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ONWARDS 5: A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins in People With Type 2 Diabetes Who Have Not Used Insulin Before

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04760626
Collaborator
(none)
1,085
Enrollment
200
Locations
2
Arms
17.5
Anticipated Duration (Months)
5.4
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study compares insulin icodec to different daily insulins in people with type 2 diabetes.

The study will look at how well insulin icodec taken once weekly controls blood sugar compared to the insulins taken once daily. Participants will either get insulin icodec, that participants will have to inject once a week on the same day of the week, or a marketed insulin, that participants will have to inject once a day. Which treatment participants get is decided at random.

The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach.

Participants will measure their blood sugar every day. Participants will get a study phone to record safety data in the electronic diary (eDiary). If participants get a daily insulin they will record their insulin doses in the eDiary. If Participants get weekly insulin icodec, participants study phone will also have the DoseGuide App. The DoseGuide App gives dose recommendations based on their blood sugar and previous doses. Participants will record their insulin doses in the DoseGuide App.

The study will last for about 1 year and 2 months. Participants will have 8 planned clinic visits with the study doctor. More visits will be planned to meet individual needs. At 6 clinic visits participants will have blood samples taken.

Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Condition or Disease Intervention/Treatment Phase
  • Drug: Insulin icodec
  • Drug: Insulin Glargine 100U/mL
  • Drug: Insulin Degludec
  • Drug: Insulin Glargine 300U/mL
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1085 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effectiveness and Safety of Once Weekly Insulin Icodec Used With DoseGuide Versus Once Daily Basal Insulin Analogues in an Insulin naïve Type 2 Diabetes Population in a Clinical Practice Setting
Actual Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Jun 20, 2022
Anticipated Study Completion Date :
Aug 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Insulin icodec with DoseGuide

Participants randomised to insulin icodec will use insulin icodec with the DoseGuide App to guide their titration.

Drug: Insulin icodec
Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 52 weeks.
Active Comparator: Once daily basal insulin analogues

Participants randomised to basal insulin analogue injections once daily

Drug: Insulin Glargine 100U/mL
Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.

Drug: Insulin Degludec
Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.

Drug: Insulin Glargine 300U/mL
Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.

Outcome Measures

Primary Outcome Measures

  1. Change in HbA1c (glycated haemoglobin) [From baseline week 0 (V2) to week 52 (V6)]

    %-point

Secondary Outcome Measures

  1. Time from baseline to treatment discontinuation or intensification [From baseline week 0 (V2) to week 52 (V6)]

    Days

  2. Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire) in total treatment satisfaction [From baseline week 0 (V2) to week 52 (V6)]

    Score of 0-36. 6 items scored on a scale of 0 to 6. The higher the score the greater the satisfaction with treatment.

  3. Trim-D (Treatment Related Impact Measure for Diabetes) compliance domain [At end of treatment week 52 (V6)]

    Score of 4-20. 4 items scored on a scale of 1 to 5 Transformed to a 0-100 scale with higher scores corresponding to better compliance.

  4. Number of severe hypoglycaemic episodes (level 3) [From baseline week 0 (V2) to week 57 (V8)]

    Number of episodes

  5. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) [From baseline week 0 (V2) to week 57 (V8)]

    Number of episodes

  6. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) [From baseline week 0 (V2) to week 57 (V8)]

    Number of episodes

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.

  • Male or female.

  • Age above or equal to 18 years at the time of signing informed consent.

  • Diagnosed with T2D greater than or equal to 180 days prior to the day of screening.

  • HbA1c above 7.0% (53 mmol/mol) as measured by central lab.

  • Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.

  • Stable daily dose(s) greater than or equal to 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regimen(s): a .Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. b .Any metformin combination formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. c. Any of the following non-insulin antidiabetic drug classes including combinations (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose):i). Sulfonylureas ii). Meglitinides (glinides) iii). DPP-4 inhibitors iv. SGLT2 inhibitors v). Thiazolidinediones vi). Alpha-glucosidase inhibitors vii). Oral combination products (for the allowed individual Oral Antidiabetic Drugs (OADs)) viii). Oral or injectable GLP-1-receptor agonists

  • Intensification with insulin is indicated to achieve glycaemic target (4.4-7.2 mmol/L, 80-130 mg/dL) at the discretion of the treating investigator.

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial product(s) or related products.

  • Previous participation in this trial. Participation is defined as signed informed consent.

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).

  • Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening. (Simultaneous participation in a trial with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention or treatment of COVID-19 disease or postinfectious conditions is allowed if the last dose of the investigational medicinal product has been received more than 30 days before screening)

  • Any disorder which in the investigator's opinion might jeopardise subject's safety

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Birmingham Alabama United States 35233
2 Novo Nordisk Investigational Site Guntersville Alabama United States 35967
3 Novo Nordisk Investigational Site Little Rock Arkansas United States 72204
4 Novo Nordisk Investigational Site Buena Park California United States 90620
5 Novo Nordisk Investigational Site Fresno California United States 93720
6 Novo Nordisk Investigational Site Hawthorne California United States 90250
7 Novo Nordisk Investigational Site Huntington Beach California United States 92648
8 Novo Nordisk Investigational Site La Jolla California United States 92037
9 Novo Nordisk Investigational Site Lancaster California United States 93534
10 Novo Nordisk Investigational Site Lomita California United States 90717
11 Novo Nordisk Investigational Site Northridge California United States 91325
12 Novo Nordisk Investigational Site Palm Springs California United States 92262
13 Novo Nordisk Investigational Site Sacramento California United States 95821
14 Novo Nordisk Investigational Site San Diego California United States 92111
15 Novo Nordisk Investigational Site San Ramon California United States 94583
16 Novo Nordisk Investigational Site Spring Valley California United States 91978
17 Novo Nordisk Investigational Site Ventura California United States 93003
18 Novo Nordisk Investigational Site West Hills California United States 91304
19 Novo Nordisk Investigational Site Doral Florida United States 33122
20 Novo Nordisk Investigational Site Jacksonville Florida United States 32216
21 Novo Nordisk Investigational Site Mount Dora Florida United States 32757
22 Novo Nordisk Investigational Site New Port Richey Florida United States 34652
23 Novo Nordisk Investigational Site Orlando Florida United States 32825
24 Novo Nordisk Investigational Site Palm Harbor Florida United States 34684-3609
25 Novo Nordisk Investigational Site Palm Harbor Florida United States 34684
26 Novo Nordisk Investigational Site West Palm Beach Florida United States 33401
27 Novo Nordisk Investigational Site Winter Haven Florida United States 33880
28 Novo Nordisk Investigational Site Atlanta Georgia United States 30318
29 Novo Nordisk Investigational Site Lawrenceville Georgia United States 30046
30 Novo Nordisk Investigational Site Roswell Georgia United States 30076
31 Novo Nordisk Investigational Site Sugar Hill Georgia United States 30518
32 Novo Nordisk Investigational Site Blackfoot Idaho United States 83221
33 Novo Nordisk Investigational Site Chicago Illinois United States 60607
34 Novo Nordisk Investigational Site Springfield Illinois United States 62711
35 Novo Nordisk Investigational Site Avon Indiana United States 46123
36 Novo Nordisk Investigational Site Topeka Kansas United States 66606
37 Novo Nordisk Investigational Site Hyattsville Maryland United States 20782
38 Novo Nordisk Investigational Site Rockville Maryland United States 20852
39 Novo Nordisk Investigational Site Buckley Michigan United States 49620
40 Novo Nordisk Investigational Site Troy Michigan United States 48098
41 Novo Nordisk Investigational Site Jefferson City Missouri United States 65109
42 Novo Nordisk Investigational Site Omaha Nebraska United States 68114
43 Novo Nordisk Investigational Site Omaha Nebraska United States 68198-3020
44 Novo Nordisk Investigational Site Las Vegas Nevada United States 89148
45 Novo Nordisk Investigational Site Nashua New Hampshire United States 03060
46 Novo Nordisk Investigational Site Albuquerque New Mexico United States 87102
47 Novo Nordisk Investigational Site Albany New York United States 12203
48 Novo Nordisk Investigational Site Brooklyn New York United States 11215
49 Novo Nordisk Investigational Site New Windsor New York United States 12533
50 Novo Nordisk Investigational Site Smithtown New York United States 11787
51 Novo Nordisk Investigational Site West Seneca New York United States 14224
52 Novo Nordisk Investigational Site Greenville North Carolina United States 27834
53 Novo Nordisk Investigational Site Raleigh North Carolina United States 27609
54 Novo Nordisk Investigational Site Wilmington North Carolina United States 28401
55 Novo Nordisk Investigational Site Fargo North Dakota United States 58104
56 Novo Nordisk Investigational Site Canton Ohio United States 44718
57 Novo Nordisk Investigational Site Dayton Ohio United States 45439
58 Novo Nordisk Investigational Site Franklin Ohio United States 45005
59 Novo Nordisk Investigational Site Wadsworth Ohio United States 44281
60 Novo Nordisk Investigational Site Murrells Inlet South Carolina United States 29576
61 Novo Nordisk Investigational Site Simpsonville South Carolina United States 29681-1538
62 Novo Nordisk Investigational Site Athens Tennessee United States 37303
63 Novo Nordisk Investigational Site Bartlett Tennessee United States 38133
64 Novo Nordisk Investigational Site Chattanooga Tennessee United States 37404
65 Novo Nordisk Investigational Site Chattanooga Tennessee United States 37411
66 Novo Nordisk Investigational Site Kingsport Tennessee United States 37660
67 Novo Nordisk Investigational Site Morristown Tennessee United States 37813
68 Novo Nordisk Investigational Site Amarillo Texas United States 79106
69 Novo Nordisk Investigational Site Austin Texas United States 78731
70 Novo Nordisk Investigational Site Austin Texas United States 78749
71 Novo Nordisk Investigational Site Dallas Texas United States 75230
72 Novo Nordisk Investigational Site Dallas Texas United States 75390-9302
73 Novo Nordisk Investigational Site Houston Texas United States 77024
74 Novo Nordisk Investigational Site Houston Texas United States 77074
75 Novo Nordisk Investigational Site Hurst Texas United States 76054
76 Novo Nordisk Investigational Site Katy Texas United States 77450
77 Novo Nordisk Investigational Site Lampasas Texas United States 76550
78 Novo Nordisk Investigational Site Laredo Texas United States 78041
79 Novo Nordisk Investigational Site Live Oak Texas United States 78233
80 Novo Nordisk Investigational Site Round Rock Texas United States 78681
81 Novo Nordisk Investigational Site San Antonio Texas United States 78229
82 Novo Nordisk Investigational Site Sugar Land Texas United States 77478
83 Novo Nordisk Investigational Site Bountiful Utah United States 84010
84 Novo Nordisk Investigational Site Ogden Utah United States 84405
85 Novo Nordisk Investigational Site Saint George Utah United States 84790
86 Novo Nordisk Investigational Site Newport News Virginia United States 23606
87 Novo Nordisk Investigational Site Kenosha Wisconsin United States 53144
88 Novo Nordisk Investigational Site Calgary Alberta Canada T2H 2G4
89 Novo Nordisk Investigational Site Vancouver British Columbia Canada V5Y 3W2
90 Novo Nordisk Investigational Site Victoria British Columbia Canada V8V 4A1
91 Novo Nordisk Investigational Site Winnipeg Manitoba Canada R2V 4W3
92 Novo Nordisk Investigational Site Winnipeg Manitoba Canada R3C 0N2
93 Novo Nordisk Investigational Site Moncton New Brunswick Canada E1G 1A7
94 Novo Nordisk Investigational Site Mount Pearl Newfoundland and Labrador Canada A1N 1W7
95 Novo Nordisk Investigational Site St. Johns Newfoundland and Labrador Canada A1B 3V6
96 Novo Nordisk Investigational Site Barrie Ontario Canada L4N 7L3
97 Novo Nordisk Investigational Site Brampton Ontario Canada L6S 0C6
98 Novo Nordisk Investigational Site Concord Ontario Canada L4K 4M2
99 Novo Nordisk Investigational Site Etobicoke Ontario Canada M9R 4E1
100 Novo Nordisk Investigational Site Hamilton Ontario Canada L8L 5G8
101 Novo Nordisk Investigational Site Hamilton Ontario Canada L8M 1K7
102 Novo Nordisk Investigational Site London Ontario Canada N5W 6A2
103 Novo Nordisk Investigational Site London Ontario Canada N6G 2M1
104 Novo Nordisk Investigational Site Mississauga Ontario Canada L4V1P1
105 Novo Nordisk Investigational Site Nepean Ontario Canada K2J 0V2
106 Novo Nordisk Investigational Site Oakville Ontario Canada L6M 1M1
107 Novo Nordisk Investigational Site Oshawa Ontario Canada L1G4T3
108 Novo Nordisk Investigational Site Oshawa Ontario Canada L1J 1T4
109 Novo Nordisk Investigational Site Sarnia Ontario Canada N7T 4X3
110 Novo Nordisk Investigational Site Stoney Creek Ontario Canada L8J 0B6
111 Novo Nordisk Investigational Site Sudbury Ontario Canada P3B 4H5
112 Novo Nordisk Investigational Site Toronto Ontario Canada M4G 3E8
113 Novo Nordisk Investigational Site Toronto Ontario Canada M9V 4B4
114 Novo Nordisk Investigational Site Brossard Quebec Canada J4Z 2K9
115 Novo Nordisk Investigational Site Chicoutimi Quebec Canada G7H 7K9
116 Novo Nordisk Investigational Site Laval Quebec Canada H7T 2P5
117 Novo Nordisk Investigational Site Mirabel Quebec Canada J7J 2K8
118 Novo Nordisk Investigational Site Montreal Quebec Canada H2K 1H2
119 Novo Nordisk Investigational Site Montreal Quebec Canada H4A 3T2
120 Novo Nordisk Investigational Site Montreal Quebec Canada H4T 1Z9
121 Novo Nordisk Investigational Site Saint-Charles-Borromee Quebec Canada J6E 2B4
122 Novo Nordisk Investigational Site St-Marc-des-Carrières Quebec Canada G0A 4B0
123 Novo Nordisk Investigational Site Victoriaville Quebec Canada G6P 6P6
124 Novo Nordisk Investigational Site Quebec Canada G1G 3Y8
125 Novo Nordisk Investigational Site Quebec Canada G1N 4V3
126 Novo Nordisk Investigational Site Quebec Canada G1W 4R4
127 Novo Nordisk Investigational Site Red Deer Canada T4N 6V7
128 Novo Nordisk Investigational Site Bad Mergentheim Germany 97980
129 Novo Nordisk Investigational Site Berlin Germany 13597
130 Novo Nordisk Investigational Site Essen Germany 45136
131 Novo Nordisk Investigational Site Falkensee Germany 14612
132 Novo Nordisk Investigational Site Hamburg Germany 22607
133 Novo Nordisk Investigational Site Hohenmölsen Germany 06679
134 Novo Nordisk Investigational Site Münster Germany 48145
135 Novo Nordisk Investigational Site Münster Germany 48153
136 Novo Nordisk Investigational Site Oldenburg I. Holst Germany 23758
137 Novo Nordisk Investigational Site Rehlingen-Siersburg Germany 66780
138 Novo Nordisk Investigational Site Riesa Germany 01587
139 Novo Nordisk Investigational Site Saint Ingbert-Oberwürzbach Germany 66386
140 Novo Nordisk Investigational Site Stuttgart Germany 70378
141 Novo Nordisk Investigational Site Wangen Germany 88239
142 Novo Nordisk Investigational Site Athens Greece 115 25
143 Novo Nordisk Investigational Site Athens Greece GR-115 27
144 Novo Nordisk Investigational Site Athens Greece GR-11526
145 Novo Nordisk Investigational Site Athens Greece GR-11527
146 Novo Nordisk Investigational Site Athens Greece GR-17562
147 Novo Nordisk Investigational Site Larissa Greece GR-41110
148 Novo Nordisk Investigational Site Thessaloniki Greece GR-54635
149 Novo Nordisk Investigational Site Thessaloniki Greece GR-54636
150 Novo Nordisk Investigational Site Thessaloniki Greece GR-54642
151 Novo Nordisk Investigational Site Thessaloniki Greece GR-54643
152 Novo Nordisk Investigational Site Thessaloniki Greece GR-57001
153 Novo Nordisk Investigational Site Thessaloniki Greece GR-57010
154 Novo Nordisk Investigational Site Budapest Hungary 1032
155 Novo Nordisk Investigational Site Budapest Hungary 1036
156 Novo Nordisk Investigational Site Budapest Hungary 1042
157 Novo Nordisk Investigational Site Budapest Hungary 1089
158 Novo Nordisk Investigational Site Budapest Hungary 1132
159 Novo Nordisk Investigational Site Budapest Hungary 1134
160 Novo Nordisk Investigational Site Budapest Hungary 1152
161 Novo Nordisk Investigational Site Debrecen Hungary 4025
162 Novo Nordisk Investigational Site Kaposvár Hungary 7400
163 Novo Nordisk Investigational Site Komarom Hungary 2900
164 Novo Nordisk Investigational Site Szeged Hungary H-6725
165 Novo Nordisk Investigational Site Szombathely Hungary H-9700
166 Novo Nordisk Investigational Site Zalaegerszeg Hungary 8900
167 Novo Nordisk Investigational Site Gdansk Poland 80-858
168 Novo Nordisk Investigational Site Gdynia Poland 81-338
169 Novo Nordisk Investigational Site Katowice Poland 40-081
170 Novo Nordisk Investigational Site Lodz Poland 90-132
171 Novo Nordisk Investigational Site Lodz Poland 91-473
172 Novo Nordisk Investigational Site Lublin Poland 20-081
173 Novo Nordisk Investigational Site Poznan Poland 60-834
174 Novo Nordisk Investigational Site Pulawy Poland 24-100
175 Novo Nordisk Investigational Site Staszow Poland 28-200
176 Novo Nordisk Investigational Site Swidnik Poland 21-040
177 Novo Nordisk Investigational Site Wroclaw Poland 52-416
178 Novo Nordisk Investigational Site Zabrze Poland 41-800
179 Novo Nordisk Investigational Site Bayamon Puerto Rico 00961
180 Novo Nordisk Investigational Site Manati Puerto Rico 00674
181 Novo Nordisk Investigational Site Belgrade Serbia 11000
182 Novo Nordisk Investigational Site Belgrade Serbia 11080
183 Novo Nordisk Investigational Site Kragujevac Serbia 34000
184 Novo Nordisk Investigational Site Novi Sad Serbia 21000
185 Novo Nordisk Investigational Site Zajecar Serbia 19000
186 Novo Nordisk Investigational Site Adana Turkey 01000
187 Novo Nordisk Investigational Site Adana Turkey 01250
188 Novo Nordisk Investigational Site Ankara Turkey 06100
189 Novo Nordisk Investigational Site Eskisehir Turkey 26040
190 Novo Nordisk Investigational Site Gaziantep Turkey 27070
191 Novo Nordisk Investigational Site Hatay Turkey 31060
192 Novo Nordisk Investigational Site Istanbul Turkey 34303
193 Novo Nordisk Investigational Site Istanbul Turkey 34371
194 Novo Nordisk Investigational Site Istanbul Turkey 34390
195 Novo Nordisk Investigational Site Istanbul Turkey 34718
196 Novo Nordisk Investigational Site Istanbul Turkey 34722
197 Novo Nordisk Investigational Site Istanbul Turkey 34760
198 Novo Nordisk Investigational Site Istanbul Turkey 34899
199 Novo Nordisk Investigational Site Izmir Turkey 35340
200 Novo Nordisk Investigational Site Kayseri Turkey 38039

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:
NCT04760626
Other Study ID Numbers:
  • NN1436-4481
  • U1111-1247-5279
  • 2020-000476-38
First Posted:
Feb 18, 2021
Last Update Posted:
Feb 14, 2022
Last Verified:
Feb 1, 2022
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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin
Insulin, Globin Zinc
Insulin Glargine

Study Results

No Results Posted as of Feb 14, 2022