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Current Studies

Type 1 Diabetes Trials:

Study – EFC15178

  • Participant must be 18 years of age inclusive, at the time of signing the informed consent.
  • Type 1 diabetes diagnosed at least 12 months before screening
  • Participants on continuous insulin treatment for at least 12 months prior to screening
  • Participants on a multiple (≥3) daily injection insulin regimen using NovoLog as mealtime insulin and insulin glargine (100 U/mL) as basal insulin for at least 3 months prior to screening
  • HbA1c below 10% (85.79 mmol/mol) (inclusive) at screening
  • Body mass index ≤35 kg/m² at screening.

Study - Mylan 3001

  • 32 Weeks / 5 phone calls / 11 office visits
  • Male and female 18 to 65 years
  • Clinical diagnosis of type 1 diabetes mellitus for at least 6 months prior to screening
  • Stable dose of once daily basal Lantus® or Toujeo® injection and multiple daily bolus NovoLog® injections for at least 3 months at screening.
  • Body mass index (BMI) of 18.5 to 35 kg/m2 at screening (both values inclusive).
  • Stable weight, with no more than 5 kg gain or loss in the 3 months prior to screening (collected by subject interview during medical history).
  • Glycosylated hemoglobin (HbA1c) 6.5-10% at screening. 

Diasome

  • Male or female of age 18 to 65 years, inclusive.
  • If female of child-bearing potential, must agree for the duration of the study. to use adequate contraceptive measures, such as, intra-uterine device [IUD], oral or injectable contraceptives, or barrier method plus spermicide.
  • Has at Screening been diagnosed as T1DM for at least 12 months.
  • Has at Screening C-peptide ≤0.8 ng/mL (single retest allowed).
  • Has at Screening been on treatment with rapid analog insulin for the previous six (6) months.
  • Has at Screening willingness to use continuous glucose monitoring (CGM) technology throughout study.
  • Is, for the duration of the study, willing to use insulin lispro as the only analog bolus insulin and insulin degludec as the only basal insulin.
  • Has at Screening a BMI ≥18.0 kg/m2 and ≤33.0 kg/m2.
  • Has at Screening HbA1c ≥6.5% and ≤8.5%.

ITRO

  • Men or women diagnosed with T1D for at least 1 year prior to screening, and continuously using insulin for at least 1 year
  • Are at least 18 years of age
  • Have HbA1c values ≥6.5% and ≤9.0%.
  • BMI of ≤35.0 kg/m2
  • Currently treated with <100 Units of one of the following rapid-acting analog insulin via CSII for at least the last 30 days prior to screening
    • insulin lispro U-100
    • insulin aspart
    • fast-acting insulin aspart (where approved)
    • insulin glulisine
  • Have been using CSII therapy for a minimum of 6 months prior to screening.
  • Must be using MiniMed 530G or 630G (US), 640G (EU). insulin pump for at least 90 days.

Type 2 Diabetes Trials:

Study – NN4465

  • Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
  • Diagnosed with type 2 diabetes mellitus ≥ 180 days prior to the day of screening.
  • HbA1c of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as assessed by central laboratory.
  • Body mass index (BMI) ≤ 40.0 kg/m2.

Study – EX4473

  • Male or female, age ≥50 years at the time of signing informed consent
  • Diagnosed with type 2 diabetes mellitus
  • HbA1c 6.5% - 10.0% (47 - 86 mmol/mol) (both inclusive)a
  • At least one of the below conditions (a-d):
    • Coronary heart disease
    • Cerebrovascular disease
    • Symptomatic peripheral artery disease (PAD)
    • Chronic kidney disease defined as:
  • eGFR < 60 mL/min/1.73 m2 b

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 < 50 mL/min/1.73 m2 (CKD-EPI) and UACR > 100 and < 5000 mg/g

Study - NN4506

  • Male or female, age ≥18 years at the time of signing informed consent.
  • Diagnosed with type 2 diabetes mellitus ≥ 180 days prior to the day of screening.
  • HbA1c of 8-10% (64−86 mmol/mol) (both inclusive)
  • Stable daily dose(s) for 90 days prior to the day of screening of: any metformin formulations(≥1500 mg or maximum tolerated or effective dose) alone or in combination with sulfonylureas(SU) (≥half of the maximum approved dose according to local label or maximum tolerated or effective dose).

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 – NN4466

  • Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
  • Diagnosed with type 2 diabetes mellitus ≥ 180 days prior to the day of screening.
  • HbA1c of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as assessed by central laboratory.
  • Treated with once daily or twice daily basal insulin analogue (insulin degludec, insulin detemir, insulin glargine U100 or U300, total daily dose of 10-50 U, both inclusive) ≥ 90 days prior to the day of screening.
  • Stable daily dose(s) for 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regime(s):
    • Any metformin formulations ≥ 1500 mg or maximum tolerated or effective dose (as documented in subject's medical records)
    • Free or fixed combination therapy: Metformin as outlined above ± DPP4i ± SGLT2i is allowed:
      • DPP4i (≥ half of the maximum approved dose according to local label or maximum tolerated or effective dose)
      • SGLT2i (≥ half of the maximum approved dose according to local label or maximum tolerated or effective dose) 7. Body mass index (BMI) ≤ 40.0 kg/m2

Study - EFC14875

  • 1 year / 15 office visits / 16 phone visits
  • Type 2 diabetes with HbA1c ≥7% (53 mmol/mol) at Screening
  • Patients either:
    • Age ≥18 years with at least 1 (one) of the major CV risk factor
    • OR
    • In the absence of a major CV risk factor, age ≥55 years with at least 2 (two)of minor CV risk factors

Type 1 or 2 Diabetes Trials:

Study – BI1366.4

  • 6 Weeks / 15 Office Visits / 1 Phone Visits
  • eGFR (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) ≥20 and < 60 mL/min/1.73 m2 at Visit 1 measured by the central laboratory and no planned start of renal replacement therapy during the trial
  • Patients with type 1 or type 2 diabetes mellitus, diagnosed before informed consent and treated with insulin, glucagon-like peptide (GLP) 1 agonists and/or oral antidiabetic medication. Treatment should have been unchanged (investigator’s judgment) within 4 weeks before Visit 1 and until randomisation
  • Glycated Haemoglobin (HbA1c) ≥ 6.5% and < 10.0% at Visit 1 measured by the central laboratory
  • Seated SBP ≥ 110 and ≤ 180 mmHg and DBP ≥ 70 and ≤ 110 mmHg at Visit 1
  • Age at screening ≥ 18 years for male and permanently sterilized female patients and ≥ 45 years for postmenopausal female patients
  • Body Mass Index (BMI) ≥ 18.5 and < 45 kg/m2

Study – CIP318

  • Subject is 2-75 years of age at time of screening
  • A clinical diagnosis of type 1 or type 2 diabetes as determined by investigator, for at least the last 12 months
  • 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 (Phase 1)/20 minutes (Phase 2) during FST
 
Endocrine Research Solutions, Inc.
1475 Holcomb Bridge Road, Suite 129, Roswell, GA 30076
Ph: 678.878.4750 Fx: 678.878.4751