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Phase 3 Completed N=68 Randomized Double-blind Treatment

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

Source: ClinicalTrials.gov NCT02132637 ↗
Enrolled (actual)
68
Serious AEs
2.3%
Results posted
Apr 2018
Primary outcomePrimary: Percentage of Participants With Clinically Significant Hypoglycemia — 6.6; 35.5 percentage of participants
◆ Published Evidence
No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants With Clinically Significant Hypoglycemia
6.6; 35.5
SECONDARY
Percentage of Participants With Clinically Significant Hypoglycemia 12 Hours Post Double Dose
1.6; 22.6
SECONDARY
Percentage of Participants With Hypoglycemia
19.7; 64.5; 42.6; 82.3
SECONDARY
Nadir Glucose
61.70; 55.93
SECONDARY
Time to the Nadir Glucose
35.92; 28.15
SECONDARY
Duration of Glucose ≤70 mg/dL
95.28; 362.26
SECONDARY
Fasting Blood Glucose
102.03; 85.61; 100.94; 86.16; 102.18; 86.27
SECONDARY
Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC)
633.50; 568.64; 566.00; 568.20; 564.68; 577.46
SECONDARY
Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC) Excursion
266.33; 270.32; -2.38; 36.92; 134.40; 150.23
SECONDARY
Beta Cell Function
88.65; 103.62

Eligibility Criteria

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 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02132637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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