Condition or disease | Intervention/treatment | Phase |
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Diabetes Mellitus, Type 2 | Drug: Insulin icodec Drug: Insulin glargine U100 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 154 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Trial Comparing NNC0148-0287 C (Insulin 287) Versus Insulin Glargine U100, Both in Combination With Metformin, With or Without DPP4 Inhibitors and With or Without SGLT2 Inhibitors, in Basal Insulin Treated Subjects With Type 2 Diabetes Mellitus |
Actual Study Start Date : | May 9, 2019 |
Actual Primary Completion Date : | December 19, 2019 |
Actual Study Completion Date : | January 27, 2020 |
Arm | Intervention/treatment |
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Experimental: Insulin 287 (with 100% loading dose)
Participants will receive insulin 287 injections once weekly (OW). A unit to unit switch approach with an additional 100% loading dose of insulin 287 will be used.
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Drug: Insulin icodec
Participants will receive subcutaneous (s.c.) injections of Insulin 287 OW for 16 weeks.
Other Name: Insulin 287
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Experimental: Insulin 287 (without loading dose)
Participants will receive insulin 287 injections OW. A unit to unit switch approach without loading dose of insulin 287 will be used.
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Drug: Insulin icodec
Participants will receive subcutaneous (s.c.) injections of Insulin 287 OW for 16 weeks.
Other Name: Insulin 287
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Active Comparator: Insulin glargine U100
Participants will receive insulin glargine U100 once daily (OD).
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Drug: Insulin glargine U100
Participants will receive s.c. injections of insulin glargine OD for 16 weeks
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Stable daily dose(s) for 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regime(s):
Exclusion criteria:
United States, California | |
Novo Nordisk Investigational Site | |
Walnut Creek, California, United States, 94598 | |
United States, Georgia | |
Novo Nordisk Investigational Site | |
Roswell, Georgia, United States, 30076 | |
United States, Idaho | |
Novo Nordisk Investigational Site | |
Idaho Falls, Idaho, United States, 83404-7596 | |
United States, Nevada | |
Novo Nordisk Investigational Site | |
Las Vegas, Nevada, United States, 89148 | |
United States, New Hampshire | |
Novo Nordisk Investigational Site | |
Nashua, New Hampshire, United States, 03063 | |
United States, Tennessee | |
Novo Nordisk Investigational Site | |
Chattanooga, Tennessee, United States, 37404 | |
Novo Nordisk Investigational Site | |
Chattanooga, Tennessee, United States, 37411 | |
Novo Nordisk Investigational Site | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
Novo Nordisk Investigational Site | |
Dallas, Texas, United States, 75230 | |
Novo Nordisk Investigational Site | |
Dallas, Texas, United States, 75231 | |
Novo Nordisk Investigational Site | |
Dallas, Texas, United States, 75246 | |
Novo Nordisk Investigational Site | |
Dallas, Texas, United States, 75390-9302 | |
United States, Washington | |
Novo Nordisk Investigational Site | |
Renton, Washington, United States, 98057 | |
Canada, Alberta | |
Novo Nordisk Investigational Site | |
Edmonton, Alberta, Canada, T6G 2E1 | |
Canada, British Columbia | |
Novo Nordisk Investigational Site | |
Surrey, British Columbia, Canada, V3Z 2N6 | |
Novo Nordisk Investigational Site | |
Vancouver, British Columbia, Canada, V5Y 3W2 | |
Canada, Nova Scotia | |
Novo Nordisk Investigational Site | |
Halifax, Nova Scotia, Canada, B3H 2Y9 | |
Canada, Ontario | |
Novo Nordisk Investigational Site | |
Brampton, Ontario, Canada, L6S 0C6 | |
Novo Nordisk Investigational Site | |
Concord, Ontario, Canada, L4K 4M2 | |
Novo Nordisk Investigational Site | |
Etobicoke, Ontario, Canada, M9R 4E1 | |
Novo Nordisk Investigational Site | |
Hamilton, Ontario, Canada, L8M 1K7 | |
Novo Nordisk Investigational Site | |
Markham, Ontario, Canada, L3P 7P2 | |
Novo Nordisk Investigational Site | |
Sarnia, Ontario, Canada, N7T 4X3 | |
Czechia | |
Novo Nordisk Investigational Site | |
Broumov, Czechia, 550 01 | |
Novo Nordisk Investigational Site | |
Holešov, Czechia, 76901 | |
Novo Nordisk Investigational Site | |
Hranice, Czechia, 75301 | |
Novo Nordisk Investigational Site | |
Trutnov, Czechia, 541 01 | |
Germany | |
Novo Nordisk Investigational Site | |
Falkensee, Germany, 14612 | |
Novo Nordisk Investigational Site | |
Hamburg, Germany, 22607 | |
Novo Nordisk Investigational Site | |
Ludwigshafen, Germany, 67059 | |
Novo Nordisk Investigational Site | |
Münster, Germany, 48145 | |
Novo Nordisk Investigational Site | |
Oldenburg I. Holst, Germany, 23758 | |
Novo Nordisk Investigational Site | |
Saint Ingbert-Oberwürzbach, Germany, 66386 | |
Italy | |
Novo Nordisk Investigational Site | |
Bergamo, Italy, 24127 | |
Novo Nordisk Investigational Site | |
Catanzaro, Italy, 88100 | |
Novo Nordisk Investigational Site | |
Milano, Italy, 20122 | |
Novo Nordisk Investigational Site | |
Milano, Italy, 20132 | |
Novo Nordisk Investigational Site | |
Roma, Italy, 00161 |
Study Director: | Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S |
Tracking Information | |||||||
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First Submitted Date ICMJE | April 17, 2019 | ||||||
First Posted Date ICMJE | April 22, 2019 | ||||||
Results First Submitted Date ICMJE | December 11, 2020 | ||||||
Results First Posted Date ICMJE | January 8, 2021 | ||||||
Last Update Posted Date | April 5, 2021 | ||||||
Actual Study Start Date ICMJE | May 9, 2019 | ||||||
Actual Primary Completion Date | December 19, 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Percentage of Time in Target Range 3.9-10.0 mmol/L (70-180 Milligrams Per Deciliter (mg/dL)) Measured Using CGM (Continuous Glucose Monitoring) [ Time Frame: During the last 2 weeks of treatment (week 15 and 16) ] The percentage of time spent in glycaemic target range was calculated as 100 times the number of recorded measurements in glycaemic target range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive divided by the total number of recorded measurements. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication).
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Original Primary Outcome Measures ICMJE |
Time in target range 3.9-10.0 mmol/L (70-180 mg/dL) measured using continuous glucose monitoring (CGM) [ Time Frame: During the last 2 weeks of treatment (week 15 and 16) ] Measured in percent
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | A Research Study in People With Type 2 Diabetes to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine | ||||||
Official Title ICMJE | A Trial Comparing NNC0148-0287 C (Insulin 287) Versus Insulin Glargine U100, Both in Combination With Metformin, With or Without DPP4 Inhibitors and With or Without SGLT2 Inhibitors, in Basal Insulin Treated Subjects With Type 2 Diabetes Mellitus | ||||||
Brief Summary | This study compares insulin 287 (a possible new medicine) to insulin glargine (a medicine doctors can already prescribe) in people with type 2 diabetes. Different ways of switching from the insulin which the participants are already on to insulin 287 are also compared. This is done to find the best way to switch to insulin 287. The participants will either get insulin 287 that they will have to inject once a week or insulin glargine that they will have to inject once a day. Which treatment any participant gets is decided by chance. The study will last for about 5 months (23 weeks). The participants will have 14 clinic visits and 6 phone calls with the study doctor. At 3 of the clinic visits participants will be asked not to eat or drink anything (except for water) in the last 8 hours before the visit. During the study, the doctor will ask the participants to: 1) measure their blood sugar every day with a blood sugar meter using a finger prick; 2) write down different information in a diary daily and return this to their study doctor. 3) wear a medical device (sensor) that measures the participants blood sugar all the time for 18 weeks (about 4 months) during the study. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Diabetes Mellitus, Type 2 | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
154 | ||||||
Original Estimated Enrollment ICMJE |
150 | ||||||
Actual Study Completion Date ICMJE | January 27, 2020 | ||||||
Actual Primary Completion Date | December 19, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion criteria:
Exclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Canada, Czechia, Germany, Italy, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03922750 | ||||||
Other Study ID Numbers ICMJE | NN1436-4466 U1111-1219-5541 ( Other Identifier: World Health Organization (WHO) ) 2018-003407-18 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Novo Nordisk A/S | ||||||
Study Sponsor ICMJE | Novo Nordisk A/S | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Novo Nordisk A/S | ||||||
Verification Date | March 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |