Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus
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| ClinicalTrials.gov Identifier: NCT01194245 |
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Recruitment Status :
Completed
First Posted : September 2, 2010
Results First Posted : August 19, 2014
Last Update Posted : February 26, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Mellitus, Type 1 | Drug: Insulin lispro Drug: recombinant human hyaluronidase PH20 Drug: Insulin aspart Drug: Insulin glulisine Drug: Insulin glargine | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 135 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II, Randomized, Double Blind, 2-Way Crossover Safety and Efficacy Study of Subcutaneously Injected Prandial Insulins: Lispro-PH20 or Aspart-PH20 Compared to Insulin Lispro (Humalog®) in Patients With Type 1 Diabetes |
| Study Start Date : | August 2010 |
| Actual Primary Completion Date : | August 2011 |
| Actual Study Completion Date : | August 2011 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Lispro-PH20 / Insulin Lispro
All enrolled participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually. Next participants were randomly assigned to 1 of 2 study treatments (Treatment A or B) for the first of two, 3-month treatment cycles. Each participant then received the second treatment for the second cycle with no washout period. Lispro-PH20 (Treatment A): 100 U/mL insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine. |
Drug: Insulin lispro
Other Name: Humalog Drug: recombinant human hyaluronidase PH20 Other Names:
Drug: Insulin glulisine Other Name: Apidra Drug: Insulin glargine Other Name: Lantus |
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Experimental: Aspart-PH20 / Insulin Lispro
All enrolled participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually. Next participants were randomly assigned to 1 of 2 study treatments (Treatment A or B) for the first of two, 3-month treatment cycles. Each participant then received the second treatment for the second cycle with no washout period. Aspart-PH20 (Treatment A): 100 U/mL insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine. |
Drug: Insulin lispro
Other Name: Humalog Drug: recombinant human hyaluronidase PH20 Other Names:
Drug: Insulin aspart Drug: Insulin glulisine Other Name: Apidra Drug: Insulin glargine Other Name: Lantus |
- Change From Baseline in Glycosylated Hemoglobin A1C (HbA1c) at the End of Each Treatment Period [ Time Frame: Baseline, Week 12 and Week 24 ]Glycosylated hemoglobin A1C (HBA1c) levels were measured at baseline (Week 0) and at the end of each treatment period (Week 12 and Week 24). Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). Least Squares (LS) means were calculated from mixed effects linear models with treatment (Lispro, Aspart), recombinant human hyaluronidase PH20 (rHuPH20; yes, no), and treatment sequence as fixed effects and participant within treatment sequence as a random effect.
- Mean Daily Insulin Dose [ Time Frame: Week 10 and Week 22 ]Prandial insulin doses were recorded during 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). The mean daily insulin dose over the 3 days during each treatment period is presented. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).
- Percentage of Participants Meeting Glucose Targets [ Time Frame: Baseline through Week 24, excluding 10-point glucose monitoring days ]Participants were instructed to monitor their blood glucose levels a minimum of 4 times per day on all non-10-point glucose monitoring days. The number of participants meeting 90-minute postprandial plasma glucose (PPG) targets of <140 and <180 milligrams per deciliter (mg/dL) for at least 2/3 of values during non-10-point glucose monitoring days was recorded. The percentage was calculated by dividing the number of participants with values meeting the specified target at least 2/3 of the time by the total number of participants analyzed, multiplied by 100. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).
- Rates of Hypoglycemia at the End of Each Treatment Period [ Time Frame: Week 12 and Week 24 ]Overall rates of hypoglycemia (blood glucose ≤70 milligrams per deciliter [mg/dL] and <56 mg/dL) were calculated based on 4 weeks of observation for each treatment period. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
- Change From Baseline in Body Weight at the End of Each Treatment Period [ Time Frame: Baseline, Week 12 and Week 24 ]Body weight was measured at baseline (Week 0) and at the end of each treatment period (Week 12 and Week 24). Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).
- Mean Daily Postprandial Glucose (PPG) Excursions [ Time Frame: Week 10 and Week 22 ]Participants performed 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). Mean daily postprandial plasma glucose (PPG) excursions (referring to the change in blood glucose levels from before to after a meal) during 10-point glucose monitoring for breakfast, lunch, and dinner are presented. Data were collected 1 and 2 hours (hr) after each meal for 3 days and the means of each excursion are presented.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01194245
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| Study Director: | Douglas Muchmore, M.D. | Halozyme Therapeutics |
| Responsible Party: | Halozyme Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01194245 |
| Other Study ID Numbers: |
HALO-117-205 |
| First Posted: | September 2, 2010 Key Record Dates |
| Results First Posted: | August 19, 2014 |
| Last Update Posted: | February 26, 2019 |
| Last Verified: | February 2019 |
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Type 1 diabetes |
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Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Insulin |
Insulin, Globin Zinc Insulin Glargine Insulin Aspart Insulin Lispro Insulin glulisine Hypoglycemic Agents Physiological Effects of Drugs |