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)

NCT01868542 | Completed Phase 4 Results

• 2 other identifiers: NN304-3994U1111-1132-9267
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 0, week 20

Secondary Outcomes (6)

• Change in HbA1c

  Week 0, week 12

• Proportion of Subjects Achieving HbA1c Below 7.0%

  Week 20

• Change in Fasting Plasma Glucose From Baseline

  week 0, week 12

• Incidence of Hypoglycaemic Episodes : Nocturnal (23:00-05:59) and Over 24 Hours.

  For 20 weeks of treatment and over 24 hours

• Change in Fasting Plasma Glucose From Baseline

  Week 0, week 20

Study Arms (2)

3-0-3 Algorithm

EXPERIMENTAL

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.

Drug: insulin detemir

2-4-6-8 Algorithm

EXPERIMENTAL

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.

Drug: insulin detemir

Interventions

insulin detemir 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; 3-0-3 Algorithm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (6)

Novo Nordisk Investigational Site

Daejeon, 301-721, South Korea

Location

Novo Nordisk Investigational Site

Daejeon, 301-723, South Korea

Location

Novo Nordisk Investigational Site

Daejeon, 302-120, South Korea

Location

Novo Nordisk Investigational Site

Daejeon, 302-718, South Korea

Location

Novo Nordisk Investigational Site

Daejeon, 330-721, South Korea

Location

Novo Nordisk Investigational Site

Daejeon, 361-711, South Korea

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Insulin Detemir

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Public Access to Clinical Trials
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 4, 2013
• Study Start: June 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: March 3, 2017
• Results First Posted: June 29, 2016

Record last verified: 2017-01

Locations

KR (6)