Phase 2
Completed N=132
Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Patients With Type 2 Diabetes Mellitus
Diabetes Mellitus, Type II
Source: ClinicalTrials.gov NCT01194258 ↗
Enrolled (actual)
132
Serious AEs
1.9%
Results posted
Aug 2014
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin A1C (HbA1C) at the End of Each Treatment Period — -0.48; -0.46 percentage of HbA1C — p=0.3876
Summary
The purpose of the study was to compare Humalog (insulin lispro)-recombinant human hyaluronidase PH20 (rHuPH20) or Novolog (insulin aspart)-rHuPH20 to insulin lispro for the treatment of Type 2 diabetes mellitus (T2DM) in basal-bolus therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin A1C (HbA1C) at the End of Each Treatment Period |
-0.48; -0.46 | 0.3876 |
| SECONDARY Mean Daily Insulin Dose as Recorded During 10-Point Glucose Monitoring |
122.99; 127.47 | — |
| SECONDARY Percentage of Participants Meeting Glucose Targets at Least 2/3 of the Time |
13.9; 14.8; 24.3; 17.4; 28.7; 26.1 | — |
| SECONDARY Rates of Hypoglycemia at the End of Each Treatment Period |
7.92; 7.66; 1.99; 1.78 | — |
| SECONDARY Change From Baseline in Body Weight at the End of Each Treatment Period |
3.35; 3.44 | — |
| SECONDARY Mean Daily PPG Excursions |
33.67; 40.38; 16.64; 22.94; 18.47; 27.28 | — |
Eligibility Criteria
Inclusion Criteria
- Males or females ≥18 years
- Type 2 diabetes mellitus (T2DM) treated with insulin ≥12 months and prandial insulin (at least 2 meals per day) for ≥2 months
- Body mass index (BMI) of 23.0 to 45.0 kilograms per meter squared (kg/m^2)
- Glycosylated hemoglobin (HbA1C) level 7.0 to 8.5%, inclusive
- Fasting C-peptide <0.6 nanograms per milliliter (ng/mL)
- Willingness to use insulin glargine twice a day as basal insulin for the duration of the study
- Willingness to avoid use of an insulin infusion pump or unblinded continuous glucose monitoring (CGM) during the study
Exclusion Criteria
- Known or suspected allergy to any component of any of the study drugs
- Exclusive use of pre-mixed insulins
- Use of pramlintide, exenatide, and/or liraglutide within 30 days of screening
- Use of sulfonylureas within two months of screening
- Use of drugs (such as corticosteroids or antimetabolites) that could interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia, during the study or within 30 days of screening
- Recurrent severe hypoglycemia (more than 2 episodes over the last 6 months) or hypoglycemic unawareness, as judged by the investigator
Data sourced from ClinicalTrials.gov (NCT01194258). 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.