CLINICAL TRIALS

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DIABETES TYPE 1 AND TYPE 2:

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Type 2 Diabetes - Study (CIP341)

  • 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: NN4388-4896)

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 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.

CARDIOVASCULAR DISEASE AND DIABETES

Study – NN4942 Trial

  • 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

Study – EX4758

  • 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:

DIABETIC KIDNEY DISEASE

Type 1 or Type 2 – (INV-CL-106 Trial)

  • 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