : Nocturnal (23:00-05:59) and Over 24 Hours.
Description
A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of the investigational medicinal product (IMP), and no later than the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 inclusive. All plasma glucose values: · equal or below 3.9 mmol/L (70 mg/dL) or · higher than 3.9 mmol/L (70 mg/dL) when they occur in conjunction with hypoglycaemic symptoms.
Time Frame
For 20 weeks of treatment and over 24 hours
Title
Change in Fasting Plasma Glucose From Baseline
Description
Change in fasting plasma glucose from baseline.
Time Frame
Week 0, week 20
Title
Incidence of Adverse Events
Description
A treatment emergent adverse event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the day of visit 22.(week 20)
Time Frame
Week 20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Daejeon
ZIP/Postal Code
301-721
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Daejeon
ZIP/Postal Code
301-723
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Daejeon
ZIP/Postal Code
302-120
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Daejeon
ZIP/Postal Code
302-718
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Daejeon
ZIP/Postal Code
330-721
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Daejeon
ZIP/Postal Code
361-711
Country
Korea, Republic of
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
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)
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