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Completed

NCT Number: NCT00909480

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

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).

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin detemir

Drug

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

insulin glargine

Drug

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 outcomes

  1. Change in HbA1c From Baseline

    Time frame: Week 0, Week 26

Secondary outcomes

  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"

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: EFFICACY

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 28, 2009
Registry last updated
Mar 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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