Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00700817
First received: June 18, 2008
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

This trial is conducted in Europe and North America. The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone.

The trial has been extended by 52 weeks. The extension will consist of two 26-week periods:

  1. Week 27-52 after randomisation

    - All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and dosing regimen.

  2. Week 53-78 after randomisation

    • Subjects receiving sitagliptin at the end of week 52 after randomisation will discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and increased to 1.2 mg/day or 1.8 mg/day in weekly intervals.
    • Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after randomisation will continue the treatment at unchanged dose and dosing regimen. Trial completion is planned for June 2010.

Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: liraglutide
Drug: sitagliptin
Drug: metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Subjects With Type 2 Diabetes. A 26-week, Randomised, Open-label, Active Comparator, Three-armed, Parallel-group, Multi-centre, Multinational Trial With a 52-week Extension

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26 [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.

  • Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 [ Time Frame: Week 0, Week 52 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.

  • Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78 [ Time Frame: Week 0, Week 78 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.

  • Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ] [ Designated as safety issue: No ]
    Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78


Secondary Outcome Measures:
  • Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26 [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26

  • Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52 [ Time Frame: Week 0, Week 52 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 52

  • Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78 [ Time Frame: Week 0, Week 78 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the FAS.

  • Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78 [ Time Frame: Week 0, Week 78 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the extension 2 FAS.

  • Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26 [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Calculated as the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 26

  • Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52 [ Time Frame: Week 0, Week 52 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 52

  • Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78 [ Time Frame: Week 0, Week 78 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the FAS.

  • Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78 [ Time Frame: Week 0, Week 78 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the extension 2 FAS.

  • Mean Change From Baseline in Body Weight at Week 26 [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in body weight at Week 26.

  • Mean Change From Baseline in Body Weight at Week 52 [ Time Frame: Week 0, Week 52 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in body weight at Week 52.

  • Mean Change in Body Weight From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ] [ Designated as safety issue: No ]
    Mean change in body weight from Week 52 to Week 78.

  • Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.

  • Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 [ Time Frame: Week 0, Week 52 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.

  • Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78 [ Time Frame: Week 0, Week 78 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.

  • Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ] [ Designated as safety issue: No ]
    Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.

  • Mean Change From Baseline in Beta-cell Function at Week 26 [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]

    Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26.

    Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).


  • Mean Change From Baseline in Beta-cell Function at Week 52 [ Time Frame: Week 0, Week 52 ] [ Designated as safety issue: No ]

    Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52.

    Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).


  • Mean Change in Beta-cell Function From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ] [ Designated as safety issue: No ]
    Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

  • Mean Change From Baseline in Total Cholesterol at Week 26 [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.

  • Mean Change From Baseline in Total Cholesterol at Week 52 [ Time Frame: Week 0, Week 52 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.

  • Mean Change in Total Cholesterol From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ] [ Designated as safety issue: No ]
    Mean change in total cholesterol from Week 52 to Week 78

  • Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26 [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26.

  • Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52 [ Time Frame: Week 0, Week 52 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52.

  • Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ] [ Designated as safety issue: No ]
    Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78.

  • Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26 [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26.

  • Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52 [ Time Frame: Week 0, Week 52 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52.

  • Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ] [ Designated as safety issue: No ]
    Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78.

  • Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26 [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26.

  • Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 [ Time Frame: Week 0, Week 52 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52.

  • Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ] [ Designated as safety issue: No ]
    Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78.

  • Mean Change From Baseline in Triglycerides (TG) at Week 26 [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26.

  • Mean Change From Baseline in Triglycerides (TG) at Week 52 [ Time Frame: Week 0, Week 52 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52.

  • Mean Change in Triglycerides (TG) From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ] [ Designated as safety issue: No ]
    Mean change in triglycerides (TG) from Week 52 to Week 78.

  • Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26 [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26.

  • Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52 [ Time Frame: Week 0, Week 52 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52.

  • Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ] [ Designated as safety issue: No ]
    Mean change in free fatty acids (FFA) from Week 52 to Week 78.

  • Mean Change From Baseline in Apolipoprotein B at Week 26 [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26.

  • Mean Change From Baseline in Apolipoprotein B at Week 52 [ Time Frame: Week 0, Week 52 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52.

  • Mean Change in Apolipoprotein B From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ] [ Designated as safety issue: No ]
    Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78.

  • Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26 [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26.

  • Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26. [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26.

  • Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26. [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26.

  • Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26. [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.

  • Mean Change From Baseline in Adiponectin at Week 26. [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26.

  • Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26. [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.

  • Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26. [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis.

  • Mean Change From Baseline in Waist to Hip Ratio at Week 26. [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip.

  • Mean Change From Baseline in Waist to Hip Ratio at Week 52 [ Time Frame: Week 0, Week 52 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip.

  • Mean Change in Waist to Hip Ratio From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ] [ Designated as safety issue: No ]
    Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip.

  • Mean Change From Baseline in Waist Circumference at Week 26. [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26

  • Mean Change From Baseline in Waist Circumference at Week 52 [ Time Frame: Week 0, Week 52 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52.

  • Mean Change in Waist Circumference From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ] [ Designated as safety issue: No ]
    Mean change in Waist Circumference from Week 52 to Week 78.

  • Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26 [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26

  • Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52 [ Time Frame: Week 0, Week 52 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52.

  • Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ] [ Designated as safety issue: No ]
    Mean change in systolic blood pressure (SBP) from Week 52 to Week 78.

  • Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26 [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26.

  • Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52 [ Time Frame: Week 0, Week 52 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52.

  • Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ] [ Designated as safety issue: No ]
    Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78.

  • Mean Change From Baseline in Pulse at Week 26 [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in pulse at Week 26.

  • Mean Change From Baseline in Pulse at Week 52 [ Time Frame: Week 0, Week 52 ] [ Designated as safety issue: No ]
    Calculated as an estimate of the mean change from baseline in pulse at Week 52.

  • Mean Change in Pulse From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ] [ Designated as safety issue: No ]
    Mean change in pulse from Week 52 to Week 78.

  • Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26 [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.

  • Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52 [ Time Frame: Week 0, Week 52 ] [ Designated as safety issue: No ]
    The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.

  • Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ] [ Designated as safety issue: No ]
    The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.

  • Hypoglyceamic Episodes, Weeks 0-26 [ 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 (Excluding Outlier Subject), Weeks 0-26 [ 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.

  • Hypoglyceamic Episodes, Weeks 0-52 [ Time Frame: Weeks 0-52 ] [ Designated as safety issue: No ]
    Number of hypoglycaemic episodes from Week 0 to Week 52, 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 (Excluding Outlier Subject), Weeks 0-52 [ Time Frame: Weeks 0-52 ] [ Designated as safety issue: No ]
    Number of hypoglycaemic episodes from Week 0 to Week 52, 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.

  • Hypoglyceamic Episodes, Weeks 0-78 [ Time Frame: Weeks 0-78 ] [ Designated as safety issue: No ]
    Number of hypoglycaemic episodes from Week 0 to Week 78, 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 (Excluding Outlier Subject), Weeks 0-78 [ Time Frame: Weeks 0-78 ] [ Designated as safety issue: No ]
    Number of hypoglycaemic episodes from Week 0 to Week 78, 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.

  • Hypoglycaamic Episodes, Weeks 52-78 [ Time Frame: Week 52-78 ] [ Designated as safety issue: No ]
    Number of hypoglycaemic episodes from Week 52 to Week 78, 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.


Enrollment: 665
Study Start Date: June 2008
Study Completion Date: June 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Drug: liraglutide
1.2 mg once daily, subcutaneous (under the skin) injection
Drug: metformin
Tablets, minimum 1500 mg daily
Experimental: Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Drug: metformin
Tablets, minimum 1500 mg daily
Drug: liraglutide
1.8 mg once daily, subcutaneous (under the skin) injection
Active Comparator: Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Drug: sitagliptin
Tablets, 100 mg daily
Drug: metformin
Tablets, minimum 1500 mg daily
Experimental: Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Drug: liraglutide
1.2 mg once daily, subcutaneous (under the skin) injection
Drug: sitagliptin
Tablets, 100 mg daily
Drug: metformin
Tablets, minimum 1500 mg daily
Experimental: Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Drug: sitagliptin
Tablets, 100 mg daily
Drug: metformin
Tablets, minimum 1500 mg daily
Drug: liraglutide
1.8 mg once daily, subcutaneous (under the skin) injection

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Treatment with metformin alone for at least three months
  • HbA1c (glycosylated haemoglobin A1c) 7.5-10.0% (both inclusive)
  • Body Mass Index (BMI) less than or equal to 45.0

Exclusion Criteria:

  • Previous treatment with insulin, glucagon like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase-4 (DPP-4) inhibitors
  • Treatment with anti-diabetic drugs other than metformin within the last three months
  • Any serious medical condition
  • Females who are pregnant, have the intention of becoming pregnant or are breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700817

  Show 78 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00700817     History of Changes
Other Study ID Numbers: NN2211-1860, 2007-003937-17
Study First Received: June 18, 2008
Results First Received: June 11, 2010
Last Updated: August 8, 2014
Health Authority: Canada: Health Canada
Croatia: Ministry of Health and Social Care
Germany: Federal Institute for Drugs and Medical Devices
Ireland: Irish Medicines Board
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Romania: National Medicines Agency
Serbia: Medicines and Medical Devices Agency of Serbia
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Spain: Spanish Drug Agency and Medicinal Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glucagon-Like Peptide 1
Liraglutide
Metformin
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014