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Current Studies

Type 1 Diabetes Trials:

Study – CEP304 – Pump Trial

  • 6 months with a 6-month continuation / 15 Office Visits / 8 Phone Visits
  • Subject is age 2-80 years at time of screening
  • Subjects who are 2-21 years are determined by the investigator to have the appropriate, requisite support (family, caregiver or social network) to successfully participate in this study
  • Subject must have a minimum daily insulin requirement (Total Daily Dose) of equal to or greater than 8 units/day
  • Subject has been diagnosed with type 1 diabetes for at least three months
  • Subject is willing to wear the system continuously throughout the study for at least 80% of the time. 

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 - 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

Study – NN4383

  • 26 Weeks / 16 Office Visits / 14 Phone Calls
  • 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 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory.
  • 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): a) Any metformin formulations ≥ 1500 mg or maximum tolerated or effective dose (as documented in subject's medical record) b) Any metformin formulations ≥ 1500 mg or maximum tolerated or effective dose (as documented in subject medical record) with DPP4i (≥ half of the maximum approved dose according to local label or maximum tolerated or effective dose (as documented in subject's medical records)
  • 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.
  • Body mass index (BMI) ≤ 40.0 kg/m2 

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