A Study to Compare the Effect of a Double Dose of Two Long-acting Insulin Therapies in Participants With Type 2 Diabetes



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 70
Updated:4/22/2018
Start Date:May 2014
End Date:July 2015

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A Comparison of Pharmacodynamics When Receiving a Double Dose of Insulin Peglispro or Insulin Glargine in Patients With Type 2 Diabetes Mellitus: A Double-Blind, Crossover Design Study

The primary purpose of this study is to compare the effect of a double dose of a study drug
known as insulin peglispro to a double dose of insulin glargine in participants who have type
2 diabetes. Participants will be treated with study insulin daily, in two 4-week study
periods. Each participant will receive insulin peglispro during one treatment period and
insulin glargine during the other treatment period.


Inclusion Criteria:

- Have type 2 diabetes mellitus (T2DM), based on the World Health Organization (WHO)
classification, for ≥1 year.

- Use any type of basal insulin (except degludec), including once-or twice-daily human
insulin neutral protamine Hagedom (NPH), insulin detemir, or insulin glargine.

- Have hemoglobin A1c (HbA1c) levels ≤9.0% according to local laboratory testing at
screening.

- Have body mass index (BMI) ≤40.0 kilograms/square meter (kg/m^2).

- Have been treated with stable doses of insulin for at least 30 days before screening
with:

- Basal insulin with daily doses ±30% of mean during the last 4 weeks.

- Doses of a basal insulin must be between 0.3 unit/kg/day and 1 unit/kg/day.

- If on metformin, thiazolidinediones (TZDs), sodium glucose co-transporter 2 (SGLT-2)
inhibitors, or dipeptidyl peptidase (DPP4) inhibitors, must be on stable doses for the
last 30 days.

Exclusion Criteria:

- Are using prandial, self-mixed, or premixed insulin. Participants using prandial
insulin may be switched to everyday (qd) glargine if investigator judges that the
participant will still meet fasting glucose requirements for randomization.

- Are using insulin pump therapy.

- Have excessive insulin resistance: Defined as >1.0 unit/kg/day as baseline treatment.

- If being treated with sulfonylureas (SUs) before screening, then must have SUs washed
out between screening and randomization.

- Use any of these concomitant medications: morphine, codeine, antidiuretics,
glucagon-like peptide-1 (GLP-1) receptor agonists (for example, exenatide, exenatide
once weekly, lixisenatide or liraglutide), or pramlintide, used concurrently or within
90 days before screening.

- Have hypoglycemia unawareness, defined as confirmed by laboratory test results or by
historical episodes of hypoglycemia <54 mg/dL (3.0 mmol/L) without symptoms.

- Have fasting hypertriglyceridemia >400 mg/dL (>4.5 mmol/L) at screening, as determined
by the local laboratory.

- Have had any episode of severe hypoglycemia (defined by requiring assistance due to
neurologically disabling hypoglycemia) within 6 months before entry into the study.

- Have had 2 or more emergency room visits or hospitalizations due to poor glucose
control in the past 6 months.

- Have had a previous clinically significant episode of ketoacidosis as determined by
the investigator (ketone bodies at fasting and without acidosis is acceptable) in the
past 6 months.

- Have history of renal transplantation, are currently receiving renal dialysis, or have
estimated Glomerular Filtration Rate (eGFR) <60 milliliters/minute.

- Have obvious clinical signs or symptoms of liver disease (excluding nonalcoholic fatty
liver disease), acute or chronic hepatitis, nonalcoholic steatohepatitis, or elevated
liver enzyme measurements.

- Have active or untreated malignancy, have been in remission from clinically
significant malignancy (other than basal cell or squamous cell skin cancer) for less
than 5 years, or are at increased risk for developing cancer or a recurrence of cancer
in the opinion of the investigator.
We found this trial at
2
sites
Chula Vista, California 91911
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