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Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes
Phase 3 trial testing semaglutide in Diabetes in 1,089 participants. Completed in 3 September 2015.
| Lead sponsor | Novo Nordisk A/S |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1,089 |
| Start date | 4 August 2014 |
| Primary completion | 3 September 2015 |
| Estimated completion | 3 September 2015 |
| Sites | 231 locations across France, South Africa, Netherlands, North Macedonia, Slovakia, United Kingdom, Germany, Mexico |
Novo Nordisk A/S — full company profile →
18 and older, any sex, with Diabetes or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in HbA1c from baseline to week 30.
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide 0.5mg/Week | -1.21 | ± 0.05 |
| Semaglutide 1.0 mg/Week | -1.64 | ± 0.05 |
| Insulin Glargine | -0.83 | ± 0.05 |
Change in body weight from baseline to week 30.
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide 0.5mg/Week | -3.47 | ± 0.24 |
| Semaglutide 1.0 mg/Week | -5.17 | ± 0.24 |
| Insulin Glargine | 1.15 | ± 0.23 |
Change in fasting plasma glucose from baseline to week 30.
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide 0.5mg/Week | -36.74 | ± 2.14 |
| Semaglutide 1.0 mg/Week | -49.21 | ± 2.15 |
| Insulin Glargine | -38.18 | ± 2.03 |
Change in diastolic blood pressure from baseline to week 30.
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide 0.5mg/Week | -1.38 | ± 0.43 |
| Semaglutide 1.0 mg/Week | -0.98 | ± 0.44 |
| Insulin Glargine | -1.44 | ± 0.41 |
Change in systolic blood pressure from baseline to week 30.
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide 0.5mg/Week | -4.65 | ± 0.72 |
| Semaglutide 1.0 mg/Week | -5.17 | ± 0.73 |
| Insulin Glargine | -1.68 | ± 0.68 |
The Short Form (SF)-36v2™ patient reported outcomes (PRO) questionnaire was used to assess the subject's overall health related quality of life (HRQoL. PRO questionnaire (SF-36v2™) measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population. The (SF-36v2™) values displayed are the estimated mean change from baseline to week 30
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide 0.5mg/Week | 0.95 | ± 0.51 |
| Semaglutide 1.0 mg/Week | 1.76 | ± 0.51 |
| Insulin Glargine | 0.90 | ± 0.48 |
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide 0.5mg/Week | 1.95 | ± 0.38 |
| Semaglutide 1.0 mg/Week | 2.78 | ± 0.38 |
| Insulin Glargine | 1.63 | ± 0.36 |
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide 0.5mg/Week | 1.23 | ± 0.47 |
| Semaglutide 1.0 mg/Week | 1.33 | ± 0.47 |
| Insulin Glargine | 0.25 | ± 0.44 |
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide 0.5mg/Week | 1.69 | ± 0.46 |
| Semaglutide 1.0 mg/Week | 1.17 | ± 0.47 |
| Insulin Glargine | 0.54 | ± 0.44 |
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide 0.5mg/Week | 1.18 | ± 0.36 |
| Semaglutide 1.0 mg/Week | 2.09 | ± 0.36 |
| Insulin Glargine | 1.18 | ± 0.34 |
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide 0.5mg/Week | 1.64 | ± 0.43 |
| Semaglutide 1.0 mg/Week | 1.49 | ± 0.43 |
| Insulin Glargine | 0.69 | ± 0.41 |
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide 0.5mg/Week | 0.88 | ± 0.54 |
| Semaglutide 1.0 mg/Week | 1.73 | ± 0.54 |
| Insulin Glargine | 0.06 | ± 0.51 |
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide 0.5mg/Week | 0.90 | ± 0.46 |
| Semaglutide 1.0 mg/Week | 1.97 | ± 0.46 |
| Insulin Glargine | 0.78 | ± 0.43 |
The Diabetes Treatment Satisfaction Questionnaire (DTSQs) questionnaire was to be used to assess a subject's treatment satisfaction. This questionnaire contained 8 components and measured 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 i
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide 0.5mg/Week | 4.86 | ± 0.28 |
| Semaglutide 1.0 mg/Week | 5.37 | ± 0.29 |
| Insulin Glargine | 3.99 | ± 0.27 |
Subjects who achieve HbA1c ≤6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) after 30 weeks of treatment
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide 0.5mg/Week | 135 | |
| Semaglutide 1.0 mg/Week | 195 | |
| Insulin Glargine | 63 |
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide 0.5mg/Week | 227 | |
| Semaglutide 1.0 mg/Week | 165 | |
| Insulin Glargine | 297 |
Time frame: All adverse events presented here are treatment emergent adverse events (TEAE). 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 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Semaglutide 0.5mg/Week | Semaglutide 1.0 mg/Week | Insulin Glargine |
|---|---|---|---|---|
| Hyponatraemia | Metabolism and nutrition disorders | — | — | — |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | — | — | — |
| Pneumonia | Infections and infestations | — | — | — |
| Transient ischaemic attack | Nervous system disorders | — | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — | — |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — |
| Anal fissure | Gastrointestinal disorders | — | — | — |
| Arteriosclerosis coronary artery | Cardiac disorders | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — |
| Atypical pneumonia | Infections and infestations | — | — | — |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Bronchitis | Infections and infestations | — | — | — |
| Carotid artery stenosis | Nervous system disorders | — | — | — |
| Carotid endarterectomy | Surgical and medical procedures | — | — | — |
| Cataract | Eye disorders | — | — | — |
| Cerebrovascular accident | Nervous system disorders | — | — | — |
| Chondropathy | Musculoskeletal and connective tissue disorders | — | — | — |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Corneal graft rejection | Immune system disorders | — | — | — |
| Coronary arterial stent insertion | Surgical and medical procedures | — | — | — |
| Coronary artery disease | Cardiac disorders | — | — | — |
| Coronary artery stenosis | Cardiac disorders | — | — | — |
| Death | General disorders | — | — | — |
| Diverticulitis | Infections and infestations | — | — | — |
| Reaction | System | Semaglutide 0.5mg/Week | Semaglutide 1.0 mg/Week | Insulin Glargine |
|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Lipase increased | Investigations | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — |
Most-reported serious reactions: Hyponatraemia, Osteoarthritis, Pneumonia, Transient ischaemic attack, Acute kidney injury, Acute respiratory failure, Anaemia, Anal fissure.
Data from ClinicalTrials.gov NCT02128932 adverse events section.
This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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