Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
No head to head comparisons between exenatide once weekly and liraglutide have been performed. Therefore, the purpose of this study is to compare exenatide once weekly to once-daily liraglutide with regard to HbA1c, body weight, subject-reported outcomes, and other clinical benefits. The study includes a 26-week treatment period and a safety follow-up visit 10 weeks after the final study drug dose.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exenatide once weekly | Drug | subcutaneous injection, 2mg, once weekly |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c From Baseline to Week 26 | Change in HbA1c from baseline to the treatment endpoint at Week 26. | Baseline, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving HbA1c <7.0% at Week 26 | Percentage of patients achieving HbA1c <7.0% at treatment endpoint at Week 26. | Baseline, Week 26 |
| Change in Fasting Serum Glucose From Baseline to Week 26 |
Not provided
Inclusion Criteria:
Diagnosed with type 2 diabetes
Have suboptimal glycemic control as evidenced by an HbA1c measurement at study start 7.1% and 11.0%, inclusive
Have a body mass index (BMI) ≤45 kg/m^2
Have been treated with lifestyle modification (diet and exercise) and with one of the following single oral antidiabetic agents (OADs) or combinations of OADs administered at maximum tolerated dose:
Exclusion Criteria:
Have any contraindication, allergy, or hypersensitivity for the study drug (exenatide once weekly or liraglutide), exenatide twice daily, the OAD(s) being used, or the excipients contained in these agents
If taking metformin and have a contraindication to metformin use
Have been treated within 8 weeks of study start with systemic glucocorticoid therapy by oral, intravenous, intra-articular, or intramuscular route
Have been treated with drugs that promote weight loss (e.g., Xenical® [orlistat], Meridia® [sibutramine], Acomplia® [rimonabant], Acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of study start
Have taken any of the following excluded medications for more than 1 week within the 3 months prior to study start, or have taken any of the following excluded medications within 1 month prior to study start:
Have donated blood within 30 days prior to study start or have had a blood transfusion or severe blood loss within 3 months prior to study start
Have at any time, including a clinical trial, taken exenatide once weekly, exenatide twice daily, liraglutide, or any other GLP-1 receptor agonist or GLP-1 analog
Are currently enrolled in, or discontinued within the last 3 months or longer if required by local guidelines, from a clinical trial involving use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Have previously been screen-failed from this study for any reason
If a subject discontinues metformin, sulfonylurea, or pioglitazone prior to screening, the subject can be included if they discontinued the medication (whether alone or as component of combined medication) according to a specific schedule.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer, MD | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Buenos Aires | Argentina | ||||
| Research site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23748506 | Derived | Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660. | |
| 23141817 | Derived | Buse JB, Nauck M, Forst T, Sheu WH, Shenouda SK, Heilmann CR, Hoogwerf BJ, Gao A, Boardman MK, Fineman M, Porter L, Schernthaner G. Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study. Lancet. 2013 Jan 12;381(9861):117-24. doi: 10.1016/S0140-6736(12)61267-7. Epub 2012 Nov 7. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Exenatide Once Weekly | Subcutaneous injection, 2mg, once weekly |
| FG001 | Liraglutide Once Daily | Subcutaneous injection, forced titration to 1.8mg, once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| liraglutide |
| Drug |
subcutaneous injection, forced titration to 1.8mg, once daily |
|
|
Change in fasting serum glucose from baseline to the treatment endpoint at Week 26.
| Baseline, Week 26 |
| Change in Body Weight From Baseline to Week 26 | Change in body weight from baseline to the treatment endpoint at Week 26. | Baseline, Week 26 |
| Change in Total Cholesterol From Baseline to Week 26 | Change in total cholesterol from baseline to the treatment endpoint at Week 26. | Baseline, Week 26 |
| Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 | Change in HDL-C from baseline to the treatment endpoint at Week 26. | Baseline, Week 26 |
| Ratio of Fasting Triglycerides at Week 26 to Baseline | Ratio of fasting triglycerides (measured in mmol/L) treatment endpoint at Week 26 to baseline. Log(Postbaseline fasting triglycerides) - log(Baseline fasting triglycerides); change from baseline to the treatment endpoint at Week 26 is presented as ratio of Week 26 to baseline. | Baseline, Week 26 |
| Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 | Change in SBP from baseline to the treatment endpoint at Week 26. | Baseline, Week 26 |
| Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26 | Change in DBP from baseline to the treatment endpoint at Week 26. | Baseline, Week 26 |
| Assessment of Event Rate of Treatment-emergent Hypoglycemic Events | Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT. | Baseline to Week 26 |
| Mendoza |
| Argentina |
| Research Site | Rosario | Argentina |
| Research Site | Box Hill | Australia |
| Research Site | Geelong | Australia |
| Research Site | Keswick | Australia |
| Research Site | Vienna | Austria |
| Research site | Bonheiden | Belgium |
| Research Site | Edegem | Belgium |
| Research Site | Genk | Belgium |
| Research Site | Leuven | Belgium |
| Research Site | Liège | Belgium |
| Research Site | Charlottetown | Canada |
| Research Site | Gatineau | Canada |
| Research Site | Ottawa | Canada |
| Research Site | Sherbrooke | Canada |
| Research Site | Vancouver | Canada |
| Research Site | Victoria | Canada |
| Research Site | Windsor | Canada |
| Research Site | Winnipeg | Canada |
| Research Site | Brandýs nad Labem | Czechia |
| Research Site | Prague | Czechia |
| Research Site | Přerov | Czechia |
| Research Site | Grenoble | France |
| Research Site | Le Creuzot | France |
| Research Site | Marseille | France |
| Research Site | Paris | France |
| Research Site | Poitiers | France |
| Research Site | Reims | France |
| Research Site | Strasbourg | France |
| Research Site | Bad Staffelstein | Germany |
| Research Site | Beckum | Germany |
| Research Site | Biberach | Germany |
| Research Site | Datteln | Germany |
| Research Site | Dresden | Germany |
| Research Site | Essen | Germany |
| Research Site | Ludwigshafen | Germany |
| Research Site | Mainz | Germany |
| Research Site | Meissen | Germany |
| Research Site | Münster | Germany |
| Research Site | Regensburg | Germany |
| Research Site | Riesa | Germany |
| Research Site | Stuttgart | Germany |
| Research Site | Athens | Greece |
| Research Site | Cholargós | Greece |
| Research Site | Pátrai | Greece |
| Research Site | Békéscsaba | Hungary |
| Research Site | Budapest | Hungary |
| Research Site | Makó | Hungary |
| Research Site | Mosonmagyaróvár | Hungary |
| Research Site | Nagykanizsa | Hungary |
| Research Site | Székesfehérvár | Hungary |
| Research Site | Aligarh | India |
| Research Site | Bangalore | India |
| Research Site | Chennai | India |
| Research Site | Coimbatore | India |
| Research Site | Hyderabad | India |
| Research Site | Indore | India |
| Research Site | Karnal/Haryana | India |
| Research site | Karnataka | India |
| Research Site | Mumbai | India |
| Research Site | Pune | India |
| Research Site | Beersheba | Israel |
| Research Site | Haifa | Israel |
| Research Site | Jerusalem | Israel |
| Research Site | Raanana | Israel |
| Research Site | Bari | Italy |
| Research Site | Cagliari | Italy |
| Research Site | Catanzaro | Italy |
| Research Site | Chieti | Italy |
| Research Site | Naples | Italy |
| Research Site | Roma | Italy |
| Research Site | Treviglio | Italy |
| Research Site | Guadalajara | Mexico |
| Research Site | México | Mexico |
| Research Site | Monterrey | Mexico |
| Research Site | Bialystok | Poland |
| Research Site | Krakow | Poland |
| Research Site | Lodz | Poland |
| Research Site | Poznan | Poland |
| Research site | Rzeszów | Poland |
| Research Site | Warsaw | Poland |
| Research site | Bucharest | Romania |
| Research site | Galati | Romania |
| Research site | Iași | Romania |
| Research site | Oradea | Romania |
| Research Site | Bratislava | Slovakia |
| Research Site | Košice | Slovakia |
| Research Site | Malacky | Slovakia |
| Research Site | Martin | Slovakia |
| Research Site | Halfway House | South Africa |
| Research Site | Johannesburg | South Africa |
| Research Site | Kempton Park | South Africa |
| Research Site | Parktown | South Africa |
| Research Site | Pretoria | South Africa |
| Research Site | Seoul | South Korea |
| Research Site | Ulsan | South Korea |
| Research Site | Alicante | Spain |
| Research Site | Alzira | Spain |
| Research Site | Bilbao | Spain |
| Research Site | Madrid | Spain |
| Research Site | Majadahonda | Spain |
| Research Site | Teruel | Spain |
| Research Site | Changhua | Taiwan |
| Research Site | Taichung | Taiwan |
| Research Site | Xindian | Taiwan |
| Research Site | Yung-Kang, Tainan | Taiwan |
| Research Site | Zhonghe | Taiwan |
| Intent to Treat (ITT) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Exenatide Once Weekly | Subcutaneous injection, 2mg, once weekly |
| BG001 | Liraglutide Once Daily | Subcutaneous injection, forced titration to 1.8mg, once daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Glycosylated hemoglobin (HbA1c) | Mean | Standard Deviation | percentage of total hemoglobin |
| |||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||||
| Background Oral Antidiabetic Agent (OAD) | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in HbA1c From Baseline to Week 26 | Change in HbA1c from baseline to the treatment endpoint at Week 26. | ITT Population: all patients who were randomized and received study drug. All observed data from all scheduled visits (including early termination visits) were included in the mixed-model repeated measures (MMRM) analysis. Data collected at the early termination visits were mapped into the following scheduled visits. | Posted | Least Squares Mean | Standard Error | percentage of total hemoglobin | Baseline, Week 26 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Achieving HbA1c <7.0% at Week 26 | Percentage of patients achieving HbA1c <7.0% at treatment endpoint at Week 26. | ITT Population. Missing data at endpoint was imputed using last observation carried forward approach. | Posted | Number | percentage of patients | Baseline, Week 26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Fasting Serum Glucose From Baseline to Week 26 | Change in fasting serum glucose from baseline to the treatment endpoint at Week 26. | ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Body Weight From Baseline to Week 26 | Change in body weight from baseline to the treatment endpoint at Week 26. | ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits. | Posted | Least Squares Mean | Standard Error | kg | Baseline, Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Total Cholesterol From Baseline to Week 26 | Change in total cholesterol from baseline to the treatment endpoint at Week 26. | ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 | Change in HDL-C from baseline to the treatment endpoint at Week 26. | ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Ratio of Fasting Triglycerides at Week 26 to Baseline | Ratio of fasting triglycerides (measured in mmol/L) treatment endpoint at Week 26 to baseline. Log(Postbaseline fasting triglycerides) - log(Baseline fasting triglycerides); change from baseline to the treatment endpoint at Week 26 is presented as ratio of Week 26 to baseline. | ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits. | Posted | Least Squares Mean | Standard Error | ratio | Baseline, Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 | Change in SBP from baseline to the treatment endpoint at Week 26. | ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline, Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26 | Change in DBP from baseline to the treatment endpoint at Week 26. | ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline, Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Assessment of Event Rate of Treatment-emergent Hypoglycemic Events | Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT. | ITT Population. | Posted | Mean | Standard Error | events per subject-year | Baseline to Week 26 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exenatide Once Weekly | Subcutaneous injection, 2mg, once weekly | 13 | 461 | 160 | 461 | ||
| EG001 | Liraglutide Once Daily | Subcutaneous injection, forced titration to 1.8mg, once daily | 7 | 450 | 212 | 450 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Spinal cord neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Brain stem infarction | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site nodule | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Therapeutic response unexpected | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Ohman, Medical Science Director | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Sulfonylurea (SU) |
|
| Pioglitazone (PIO) |
|
| MET+SU |
|
| MET+PIO |
|
| MET+SU+PIO |
|
Superiority of exenatide once weekly with respect to change in HbA1c was concluded if the upper limit of the 2-sided 95% confidence interval (CI) for the treatment difference (exenatide once weekly minus liraglutide) was less than zero. Non-inferiority was concluded if the upper limit of the CI was <0.25%. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subcutaneous injection, 2mg, once weekly and without SU use at screening |
| OG003 | Liraglutide Once Daily Without SU Use at Screening | Subcutaneous injection, forced titration to 1.8mg, once daily and without SU use at screening |
|
|