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A Trial Investigating the Efficacy and Safety of Flexible vs. Fixed Dosing and Simple vs. Stepwise Titration With Once Daily (OD) Insulin Degludec in Inadequately Treated Subjects With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01880736
Recruitment Status : Completed
First Posted : June 19, 2013
Results First Posted : March 17, 2016
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and safety of flexible versus fixed dosing and simple versus stepwise titration with OD insulin degludec in inadequately treated subjects with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin degludec Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 458 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Efficacy and Safety of Flexible vs. Fixed Dosing and Simple vs. Stepwise Titration With Once Daily Insulin Degludec in Inadequately Treated Subjects With Type 2 Diabetes
Study Start Date : June 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IDeg OD Flexible Dose Drug: insulin degludec
Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD with the option to vary time of administration within a window of plus/minus 8 hours. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.

Drug: insulin degludec
Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD at the same time each day. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.

Drug: insulin degludec
Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered subcutaneously (under the skin) OD at the same time each day. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) are allowed during the trial at an unchanged, stable dose level and dosing frequency.

Experimental: IDeg OD Fixed Dose Drug: insulin degludec
Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD with the option to vary time of administration within a window of plus/minus 8 hours. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.

Drug: insulin degludec
Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD at the same time each day. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.

Drug: insulin degludec
Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered subcutaneously (under the skin) OD at the same time each day. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) are allowed during the trial at an unchanged, stable dose level and dosing frequency.

Experimental: IDeg OD Simple Drug: insulin degludec
Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD with the option to vary time of administration within a window of plus/minus 8 hours. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.

Drug: insulin degludec
Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD at the same time each day. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.

Drug: insulin degludec
Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered subcutaneously (under the skin) OD at the same time each day. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) are allowed during the trial at an unchanged, stable dose level and dosing frequency.

Experimental: IDeg OD Stepwise Drug: insulin degludec
Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD with the option to vary time of administration within a window of plus/minus 8 hours. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.

Drug: insulin degludec
Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD at the same time each day. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.

Drug: insulin degludec
Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered subcutaneously (under the skin) OD at the same time each day. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) are allowed during the trial at an unchanged, stable dose level and dosing frequency.




Primary Outcome Measures :
  1. Change From Baseline in HbA1c (%) Glycosylated Haemoglobin) [ Time Frame: Week 0, week 26 ]
    Changes from baseline in HbA1c values over time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise)


Secondary Outcome Measures :
  1. Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 26 ]
    Changes from baseline in FPG values over the time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).

  2. Responder for HbA1c (%) Based on Central Laboratory Assessment: HbA1c Below 7.0% at End of Trial [ Time Frame: After 26 weeks of treatment ]
    The number of subjects who achieved the pre-defined HbA1c target (<7.0%) after 26 weeks of treatment was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).

  3. Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Weeks 0-26 ]
    The incidences of treatment emergent adverse events (TEAEs) over the time period of Week 0-26 were recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise).

  4. Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Defined as Severe Hypoglycaemia and/or a Measured Plasma Glucose (PG) Less Than 3.1 mmol/L (Less Than 56 mg/dL)) [ Time Frame: Weeks 0-26 ]
    The confirmed hypoglycaemic episodes (defined as severe hypoglycaemia and/or a measured plasma glucose (PG) less than 3.1 mmol/L [less than 56 mg/dL]) over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise).

  5. Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition [ Time Frame: Weeks 0-26 ]
    Number of treatment emergent hypoglycaemic episodes according to the ADA definition (classified as severe hypoglycaemia, documented hypoglycaemia, asymptomatic hypoglycaemia, probable symptomatic hypoglycaemia, relative hypoglycaemia) over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).

  6. Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period [ Time Frame: From Week 16 to end of trial (week 27) ]
    The number of treatment mergent confirmed hypoglycaemic episodes in the maintenance period from Week 16 to end of trial (week 27) was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs. stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L.

  7. Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes [ Time Frame: Weeks 0-26 ]
    The number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.

  8. Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes in the Maintenance Period [ Time Frame: From week 16 to end of trial (week 27) ]
    The number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes in the maintenance period from 16 weeks to end of trial (week 27) was recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current treatment with IGlar (insulin glargine) with or without OADs (oral antidiabetic drug). All antidiabetic treatments should have been on-going for at least 12 weeks prior to randomisation, and doses of OADs should have been stable in this period of time. - Please note that a maximum of 3 OADs are allowed during this trial: metformin, sulphonylurea (SU)/glinides, dipeptidyl peptidase 4 (DPP-IV) inhibitors, alfa-glucosidaseinhibitors or pioglitazone.
  • Diagnosis of T2DM (type 2 diabetes mellitus) at the discretion of the investigator for at least 26 weeks prior to visit 1 (Screening visit)
  • HbA1c 7.0-9.5% (both inclusive) by central laboratory analysis
  • Body mass index (BMI) equal to or below 35 kg/m^2

Exclusion Criteria:

  • Any chronic disorder or severe disease which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
  • Stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 26 weeks prior to Visit 1 (Screening visit)
  • Impaired renal function, defined as serum-creatinine higher than or equal to 1.4 mg/dL for males and higher than or equal to 1.3 mg/dL for females
  • Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)
  • Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to randomisation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880736


Locations
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Japan
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, Japan, 103 0002
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, Japan, 103 0027
Novo Nordisk Investigational Site
Fukui-shi, Fukui, Japan, 918-8503
Novo Nordisk Investigational Site
Fukuoka, Japan, 812 0025
Novo Nordisk Investigational Site
Gifu-shi, Gifu, Japan, 501-1194
Novo Nordisk Investigational Site
Izumisano-shi, Japan, 598 0048
Novo Nordisk Investigational Site
Kagoshima-shi, Kagoshima, Japan, 890-8520
Novo Nordisk Investigational Site
Kamakura-shi, Japan, 247 0056
Novo Nordisk Investigational Site
Kashiwara-shi, Osaka, Japan, 582 0005
Novo Nordisk Investigational Site
Katsushika-ku, Tokyo, Japan, 125 0054
Novo Nordisk Investigational Site
Kawasaki-shi, Kanagawa, Japan, 216-8511
Novo Nordisk Investigational Site
Kitakyushu-shi, Fukuoka, Japan, 800 0252
Novo Nordisk Investigational Site
Kitakyushu-shi, Fukuoka, Japan, 807-8555
Novo Nordisk Investigational Site
Kitakyusyu-shi, Fukuoka, Japan, 800-0222
Novo Nordisk Investigational Site
Koriyama-shi, Fukushima, Japan, 963 8851
Novo Nordisk Investigational Site
Kumamoto-shi,Kumamoto, Japan, 862 0976
Novo Nordisk Investigational Site
Mito-shi, Ibaraki, Japan, 310-0845
Novo Nordisk Investigational Site
Miyazaki-shi, Japan, 880 0034
Novo Nordisk Investigational Site
Naka-shi, Ibaraki, Japan, 311 0113
Novo Nordisk Investigational Site
Niigata-shi, Niigata, Japan, 951-8520
Novo Nordisk Investigational Site
Nishinomiya-shi, Hyogo, Japan, 663-8501
Novo Nordisk Investigational Site
Oita-shi, Japan, 870 0039
Novo Nordisk Investigational Site
Okawa-shi, Fukuoka, Japan, 831 0016
Novo Nordisk Investigational Site
Osaka-shi, Osaka, Japan, 532 0003
Novo Nordisk Investigational Site
Oyama-shi, Tochigi, Japan, 323 0022
Novo Nordisk Investigational Site
Sakaide-shi, Kagawa, Japan, 762-0031
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, Japan, 060 0062
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, Japan, 060-0001
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, Japan, 062 0007
Novo Nordisk Investigational Site
Sendai-shi, Japan, 980 0021
Novo Nordisk Investigational Site
Shimotsuke-shi, Tochigi, Japan, 329 0433
Novo Nordisk Investigational Site
Suita-shi, Osaka, Japan, 565-0853
Novo Nordisk Investigational Site
Takatsuki-shi, Osaka, Japan, 569 1096
Novo Nordisk Investigational Site
Tokyo, Japan, 103-0028
Novo Nordisk Investigational Site
Tokyo, Japan, 113-8655
Novo Nordisk Investigational Site
Tokyo, Japan, 123-0845
Novo Nordisk Investigational Site
Tokyo, Japan, 143-8541
Novo Nordisk Investigational Site
Tokyo, Japan, 144-0051
Novo Nordisk Investigational Site
Tokyo, Japan, 162-8655
Novo Nordisk Investigational Site
Yokkaichi-shi, Mie, Japan, 510-0829
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01880736     History of Changes
Other Study ID Numbers: NN1250-4060
U1111-1137-0953 ( Other Identifier: WHO )
JapicCTI- 132164 ( Other Identifier: JAPIC )
First Posted: June 19, 2013    Key Record Dates
Results First Posted: March 17, 2016
Last Update Posted: February 10, 2017
Last Verified: December 2016
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs