Phase 4
Completed N=456
CONSISTENT 1: Metabolic and Safety Outcomes of Hylenex Recombinant (Hyaluronidase Human Injection) Preadministered at CSII Infusion Site in Participants With Type 1 Diabetes Mellitus (T1DM)
Source: ClinicalTrials.gov NCT01848990 ↗Enrolled (actual)
456
Serious AEs
7.5%
Results posted
Oct 2014
Primary outcomePrimary: Change From Baseline to 6 Months in Glycosylated Hemoglobin (HbA1c) — -0.14; -0.18 percentage of HbA1c — p=0.4516
Summary
The primary objectives of this study are to compare the difference in glycosylated hemoglobin (HbA1c) from baseline to Month 6 using Hylenex recombinant preadministration in continuous subcutaneous insulin infusion (CSII) versus standard CSII and to evaluate the safety of Hylenex recombinant preadministration, including local tolerability, adverse events, and hypo- and hyperglycemia rates.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 6 Months in Glycosylated Hemoglobin (HbA1c) |
-0.14; -0.18 | 0.4516 |
| PRIMARY Change From Baseline to 12 Months in HbA1c |
-0.13; -0.26 | 0.0711 |
| SECONDARY Rates of Hypoglycemia Events (HE) to Month 6 |
2.9103; 4.1970; 11.6219; 14.7112; 1.6224; 2.0727 | 0.0105 sig |
| SECONDARY Rates of HEs to Month 12 |
2.6792; 3.3022; 11.3803; 12.3591; 1.6754; 1.9203 | 0.0456 sig |
| SECONDARY Rates of Hyperglycemia Events to Month 6 |
18.0422; 18.4696; 6.4768; 6.8155 | 0.7292 |
| SECONDARY Rates of Hyperglycemia Events to Month 12 |
18.9784; 18.2785; 7.1138; 6.8900 | 0.5414 |
| SECONDARY Mean Glucose Excursions at 6 Months |
17.3; 20.7; 22.2; 17.9; 12.6; 12.5 | 0.5394 |
| SECONDARY Mean Glucose Excursions at 12 Months |
20.1; 24.9; 22.4; 21.0; 12.7; 13.8 | 0.3239 |
| SECONDARY Standard Deviation of Self-Monitoring Blood Glucose Values at 6 Months |
70.9; 72.2 | 0.5260 |
| SECONDARY Standard Deviation of Self-Monitoring Blood Glucose Values at 12 Months |
72.9; 72.4 | 0.8049 |
| SECONDARY Number of Participants Achieving HbA1c <7.0% and HbA1c ≤6.5% at Month 12 |
61; 21; 18; 6 | 0.8955 |
| SECONDARY Change From Baseline in Body Weight to Month 12 |
-0.10; 0.19; -0.11; 0.20; -0.03; 0.48 | 0.7735 |
| SECONDARY Average of Daily Insulin Doses (Bolus, Basal, and Total) |
21.9; 22.9; 28.0; 25.7; 49.9; 48.5 | 0.4948 |
| SECONDARY Average Carbohydrate Factor (CarbF) Values |
11.1; 11.0 | 0.8778 |
| SECONDARY Average Correction Factor (CorrF) Values |
43.2; 45.3 | 0.3233 |
| SECONDARY Average of Bolus Times Relative to Meal Times |
-2.3; -3.9; -1.8; -1.6; -1.7; -1.7 | — |
| SECONDARY Average Glucose, Median Glucose, and Average Daily Standard Deviation |
152.9; 151.9; 145.2; 143.4; 48.9; 49.7 | 0.7708 |
| SECONDARY Time Per Day <56 Milligrams Per Deciliter (mg/dL), ≤70 mg/dL, >70 mg/dL, <140 mg/dL, ≥140 mg/dL, Outside of 71 to 180 mg/dL, and Outside of 71 to 139 mg/dL |
18.1; 20.3; 63.0; 68.5; 1358.8; 1351.9 | 0.6252 |
| SECONDARY Area Per Day <56 mg/dL, ≤70 mg/dL, ≥140 mg/dL, Outside of 71 to 180 mg/dL, and Outside of 71 to 139 mg/dL |
129.7; 163.2; 687.0; 771.7; 42660.2; 42317.2 | 0.4216 |
| SECONDARY Change From Baseline in Weighted Impact ADDQoL Values at Month 12 |
-0.2; 0.0; -0.1; 0.0; -0.4; -0.2 | 0.5246 |
| SECONDARY Change From Baseline in Average Weighted Impact ADDQoL Values at Month 12 |
0.0; 0.0 | 0.9901 |
| SECONDARY Change From Baseline in DTSQs and DTSQc at Month 12 |
0.0; 0.0; 9.4; 9.4 | 0.9081 |
| SECONDARY Mean Time to Change Infusion Site |
5.7; 4.7 | — |
| SECONDARY Mean Additional Time for Hylenex Pre-administration |
2.9; 3.8 | — |
| SECONDARY Number of Participants With the Indicated Responses to the Question Regarding the Difficulty of Infusion Site Change |
143; 49; 130; 46; 3; 1 | — |
| SECONDARY Number of Participants With the Indicated Responses to the Device Handling Questions |
5; 0; 110; 28; 97; 44 | — |
| SECONDARY Mean Times Per Week Participants Said They Were Eating to Avoid Going Low Due to Late Insulin Action |
2.1; 2.5 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female of age 18 years or older with a history of T1DM for at least 12 months
- Glycosylated hemoglobin (HbA1c) 6.5% to 9.5% (inclusive) based on central laboratory results
- Fasting C-peptide 100 millimeters of mercury [mmHg]) are exclusionary
- As judged by the Investigator, clinically significant active disease of the gastrointestinal, cardiovascular (including history of stroke, history of arrhythmia, or conduction delays on electrocardiogram [ECG]), hepatic, neurological, renal, genitourinary, pulmonary, or hematological systems of such severity as to impede the participant's ability to comply with protocol procedures
- History of any illness or disease that in the opinion of the Investigator might confound the results of the study or pose additional risk in administering the study drugs to the participant
- As judged by the Investigator, clinically significant findings in routine laboratory data at screening
- Use of drugs that may interfere with the interpretation of study results or are known to cause clinically relevant interference with hyaluronidase action, insulin action, glucose utilization, or recovery from hypoglycemia (including systemic pharmacologic corticosteroid). Use of pramlintide or a glucagon-like peptide [GLP]-1 receptor agonist is not exclusionary but participants using these agents will be subjected to stratified randomization. Use of aspirin (acetylsalicylic acid [ASA]) up to 325 milligrams (mg)/day is not exclusionary but should be noted for analysis.
- Hypoglycemic unawareness of such severity as to impede the participant's ability to comply with protocol procedures, as judged by the Investigator.
- Current addiction to alcohol or substance abuse as determined by the Investigator.
- Pregnancy, breast-feeding, the intention of becoming pregnant, or not using adequate contraceptive measures (adequate contraceptive measures consist of sterilization, intra-uterine device [IUD], oral or injectable contraceptives, and/or barrier methods). Abstinence alone is not considered an adequate contraceptive measure for the purposes of this study.
- Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation in this study
Data sourced from ClinicalTrials.gov (NCT01848990). 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.