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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00909480
First received: May 27, 2009
Last updated: November 9, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
 Drug: insulin detemir
Drug: insulin glargine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Change in HbA1c From Baseline [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0% [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c less than or equal to 7%

  • Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5% [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c of 6.5% or less

  • Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    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.

  • Fasting Plasma Glucose (FPG) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    The median values of the sample standard variation (the within subject variation) within the IDet and IGlar arms were plotted against time.

  • Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    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.

  • Incidence of Hypoglycaemic Episodes During the Trial [ Time Frame: Weeks 0-26 ] [ Designated as safety issue: No ]
    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.

  • Hypoglycaemic Episodes, Diurnal [ Time Frame: Weeks 0-26 ] [ Designated as safety issue: No ]
    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.

  • Hypoglycaemic Episodes, Nocturnal [ Time Frame: Weeks 0-26 ] [ Designated as safety issue: No ]
    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.

  • Hypoglycemic Episodes, Unclassifiable [ Time Frame: Weeks 0-26 ] [ Designated as safety issue: No ]
    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.

  • Change in Body Weight From Baseline [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
  • Number of Subjects Having the Adverse Event "Incorrect Dose Administered" [ Time Frame: Weeks 0-26 ] [ Designated as safety issue: No ]
    Number of subjects having the adverse event "incorrect dose administered" within the system organ class "Injury, poisoning and procedural complications"


Enrollment: 457
Study Start Date: May 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909480

  Show 74 Study Locations
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Eva Gunge, MSc.Odont. Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00909480     History of Changes
Other Study ID Numbers: NN304-1768
Study First Received: May 27, 2009
Results First Received: June 10, 2011
Last Updated: November 9, 2011
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
India: Ministry of Health
South Korea: Korea Food and Drug Administration (KFDA)
Thailand: Thai FDA

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
 Insulin
Metformin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013