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Current Studies

Type 1 Diabetes Trials:

Study – LPS14947

  • Participant must be 18 to 70 years of age.
  • Participants with T1DM.
  • Participants treated with multiple daily injections (MDI) using basal insulin analog once daily and rapid acting insulin analogs for at least one year.
  • HbA1c ≥7% (48 mmol/mol) and ≤ 10% (86 mmol/mol) at screening.

Study – GPHN

  • Have Type 1 Diabetes
  • Are at least 18 years of age and age of majority per local laws and regulations
  • Have a BMI of:
    • ≥30 kg/m2 or
    • ≥27 kg/m2 and previously diagnosed with at least 1 of the following weight-related comorbidities:
      • Hypertension: treated or with systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg
      • Dyslipidemia: treated or with low-density lipoprotein (LDL) ≥160 mg/dL (4.1 mmol/L), or triglycerides ≥150 mg/dL (1.7 mmol/L), or high-density lipoprotein (HDL)
      • Obstructive sleep apnea
      • Cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association [NYHA] Functional Classification Class I-III heart failure)
  • Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight

Type 2 Diabetes Trials:

Study – NN4321

  • Male or female, age ≥ 18 years at the time of signing informed consent.
  • Diagnosed with type 2 diabetes mellitus
  • HbA1c ≤ 10% (≤ 86 mmol/mol)
  • Renal impairment defined either by:
    • serum creatinine-based eGFR ≥ 50 and ≤ 75 mL/min/1.73 m2 (CKD-EPI) and UACR > 300 and < 5000 mg/g
      or
    • serum creatinine-based eGFR ≥ 25 and 100 and < 5000 mg/g

Study – NN4352

  • Male or female, age ≥18 years at the time of signing informed consent.
  • Diagnosed with type 2 diabetes mellitus ≥ 10 years prior to the day of screening.
  • HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive).

Study – NN4478

  • Male or female aged above or equal to 18 years at the time of signing informed consent.
  • Diagnosed with T2D ≥ 180 days prior to the day of screening.
  • HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol) both inclusive at screening confirmed by central laboratory analysis.
  • 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): ≥ 90 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses ≥ 90 days prior to screening:
    • Metformin
    • Sulfonylureas
    • Meglitinides (glinides)
    • DPP-4 inhibitors
    • SGLT2 inhibitors
    • Thiazolidinediones
    • Alpha-glucosidase inhibitors
    • Oral combination products (for the allowed individual oral anti-diabetic drugs)
    • Oral or injectable GLP-1-receptor agonists
  • Body mass index (BMI) ≤ 40.0 kg/m2.

Study – NN4481

  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
  • Male or female.
  • Age above or equal to 18 years at the time of signing informed consent.
  • Diagnosed with T2D ≥ 180 days prior to the day of screening.
  • HbA1c above 7.0% (53 mmol/mol) as measured by central lab.
  • Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
  • Stable daily dose(s) ≥ 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regimen(s):
    • Any metformin formulations ≥ 1500 mg or maximum tolerated or effective dose.
    • Any metformin combination formulations ≥ 1500 mg or maximum tolerated or effective dose.
    • Any of the following non-insulin antidiabetic drug classes including combinations (≥ half of the maximum approved dose according to local label or maximum tolerated or effective dose):
      • Sulfonylureas
      • Meglitinides (glinides)
      • DPP-4 inhibitors
      • SGLT2 inhibitors
      • Thiazolidinediones
      • Alpha-glucosidase inhibitors
      • Oral combination products (for the allowed individual Oral Antidiabetic Drugs (OADs))
      • Oral or injectable GLP-1-receptor agonists
  • Intensification with insulin is indicated to achieve glycaemic target (4.4-7.2 mmol/L, 80-130 mg/dL) at the discretion of the treating investigator.

Type 1 or 2 Diabetes Trials:

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