Trial Search Results

A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs

This trial is conducted in Europe and North America. The aim of the trial is to compare the efficacy and safety of insulin degludec and insulin glargine 300 units/mL in subjects with type 2 diabetes mellitus inadequately treated with basal insulin with or without oral antidiabetic drugs. Due to change in glycaemic data collection process, this trial is amended to allow for a full 36 weeks (maintenance 2 period) of the use of the new process.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Novo Nordisk A/S

Stanford Investigator(s):

Intervention(s):

  • Drug: Insulin degludec
  • Drug: Insulin glargine

Phase:

Phase 3

Eligibility


Inclusion criteria: - Male or female, age above or equal to 18 years at the time of signing
informed consent. - Subjects fulfilling at least one of the below criteria (For this
inclusion criterion the aim is to include minimum 80% of individuals with a previous
episode of hypoglycaemia (criterion e). The remaining subjects will have to fulfil at least
one of criteria a-d.): - a) Experienced at least one severe hypoglycaemic episode within
the last year (according to the ADA definition, April 2013 (An episode requiring assistance
of another person to actively administer carbohydrate, glucagon, or take other corrective
actions. Plasma glucose concentrations may not be available during an event, but
neurological recovery following the return of plasma glucose to normal is considered
sufficient evidence that the event was induced by a low plasma glucose concentration.). -
b) Moderate chronic renal failure, defined as glomerular filtration rate 30 - 59
mL/min/1.73 m^2 per CKD-EPI by central laboratory analysis. - c) Hypoglycaemic symptom
unawareness (History of impaired autonomic responses (tremulousness, sweating,
palpitations, and hunger) during hypoglycaemia). - d) Treated with insulin for more than 5
years. - e) Episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode
with low glucose measurement (equal to or below 70 mg/dL [equal to or below 3.9 mmol/L]))
within the last 12 weeks prior to Visit 1 (screening). - Subjects diagnosed (clinically)
with type 2 diabetes mellitus. - Treated with basal only insulin (once daily or twice-daily
insulin (insulin detemir; insulin glargine 100 U/mL, biosimilar of insulin glargine 100
U/mL or insulin Neutral Protamine Hagedorn)) equal to or above 90 days prior to the day of
screening with or without any of the following anti-diabetic drugs with stable doses for
equal to or above 90 days prior to screening: - a) Metformin - b) Dipeptidyl peptidase -4
inhibitor - c) Sodium-glucose co-transporter 2 inhibitor - d) Alpha-glucosidase-inhibitors
(acarbose) - e) Thiazolidinediones - f) Marketed oral combination products only including
the products listed in criteria 5a-5e - HbA1c equal to or below 9.5% (80 mmol/mol) at
screening by central laboratory analysis. - BMI equal to or below 45 kg/m^2. Exclusion
Criteria: - Treatment with any medication for the indication of diabetes or obesity other
than stated in the inclusion criteria in a period of 90 days before the day of screening

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting