Phase 2
Completed N=135
Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT01194245 ↗
Enrolled (actual)
135
Serious AEs
1.1%
Results posted
Aug 2014
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin A1C (HbA1c) at the End of Each Treatment Period — -0.14; -0.19 percentage of hemoglobin A1C — p=0.2878
Summary
The purpose of the study is to compare Humalog (Insulin lispro)-recombinant human hyaluronidase (rHuPH20) or Novolog (Insulin aspart)-rHuPH20 to Humalog (Insulin lispro) for the treatment of Type 1 Diabetes Mellitus (T1DM) 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 |
-0.14; -0.19 | 0.2878 |
| SECONDARY Mean Daily Insulin Dose |
54.28; 56.05 | — |
| SECONDARY Percentage of Participants Meeting Glucose Targets |
15.0; 8.8; 21.4; 10.6; 69.9; 59.3 | — |
| SECONDARY Rates of Hypoglycemia at the End of Each Treatment Period |
18.96; 19.91; 7.50; 8.05 | — |
| SECONDARY Change From Baseline in Body Weight at the End of Each Treatment Period |
-0.25; 0.10 | — |
| SECONDARY Mean Daily Postprandial Glucose (PPG) Excursions |
18.85; 27.46; -5.63; 7.08; 16.26; 26.25 | — |
Eligibility Criteria
Inclusion Criteria
- Males or females aged ≥18 years
- Type 1 Diabetes Mellitus (T1DM) treated with insulin for ≥12 months
- Body mass index (BMI) 18.0 to 40.0 kilograms per square meter (kg/m^2).
- Hemoglobin A1C (HbA1C) level 6.7% to 8.2%, inclusive
- Fasting C-peptide <0.6 nanograms per milliliter (ng/mL)
- Willingness to use twice daily (BID) insulin glargine 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
- Use of pramlintide within 30 days of Screening
- Use of drugs during the study or within 30 days of Screening (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
- 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 (NCT01194245). 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.