CLINICAL TRIALS
ENROLLING NOW
DIABETES TYPE 1 AND TYPE 2:
Type 1 Diabetes - Insulin Trial (TRIAL: DP-01-2023-01)
- 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*
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: NN4388-4894)
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.
Learn More about the Study
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.
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.
|