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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700817
• Other study ID #: NN2211-1860
• Secondary ID: 2007-003937-17
• Status: Completed
• Phase: Phase 3
• First received: June 18, 2008
• Last updated: August 8, 2014
• Start date: June 2008
• Est. completion date: June 2010

Study information

• Verified date: August 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCroatia: Ministry of Health and Social CareGermany: Federal Institute for Drugs and Medical DevicesIreland: Irish Medicines BoardItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Romania: National Medicines AgencySerbia: Medicines and Medical Devices Agency of SerbiaSlovakia: State Institute for Drug ControlSlovenia: Agency for Medicinal Products and Medical Devices of the Republic of SloveniaSpain: Spanish Drug Agency and Medicinal ProductsUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 665
• Est. completion date: June 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• liraglutide
1.2 mg once daily, subcutaneous (under the skin) injection
• sitagliptin
Tablets, 100 mg daily
• metformin
Tablets, minimum 1500 mg daily
• liraglutide
1.8 mg once daily, subcutaneous (under the skin) injection

Locations

Country	Name	City	State
Puerto Rico	Novo Nordisk Clinical Trial Call Center	Caquas
Puerto Rico	Novo Nordisk Clinical Trial Call Center	Guaynabo
Puerto Rico	Novo Nordisk Clinical Trial Call Center	Manati
Puerto Rico	Novo Nordisk Clinical Trial Call Center	Rio Piedras
Puerto Rico	Novo Nordisk Clinical Trial Call Center	Trujillo Alto
United States	Novo Nordisk Clinical Trial Call Center	Arlington	Texas
United States	Novo Nordisk Clinical Trial Call Center	Athens	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Atlanta	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Berlin	New Jersey
United States	Novo Nordisk Clinical Trial Call Center	Birmingham	Alabama
United States	Novo Nordisk Clinical Trial Call Center	Boise	Idaho
United States	Novo Nordisk Clinical Trial Call Center	Chicago	Illinois
United States	Novo Nordisk Clinical Trial Call Center	Cincinnati	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Cleveland	Mississippi
United States	Novo Nordisk Clinical Trial Call Center	Columbus	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Crystal River	Florida
United States	Novo Nordisk Clinical Trial Call Center	Cuyahoga Falls	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Dallas	Texas
United States	Novo Nordisk Clinical Trial Call Center	Dayton	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Dayton	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Denver	Colorado
United States	Novo Nordisk Clinical Trial Call Center	Dunwoody	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Escondido	California
United States	Novo Nordisk Clinical Trial Call Center	Eugene	Oregon
United States	Novo Nordisk Clinical Trial Call Center	Fresno	California
United States	Novo Nordisk Clinical Trial Call Center	Honolulu	Hawaii
United States	Novo Nordisk Clinical Trial Call Center	Houston	Texas
United States	Novo Nordisk Clinical Trial Call Center	Houston	Texas
United States	Novo Nordisk Clinical Trial Call Center	Huntington Beach	California
United States	Novo Nordisk Clinical Trial Call Center	Hurst	Texas
United States	Novo Nordisk Clinical Trial Call Center	Hyattsville	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Jacksonville	Florida
United States	Novo Nordisk Clinical Trial Call Center	Jacksonville	Florida
United States	Novo Nordisk Clinical Trial Call Center	Kingsport	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Las Vegas	Nevada
United States	Novo Nordisk Clinical Trial Call Center	Lithia Springs	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Long Beach	California
United States	Novo Nordisk Clinical Trial Call Center	Mentor	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Metairie	Louisiana
United States	Novo Nordisk Clinical Trial Call Center	Miami	Florida
United States	Novo Nordisk Clinical Trial Call Center	Milwaukee	Wisconsin
United States	Novo Nordisk Clinical Trial Call Center	Minneapolis	Minnesota
United States	Novo Nordisk Clinical Trial Call Center	New Braunfels	Texas
United States	Novo Nordisk Clinical Trial Call Center	Norfolk	Virginia
United States	Novo Nordisk Clinical Trial Call Center	Norristown	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Northport	New York
United States	Novo Nordisk Clinical Trial Call Center	Northridge	California
United States	Novo Nordisk Clinical Trial Call Center	Ocala	Florida
United States	Novo Nordisk Clinical Trial Call Center	Ogden	Utah
United States	Novo Nordisk Clinical Trial Call Center	Orange	California
United States	Novo Nordisk Clinical Trial Call Center	Panama City	Florida
United States	Novo Nordisk Clinical Trial Call Center	Pinehurst	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Poway	California
United States	Novo Nordisk Clinical Trial Call Center	Richmond	Virginia
United States	Novo Nordisk Clinical Trial Call Center	Rosedale	New York
United States	Novo Nordisk Clinical Trial Call Center	San Antonio	Texas
United States	Novo Nordisk Clinical Trial Call Center	Shawnee Mission	Kansas
United States	Novo Nordisk Clinical Trial Call Center	South Burlington	Vermont
United States	Novo Nordisk Clinical Trial Call Center	St. Cloud	Florida
United States	Novo Nordisk Clinical Trial Call Center	St. George	Utah
United States	Novo Nordisk Clinical Trial Call Center	St. Peters	Missouri
United States	Novo Nordisk Clinical Trial Call Center	Sugar Land	Texas
United States	Novo Nordisk Clinical Trial Call Center	Tabor City	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Tipton	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Canada,  Croatia,  Former Serbia and Montenegro,  Germany,  Ireland,  Italy,  Netherlands,  Puerto Rico,  Romania,  Slovakia,  Slovenia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26	Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.	Week 0, Week 26	No
Primary	Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52	Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.	Week 0, Week 52	No
Primary	Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78	Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.	Week 0, Week 78	No
Primary	Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78	Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78	Week 52, Week 78	No
Secondary	Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26	Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26	Week 0, Week 26	No
Secondary	Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52	Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 52	Week 0, Week 52	No
Secondary	Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at 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.	Week 0, Week 78	No
Secondary	Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at 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.	Week 0, Week 78	No
Secondary	Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26	Calculated as the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 26	Week 0, Week 26	No
Secondary	Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52	Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 52	Week 0, Week 52	No
Secondary	Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at 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.	Week 0, Week 78	No
Secondary	Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at 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.	Week 0, Week 78	No
Secondary	Mean Change From Baseline in Body Weight at Week 26	Calculated as an estimate of the mean change from baseline in body weight at Week 26.	Week 0, Week 26	No
Secondary	Mean Change From Baseline in Body Weight at Week 52	Calculated as an estimate of the mean change from baseline in body weight at Week 52.	Week 0, Week 52	No
Secondary	Mean Change in Body Weight From Week 52 to Week 78	Mean change in body weight from Week 52 to Week 78.	Week 52, Week 78	No
Secondary	Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.	Week 0, Week 26	No
Secondary	Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52	Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.	Week 0, Week 52	No
Secondary	Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78	Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.	Week 0, Week 78	No
Secondary	Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78	Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.	Week 52, Week 78	No
Secondary	Mean Change From Baseline in Beta-cell Function at 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).	Week 0, Week 26	No
Secondary	Mean Change From Baseline in Beta-cell Function at 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).	Week 0, Week 52	No
Secondary	Mean Change in Beta-cell Function From Week 52 to 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).	Week 52, Week 78	No
Secondary	Mean Change From Baseline in Total Cholesterol at Week 26	Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.	Week 0, Week 26	No
Secondary	Mean Change From Baseline in Total Cholesterol at Week 52	Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.	Week 0, Week 52	No
Secondary	Mean Change in Total Cholesterol From Week 52 to Week 78	Mean change in total cholesterol from Week 52 to Week 78	Week 52, Week 78	No
Secondary	Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26	Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26.	Week 0, Week 26	No
Secondary	Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52	Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52.	Week 0, Week 52	No
Secondary	Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78	Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78.	Week 52, Week 78	No
Secondary	Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26	Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26.	Week 0, Week 26	No
Secondary	Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52	Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52.	Week 0, Week 52	No
Secondary	Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78	Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78.	Week 52, Week 78	No
Secondary	Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26	Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26.	Week 0, Week 26	No
Secondary	Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52	Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52.	Week 0, Week 52	No
Secondary	Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78	Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78.	Week 52, Week 78	No
Secondary	Mean Change From Baseline in Triglycerides (TG) at Week 26	Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26.	Week 0, Week 26	No
Secondary	Mean Change From Baseline in Triglycerides (TG) at Week 52	Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52.	Week 0, Week 52	No
Secondary	Mean Change in Triglycerides (TG) From Week 52 to Week 78	Mean change in triglycerides (TG) from Week 52 to Week 78.	Week 52, Week 78	No
Secondary	Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26	Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26.	Week 0, Week 26	No
Secondary	Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52	Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52.	Week 0, Week 52	No
Secondary	Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78	Mean change in free fatty acids (FFA) from Week 52 to Week 78.	Week 52, Week 78	No
Secondary	Mean Change From Baseline in Apolipoprotein B at Week 26	Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26.	Week 0, Week 26	No
Secondary	Mean Change From Baseline in Apolipoprotein B at Week 52	Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52.	Week 0, Week 52	No
Secondary	Mean Change in Apolipoprotein B From Week 52 to Week 78	Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78.	Week 52, Week 78	No
Secondary	Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26	Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26.	Week 0, Week 26	No
Secondary	Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.	Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26.	Week 0, Week 26	No
Secondary	Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.	Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26.	Week 0, Week 26	No
Secondary	Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at 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.	Week 0, Week 26	No
Secondary	Mean Change From Baseline in Adiponectin at Week 26.	Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26.	Week 0, Week 26	No
Secondary	Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.	Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.	Week 0, Week 26	No
Secondary	Mean Change From Baseline in Von Willebrand Factor (vWf) at 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.	Week 0, Week 26	No
Secondary	Mean Change From Baseline in Waist to Hip Ratio at 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.	Week 0, Week 26	No
Secondary	Mean Change From Baseline in Waist to Hip Ratio at 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.	Week 0, Week 52	No
Secondary	Mean Change in Waist to Hip Ratio From Week 52 to 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.	Week 52, Week 78	No
Secondary	Mean Change From Baseline in Waist Circumference at Week 26.	Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26	Week 0, Week 26	No
Secondary	Mean Change From Baseline in Waist Circumference at Week 52	Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52.	Week 0, Week 52	No
Secondary	Mean Change in Waist Circumference From Week 52 to Week 78	Mean change in Waist Circumference from Week 52 to Week 78.	Week 52, Week 78	No
Secondary	Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26	Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26	Week 0, Week 26	No
Secondary	Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52	Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52.	Week 0, Week 52	No
Secondary	Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78	Mean change in systolic blood pressure (SBP) from Week 52 to Week 78.	Week 52, Week 78	No
Secondary	Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26	Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26.	Week 0, Week 26	No
Secondary	Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52	Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52.	Week 0, Week 52	No
Secondary	Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78	Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78.	Week 52, Week 78	No
Secondary	Mean Change From Baseline in Pulse at Week 26	Calculated as an estimate of the mean change from baseline in pulse at Week 26.	Week 0, Week 26	No
Secondary	Mean Change From Baseline in Pulse at Week 52	Calculated as an estimate of the mean change from baseline in pulse at Week 52.	Week 0, Week 52	No
Secondary	Mean Change in Pulse From Week 52 to Week 78	Mean change in pulse from Week 52 to Week 78.	Week 52, Week 78	No
Secondary	Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at 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.	Week 0, Week 26	No
Secondary	Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at 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.	Week 0, Week 52	No
Secondary	Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to 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.	Week 52, Week 78	No
Secondary	Hypoglyceamic Episodes, 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.	Weeks 0-26	No
Secondary	Hypoglycaemic Episodes (Excluding Outlier Subject), 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.	Weeks 0-26	No
Secondary	Hypoglyceamic Episodes, 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.	Weeks 0-52	No
Secondary	Hypoglycaemic Episodes (Excluding Outlier Subject), 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.	Weeks 0-52	No
Secondary	Hypoglyceamic Episodes, 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.	Weeks 0-78	No
Secondary	Hypoglycaemic Episodes (Excluding Outlier Subject), 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.	Weeks 0-78	No
Secondary	Hypoglycaamic Episodes, Weeks 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.	Week 52-78	No

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