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Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control in Subjects With Type 2 Diabetes (EFFICACY)

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ClinicalTrials.gov Identifier: NCT00909480
Recruitment Status : Completed
First Posted : May 28, 2009
Results First Posted : September 27, 2011
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:

This trial is conducted in Asia, South America and the United States of America (USA).

The aim of this clinical trial is to determine whether two insulin treatments given once daily are equally effective with respect to the blood glucose lowering effect in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without an additional anti-diabetic drug (OAD).


Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin detemir Drug: insulin glargine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 457 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 26 Week Randomised, Multinational, Open Labelled, 2 Armed, Parallel Group, Treat-to-target Once Daily Treatment Trial With Insulin Detemir Versus Insulin Glargine, Both in Combination With Metformin in Subjects With Type 2 Diabetes
Study Start Date : May 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IDet
Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
Drug: insulin detemir

Treat-to-target (individually adjusted dose) titration according to titration algorithm.

S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued


Active Comparator: IGlar
Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
Drug: insulin glargine

Treat-to-target (individually adjusted dose) titration according to titration algorithm.

S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued





Primary Outcome Measures :
  1. Change in HbA1c From Baseline [ Time Frame: Week 0, Week 26 ]

Secondary Outcome Measures :
  1. Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0% [ Time Frame: Week 26 ]
    The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c less than or equal to 7%

  2. Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia [ Time Frame: Week 26 ]
    The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment.

  3. Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5% [ Time Frame: Week 26 ]
    The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c of 6.5% or less

  4. Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia [ Time Frame: Week 26 ]
    The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment.

  5. Fasting Plasma Glucose (FPG) [ Time Frame: Week 26 ]
  6. Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast [ Time Frame: Week 26 ]
    The median values of the sample standard variation (the within subject variation) within the IDet and IGlar arms were plotted against time.

  7. Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) [ Time Frame: Week 26 ]
    Plasma glucose measured: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime and at 3 am.

  8. Incidence of Hypoglycaemic Episodes During the Trial [ Time Frame: Weeks 0-26 ]
    Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

  9. Hypoglycaemic Episodes, Diurnal [ Time Frame: Weeks 0-26 ]
    Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

  10. Hypoglycaemic Episodes, Nocturnal [ Time Frame: Weeks 0-26 ]
    Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

  11. Hypoglycemic Episodes, Unclassifiable [ Time Frame: Weeks 0-26 ]
    Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

  12. Change in Body Weight From Baseline [ Time Frame: Week 0, Week 26 ]
  13. Number of Subjects Having the Adverse Event "Incorrect Dose Administered" [ Time Frame: Weeks 0-26 ]
    Number of subjects having the adverse event "incorrect dose administered" within the system organ class "Injury, poisoning and procedural complications"



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with type 2 diabetes for at least 6 months
  • Stable treatment with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) with or without one other OAD (sulphonylureas, meglitinides, thiazolidinediones or dipeptidyl peptidase-4 (DPP-4) inhibitors) for at least 3 months
  • Subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed)
  • HbA1c (glycosylated haemoglobin) 7.0-9.0 % (both inclusive) by central laboratory analysis (one re-test within one week is allowed)
  • Body Mass Index (BMI) less than or equal to 35.0 kg/m^2

Exclusion Criteria:

  • Any contraindication to insulin detemir or insulin glargine according to the local labelling
  • Receipt of any investigational product within 4 weeks
  • Anticipated change of dose of any systemic treatment with products, which in the Investigator's opinion could interfere with glucose metabolism (e.g. systemic corticosteroids)
  • 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 other condition that the Investigator feels would interfere with trial participation or evaluation of results

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): NCT00909480


Locations
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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: NCT00909480    
Other Study ID Numbers: NN304-1768
First Posted: May 28, 2009    Key Record Dates
Results First Posted: September 27, 2011
Last Update Posted: March 10, 2017
Last Verified: January 2017
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 Glargine
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs