Phase 3
N=536
A Study in Adults With Type 1 Diabetes
Diabetes Mellitus, Type 1
Bottom Line
View on ClinicalTrials.gov: NCT01421147 ↗Enrolled (actual)
536
Serious AEs
8.2%
Results posted
Oct 2014
Primary outcome: Primary: Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c) — -0.352; -0.460 percentage of glycosylated hemoglobin — p=0.055
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- LY2963016 (Drug); Lantus (Drug); Insulin Lispro (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c) |
-0.352; -0.460 | 0.055 |
| SECONDARY Change From Baseline in Insulin Antibody Levels |
0.30; -0.12; 0.02; -0.38; 0.47; 0.09 | 0.205 |
| SECONDARY Change From Baseline in Hemoglobin A1c (HbA1c) |
-0.369; -0.362; -0.359; -0.472; -0.383; -0.481 | 0.860 |
| SECONDARY 7-Point Self-Monitored Blood Glucose (SMBG) Profiles |
8.37; 8.19; 8.93; 9.41; 7.86; 8.14 | 0.489 |
| SECONDARY Glycemic Variability of Fasting Blood Glucose |
2.51; 2.68; 2.25; 2.29; 2.08; 2.34 | 0.320 |
| SECONDARY Change From Baseline in Body Weight |
0.45; 0.42; 0.59; 0.48; 0.72; 0.55 | 0.823 |
| SECONDARY Adult Low Blood Sugar Survey (ALBSS) |
13.63; 12.99; 12.73; 12.53; 13.19; 13.03 | 0.401 |
| SECONDARY Insulin Treatment Satisfaction Questionnaire (ITSQ) |
74.62; 75.39; 79.32; 78.76; 79.50; 80.44 | 0.681 |
| SECONDARY Insulin Dose Per Body Weight (U/kg) (Total and by Component [Basal and Bolus (Lispro)]) |
0.371; 0.358; 0.352; 0.346; 0.723; 0.704 | 0.235 |
| SECONDARY Insulin Dose - Units [Total and by Component [Basal and Bolus (Lispro)]) |
27.773; 26.049; 26.337; 25.069; 54.118; 51.154 | 0.096 |
| SECONDARY Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% and HbA1c ≤6.5% |
28.8; 19.5; 13.9; 12.0; 37.0; 26.4 | 0.015 sig |
| SECONDARY Incidence of Hypoglycemic Events |
10411; 10976; 19541; 20852; 6; 10 | 0.703 |
| SECONDARY Rate Per 30 Days of Hypoglycemic Events |
7.10; 7.32; 0.00; 0.01; 1.50; 1.51 | 0.717 |
Summary
The purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus when taken once daily in combination with insulin lispro before meals three times a day.
Eligibility Criteria
Inclusion Criteria
- Have type 1 diabetes mellitus based on the disease diagnostic criteria [World Health Organization (WHO) Classification]
- Have duration of diabetes greater than or equal to one year
- Have Hemoglobin A1c (HbA1c) less than or equal to 11.0%
- On basal-bolus insulin therapy for at least 1 year [basal insulin must be once daily (QD) injection of human insulin isophane suspension (NPH), Lantus, or detemir and combined with mealtime injections of human regular insulin, or insulin analog lispro, aspart or glulisine]
- Have a body mass index (BMI) of less than or equal to 35 kilograms/square meter (kg/m²)
Exclusion Criteria
- Have had more than one episode of severe low blood sugar (defined as needing someone else to help because you had very low blood sugar) within the 6 months before entering the study
- Have had more than one episode of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months before entering the study
- Have known hypersensitivity or allergy to any of the study insulins (insulin glargine or insulin lispro) or to excipients of the study insulins
- Have significant renal, cardiac, gastrointestinal or liver disease
- Have active cancer or cancer within the past 5 years
Data sourced from ClinicalTrials.gov (NCT01421147). 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.