Phase 3
Completed N=759
A Study in Adults With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01421459 ↗Enrolled (actual)
759
Serious AEs
4.4%
Results posted
Oct 2014
Primary outcomePrimary: Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c) — -1.286; -1.338 percentage of glycosylated hemoglobin — p=0.403
Summary
The main purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus in controlling blood sugar levels in combination with two or more oral diabetes medications.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c) |
-1.286; -1.338 | 0.403 |
| SECONDARY Change From Baseline in Insulin Antibody Levels |
-1.07; -3.25; -1.57; -4.39; -2.61; -3.21 | — |
| SECONDARY Change From Baseline in Hemoglobin A1c (HbA1c) |
-0.452; -0.481; -0.871; -0.866; -1.134; -1.143 | 0.382 |
| SECONDARY 7-Point Self-Monitored Blood Glucose (SMBG) Profiles |
8.82; 8.86; 11.68; 11.80; 9.09; 9.44 | 0.837 |
| SECONDARY Glycemic Variability of Fasting Blood Glucose |
1.18; 1.20; 0.81; 0.79 | 0.779 |
| SECONDARY Change From Baseline in Body Weight |
0.292; 0.526; 0.999; 1.152; 1.271; 1.440 | 0.687 |
| SECONDARY Adult Low Blood Sugar Survey (ALBSS) |
8.41; 8.64; 8.95; 9.36; 7.90; 8.36 | 0.726 |
| SECONDARY Insulin Treatment Satisfaction Questionnaire (ITSQ) |
86.10; 86.12; 83.44; 84.54; 85.62; 85.21 | 0.983 |
| SECONDARY Insulin Dose Per Body Weight (U/kg) Per Day |
0.500; 0.479 | 0.393 |
| SECONDARY Insulin Dose (Units) |
44.465; 41.015 | 0.185 |
| SECONDARY Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5% |
6.2; 7.2; 3.5; 2.4; 16.6; 15.4 | 0.661 |
| SECONDARY Incidence of Hypoglycemic Events |
3564; 3845; 7; 2; 1248; 1386 | 0.594 |
| SECONDARY Rate Per 30 Days of Hypoglycemic Events |
1.75; 1.83; 0.00; 0.00; 0.61; 0.66 | 0.995 |
Eligibility Criteria
Inclusion Criteria
- Have Type 2 Diabetes Mellitus based on the disease diagnostic criteria World Health Organization (WHO) classification
- Have been taking at least 2 types of oral diabetes medications for at least 12 weeks prior to entering the study
- Have a Hemoglobin A1c value greater than or equal to 7.0 percent and less than or equal to 11.0 percent if insulin naive If previously on Lantus, then Hemoglobin A1c must be less than or equal to 11.0 percent
- Have a body mass index of less than or equal to 45 kilogram per meter squared (kg/m^2)
Exclusion Criteria
- Have significant liver, cardiac or gastrointestinal disease
- Have active cancer or have had cancer within the past 5 years (with the exception of basal cell carcinoma or carcinoma in situ)
- Have an excessive resistance to insulin or hypersensitivity to Lantus
- 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 taken any other insulin other than Lantus within the past 30 days
- Taking any other diabetes medicines that are not allowed in the study or not approved to be taken with insulin
Data sourced from ClinicalTrials.gov (NCT01421459). 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.