PIONEER PLUS: Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People With Type 2 Diabetes

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04707469
Collaborator
(none)
1,224
Enrollment
179
Locations
3
Arms
25.7
Anticipated Duration (Months)
6.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study compares three doses of once daily semaglutide tablets in people with type 2 diabetes who were previously treated with other oral anti-diabetic medicines. Participants will be initiated on the lowest starting dose of 3 mg and gradually increased until they reach the final trial dose of 14 mg, 25 mg or 50 mg once daily semaglutide tablets. The final three doses will be randomized (i.e., decided by chance). Participants will be administered one tablet per day for 68 weeks. Women cannot take part if they are pregnant, breast-feeding or planning to become pregnant during the study period. Women who can get pregnant will be checked for pregnancy via urine tests. Once daily semaglutide tablets (3 mg, 7 mg and 14 mg) are approved for the treatment of type 2 diabetes in the US, in the EU and in some other countries, under the brand name Rybelsus®.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Oral semaglutide
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1224 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Once-daily Oral Semaglutide 25 mg and 50 mg Compared With 14 mg in Subjects With Type 2 Diabetes
Actual Study Start Date :
Jan 15, 2021
Anticipated Primary Completion Date :
Aug 11, 2022
Anticipated Study Completion Date :
Mar 7, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Oral semaglutide 50 mg

Participants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12), 25 mg (week 13-16) and 50 mg (week 17-68).

Drug: Oral semaglutide
Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 68 weeks.

Experimental: Oral semaglutide 25 mg

Participants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12) and 25 mg (week 13-68).

Drug: Oral semaglutide
Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 68 weeks.

Active Comparator: Oral semaglutide 14 mg

Participants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8) and 14 mg (week 9-68).

Drug: Oral semaglutide
Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 68 weeks.

Outcome Measures

Primary Outcome Measures

  1. Change in glycated haemoglobin (HbA1c) [From baseline (week 0) to week 52]

    %-point

Secondary Outcome Measures

  1. Change in body weight [From baseline (week 0) to week 52]

    kg

  2. Change in fasting plasma glucose (FPG) [From baseline (week 0) to week 52]

    mmol/L

  3. Achievement of HbA1c below 7% (Yes/No) [At week 52]

    Count of participants

  4. Achievement of HbA1c equal to or below 6.5% (Yes/No) [At week 52]

    Count of participants

  5. Relative change in body weight [From baseline (week 0) to week 52]

    Percentage (%)

  6. Change in waist circumference [From baseline (week 0) to week 52]

    cm

  7. Achievement of weight loss equal to or above 5% (Yes/No) [At week 52]

    Count of participants

  8. Achievement of weight loss equal to or above 10% (Yes/No) [At week 52]

    Count of participants

  9. Adverse events [From baseline (week 0) to follow-up visit (week 73)]

    Count of events

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, age above or equal to 18 years at the time of signing informed consent.

  • Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening.

  • HbA1c of 8.0-10.5% (64-91 mmol/mol) (both inclusive).

  • BMI equal to or above 25 kg/m^2

  • Stable daily dose(s) for 90 days prior to the day of screening of any of the following treatment regimens:

  • No more than 3 of the following oral anti-diabetic drugs and at least 1 marked with a *:

  • Metformin (equal to or above1500 mg or maximum tolerated or effective dose).

  • Sulfonylureas (SU) (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose).

  • Sodium/glucose cotransporter 2 (SGLT2) inhibitors (maximum tolerated dose).

  • Dipeptidyl peptidase-4 (DPP-4) inhibitors (maximally indicated dose as per local label).

  • Subjects, on treatment with stable dose of DPP-4 inhibitors at inclusion, must be willing to discontinue DPP-4 inhibitor treatment at randomisation (with no wash-out).

Exclusion Criteria:
  • Treatment with any medication indicated for the treatment of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed.

  • Renal impairment measured as estimated glomerular filtration rate (eGFR) value of below 30 mL/min/1.73 m^2 according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by kidney disease improving global outcomes (KDIGO 2012) classification.

  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Novo Nordisk Investigational SiteBuena ParkCaliforniaUnited States90620
2Novo Nordisk Investigational SiteCanoga ParkCaliforniaUnited States91304
3Novo Nordisk Investigational SiteFresnoCaliforniaUnited States93720
4Novo Nordisk Investigational SiteLa MesaCaliforniaUnited States91942
5Novo Nordisk Investigational SiteLancasterCaliforniaUnited States93534
6Novo Nordisk Investigational SiteLos AlamitosCaliforniaUnited States90720
7Novo Nordisk Investigational SiteLos AngelesCaliforniaUnited States90057
8Novo Nordisk Investigational SitePalm SpringsCaliforniaUnited States92262
9Novo Nordisk Investigational SitePowayCaliforniaUnited States92064
10Novo Nordisk Investigational SiteSpring ValleyCaliforniaUnited States91978
11Novo Nordisk Investigational SiteWalnut CreekCaliforniaUnited States94598
12Novo Nordisk Investigational SiteColorado SpringsColoradoUnited States80906
13Novo Nordisk Investigational SiteWaterburyConnecticutUnited States06708
14Novo Nordisk Investigational SiteJacksonvilleFloridaUnited States32204
15Novo Nordisk Investigational SiteMiami LakesFloridaUnited States33014
16Novo Nordisk Investigational SiteOrmond BeachFloridaUnited States32174-6302
17Novo Nordisk Investigational SiteRoswellGeorgiaUnited States30076
18Novo Nordisk Investigational SiteHonoluluHawaiiUnited States96814
19Novo Nordisk Investigational SiteBlackfootIdahoUnited States83221
20Novo Nordisk Investigational SiteIdaho FallsIdahoUnited States83404-7596
21Novo Nordisk Investigational SiteMeridianIdahoUnited States83646
22Novo Nordisk Investigational SiteChicagoIllinoisUnited States60607
23Novo Nordisk Investigational SiteEvanstonIllinoisUnited States60201-2477
24Novo Nordisk Investigational SiteGillespieIllinoisUnited States62033
25Novo Nordisk Investigational SiteIndianapolisIndianaUnited States46260
26Novo Nordisk Investigational SiteWest Des MoinesIowaUnited States50265
27Novo Nordisk Investigational SiteTopekaKansasUnited States66606
28Novo Nordisk Investigational SiteLexingtonKentuckyUnited States40503
29Novo Nordisk Investigational SiteLouisvilleKentuckyUnited States40213
30Novo Nordisk Investigational SiteBaton RougeLouisianaUnited States70808
31Novo Nordisk Investigational SiteOxon HillMarylandUnited States20745
32Novo Nordisk Investigational SiteBostonMassachusettsUnited States02115-5804
33Novo Nordisk Investigational SiteWalthamMassachusettsUnited States02453
34Novo Nordisk Investigational SiteFlintMichiganUnited States48504
35Novo Nordisk Investigational SiteTroyMichiganUnited States48098
36Novo Nordisk Investigational SiteButteMontanaUnited States59701
37Novo Nordisk Investigational SiteTrentonNew JerseyUnited States08611
38Novo Nordisk Investigational SiteChapel HillNorth CarolinaUnited States27514
39Novo Nordisk Investigational SiteWilmingtonNorth CarolinaUnited States28401
40Novo Nordisk Investigational SiteFargoNorth DakotaUnited States58104
41Novo Nordisk Investigational SiteFranklinOhioUnited States45005
42Novo Nordisk Investigational SiteMasonOhioUnited States45040
43Novo Nordisk Investigational SiteNormanOklahomaUnited States73069
44Novo Nordisk Investigational SiteCorvallisOregonUnited States97330-3737
45Novo Nordisk Investigational SitePittsburghPennsylvaniaUnited States15236
46Novo Nordisk Investigational SiteBristolTennesseeUnited States37620-7352
47Novo Nordisk Investigational SiteChattanoogaTennesseeUnited States37404
48Novo Nordisk Investigational SiteMemphisTennesseeUnited States38119
49Novo Nordisk Investigational SiteArlingtonTexasUnited States76012-4637
50Novo Nordisk Investigational SiteDallasTexasUnited States75230
51Novo Nordisk Investigational SiteDallasTexasUnited States75390-9302
52Novo Nordisk Investigational SiteForneyTexasUnited States75126
53Novo Nordisk Investigational SiteHoustonTexasUnited States77074
54Novo Nordisk Investigational SiteLongviewTexasUnited States75605
55Novo Nordisk Investigational SitePlanoTexasUnited States75093
56Novo Nordisk Investigational SiteSan AntonioTexasUnited States78230
57Novo Nordisk Investigational SiteShavano ParkTexasUnited States78231
58Novo Nordisk Investigational SiteNewport NewsVirginiaUnited States23606
59Novo Nordisk Investigational SiteNorfolkVirginiaUnited States23510-2015
60Novo Nordisk Investigational SiteRichmondVirginiaUnited States23219
61Novo Nordisk Investigational SiteOlympiaWashingtonUnited States98502
62Novo Nordisk Investigational SiteLiverpoolNew South WalesAustralia2170
63Novo Nordisk Investigational SiteHerstonQueenslandAustralia4029
64Novo Nordisk Investigational SiteMiltonQueenslandAustralia4064
65Novo Nordisk Investigational SiteKeswickSouth AustraliaAustralia5035
66Novo Nordisk Investigational SiteOaklands ParkSouth AustraliaAustralia5046
67Novo Nordisk Investigational SiteGeelongAustralia3220
68Novo Nordisk Investigational SiteBlagoevgradBulgaria2700
69Novo Nordisk Investigational SiteLomBulgaria3600
70Novo Nordisk Investigational SitePazardzhikBulgaria4400
71Novo Nordisk Investigational SitePazardzhikBulgaria4401
72Novo Nordisk Investigational SitePlovdivBulgaria4001
73Novo Nordisk Investigational SiteSmolyanBulgaria4700
74Novo Nordisk Investigational SiteSofiaBulgaria1431
75Novo Nordisk Investigational SiteSofiaBulgaria1606
76Novo Nordisk Investigational SiteVarnaBulgaria9010
77Novo Nordisk Investigational SiteVarnaBulgaria9020
78Novo Nordisk Investigational SiteVratsaBulgaria3001
79Novo Nordisk Investigational SiteYambolBulgaria8600
80Novo Nordisk Investigational SiteCalgaryAlbertaCanadaT2H 2G4
81Novo Nordisk Investigational SiteCalgaryAlbertaCanadaT2V 4J2
82Novo Nordisk Investigational SiteMonctonNew BrunswickCanadaE1G 1A7
83Novo Nordisk Investigational SiteBramptonOntarioCanadaL6S 0C6
84Novo Nordisk Investigational SiteConcordOntarioCanadaL4K 4M2
85Novo Nordisk Investigational SiteEtobicokeOntarioCanadaM9R 4E1
86Novo Nordisk Investigational SiteHamiltonOntarioCanadaL8L 5G8
87Novo Nordisk Investigational SiteNepeanOntarioCanadaK2J 0V2
88Novo Nordisk Investigational SiteOakvilleOntarioCanadaL6M 1M1
89Novo Nordisk Investigational SiteStaynerOntarioCanadaL0M 1S0
90Novo Nordisk Investigational SiteStoney CreekOntarioCanadaL8J 0B6
91Novo Nordisk Investigational SiteTorontoOntarioCanadaM4G 3E8
92Novo Nordisk Investigational SiteMontrealQuebecCanadaH4A 3T2
93Novo Nordisk Investigational SiteMontrealQuebecCanadaH4T 1Z9
94Novo Nordisk Investigational SiteBjelovarCroatia43000
95Novo Nordisk Investigational SiteOsijekCroatia31 000
96Novo Nordisk Investigational SiteRijekaCroatia51000
97Novo Nordisk Investigational SiteSlavonski BrodCroatia35 000
98Novo Nordisk Investigational SiteZagrebCroatia10000
99Novo Nordisk Investigational SiteZagrebCroatia10000
100Novo Nordisk Investigational SiteChomutovCzechia430 02
101Novo Nordisk Investigational SiteHolešovCzechia76901
102Novo Nordisk Investigational SitePlzeňCzechia301 00
103Novo Nordisk Investigational SitePrahaCzechia100 00
104Novo Nordisk Investigational SitePrahaCzechia140 21
105Novo Nordisk Investigational SiteTallinnEstonia10617
106Novo Nordisk Investigational SiteTartuEstonia50406
107Novo Nordisk Investigational SiteViljandiEstonia71024
108Novo Nordisk Investigational SiteBerlinGermany10437
109Novo Nordisk Investigational SiteEssenGermany45359
110Novo Nordisk Investigational SiteFalkenseeGermany14612
111Novo Nordisk Investigational SiteHamburgGermany22041
112Novo Nordisk Investigational SiteHamburgGermany22607
113Novo Nordisk Investigational SiteMünsterGermany48145
114Novo Nordisk Investigational SiteOldenburg I. HolstGermany23758
115Novo Nordisk Investigational SiteRehlingen-SiersburgGermany66780
116Novo Nordisk Investigational SiteBudapestHungary1036
117Novo Nordisk Investigational SiteBudapestHungary1106
118Novo Nordisk Investigational SiteDebrecenHungary4043
119Novo Nordisk Investigational SiteDebrecenHungaryH-4032
120Novo Nordisk Investigational SiteKomaromHungary2900
121Novo Nordisk Investigational SitePécsHungary7623
122Novo Nordisk Investigational SiteSzombathelyHungaryH-9700
123Novo Nordisk Investigational SiteSzékesfehérvárHungary8000
124Novo Nordisk Investigational SiteGunturAndhra PradeshIndia522001
125Novo Nordisk Investigational SiteHyderabadAndhra PradeshIndia500034
126Novo Nordisk Investigational SiteSuratGujaratIndia395002
127Novo Nordisk Investigational SiteRohtakHaryanaIndia124001
128Novo Nordisk Investigational SiteKochiKeralaIndia682041
129Novo Nordisk Investigational SiteMumbaiMaharashtraIndia400012
130Novo Nordisk Investigational SiteMumbaiMaharashtraIndia400614
131Novo Nordisk Investigational SitePuneMaharashtraIndia411004
132Novo Nordisk Investigational SitePuneMaharashtraIndia411040
133Novo Nordisk Investigational SiteNew DehliNew DelhiIndia110029
134Novo Nordisk Investigational SiteVelloreTamil NaduIndia632004
135Novo Nordisk Investigational SiteHyderabadTelenganaIndia500003
136Novo Nordisk Investigational SiteHyderabadTelenganaIndia500004
137Novo Nordisk Investigational SiteLucknowUttar PradeshIndia226003
138Novo Nordisk Investigational SiteKolkataWest BengalIndia700020
139Novo Nordisk Investigational SiteKolkataWest BengalIndia700054
140Novo Nordisk Investigational SiteBelgaumIndia590010
141Novo Nordisk Investigational SiteHyderabadIndia500 012
142Novo Nordisk Investigational SiteLudhianaIndia141001
143Novo Nordisk Investigational SiteNew DelhiIndia110088
144Novo Nordisk Investigational SiteBialystokPoland15-276
145Novo Nordisk Investigational SiteBialystokPoland15-351
146Novo Nordisk Investigational SiteBialystokPoland15-404
147Novo Nordisk Investigational SiteBialystokPoland15-435
148Novo Nordisk Investigational SiteBialystokPoland15-481
149Novo Nordisk Investigational SiteElblagPoland82-300
150Novo Nordisk Investigational SiteGdanskPoland80-546
151Novo Nordisk Investigational SiteGorzow WielkopolskiPoland66-400
152Novo Nordisk Investigational SiteKatowicePoland40-752
153Novo Nordisk Investigational SiteKrakowPoland30-688
154Novo Nordisk Investigational SiteLodzPoland90-242
155Novo Nordisk Investigational SiteLublinPoland20-538
156Novo Nordisk Investigational SitePoznanPoland60-589
157Novo Nordisk Investigational SitePoznanPoland61-251
158Novo Nordisk Investigational SiteRadomPoland26-600
159Novo Nordisk Investigational SiteWarsawPoland00-465
160Novo Nordisk Investigational SiteWarszawaPoland02-507
161Novo Nordisk Investigational SiteWroclawPoland52-416
162Novo Nordisk Investigational SiteZabrzePoland41-800
163Novo Nordisk Investigational SiteManatiPuerto Rico00674
164Novo Nordisk Investigational SiteBardejovSlovakia08501
165Novo Nordisk Investigational SiteHnustaSlovakia98101
166Novo Nordisk Investigational SiteKezmarokSlovakia06001
167Novo Nordisk Investigational SiteKralovsky ChlmecSlovakia077 01
168Novo Nordisk Investigational SiteLucenecSlovakia984 01
169Novo Nordisk Investigational SitePresovSlovakia080 01
170Novo Nordisk Investigational SiteRimavska SobotaSlovakia97901
171Novo Nordisk Investigational SiteSabinovSlovakia08301
172Novo Nordisk Investigational SiteSpisska Nova VesSlovakia052 01
173Novo Nordisk Investigational SiteCeljeSloveniaSI-3000
174Novo Nordisk Investigational SiteKoperSloveniaSI-6000
175Novo Nordisk Investigational SiteLjubljanaSloveniaSI-1000
176Novo Nordisk Investigational SiteMariborSloveniaSI-2000
177Novo Nordisk Investigational SiteNova GoricaSloveniaSI-5000
178Novo Nordisk Investigational SiteTaichung CityTaiwan407
179Novo Nordisk Investigational SiteTainan CityTaiwan704

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT04707469
Other Study ID Numbers:
  • NN9924-4635
  • U1111-1247-0210
  • 2020-000299-39
First Posted:
Jan 13, 2021
Last Update Posted:
Nov 29, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 29, 2021