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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00700817
Recruitment Status : Completed
First Posted : June 19, 2008
Results First Posted : August 4, 2010
Last Update Posted : March 8, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide Drug: sitagliptin Drug: metformin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 665 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26 [ Time Frame: Week 0, Week 26 ]
    Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.

  2. Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 [ Time Frame: Week 0, Week 52 ]
    Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.

  3. Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78 [ Time Frame: Week 0, Week 78 ]
    Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.

  4. Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ]
    Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78


Secondary Outcome Measures :
  1. Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26 [ Time Frame: Week 0, Week 26 ]
    Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26

  2. Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52 [ Time Frame: Week 0, Week 52 ]
    Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 52

  3. Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78 [ Time Frame: Week 0, Week 78 ]
    Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the FAS.

  4. Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78 [ Time Frame: Week 0, Week 78 ]
    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.

  5. Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26 [ Time Frame: Week 0, Week 26 ]
    Calculated as the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 26

  6. Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52 [ Time Frame: Week 0, Week 52 ]
    Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 52

  7. Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78 [ Time Frame: Week 0, Week 78 ]
    Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the FAS.

  8. Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78 [ Time Frame: Week 0, Week 78 ]
    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.

  9. Mean Change From Baseline in Body Weight at Week 26 [ Time Frame: Week 0, Week 26 ]
    Calculated as an estimate of the mean change from baseline in body weight at Week 26.

  10. Mean Change From Baseline in Body Weight at Week 52 [ Time Frame: Week 0, Week 52 ]
    Calculated as an estimate of the mean change from baseline in body weight at Week 52.

  11. Mean Change in Body Weight From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ]
    Mean change in body weight from Week 52 to Week 78.

  12. Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 [ Time Frame: Week 0, Week 26 ]
    Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.

  13. Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 [ Time Frame: Week 0, Week 52 ]
    Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.

  14. Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78 [ Time Frame: Week 0, Week 78 ]
    Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.

  15. Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ]
    Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.

  16. Mean Change From Baseline in Beta-cell Function at Week 26 [ Time Frame: Week 0, Week 26 ]

    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).


  17. Mean Change From Baseline in Beta-cell Function at Week 52 [ Time Frame: Week 0, Week 52 ]

    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).


  18. Mean Change in Beta-cell Function From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ]
    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).

  19. Mean Change From Baseline in Total Cholesterol at Week 26 [ Time Frame: Week 0, Week 26 ]
    Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.

  20. Mean Change From Baseline in Total Cholesterol at Week 52 [ Time Frame: Week 0, Week 52 ]
    Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.

  21. Mean Change in Total Cholesterol From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ]
    Mean change in total cholesterol from Week 52 to Week 78

  22. Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26 [ Time Frame: Week 0, Week 26 ]
    Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26.

  23. Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52 [ Time Frame: Week 0, Week 52 ]
    Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52.

  24. Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ]
    Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78.

  25. Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26 [ Time Frame: Week 0, Week 26 ]
    Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26.

  26. Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52 [ Time Frame: Week 0, Week 52 ]
    Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52.

  27. Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ]
    Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78.

  28. Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26 [ Time Frame: Week 0, Week 26 ]
    Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26.

  29. Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 [ Time Frame: Week 0, Week 52 ]
    Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52.

  30. Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ]
    Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78.

  31. Mean Change From Baseline in Triglycerides (TG) at Week 26 [ Time Frame: Week 0, Week 26 ]
    Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26.

  32. Mean Change From Baseline in Triglycerides (TG) at Week 52 [ Time Frame: Week 0, Week 52 ]
    Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52.

  33. Mean Change in Triglycerides (TG) From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ]
    Mean change in triglycerides (TG) from Week 52 to Week 78.

  34. Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26 [ Time Frame: Week 0, Week 26 ]
    Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26.

  35. Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52 [ Time Frame: Week 0, Week 52 ]
    Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52.

  36. Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ]
    Mean change in free fatty acids (FFA) from Week 52 to Week 78.

  37. Mean Change From Baseline in Apolipoprotein B at Week 26 [ Time Frame: Week 0, Week 26 ]
    Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26.

  38. Mean Change From Baseline in Apolipoprotein B at Week 52 [ Time Frame: Week 0, Week 52 ]
    Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52.

  39. Mean Change in Apolipoprotein B From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ]
    Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78.

  40. Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26 [ Time Frame: Week 0, Week 26 ]
    Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26.

  41. Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26. [ Time Frame: Week 0, Week 26 ]
    Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26.

  42. Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26. [ Time Frame: Week 0, Week 26 ]
    Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26.

  43. Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26. [ Time Frame: Week 0, Week 26 ]
    Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.

  44. Mean Change From Baseline in Adiponectin at Week 26. [ Time Frame: Week 0, Week 26 ]
    Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26.

  45. Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26. [ Time Frame: Week 0, Week 26 ]
    Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.

  46. Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26. [ Time Frame: Week 0, Week 26 ]
    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.

  47. Mean Change From Baseline in Waist to Hip Ratio at Week 26. [ Time Frame: Week 0, Week 26 ]
    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.

  48. Mean Change From Baseline in Waist to Hip Ratio at Week 52 [ Time Frame: Week 0, Week 52 ]
    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.

  49. Mean Change in Waist to Hip Ratio From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ]
    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.

  50. Mean Change From Baseline in Waist Circumference at Week 26. [ Time Frame: Week 0, Week 26 ]
    Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26

  51. Mean Change From Baseline in Waist Circumference at Week 52 [ Time Frame: Week 0, Week 52 ]
    Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52.

  52. Mean Change in Waist Circumference From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ]
    Mean change in Waist Circumference from Week 52 to Week 78.

  53. Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26 [ Time Frame: Week 0, Week 26 ]
    Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26

  54. Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52 [ Time Frame: Week 0, Week 52 ]
    Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52.

  55. Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ]
    Mean change in systolic blood pressure (SBP) from Week 52 to Week 78.

  56. Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26 [ Time Frame: Week 0, Week 26 ]
    Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26.

  57. Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52 [ Time Frame: Week 0, Week 52 ]
    Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52.

  58. Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ]
    Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78.

  59. Mean Change From Baseline in Pulse at Week 26 [ Time Frame: Week 0, Week 26 ]
    Calculated as an estimate of the mean change from baseline in pulse at Week 26.

  60. Mean Change From Baseline in Pulse at Week 52 [ Time Frame: Week 0, Week 52 ]
    Calculated as an estimate of the mean change from baseline in pulse at Week 52.

  61. Mean Change in Pulse From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ]
    Mean change in pulse from Week 52 to Week 78.

  62. Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26 [ Time Frame: Week 0, Week 26 ]
    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.

  63. Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52 [ Time Frame: Week 0, Week 52 ]
    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.

  64. Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78 [ Time Frame: Week 52, Week 78 ]
    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.

  65. Hypoglyceamic Episodes, Weeks 0-26 [ 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.

  66. Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 [ 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.

  67. Hypoglyceamic Episodes, Weeks 0-52 [ Time Frame: Weeks 0-52 ]
    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.

  68. Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52 [ Time Frame: Weeks 0-52 ]
    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.

  69. Hypoglyceamic Episodes, Weeks 0-78 [ Time Frame: Weeks 0-78 ]
    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.

  70. Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78 [ Time Frame: Weeks 0-78 ]
    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.

  71. Hypoglycaamic Episodes, Weeks 52-78 [ Time Frame: Week 52-78 ]
    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.


Eligibility Criteria
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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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00700817


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Layout table for investigator information
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00700817    
Other Study ID Numbers: NN2211-1860
2007-003937-17 ( EudraCT Number )
First Posted: June 19, 2008    Key Record Dates
Results First Posted: August 4, 2010
Last Update Posted: March 8, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Sitagliptin Phosphate
Liraglutide
Hypoglycemic Agents
 Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action