A Phase 3 interventional study of semaglutide and exenatide in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 146 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-13.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
This trial is conducted in Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of semaglutide once-weekly versus exenatide ER (extended release) 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with type 2 diabetes.
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Inclusion Criteria: - Subjects diagnosed with type 2 diabetes and on stable diabetes treatment with 1-2 OADs (Metformin equal to or above 1500 mg or maximum tolerated dose and/or thiazolidinedione (TZD) and sulfonylureas (SUs) equal to or above half of maximum dose allowed according to national label) for at least 90 days prior to screening. Stable is defined as unchanged medication and unchanged dose - HbA1c 7.0 - 10.5 % (53 - 91 mmol/mol) (both inclusive) Exclusion Criteria: - Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 week follow-up period (adequate contraceptive measures as required by local law or practice) - Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol - Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value equal to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73 m\^2 per modification of diet in renal disease (MDRD) formula (4 variable version) - Acute coronary or cerebrovascular event within 90 days before randomisation - Heart failure, New York Heart Association (NYHA) class IV
Drug: semaglutide
Drug: exenatide
One dose of 1.0 mg semaglutide administered subcutaneously (s.c., under the skin) once-weekly
One dose of 2.0 mg exenatide ER administered subcutaneously (s.c., under the skin) once-weekly
Also known as: Bydureon®
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Mean change in HbA1c from baseline to week 56.
Time frame: Week 0, week 56
Change From Baseline in Body Weight
Mean change in body weight from baseline to week 56.
Time frame: Week 0, week 56
Change From Baseline in Fasting Plasma Glucose (FPG)
Mean change in FPG from baseline to week 56.
Time frame: Week 0, week 56
Change From Baseline in Systolic and Diastolic Blood Pressure
Mean changes in systolic and diastolic blood pressure from baseline to week 56.
Time frame: Week 0, week 56
Change From Baseline in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs)
The Diabetes Treatment Satisfaction Questionnaire (DTSQs) was used to assess a subject's treatment satisfaction. This questionnaire contained 8 components and measures the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction.
Time frame: Week 0, week 56
Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target: (Yes/no)
The endpoint considered HbA1c ≤6.5% (48 mmol/mol) as per the AACE target after 56 weeks of treatment.
Time frame: After 56 weeks' treatment
Out of 146 sites selected for recruitment, 138 sites in 12 countries randomised subjects to the treatment viz. Argentina: 4 sites; Croatia: 5 sites; Finland: 5 sites; France: 7 sites; Germany: 7 sites; Greece: 5 sites; Italy: 6 sites; Netherlands: 8 sites; Serbia: 5 sites; Switzerland: 5 sites; United Kingdom: 6 sites and United States: 75 sites
| Milestone | Semaglutide 1.0 mg | Exenatide ER 2.0 mg |
|---|---|---|
| Started | 406 | 407 |
| Exposed | 404 | 405 |
| Premature discontinuation of treatment | 82 | 85 |
| Completed | 374 | 369 |
| Not completed | 32 | 38 |
| Withdrew: Unclassified | 32 | 38 |
Mean change in HbA1c from baseline to week 56.
| percentage of glycosylated haemoglobin | Semaglutide 1.0 mg | Exenatide ER 2.0 mg |
|---|---|---|
| Change From Baseline in HbA1c (Glycosylated Haemoglobin) | -1.54 ± 0.06 | -0.92 ± 0.06 |
Mean change in body weight from baseline to week 56.
| kilograms | Semaglutide 1.0 mg | Exenatide ER 2.0 mg |
|---|---|---|
| Change From Baseline in Body Weight | -5.63 ± 0.29 | -1.85 ± 0.29 |
Mean change in FPG from baseline to week 56.
| mg/dL | Semaglutide 1.0 mg | Exenatide ER 2.0 mg |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) | -51.22 ± 2.36 | -36.1 ± 2.45 |
Mean changes in systolic and diastolic blood pressure from baseline to week 56.
| mm Hg | Semaglutide 1.0 mg | Exenatide ER 2.0 mg |
|---|---|---|
| Systolic blood pressure | -4.6 ± 0.68 | -2.23 ± 0.7 |
| Diastolic blood pressure | -1.0 ± 0.45 | -0.1 ± 0.46 |
The Diabetes Treatment Satisfaction Questionnaire (DTSQs) was used to assess a subject's treatment satisfaction. This questionnaire contained 8 components and measures the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction.
| Units on a scale | Semaglutide 1.0 mg | Exenatide ER 2.0 mg |
|---|---|---|
| Change From Baseline in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) | 4.98 ± 0.26 | 3.96 ± 0.27 |
The endpoint considered HbA1c ≤6.5% (48 mmol/mol) as per the AACE target after 56 weeks of treatment.
| Participants | Semaglutide 1.0 mg | Exenatide ER 2.0 mg |
|---|---|---|
| Yes | 190 | 89 |
| No | 214 | 316 |
Collected over All adverse events are treatment-emergent adverse events (TEAEs). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-56 treatment period) and no later than the date of last dose + 42 days of follow-up.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sema 1.0 mg | — | 38/404 (9.4%) | 194/404 (48%) |
| Exenatide ER | — | 24/405 (5.9%) | 187/405 (46.2%) |
| Event | Sema 1.0 mg | Exenatide ER |
|---|---|---|
| PancreatitisGastrointestinal disorders | 3/404 | 0/405 |
| Atrial fibrillationCardiac disorders | 0/404 | 3/405 |
| Coronary artery bypassSurgical and medical procedures | 2/404 | 0/405 |
| NephrolithiasisRenal and urinary disorders | 2/404 | 0/405 |
| GastroenteritisInfections and infestations | 0/404 | 2/405 |
| Angina pectorisCardiac disorders | 1/404 | 0/405 |
| AnxietyPsychiatric disorders | 1/404 | 0/405 |
| Arteriosclerosis coronary arteryCardiac disorders | 1/404 | 0/405 |
| Back painMusculoskeletal and connective tissue disorders | 1/404 | 0/405 |
| Benign renal neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/404 | 0/405 |
| Event | Sema 1.0 mg | Exenatide ER |
|---|---|---|
| NauseaGastrointestinal disorders | 90/404 | 48/405 |
| Injection site noduleGeneral disorders | 0/404 | 49/405 |
| Lipase increasedInvestigations | 41/404 | 49/405 |
| DiarrhoeaGastrointestinal disorders | 46/404 | 34/405 |
| NasopharyngitisInfections and infestations | 39/404 | 38/405 |
| HeadacheNervous system disorders | 38/404 | 39/405 |
| Decreased appetiteMetabolism and nutrition disorders | 32/404 | 21/405 |
| VomitingGastrointestinal disorders | 29/404 | 25/405 |
| DyspepsiaGastrointestinal disorders | 27/404 | 19/405 |
| ConstipationGastrointestinal disorders | 26/404 | 21/405 |
The full analysis set (FAS) included all randomised subjects who have received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.
| Age, Continuous(years) | Semaglutide 1.0 mg | Exenatide ER 2.0 mg | Total |
|---|---|---|---|
| Mean | 56.4 ± 10.3 | 56.7 ± 11.1 | 56.6 ± 10.7 |
| Sex: Female, Male(Participants) | Semaglutide 1.0 mg | Exenatide ER 2.0 mg | Total |
|---|---|---|---|
| Female | 185 | 177 | 362 |
| Male | 219 | 228 | 447 |
| Glycosylated haemoglobin (HbA1c)(percentage of glycosylated haemoglobin) | Semaglutide 1.0 mg | Exenatide ER 2.0 mg | Total |
|---|---|---|---|
| Mean | 8.36 ± 0.95 | 8.33 ± 0.96 | 8.35 ± 0.95 |
| Body Weight(kilogram (s)) | Semaglutide 1.0 mg | Exenatide ER 2.0 mg | Total |
|---|---|---|---|
| Mean | 96.21 ± 22.5 | 95.37 ± 20.46 | 95.79 ± 21.49 |
| Fasting Plasma Glucose(mg/ dL) | Semaglutide 1.0 mg | Exenatide ER 2.0 mg | Total |
|---|---|---|---|
| Mean | 190.5 ± 48.06 | 187.5 ± 49.41 | 189.0 ± 48.74 |
| Systolic blood pressure(mm Hg) | Semaglutide 1.0 mg | Exenatide ER 2.0 mg | Total |
|---|---|---|---|
| Mean | 133.35 ± 14.87 | 133.66 ± 14.25 | 133.51 ± 14.55 |
| Diastolic blood pressure(mm Hg) | Semaglutide 1.0 mg | Exenatide ER 2.0 mg | Total |
|---|---|---|---|
| Mean | 80.23 ± 8.67 | 79.57 ± 8.8 | 79.90 ± 8.73 |
| Patient-reported outcome: Diabetes Treatment Satisfaction Questionnaire (DTSQ)(Units on a scale) | Semaglutide 1.0 mg | Exenatide ER 2.0 mg | Total |
|---|---|---|---|
| Mean | 27.35 ± 6.55 | 27.23 ± 6.62 | 27.29 ± 6.58 |
Showing the first 100 of 146 sites across 13 countries.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S