CLINICAL TRIALS

ENROLLING NOW

Age 18 to <80 years="" at="" time="" of="" signing="" informed="" consent="" li="">
Clinical diagnosis of Type 1 diabetes
Multiple Daily insulin regimen dosing
Willing to use study-provided insulin lispro as the only bolus insulin and insulin degludec as the only basal insulin during the study.* Degludec will be used once daily in either the morning or the evening, but not both, and will be used at the same time throughout the study.
Screening A1C ≥6.5% and ≤9.0%
BMI ≥18.0 kg/m2 and ≤33.0 kg/m2
Willing to use a CGM device throughout study*

Is age 18 - 80 years at time of screening.
Has a clinical diagnosis of type 2 diabetes for 2 years or more.
Is on multiple daily injection (MDI) regimen (basal/bolus regimen with longacting insulin and rapid-acting analogs), defined as greater than or equal to 2 injections per day for at least 3 months.
Is willing to perform fingerstick blood glucose measurements as needed.
Is willing to wear the system continuously throughout the study.
Has a Glycosylated hemoglobin (HbA1c) of less than 10% (as processed by Central Lab) at time of screening visit.
Is willing to upload data from the study pump, must have Internet access, and a computer system, or compatible smartphone that meets the requirements for uploading the study pump.

Type 2 Diabetes - Oral GLP1 (Trial: GZGQ)

Participants are eligible to be included in the study only if all of the following criteria apply:

Participants must be ≥18 years of age inclusive, or the legal age of consent in the jurisdiction in which the study is taking place at screening.
Have BMI ≥27.0 kg/m2 at Visit 1.
Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
Have a diagnosis of T2D according to the WHO classification or other locally applicable standards, with HbA1c ≥7% (≥53 mmol/mol) to ≤10% (86 mmol/mol) at Visit 1.
Are on stable treatment for T2D for at least 90 days prior to Visit 1, consisting of:
- either diet/exercise alone, or
- up to 3 oral AHMs (excluding DPP-4i or GLP-1 RA).

Type 2 Diabetes - Once Weekly Injectable GLP1 – (Trial: NN4388-4894)

Participants are eligible to be included in the study only if all of the following criteria apply:

Male or female age 18 years or above at the time of signing the informed consent.
Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
Stable daily dose(s) ≥ 180 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without an SGLT2 inhibitor.
HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening.
BMI ≥ 30 kg/m2 at screening. BMI will be calculated in the eCRF based on height and body weight at screening.

Type 2 Diabetes - Once Weekly Injectable GLP1 – (Trial: NN4388-4896)

Participants are eligible to be included in the study only if all of the following criteria apply:

Male or female.
Age 18 years or above at the time of signing the informed consent.
Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
Stable daily dose(s) ≥ 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without an SGLT2 inhibitor.
HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening.
BMI ≥ 25 kg/m2 at screening. BMI will be calculated in the eCRF based on height and body weight at screening.

Type 2 Diabetes - ONCE WEEKLY INSULIN (TRIAL: NN4988 COMBINE 4)

Participants are eligible to be included in the study only if all of the following criteria apply:

Participants must be ≥18 years of age inclusive.
Diagnosed with Type 2 Diabetes for over 6 months
Have been taking one to three different types of oral anti-diabetic drugs for at least 3 months, but whose blood sugar level is not adequately controlled.
Hemoglobin A1c must be ≥ 8.0%

Type 1 or 2 Diabetes Study (CIP322)

Individual is 2-75 years of age at time of enrollment.
Subject has a clinical diagnosis of type 1 or type 2 diabetes for a minimum of 6 months duration as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis.
Subject is using insulin to treat their diabetes.
Subject agrees to comply with the study protocol requirements.
Subject is willing to perform SMBG approximately every 15 minutes /20 minutes during FST.
If subject is participating in YSI FST, subject has adequate venous access as assessed by investigator or appropriate staff.

Male or female
Age above or equal to 55 years at the time of signing informed consent.
Body mass index (BMI) ≥30.0 kg/
Established CVD as evidenced by at least one of the following:
- Intermittent claudication with an Ankle-brachial index (ABI) <0.85 at rest
- Intermittent claudication with a 50% stenosis in a lower extremity peripheral artery documented by X-ray.
- Prior revascularization procedure of a lower extremity peripheral artery
- Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g., trauma or osteomyelitis)

For participants with T2D at screening the following inclusion criteria also apply:

Diagnosed with type 2 diabetes mellitus (T2D) ≥180 days before screening
HbA1c 7%-10% (53-86 mmol/mol) (both inclusive), as measured by central laboratory at screening
Treatment with either:
- Lifestyle intervention alone
- 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), DPP4-inhibitors, thiazolidinediones, or sulphonylureas (SU) as a single agent or in combination according to local label
- Basal insulin alone or in combination with up to two marketed OADs (refer to b. above), all according to local label

eGFR ≥15 and < 60 mL/min/1.73 m2
Serum hs-CRP ≥2 mg/L at screening
Evidence of ASCVD by one or more of the following within the last 5 years from screening:
- Coronary heart disease defined as at least one of the following:
- Cerebrovascular disease defined as at least one of the following:
- Symptomatic peripheral artery disease (PAD) defined as at least one of the following:

Male and female participants >18 years of age.
Able and willing to give informed consent and to comply with scheduled visits and trial procedures.
A diagnosis of DKD due to T1DM or T2DM (diagnosed for >1 year).
On a stable anti-diabetic medication regimen for >4 months prior to randomization with a HbA1c <9.5%
- Participants with T1DM may not be on any glucose-lowering medications beyond insulin.
- Participants with T2DM may be on more than 1 anti-diabetic medication regimen (eg, a sodium-glucose transport protein 2 (SGLT2) inhibitor, insulin, or other anti-diabetic medication regimen).
Participants must be on a stable dose of angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for >4 months prior to randomization and expected to remain stable for the 4-month treatment period.
Participants taking finerenone (not required), on a stable dose for >4 months prior to randomization.
Presence of albuminuria with a UACR >100 mg/g and c. HbA1c should have been performed within the last 4 months prior to randomization.

Endocrine Research Solutions, Inc.
1475 Holcomb Bridge Road, Suite 129, Roswell, GA 30076
Ph: 678.878.4750 Fx: 678.878.4751