SUSTAIN™ 4: 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
Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT02128932
Collaborator
(none)
1,089
231
3
13
4.7
0.4
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1089 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date
:
Aug 4, 2014
Actual Primary Completion Date
:
Sep 3, 2015
Actual Study Completion Date
:
Sep 3, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Semaglutide 0.5 mg/week
|
Drug: semaglutide
Injected subcutaneously (under the skin) once weekly. Following 4 doses (4 weeks) of 0.25 mg semaglutide weekly subjects will receive 0.5 mg semaglutide weekly for 26 weeks.
|
| Experimental: Semaglutide 1.0 mg/week
|
Drug: semaglutide
Injected subcutaneously (under the skin) once weekly. Following 4 doses (4 weeks) of 0.25 mg semaglutide weekly subjects will receive 0.5 mg semaglutide weekly for 26 weeks.
|
| Active Comparator: Insulin glargine
|
Drug: insulin glargine
Injected subcutaneously (under the skin) once daily. Subjects will start on 10 IU once daily and the dose will be adjusted according to fasting plasma glucose.
|
Outcome Measures
Primary Outcome Measures
- Change in HbA1c From Baseline [Week 0, week 30]
Change in HbA1c from baseline to week 30.
Secondary Outcome Measures
- Change in Body Weight From Baseline [Week 0, week 30]
Change in body weight from baseline to week 30.
- Change in Fasting Plasma Glucose From Baseline [Week 0, week 30]
Change in fasting plasma glucose from baseline to week 30.
- Change in Diastolic Blood Pressure. [Week 0, week 30]
Change in diastolic blood pressure from baseline to week 30.
- Change in Systolic Blood Pressure. [Week 0, week 30]
Change in systolic blood pressure from baseline to week 30.
- Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ [Week 0, week 30]
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.
- Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs) [Week 0, week 30]
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 indicate higher satisfaction. The values displayed are the estimated mean change from baseline to week 30.
- Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) [After 30 weeks treatment]
Subjects who achieve HbA1c ≤6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) after 30 weeks of treatment
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Male or female, 18 years or older at the time of signing informed consent
-
Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose
-
HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive
Exclusion Criteria:
-
Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period
-
Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
-
Treatment with any 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 intercurrent illness
-
History of chronic or idiopathic acute pancreatitis
-
Screening calcitonin value greater than or equal to 50 ng/L
-
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
-
Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 30 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 Class IV
-
Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
-
Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
-
Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Birmingham | Alabama | United States | 35216 |
| 2 | Novo Nordisk Investigational Site | Ozark | Alabama | United States | 36360 |
| 3 | Novo Nordisk Investigational Site | Tuscumbia | Alabama | United States | 35674 |
| 4 | Novo Nordisk Investigational Site | Gilbert | Arizona | United States | 85295 |
| 5 | Novo Nordisk Investigational Site | Phoenix | Arizona | United States | 85018 |
| 6 | Novo Nordisk Investigational Site | Phoenix | Arizona | United States | 85032 |
| 7 | Novo Nordisk Investigational Site | Anaheim | California | United States | 92801 |
| 8 | Novo Nordisk Investigational Site | Carmichael | California | United States | 95608 |
| 9 | Novo Nordisk Investigational Site | Chula Vista | California | United States | 91911 |
| 10 | Novo Nordisk Investigational Site | Elk Grove | California | United States | 95758 |
| 11 | Novo Nordisk Investigational Site | Inglewood | California | United States | 90301 |
| 12 | Novo Nordisk Investigational Site | La Mesa | California | United States | 91942 |
| 13 | Novo Nordisk Investigational Site | Long Beach | California | United States | 90807 |
| 14 | Novo Nordisk Investigational Site | Los Angeles | California | United States | 90057 |
| 15 | Novo Nordisk Investigational Site | Oceanside | California | United States | 92056 |
| 16 | Novo Nordisk Investigational Site | Orange | California | United States | 92868-2863 |
| 17 | Novo Nordisk Investigational Site | Pomona | California | United States | 91767-3008 |
| 18 | Novo Nordisk Investigational Site | Rialto | California | United States | 92376 |
| 19 | Novo Nordisk Investigational Site | Rolling Hills Estates | California | United States | 90274 |
| 20 | Novo Nordisk Investigational Site | Roseville | California | United States | 95661 |
| 21 | Novo Nordisk Investigational Site | San Diego | California | United States | 92111 |
| 22 | Novo Nordisk Investigational Site | San Mateo | California | United States | 94401 |
| 23 | Novo Nordisk Investigational Site | Sherman Oaks | California | United States | 91403 |
| 24 | Novo Nordisk Investigational Site | Spring Valley | California | United States | 91978 |
| 25 | Novo Nordisk Investigational Site | Tustin | California | United States | 92780 |
| 26 | Novo Nordisk Investigational Site | Walnut Creek | California | United States | 94598 |
| 27 | Novo Nordisk Investigational Site | Colorado Springs | Colorado | United States | 80909 |
| 28 | Novo Nordisk Investigational Site | Denver | Colorado | United States | 80220 |
| 29 | Novo Nordisk Investigational Site | Denver | Colorado | United States | 80239-3133 |
| 30 | Novo Nordisk Investigational Site | Clearwater | Florida | United States | 33761 |
| 31 | Novo Nordisk Investigational Site | Cooper City | Florida | United States | 33024 |
| 32 | Novo Nordisk Investigational Site | Hialeah | Florida | United States | 33012 |
| 33 | Novo Nordisk Investigational Site | Jacksonville | Florida | United States | 32205 |
| 34 | Novo Nordisk Investigational Site | Jacksonville | Florida | United States | 32216 |
| 35 | Novo Nordisk Investigational Site | Jacksonville | Florida | United States | 32256 |
| 36 | Novo Nordisk Investigational Site | Kissimmee | Florida | United States | 34741 |
| 37 | Novo Nordisk Investigational Site | Lakeland | Florida | United States | 33805 |
| 38 | Novo Nordisk Investigational Site | Miami Lakes | Florida | United States | 33016 |
| 39 | Novo Nordisk Investigational Site | Miami | Florida | United States | 33135 |
| 40 | Novo Nordisk Investigational Site | Miami | Florida | United States | 33156 |
| 41 | Novo Nordisk Investigational Site | Spring Hill | Florida | United States | 34609 |
| 42 | Novo Nordisk Investigational Site | Winter Haven | Florida | United States | 33880 |
| 43 | Novo Nordisk Investigational Site | Winter Park | Florida | United States | 32789 |
| 44 | Novo Nordisk Investigational Site | Conyers | Georgia | United States | 30013 |
| 45 | Novo Nordisk Investigational Site | Johns Creek | Georgia | United States | 30097 |
| 46 | Novo Nordisk Investigational Site | Marietta | Georgia | United States | 30060 |
| 47 | Novo Nordisk Investigational Site | Norcross | Georgia | United States | 30092 |
| 48 | Novo Nordisk Investigational Site | Roswell | Georgia | United States | 30076 |
| 49 | Novo Nordisk Investigational Site | Meridian | Idaho | United States | 83646 |
| 50 | Novo Nordisk Investigational Site | Chicago | Illinois | United States | 60611 |
| 51 | Novo Nordisk Investigational Site | Gurnee | Illinois | United States | 60031 |
| 52 | Novo Nordisk Investigational Site | Peoria | Illinois | United States | 61602 |
| 53 | Novo Nordisk Investigational Site | Avon | Indiana | United States | 46123 |
| 54 | Novo Nordisk Investigational Site | Indianapolis | Indiana | United States | 46254 |
| 55 | Novo Nordisk Investigational Site | Council Bluffs | Iowa | United States | 51501 |
| 56 | Novo Nordisk Investigational Site | Park City | Kansas | United States | 67219 |
| 57 | Novo Nordisk Investigational Site | Lexington | Kentucky | United States | 40503 |
| 58 | Novo Nordisk Investigational Site | Madisonville | Kentucky | United States | 42431 |
| 59 | Novo Nordisk Investigational Site | Paducah | Kentucky | United States | 42003 |
| 60 | Novo Nordisk Investigational Site | Lake Charles | Louisiana | United States | 70601 |
| 61 | Novo Nordisk Investigational Site | Metairie | Louisiana | United States | 70002 |
| 62 | Novo Nordisk Investigational Site | Natchitoches | Louisiana | United States | 71457-5881 |
| 63 | Novo Nordisk Investigational Site | Shreveport | Louisiana | United States | 71107 |
| 64 | Novo Nordisk Investigational Site | Hyattsville | Maryland | United States | 20782 |
| 65 | Novo Nordisk Investigational Site | Buckley | Michigan | United States | 49620 |
| 66 | Novo Nordisk Investigational Site | Flint | Michigan | United States | 48504 |
| 67 | Novo Nordisk Investigational Site | Sterling Heights | Michigan | United States | 48310-3503 |
| 68 | Novo Nordisk Investigational Site | Troy | Michigan | United States | 48098 |
| 69 | Novo Nordisk Investigational Site | Saint Louis | Missouri | United States | 63128 |
| 70 | Novo Nordisk Investigational Site | Saint Louis | Missouri | United States | 63141 |
| 71 | Novo Nordisk Investigational Site | Butte | Montana | United States | 59701 |
| 72 | Novo Nordisk Investigational Site | Las Vegas | Nevada | United States | 89109 |
| 73 | Novo Nordisk Investigational Site | Las Vegas | Nevada | United States | 89119 |
| 74 | Novo Nordisk Investigational Site | Las Vegas | Nevada | United States | 89120 |
| 75 | Novo Nordisk Investigational Site | Berlin | New Jersey | United States | 08009 |
| 76 | Novo Nordisk Investigational Site | Toms River | New Jersey | United States | 08755-8050 |
| 77 | Novo Nordisk Investigational Site | Trenton | New Jersey | United States | 08611 |
| 78 | Novo Nordisk Investigational Site | Albuquerque | New Mexico | United States | 87108 |
| 79 | Novo Nordisk Investigational Site | Brooklyn | New York | United States | 11229 |
| 80 | Novo Nordisk Investigational Site | New Windsor | New York | United States | 12553 |
| 81 | Novo Nordisk Investigational Site | West Seneca | New York | United States | 14224 |
| 82 | Novo Nordisk Investigational Site | Greensboro | North Carolina | United States | 27408 |
| 83 | Novo Nordisk Investigational Site | Morehead City | North Carolina | United States | 28557 |
| 84 | Novo Nordisk Investigational Site | Morganton | North Carolina | United States | 28655 |
| 85 | Novo Nordisk Investigational Site | Shelby | North Carolina | United States | 28150 |
| 86 | Novo Nordisk Investigational Site | Statesville | North Carolina | United States | 28625 |
| 87 | Novo Nordisk Investigational Site | Wilmington | North Carolina | United States | 28401 |
| 88 | Novo Nordisk Investigational Site | Fargo | North Dakota | United States | 58104 |
| 89 | Novo Nordisk Investigational Site | Canal Fulton | Ohio | United States | 44614 |
| 90 | Novo Nordisk Investigational Site | Carlisle | Ohio | United States | 45005 |
| 91 | Novo Nordisk Investigational Site | Cincinnati | Ohio | United States | 45219 |
| 92 | Novo Nordisk Investigational Site | Cincinnati | Ohio | United States | 45227 |
| 93 | Novo Nordisk Investigational Site | Cincinnati | Ohio | United States | 45242 |
| 94 | Novo Nordisk Investigational Site | Cincinnati | Ohio | United States | 45255 |
| 95 | Novo Nordisk Investigational Site | Cleveland | Ohio | United States | 44122 |
| 96 | Novo Nordisk Investigational Site | Kettering | Ohio | United States | 45429 |
| 97 | Novo Nordisk Investigational Site | Mason | Ohio | United States | 45040-6815 |
| 98 | Novo Nordisk Investigational Site | Maumee | Ohio | United States | 43537 |
| 99 | Novo Nordisk Investigational Site | Toledo | Ohio | United States | 43623 |
| 100 | Novo Nordisk Investigational Site | Corvallis | Oregon | United States | 97330-3737 |
| 101 | Novo Nordisk Investigational Site | Altoona | Pennsylvania | United States | 16602 |
| 102 | Novo Nordisk Investigational Site | Beaver | Pennsylvania | United States | 15009 |
| 103 | Novo Nordisk Investigational Site | Clairton | Pennsylvania | United States | 15025-3730 |
| 104 | Novo Nordisk Investigational Site | Jersey Shore | Pennsylvania | United States | 17740 |
| 105 | Novo Nordisk Investigational Site | Lansdale | Pennsylvania | United States | 19446-1002 |
| 106 | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | United States | 19114 |
| 107 | Novo Nordisk Investigational Site | Gaffney | South Carolina | United States | 29341 |
| 108 | Novo Nordisk Investigational Site | Murrells Inlet | South Carolina | United States | 29576 |
| 109 | Novo Nordisk Investigational Site | Rapid City | South Dakota | United States | 57701 |
| 110 | Novo Nordisk Investigational Site | Chattanooga | Tennessee | United States | 37404 |
| 111 | Novo Nordisk Investigational Site | Knoxville | Tennessee | United States | 37912 |
| 112 | Novo Nordisk Investigational Site | Amarillo | Texas | United States | 79106 |
| 113 | Novo Nordisk Investigational Site | Austin | Texas | United States | 78756 |
| 114 | Novo Nordisk Investigational Site | Dallas | Texas | United States | 75251 |
| 115 | Novo Nordisk Investigational Site | Fort Worth | Texas | United States | 76117 |
| 116 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77040 |
| 117 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77055 |
| 118 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77058 |
| 119 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77070 |
| 120 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77074 |
| 121 | Novo Nordisk Investigational Site | Humble | Texas | United States | 77338 |
| 122 | Novo Nordisk Investigational Site | Hurst | Texas | United States | 76054 |
| 123 | Novo Nordisk Investigational Site | Irving | Texas | United States | 75061-2210 |
| 124 | Novo Nordisk Investigational Site | Longview | Texas | United States | 75605 |
| 125 | Novo Nordisk Investigational Site | Marshall | Texas | United States | 75670 |
| 126 | Novo Nordisk Investigational Site | Plano | Texas | United States | 75075 |
| 127 | Novo Nordisk Investigational Site | San Antonio | Texas | United States | 78209 |
| 128 | Novo Nordisk Investigational Site | San Antonio | Texas | United States | 78229 |
| 129 | Novo Nordisk Investigational Site | Saint George | Utah | United States | 84790 |
| 130 | Novo Nordisk Investigational Site | Salt Lake City | Utah | United States | 84107 |
| 131 | Novo Nordisk Investigational Site | Arlington | Virginia | United States | 22206 |
| 132 | Novo Nordisk Investigational Site | Winchester | Virginia | United States | 22601 |
| 133 | Novo Nordisk Investigational Site | Olympia | Washington | United States | 98502 |
| 134 | Novo Nordisk Investigational Site | Renton | Washington | United States | 98057 |
| 135 | Novo Nordisk Investigational Site | Wenatchee | Washington | United States | 98801-2028 |
| 136 | Novo Nordisk Investigational Site | Kenosha | Wisconsin | United States | 53144 |
| 137 | Novo Nordisk Investigational Site | Buenos Aires | Argentina | C1425AGC | |
| 138 | Novo Nordisk Investigational Site | Caba | Argentina | C1119ACN | |
| 139 | Novo Nordisk Investigational Site | Capital Federal | Argentina | C1056ABJ | |
| 140 | Novo Nordisk Investigational Site | Godoy Cruz | Argentina | M5501ARP | |
| 141 | Novo Nordisk Investigational Site | Cakovec | Croatia | 40000 | |
| 142 | Novo Nordisk Investigational Site | Karlovac | Croatia | 47000 | |
| 143 | Novo Nordisk Investigational Site | Krapinske Toplice | Croatia | 49217 | |
| 144 | Novo Nordisk Investigational Site | Zagreb | Croatia | 10 000 | |
| 145 | Novo Nordisk Investigational Site | Bobigny | France | 93009 | |
| 146 | Novo Nordisk Investigational Site | Bois-Guillaume | France | 76320 | |
| 147 | Novo Nordisk Investigational Site | Bourgoin-jallieu | France | 38302 | |
| 148 | Novo Nordisk Investigational Site | LA ROCHE-sur-YON cedex 9 | France | 85295 | |
| 149 | Novo Nordisk Investigational Site | Le Creusot | France | 71200 | |
| 150 | Novo Nordisk Investigational Site | MARSEILLE cedex 08 | France | 13285 | |
| 151 | Novo Nordisk Investigational Site | MARSEILLE Cédex 05 | France | 13385 | |
| 152 | Novo Nordisk Investigational Site | Nanterre | France | 92014 | |
| 153 | Novo Nordisk Investigational Site | Narbonne | France | 11108 | |
| 154 | Novo Nordisk Investigational Site | NICE cedex 3 | France | 06202 | |
| 155 | Novo Nordisk Investigational Site | Paris | France | 75014 | |
| 156 | Novo Nordisk Investigational Site | Pierre-Bénite | France | 69495 | |
| 157 | Novo Nordisk Investigational Site | Pointe À Pitre | France | 97159 | |
| 158 | Novo Nordisk Investigational Site | Rang-du-fliers | France | 62180 | |
| 159 | Novo Nordisk Investigational Site | Saint Herblain | France | 44800 | |
| 160 | Novo Nordisk Investigational Site | Saint Nazaire | France | 44600 | |
| 161 | Novo Nordisk Investigational Site | Strasbourg | France | 67098 | |
| 162 | Novo Nordisk Investigational Site | Trinité - La Martinique | France | 97235 | |
| 163 | Novo Nordisk Investigational Site | Venissieux | France | 69200 | |
| 164 | Novo Nordisk Investigational Site | Berlin | Germany | 10409 | |
| 165 | Novo Nordisk Investigational Site | Essen | Germany | 45276 | |
| 166 | Novo Nordisk Investigational Site | Jerichow | Germany | 39319 | |
| 167 | Novo Nordisk Investigational Site | Lampertheim | Germany | 68623 | |
| 168 | Novo Nordisk Investigational Site | Ludwigshafen | Germany | 67059 | |
| 169 | Novo Nordisk Investigational Site | Münster | Germany | 48145 | |
| 170 | Novo Nordisk Investigational Site | Neuwied | Germany | 56564 | |
| 171 | Novo Nordisk Investigational Site | Rehlingen-Siersburg | Germany | 66780 | |
| 172 | Novo Nordisk Investigational Site | Rostock | Germany | 18057 | |
| 173 | Novo Nordisk Investigational Site | Saint Ingbert-Oberwürzbach | Germany | 66386 | |
| 174 | Novo Nordisk Investigational Site | Stuttgart | Germany | 70378 | |
| 175 | Novo Nordisk Investigational Site | Wangen | Germany | 88239 | |
| 176 | Novo Nordisk Investigational Site | Ahmedabad | Gujarat | India | 380006 |
| 177 | Novo Nordisk Investigational Site | Ahmedabad | Gujarat | India | 380007 |
| 178 | Novo Nordisk Investigational Site | Bangalore | Karnataka | India | 560092 |
| 179 | Novo Nordisk Investigational Site | Mysore | Karnataka | India | 570001 |
| 180 | Novo Nordisk Investigational Site | Mysore | Karnataka | India | 570004 |
| 181 | Novo Nordisk Investigational Site | Indore | Madhya Pradesh | India | 452010 |
| 182 | Novo Nordisk Investigational Site | Mumbai | Maharashtra | India | 400008 |
| 183 | Novo Nordisk Investigational Site | Mumbai | Maharashtra | India | 400010 |
| 184 | Novo Nordisk Investigational Site | Mumbai | Maharashtra | India | 400012 |
| 185 | Novo Nordisk Investigational Site | Mumbai | Maharashtra | India | 400022 |
| 186 | Novo Nordisk Investigational Site | New Dehli | New Delhi | India | 110029 |
| 187 | Novo Nordisk Investigational Site | Chennai | Tamil Nadu | India | 600031 |
| 188 | Novo Nordisk Investigational Site | Kolkata | West Bengal | India | 700107 |
| 189 | Novo Nordisk Investigational Site | Kolkata | India | 700026 | |
| 190 | Novo Nordisk Investigational Site | New Delhi | India | 110001 | |
| 191 | Novo Nordisk Investigational Site | Guadalajara | Jalisco | Mexico | 44150 |
| 192 | Novo Nordisk Investigational Site | Distrito Federal | México, D.F. | Mexico | 14080 |
| 193 | Novo Nordisk Investigational Site | México D.F. | México, D.F. | Mexico | 11550 |
| 194 | Novo Nordisk Investigational Site | Aguascalientes | Mexico | 20230 | |
| 195 | Novo Nordisk Investigational Site | Amsterdam | Netherlands | 1105 AZ | |
| 196 | Novo Nordisk Investigational Site | Hoofddorp | Netherlands | 2134 TM | |
| 197 | Novo Nordisk Investigational Site | Rotterdam | Netherlands | 3039 BD | |
| 198 | Novo Nordisk Investigational Site | Skopje | North Macedonia | 1000 | |
| 199 | Novo Nordisk Investigational Site | Tetovo | North Macedonia | 1220 | |
| 200 | Novo Nordisk Investigational Site | Ponce | Puerto Rico | 00717 | |
| 201 | Novo Nordisk Investigational Site | Pitesti | Arges | Romania | 110084 |
| 202 | Novo Nordisk Investigational Site | Oradea | Bihor | Romania | 410469 |
| 203 | Novo Nordisk Investigational Site | Cluj Napoca | Cluj | Romania | 400006 |
| 204 | Novo Nordisk Investigational Site | Bucharest | Romania | 011234 | |
| 205 | Novo Nordisk Investigational Site | Iasi | Romania | 700469 | |
| 206 | Novo Nordisk Investigational Site | Kosice | Slovakia | 04011 | |
| 207 | Novo Nordisk Investigational Site | Moldava nad Bodvou | Slovakia | 045 01 | |
| 208 | Novo Nordisk Investigational Site | Piestany | Slovakia | 92101 | |
| 209 | Novo Nordisk Investigational Site | Puchov | Slovakia | 02001 | |
| 210 | Novo Nordisk Investigational Site | Trencin | Slovakia | 91101 | |
| 211 | Novo Nordisk Investigational Site | Koper | Slovenia | SI-6000 | |
| 212 | Novo Nordisk Investigational Site | Ljubljana | Slovenia | 1525 | |
| 213 | Novo Nordisk Investigational Site | Novo mesto | Slovenia | 8000 | |
| 214 | Novo Nordisk Investigational Site | Johannesburg | Gauteng | South Africa | 1829 |
| 215 | Novo Nordisk Investigational Site | Johannesburg | Gauteng | South Africa | 2001 |
| 216 | Novo Nordisk Investigational Site | Pretoria | Gauteng | South Africa | 0183 |
| 217 | Novo Nordisk Investigational Site | Durban | KwaZulu-Natal | South Africa | 4001 |
| 218 | Novo Nordisk Investigational Site | Cape Town | Western Cape | South Africa | 7450 |
| 219 | Novo Nordisk Investigational Site | Basingstoke | United Kingdom | RG24 9GT | |
| 220 | Novo Nordisk Investigational Site | Bristol | United Kingdom | BS10 5NB | |
| 221 | Novo Nordisk Investigational Site | Harrogate, North Yorkshire | United Kingdom | HG2 7SX | |
| 222 | Novo Nordisk Investigational Site | Haxey | United Kingdom | DN9 2HY | |
| 223 | Novo Nordisk Investigational Site | Hull | United Kingdom | HU3 2RW | |
| 224 | Novo Nordisk Investigational Site | Ipswich | United Kingdom | IP4 5PD | |
| 225 | Novo Nordisk Investigational Site | Northwood | United Kingdom | HA6 2RN | |
| 226 | Novo Nordisk Investigational Site | Plymouth | United Kingdom | PL6 8BQ | |
| 227 | Novo Nordisk Investigational Site | Salford | United Kingdom | M6 8HD | |
| 228 | Novo Nordisk Investigational Site | Sidcup | United Kingdom | DA14 6LT | |
| 229 | Novo Nordisk Investigational Site | Soham | United Kingdom | CB7 5JD | |
| 230 | Novo Nordisk Investigational Site | Swansea | United Kingdom | SA2 8PP | |
| 231 | Novo Nordisk Investigational Site | Taunton | United Kingdom | TA1 5DA |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02128932
Other Study ID Numbers:
- NN9535-3625
- 2013-004392-12
- U1111-1146-0211
- NL47781.018.14
First Posted:
May 1, 2014
Last Update Posted:
Jun 13, 2019
Last Verified:
May 1, 2019
Study Results
Participant Flow
| Recruitment Details | The trial was conducted at196 sites in 14 countries. Argentina: 3 sites; Croatia: 3 sites; France: 5 sites; Germany: 11 sites; India: 12 sites; Macedonia: 3 sites; Mexico: 3 sites; Netherlands: 3 sites; Romania: 5 sites; Slovakia: 5 sites; Slovenia:3 sites; South Africa: 4 sites; United Kingdom: 13 sites; United States: 123 sites. |
|---|---|
| Pre-assignment Detail | Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin ≥1500 mg or maximum tolerated dose and SU≥ half of maximum allowed dose according to national label) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose. |
| Arm/Group Title | Semaglutide 0.5mg/Week | Semaglutide 1.0 mg/Week | Insulin Glargine |
|---|---|---|---|
| Arm/Group Description | Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day |
| Period Title: Overall Study | |||
| STARTED | 362 | 360 | 360 |
| COMPLETED | 335 | 341 | 342 |
| NOT COMPLETED | 27 | 19 | 18 |
Baseline Characteristics
| Arm/Group Title | Semaglutide 0.5mg/Week | Semaglutide 1.0 mg/Week | Insulin Glargine | Total |
|---|---|---|---|---|
| Arm/Group Description | Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day | Total of all reporting groups |
| Overall Participants | 362 | 360 | 360 | 1082 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
56.5
(10.3)
|
56.7
(10.4)
|
56.2
(10.6)
|
56.5
(10.4)
|
| Age, Customized (Number) [Number] | ||||
| 18-64 years |
278
76.8%
|
281
78.1%
|
281
78.1%
|
840
77.6%
|
| 65-74 years |
72
19.9%
|
61
16.9%
|
67
18.6%
|
200
18.5%
|
| 75-84 years |
12
3.3%
|
18
5%
|
12
3.3%
|
42
3.9%
|
| >=85 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
165
45.6%
|
178
49.4%
|
165
45.8%
|
508
47%
|
| Male |
197
54.4%
|
182
50.6%
|
195
54.2%
|
574
53%
|
| HbA1c (percentage) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [percentage] |
8.13
(0.85)
|
8.25
(0.94)
|
8.13
(0.88)
|
8.17
(0.89)
|
| Fasting plasma glucose (mg/dL) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mg/dL] |
172.4
(50.52)
|
179.2
(53.74)
|
174.2
(49.06)
|
175.3
(51.18)
|
| Body weight (kg) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kg] |
93.73
(21.39)
|
94.00
(22.48)
|
92.61
(21.52)
|
93.45
(21.79)
|
| Diastolic Blood pressure (mmHg) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mmHg] |
79.67
(8.04)
|
80.32
(8.32)
|
79.78
(9.20)
|
79.72
(8.53)
|
| Systolic Blood Pressure (mmHg) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mmHg] |
131.57
(14.06)
|
132.21
(16.05)
|
132.38
(15.77)
|
132.06
(15.31)
|
Outcome Measures
| Title | Change in HbA1c From Baseline |
|---|---|
| Description | Change in HbA1c from baseline to week 30. |
| Time Frame | Week 0, week 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomized semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation. |
| Arm/Group Title | Semaglutide 0.5mg/Week | Semaglutide 1.0 mg/Week | Insulin Glargine |
|---|---|---|---|
| Arm/Group Description | Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day |
| Measure Participants | 362 | 360 | 360 |
| Least Squares Mean (Standard Error) [percentage] |
-1.21
(0.05)
|
-1.64
(0.05)
|
-0.83
(0.05)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Semaglutide 1.0 mg/Week, Insulin Glargine |
|---|---|---|
| Comments | The post baseline responses were analysed using a mixed model for repeated measurements with treatment , country and stratum as fixed factors and baseline value as covariate, all nested within visit. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and insulin glargine was below the pre-specified non-inferiority margin (0.3 %). | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Treatment difference |
| Estimated Value | -0.81 | |
| Confidence Interval |
(2-Sided) 95% -0.96 to -0.67 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Semaglutide 0.5mg/Week, Insulin Glargine |
|---|---|---|
| Comments | The post baseline responses were analysed using a mixed model for repeated meausrements with treatment, country and stratum value as covariate, all nested within visit. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was concluded if the upper limit of the two-sided 95 % confidence interval for the estimated treatment difference between semaglutide 0.5 mg and insulin glargine was below the pre-specified non-inferiority margin (0.3%). | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Treatment difference |
| Estimated Value | -0.38 | |
| Confidence Interval |
(2-Sided) 95% -0.52 to -0.24 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Body Weight From Baseline |
|---|---|
| Description | Change in body weight from baseline to week 30. |
| Time Frame | Week 0, week 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation. |
| Arm/Group Title | Semaglutide 0.5mg/Week | Semaglutide 1.0 mg/Week | Insulin Glargine |
|---|---|---|---|
| Arm/Group Description | Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day |
| Measure Participants | 362 | 360 | 360 |
| Least Squares Mean (Standard Error) [Kg] |
-3.47
(0.24)
|
-5.17
(0.24)
|
1.15
(0.23)
|
| Title | Change in Fasting Plasma Glucose From Baseline |
|---|---|
| Description | Change in fasting plasma glucose from baseline to week 30. |
| Time Frame | Week 0, week 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation. |
| Arm/Group Title | Semaglutide 0.5mg/Week | Semaglutide 1.0 mg/Week | Insulin Glargine |
|---|---|---|---|
| Arm/Group Description | Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day |
| Measure Participants | 362 | 360 | 360 |
| Least Squares Mean (Standard Error) [mg/dL] |
-36.74
(2.14)
|
-49.21
(2.15)
|
-38.18
(2.03)
|
| Title | Change in Diastolic Blood Pressure. |
|---|---|
| Description | Change in diastolic blood pressure from baseline to week 30. |
| Time Frame | Week 0, week 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation. |
| Arm/Group Title | Semaglutide 0.5mg/Week | Semaglutide 1.0 mg/Week | Insulin Glargine |
|---|---|---|---|
| Arm/Group Description | Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day |
| Measure Participants | 362 | 360 | 360 |
| Least Squares Mean (Standard Error) [mmHg] |
-1.38
(0.43)
|
-0.98
(0.44)
|
-1.44
(0.41)
|
| Title | Change in Systolic Blood Pressure. |
|---|---|
| Description | Change in systolic blood pressure from baseline to week 30. |
| Time Frame | Week 0, week 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation. |
| Arm/Group Title | Semaglutide 0.5mg/Week | Semaglutide 1.0 mg/Week | Insulin Glargine |
|---|---|---|---|
| Arm/Group Description | Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day |
| Measure Participants | 362 | 360 | 360 |
| Least Squares Mean (Standard Error) [mmHg] |
-4.65
(0.72)
|
-5.17
(0.73)
|
-1.68
(0.68)
|
| Title | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ |
|---|---|
| Description | 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. |
| Time Frame | Week 0, week 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation. |
| Arm/Group Title | Semaglutide 0.5mg/Week | Semaglutide 1.0 mg/Week | Insulin Glargine |
|---|---|---|---|
| Arm/Group Description | Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day |
| Measure Participants | 362 | 360 | 360 |
| Bodily pain |
0.95
(0.51)
|
1.76
(0.51)
|
0.90
(0.48)
|
| General Health |
1.95
(0.38)
|
2.78
(0.38)
|
1.63
(0.36)
|
| Mental Component summary, MCS |
1.23
(0.47)
|
1.33
(0.47)
|
0.25
(0.44)
|
| Mental Health |
1.69
(0.46)
|
1.17
(0.47)
|
0.54
(0.44)
|
| Physical Component summary, PCS |
1.18
(0.36)
|
2.09
(0.36)
|
1.18
(0.34)
|
| Physical Functioning |
1.64
(0.43)
|
1.49
(0.43)
|
0.69
(0.41)
|
| Role-emotional |
0.88
(0.54)
|
1.73
(0.54)
|
0.06
(0.51)
|
| Role-physical |
0.90
(0.46)
|
1.97
(0.46)
|
0.78
(0.43)
|
| Social functioning |
1.13
(0.48)
|
1.04
(0.48)
|
0.36
(0.45)
|
| Vitality |
1.71
(0.46)
|
2.09
(0.46)
|
0.95
(0.44)
|
| Title | Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs) |
|---|---|
| Description | 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 indicate higher satisfaction. The values displayed are the estimated mean change from baseline to week 30. |
| Time Frame | Week 0, week 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation. |
| Arm/Group Title | Semaglutide 0.5mg/Week | Semaglutide 1.0 mg/Week | Insulin Glargine |
|---|---|---|---|
| Arm/Group Description | Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day |
| Measure Participants | 362 | 360 | 360 |
| Least Squares Mean (Standard Error) [Score on a scale] |
4.86
(0.28)
|
5.37
(0.29)
|
3.99
(0.27)
|
| Title | Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) |
|---|---|
| Description | Subjects who achieve HbA1c ≤6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) after 30 weeks of treatment |
| Time Frame | After 30 weeks treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation. |
| Arm/Group Title | Semaglutide 0.5mg/Week | Semaglutide 1.0 mg/Week | Insulin Glargine |
|---|---|---|---|
| Arm/Group Description | Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day |
| Measure Participants | 362 | 360 | 360 |
| Yes |
135
37.3%
|
195
54.2%
|
63
17.5%
|
| No |
227
62.7%
|
165
45.8%
|
297
82.5%
|
Adverse Events
| 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). | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period. | |||||
| Arm/Group Title | Semaglutide 0.5mg/Week | Semaglutide 1.0 mg/Week | Insulin Glargine | |||
| Arm/Group Description | Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day | |||
All Cause Mortality |
||||||
| Semaglutide 0.5mg/Week | Semaglutide 1.0 mg/Week | Insulin Glargine | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Semaglutide 0.5mg/Week | Semaglutide 1.0 mg/Week | Insulin Glargine | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 22/362 (6.1%) | 17/360 (4.7%) | 18/360 (5%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 0/362 (0%) | 0 | 1/360 (0.3%) | 1 | 0/360 (0%) | 0 |
| Cardiac disorders | ||||||
| Arteriosclerosis coronary artery | 0/362 (0%) | 0 | 0/360 (0%) | 0 | 1/360 (0.3%) | 1 |
| Atrial fibrillation | 1/362 (0.3%) | 1 | 1/360 (0.3%) | 1 | 1/360 (0.3%) | 1 |
| Coronary artery disease | 0/362 (0%) | 0 | 1/360 (0.3%) | 1 | 0/360 (0%) | 0 |
| Coronary artery stenosis | 0/362 (0%) | 0 | 0/360 (0%) | 0 | 1/360 (0.3%) | 1 |
| Ischaemic cardiomyopathy | 0/362 (0%) | 0 | 0/360 (0%) | 0 | 1/360 (0.3%) | 1 |
| Myocarditis | 1/362 (0.3%) | 1 | 0/360 (0%) | 0 | 0/360 (0%) | 0 |
| Ear and labyrinth disorders | ||||||
| Vertigo | 0/362 (0%) | 0 | 0/360 (0%) | 0 | 1/360 (0.3%) | 1 |
| Eye disorders | ||||||
| Cataract | 1/362 (0.3%) | 1 | 0/360 (0%) | 0 | 0/360 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Anal fissure | 1/362 (0.3%) | 1 | 0/360 (0%) | 0 | 0/360 (0%) | 0 |
| Incarcerated inguinal hernia | 0/362 (0%) | 0 | 0/360 (0%) | 0 | 1/360 (0.3%) | 1 |
| Intestinal obstruction | 1/362 (0.3%) | 1 | 0/360 (0%) | 0 | 0/360 (0%) | 0 |
| Nausea | 0/362 (0%) | 0 | 0/360 (0%) | 0 | 1/360 (0.3%) | 1 |
| Pancreatitis acute | 1/362 (0.3%) | 1 | 0/360 (0%) | 0 | 0/360 (0%) | 0 |
| Vomiting | 0/362 (0%) | 0 | 0/360 (0%) | 0 | 1/360 (0.3%) | 1 |
| General disorders | ||||||
| Death | 0/362 (0%) | 0 | 0/360 (0%) | 0 | 1/360 (0.3%) | 1 |
| Systemic inflammatory response syndrome | 1/362 (0.3%) | 1 | 0/360 (0%) | 0 | 0/360 (0%) | 0 |
| Immune system disorders | ||||||
| Corneal graft rejection | 0/362 (0%) | 0 | 0/360 (0%) | 0 | 1/360 (0.3%) | 1 |
| Infections and infestations | ||||||
| Atypical pneumonia | 1/362 (0.3%) | 1 | 0/360 (0%) | 0 | 0/360 (0%) | 0 |
| Bronchitis | 1/362 (0.3%) | 1 | 1/360 (0.3%) | 1 | 0/360 (0%) | 0 |
| Diverticulitis | 0/362 (0%) | 0 | 0/360 (0%) | 0 | 1/360 (0.3%) | 1 |
| Gangrene | 0/362 (0%) | 0 | 1/360 (0.3%) | 1 | 0/360 (0%) | 0 |
| Groin abscess | 0/362 (0%) | 0 | 1/360 (0.3%) | 1 | 0/360 (0%) | 0 |
| Hepatitis B | 1/362 (0.3%) | 1 | 1/360 (0.3%) | 1 | 0/360 (0%) | 0 |
| Infected skin ulcer | 0/362 (0%) | 0 | 1/360 (0.3%) | 1 | 0/360 (0%) | 0 |
| Pneumonia | 2/362 (0.6%) | 2 | 0/360 (0%) | 0 | 1/360 (0.3%) | 1 |
| Pyelonephritis | 1/362 (0.3%) | 1 | 0/360 (0%) | 0 | 0/360 (0%) | 0 |
| Sepsis | 1/362 (0.3%) | 1 | 0/360 (0%) | 0 | 0/360 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| Fall | 0/362 (0%) | 0 | 0/360 (0%) | 0 | 1/360 (0.3%) | 1 |
| Jaw fracture | 0/362 (0%) | 0 | 1/360 (0.3%) | 1 | 0/360 (0%) | 0 |
| Laceration | 0/362 (0%) | 0 | 1/360 (0.3%) | 1 | 0/360 (0%) | 0 |
| Pneumocephalus | 0/362 (0%) | 0 | 1/360 (0.3%) | 1 | 0/360 (0%) | 0 |
| Investigations | ||||||
| Weight decreased | 1/362 (0.3%) | 1 | 0/360 (0%) | 0 | 0/360 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||
| Hypoglycaemia | 1/362 (0.3%) | 1 | 1/360 (0.3%) | 1 | 0/360 (0%) | 0 |
| Hyponatraemia | 2/362 (0.6%) | 2 | 0/360 (0%) | 0 | 0/360 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Chondropathy | 0/362 (0%) | 0 | 1/360 (0.3%) | 1 | 0/360 (0%) | 0 |
| Intervertebral disc protrusion | 1/362 (0.3%) | 1 | 0/360 (0%) | 0 | 0/360 (0%) | 0 |
| Lumbar spinal stenosis | 0/362 (0%) | 0 | 0/360 (0%) | 0 | 1/360 (0.3%) | 1 |
| Osteoarthritis | 1/362 (0.3%) | 1 | 2/360 (0.6%) | 2 | 1/360 (0.3%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Nasopharyngeal cancer | 1/362 (0.3%) | 1 | 0/360 (0%) | 0 | 0/360 (0%) | 0 |
| Pancreatic carcinoma metastatic | 1/362 (0.3%) | 1 | 0/360 (0%) | 0 | 0/360 (0%) | 0 |
| Renal cell carcinoma | 1/362 (0.3%) | 1 | 0/360 (0%) | 0 | 0/360 (0%) | 0 |
| Thyroid neoplasm | 0/362 (0%) | 0 | 0/360 (0%) | 0 | 1/360 (0.3%) | 1 |
| Nervous system disorders | ||||||
| Carotid artery stenosis | 1/362 (0.3%) | 1 | 0/360 (0%) | 0 | 0/360 (0%) | 0 |
| Cerebrovascular accident | 1/362 (0.3%) | 1 | 0/360 (0%) | 0 | 0/360 (0%) | 0 |
| Hypoglycaemic unconsciousness | 0/362 (0%) | 0 | 0/360 (0%) | 0 | 1/360 (0.3%) | 1 |
| Ischaemic stroke | 1/362 (0.3%) | 1 | 1/360 (0.3%) | 1 | 0/360 (0%) | 0 |
| Migraine with aura | 0/362 (0%) | 0 | 0/360 (0%) | 0 | 1/360 (0.3%) | 1 |
| Sciatica | 0/362 (0%) | 0 | 0/360 (0%) | 0 | 1/360 (0.3%) | 1 |
| Transient ischaemic attack | 0/362 (0%) | 0 | 2/360 (0.6%) | 2 | 0/360 (0%) | 0 |
| VIIth nerve paralysis | 0/362 (0%) | 0 | 1/360 (0.3%) | 1 | 0/360 (0%) | 0 |
| Renal and urinary disorders | ||||||
| Acute kidney injury | 0/362 (0%) | 0 | 1/360 (0.3%) | 1 | 0/360 (0%) | 0 |
| Renal failure | 0/362 (0%) | 0 | 1/360 (0.3%) | 1 | 0/360 (0%) | 0 |
| Reproductive system and breast disorders | ||||||
| Endometrial hyperplasia | 0/362 (0%) | 0 | 1/360 (0.3%) | 1 | 0/360 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Acute respiratory failure | 1/362 (0.3%) | 1 | 0/360 (0%) | 0 | 0/360 (0%) | 0 |
| Bronchial hyperreactivity | 1/362 (0.3%) | 1 | 0/360 (0%) | 0 | 0/360 (0%) | 0 |
| Chronic obstructive pulmonary disease | 0/362 (0%) | 0 | 0/360 (0%) | 0 | 1/360 (0.3%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||
| Skin ulcer | 1/362 (0.3%) | 1 | 0/360 (0%) | 0 | 0/360 (0%) | 0 |
| Surgical and medical procedures | ||||||
| Carotid endarterectomy | 1/362 (0.3%) | 1 | 0/360 (0%) | 0 | 0/360 (0%) | 0 |
| Coronary arterial stent insertion | 0/362 (0%) | 0 | 1/360 (0.3%) | 1 | 0/360 (0%) | 0 |
| Eyelid operation | 0/362 (0%) | 0 | 0/360 (0%) | 0 | 1/360 (0.3%) | 1 |
| Vascular disorders | ||||||
| Peripheral arterial occlusive disease | 1/362 (0.3%) | 1 | 0/360 (0%) | 0 | 0/360 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| Semaglutide 0.5mg/Week | Semaglutide 1.0 mg/Week | Insulin Glargine | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 172/362 (47.5%) | 192/360 (53.3%) | 107/360 (29.7%) | |||
| Gastrointestinal disorders | ||||||
| Diarrhoea | 59/362 (16.3%) | 67 | 69/360 (19.2%) | 118 | 16/360 (4.4%) | 18 |
| Dyspepsia | 12/362 (3.3%) | 24 | 24/360 (6.7%) | 39 | 2/360 (0.6%) | 2 |
| Gastrooesophageal reflux disease | 4/362 (1.1%) | 4 | 19/360 (5.3%) | 20 | 3/360 (0.8%) | 4 |
| Nausea | 77/362 (21.3%) | 101 | 80/360 (22.2%) | 117 | 12/360 (3.3%) | 15 |
| Vomiting | 24/362 (6.6%) | 28 | 37/360 (10.3%) | 119 | 10/360 (2.8%) | 12 |
| Infections and infestations | ||||||
| Nasopharyngitis | 45/362 (12.4%) | 58 | 29/360 (8.1%) | 37 | 44/360 (12.2%) | 51 |
| Upper respiratory tract infection | 10/362 (2.8%) | 10 | 14/360 (3.9%) | 16 | 24/360 (6.7%) | 25 |
| Investigations | ||||||
| Lipase increased | 36/362 (9.9%) | 39 | 30/360 (8.3%) | 32 | 15/360 (4.2%) | 17 |
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 25/362 (6.9%) | 34 | 23/360 (6.4%) | 23 | 1/360 (0.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 11/362 (3%) | 11 | 18/360 (5%) | 20 | 7/360 (1.9%) | 10 |
| Nervous system disorders | ||||||
| Headache | 19/362 (5.2%) | 40 | 23/360 (6.4%) | 33 | 20/360 (5.6%) | 26 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator (s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for upto 60 days to protect intellectual property.
Results Point of Contact
| Name/Title | Global Clinical Registry (GCR, 1452) |
|---|---|
| Organization | Novo Nordisk A/S |
| Phone | |
| clinicaltrials@novonordisk.com |
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02128932
Other Study ID Numbers:
- NN9535-3625
- 2013-004392-12
- U1111-1146-0211
- NL47781.018.14
First Posted:
May 1, 2014
Last Update Posted:
Jun 13, 2019
Last Verified:
May 1, 2019