A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Insulin Glargine Taken Daily With Insulin Aspart (COMBINE 3)

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05013229
Collaborator
(none)
680
Enrollment
61
Locations
2
Arms
22.4
Anticipated Duration (Months)
11.1
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine taken daily with insulin aspart in people with type 2 diabetes.The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to insulin glargine taken with insulin aspart. Participants will either get IcoSema or insulin glargine taken with insulin aspart. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine and insulin aspart in many countries.

Participants will get IcoSema or insulin glargine together with insulin aspart. Participants must inject IcoSema once a week or inject insulin glargine once daily and insulin aspart 2-4 times a day. Participants will inject the medicines with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach. The study will last for about 1 year and 1 month. Participants will be asked to wear a sensor that measures participants blood sugar level all the time during an 8 week period at the beginning of the study and a 4 week period at the end of the study.

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

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
680 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL Combined With Insulin Aspart, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin. COMBINE 3
Anticipated Study Start Date :
Nov 30, 2021
Anticipated Primary Completion Date :
Sep 13, 2023
Anticipated Study Completion Date :
Oct 13, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: IcoSema

Participants will receive once weekly subcutaneous (s.c) injections of IcoSema during the 52-week treatment period.

Drug: IcoSema
Participants will receive a once weekly subcutanous (s.c.) injection of IcoSema, on the same day every week for 52 weeks.

Active Comparator: Insuling glargine/insulin aspart

Participants will receive subcutaneous (s.c) injections of insulin glargine once daily combined with 2-4 times daily injections of insulin aspart.

Drug: Insulin glargine
Participants will receive a once daily subcutaneous (s.c.) injection of insulin glargine combined with Insulin aspart 2-4 times a day during mealtimes for 52 weeks.

Drug: insulin aspart
Participants will receive a once daily subcutaneous (s.c.) injection of insulin glargine combined with Insulin aspart 2-4 times a day during mealtimes for 52 weeks.

Outcome Measures

Primary Outcome Measures

  1. Change in HbA1c [From baseline week 0 (V2) to week 52 (V54)]

    Percent-points

Secondary Outcome Measures

  1. Change in body weight [From baseline week 0 (V2) to week 52 (V54)]

    Kg

  2. Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) [From week 0 (V52) to week 52 (V54)]

    Number of episodes

  3. Time in range 3.9 - 10.0 mmol/L (70 - 180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 [From week 48 (V50) to week 52 (V54)]

    Percentage of readings

  4. Time spent more than 10.0 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 [From week 48 (V50) to week 52 (V54)]

    Percentage of readings

  5. Time spent less than 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 [From week 48 (V50) to week 52 (V54)]

    Percentage of readings

  6. Change in fasting plasma glucose (FPG) [From baseline week 0 (V2) to week 52 (V54)]

    mmol/L

  7. Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction [From baseline week 0 (V2) to week 52 (V54)]

    Score 0-36. The higher the score the greater the satisfaction with treatment.

  8. Number of severe hypoglycaemic episodes (level 3) [From baseline week 0 (V2) to week 57 (V56)]

    Number of episodes

  9. Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L (54 mg/dL), confirmed by BG meter) [From baseline week 0 (V2) to week 57 (V56)]

    Number of episodes

  10. Weekly insulin dose (total) [From week 50 (V52) to week 52 (V54)]

    Units

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

  • Diagnosed with type 2 diabetes mellitus 180 days or more before screening.

  • HbA1c of 7.0-10.0 percentage (53.- 85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.

  • Treated with once daily or twice-daily basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) 20-80 units/day 90 days or more before screening. Short term bolus insulin treatment for a maximum of 14 days before screening is allowed, as is prior insulin treatment for gestational diabetes. The treatment can be with or without any of the following anti diabetic drugs with stable doses 90 days or more before screening:

  • Metformin

  • Sulfonylureas(a)

  • Meglitinides (glinides)(a)

  • DPP-4 inhibitors(a)

  • Sodium-glucose co-transporter 2 inhibitors

  • Alpha-glucosidase-inhibitors

  • Thiazolidinediones

  • Marketed oral combination products only including the products listed above.

  • Body mass index (BMI) less than or equal to 40.0 kg/m^2.

  1. Sulfonylureas, meglitinides (glinides) and DPP-4 inhibitors must be discontinued at randomisation.
Exclusion Criteria:
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.

  • Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid, hormones, or systemic corticosteroids).

  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.

  • Any episodes of diabetic ketoacidosis within 90 days before screening. As declared by the participant or in the medical records.

  • Presence or history of pancreatitis (acute or chronic) within 180 days before screening.

  • Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening.

  • Chronic heart failure classified as being in New York Heart Association Class IV at screening.

  • Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator.

  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before 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 SiteLos AngelesCaliforniaUnited States90017
2Novo Nordisk Investigational SiteSan DiegoCaliforniaUnited States92111
3Novo Nordisk Investigational SiteDenverColoradoUnited States80209
4Novo Nordisk Investigational SiteFleming IslandFloridaUnited States32003
5Novo Nordisk Investigational SiteJacksonvilleFloridaUnited States32204
6Novo Nordisk Investigational SiteMount DoraFloridaUnited States32757
7Novo Nordisk Investigational SiteOrlandoFloridaUnited States32825
8Novo Nordisk Investigational SitePembroke PinesFloridaUnited States33027
9Novo Nordisk Investigational SiteRoswellGeorgiaUnited States30076
10Novo Nordisk Investigational SiteNampaIdahoUnited States83686-6011
11Novo Nordisk Investigational SiteWest Des MoinesIowaUnited States50265
12Novo Nordisk Investigational SiteLexingtonKentuckyUnited States40503
13Novo Nordisk Investigational SiteBuckleyMichiganUnited States49620
14Novo Nordisk Investigational SiteLas VegasNevadaUnited States89128
15Novo Nordisk Investigational SiteNashuaNew HampshireUnited States03060
16Novo Nordisk Investigational SiteWest SenecaNew YorkUnited States14224
17Novo Nordisk Investigational SiteWilmingtonNorth CarolinaUnited States28401
18Novo Nordisk Investigational SiteCantonOhioUnited States44718
19Novo Nordisk Investigational SiteFranklinOhioUnited States45005
20Novo Nordisk Investigational SiteWadsworthOhioUnited States44281
21Novo Nordisk Investigational SiteSimpsonvilleSouth CarolinaUnited States29681-1538
22Novo Nordisk Investigational SiteBartlettTennesseeUnited States38133
23Novo Nordisk Investigational SiteChattanoogaTennesseeUnited States37411
24Novo Nordisk Investigational SiteMorristownTennesseeUnited States37813
25Novo Nordisk Investigational SiteAmarilloTexasUnited States79106
26Novo Nordisk Investigational SiteDallasTexasUnited States75230
27Novo Nordisk Investigational SiteHoustonTexasUnited States77079
28Novo Nordisk Investigational SiteHurstTexasUnited States76054
29Novo Nordisk Investigational SiteLaredoTexasUnited States78041
30Novo Nordisk Investigational SitePlanoTexasUnited States75075
31Novo Nordisk Investigational SiteSan AntonioTexasUnited States78224
32Novo Nordisk Investigational SiteSchertzTexasUnited States78154
33Novo Nordisk Investigational SiteSaint GeorgeUtahUnited States84790
34Novo Nordisk Investigational SiteRentonWashingtonUnited States98057
35Novo Nordisk Investigational SiteBrnoCzechia656 91
36Novo Nordisk Investigational SiteHradec KraloveCzechia500 05
37Novo Nordisk Investigational SitePlzenCzechia304 60
38Novo Nordisk Investigational SitePrahaCzechia160 00
39Novo Nordisk Investigational SiteLA ROCHE-sur-YON cedex 9France85295
40Novo Nordisk Investigational SiteLe CoudrayFrance28630
41Novo Nordisk Investigational SiteParisFrance75010
42Novo Nordisk Investigational SitePessacFrance33600
43Novo Nordisk Investigational SiteVenissieuxFrance69200
44Novo Nordisk Investigational SiteBudapestHungary1033
45Novo Nordisk Investigational SiteBudapestHungary1088
46Novo Nordisk Investigational SiteBékéscsabaHungary5600
47Novo Nordisk Investigational SitePécsHungary7623
48Novo Nordisk Investigational SiteCatanzaroItaly88100
49Novo Nordisk Investigational SiteAichiJapan468-0009
50Novo Nordisk Investigational SiteIbarakiJapan311-0113
51Novo Nordisk Investigational SiteMito-shi, IbarakiJapan311-4153
52Novo Nordisk Investigational SiteKuala LumpurMalaysia59100
53Novo Nordisk Investigational SiteSungai BulohMalaysia47000
54Novo Nordisk Investigational SiteKoperSloveniaSI-6000
55Novo Nordisk Investigational SiteLjubljanaSlovenia1525
56Novo Nordisk Investigational SiteMurska SobotaSloveniaSI-9000
57Novo Nordisk Investigational SiteNova GoricaSloveniaSI-5290
58Novo Nordisk Investigational SiteBloemfonteinFree StateSouth Africa9301
59Novo Nordisk Investigational SiteLenasiaGautengSouth Africa1827
60Novo Nordisk Investigational SitePretoriaGautengSouth Africa0181
61Novo Nordisk Investigational SiteCape TownWestern CapeSouth Africa7441

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:
NCT05013229
Other Study ID Numbers:
  • NN1535-4593
  • U1111-1260-8295
  • 2020-005309-18
First Posted:
Aug 19, 2021
Last Update Posted:
Nov 23, 2021
Last Verified:
Nov 1, 2021
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 23, 2021