A 52-week study comparing the efficacy and safety of once weekly IcoSema and once weekly insulin Icodec, both treatment arms with or without oral anti-diabetic drugs, in participants with type 2 diabetes inadequately controlled with daily basal insulin. COMBINE 1

  • STATUS
    Recruiting
  • End date
    Apr 14, 2023
  • sponsor
    Novo Nordisk
Updated on 29 September 2022

Summary

Objective: To confirm superiority of once weekly IcoSema compared with once weekly insulin Icodec, both treatment arms with or without OADs, in terms of glycaemic control measured by change in HbA1c from baseline after 52 weeks in participants with T2D inadequately controlled with daily basal insulin.

Description

Duration:
Study duration is approximately 59 weeks and consists of:
  • 2 weeks screening period
  • 52 weeks treatment period
  • 5 weeks follow-up period
Compensation:
25 Visits - $50
31 Televisits - $25
Total - $2,025
 
Study Medication:
  • IcoSema- 700 units/mL + 2 mg/mL, subcutaneous, solution for injection, 1.5 mL pre-filled PDS290 pen injector.
  • Insulin icodec- 700 units/mL, subcutaneous, solution for injection, 3 mL pre-filled PDS290 pen-injector

Details
Condition Diabetes Mellitus Types I and II
Clinical Study IdentifierTX307742
SponsorNovo Nordisk
Last Modified on29 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
Male or female
Age above or equal to 18 years at the time of signing informed consent
Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening
HbA1c of 7.0-10.0% (53.0-85.8 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 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 before screening
Metformin
Sulfonylureasa
Meglitinides (glinides)a
DPP-4 inhibitorsa
Sodium-glucose co-transporter 2 inhibitors
Alpha-glucosidase-inhibitors
Thiazolidinediones
Marketed oral combination products only including the products listed above
Body mass index (BMI) ≤ 40.0 kg/m2
Not currently using real time continuous or flash glucose monitoring

Exclusion Criteria

Known or suspected hypersensitivity to randomised treatment or related products
Previous participation in this study. Participation is defined as signed informed consent
Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method, as defined in Appendix 4
Participation (i.e., signed informed consent) in any interventional, clinical study within 90 days before screening
Note: Simultaneous participation in a study 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 in the current study and if simultaneous participation is allowed by local authorities
Any disorder, except for conditions associated with T2D, which in the investigator’s opinion might jeopardize participant’s safety or compliance with the protocol
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
Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
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
Planned coronary, carotid or peripheral artery revascularization
Renal impairment measured as estimated glomerular filtration rate value of < 30 ml/min/1.73 m2 at screening as defined by KDIGO 2012.20
Impaired liver function, defined as alanine aminotransferase ≥ 2.5 times or bilirubin > 1.5 times upper normal limit at screening
Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire question 8.21
Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator
Inadequately treated blood pressure defined as systolic ≥ 180 mmHg or diastolic ≥ 110 mmHg at screening
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, see 8.2.4
Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in-situ carcinomas of the cervix, or in situ prostate cancer) within 5 years before screening
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note