Phase 4
Completed N=403
Comparison of Insulin Mix25 Versus Mix50
Source: ClinicalTrials.gov NCT01773473 ↗Enrolled (actual)
403
Serious AEs
3.7%
Results posted
May 2015
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 — -1.52; -1.69 percentage of glycosylated hemoglobin
Summary
The purpose of this study is to determine the efficacy and safety of insulin Lispro Mix25 (LM25) compared to insulin Lispro Mix50 (LM50) as an insulin starter in participants with Type 2 diabetes mellitus (T2DM).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 |
-1.52; -1.69 | — |
| SECONDARY Percentage of Participants Achieving HbA1c of <7.0% or ≤6.5% Baseline Through Week 26 |
45.9; 59.7; 26.1; 42.3 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (FBG) at Week 26 |
-2.37; -1.99 | — |
| SECONDARY Change From Baseline in Body Weight at Week 26 |
2.31; 2.32 | — |
| SECONDARY Number of Hypoglycemic Events Baseline Through Week 26 (Incidence) |
568; 583; 0; 1 | — |
| SECONDARY Insulin Dose at Week 26 |
40.02; 39.32 | — |
| SECONDARY Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26 |
4.24; 5.62 | — |
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of Type 2 Diabetes Mellitus (T2DM) for at least 6 months
- Have been taking sulfonylureas, biguanide, thiazolidinedione, alpha-glucosidase inhibitor, glinide, or dipeptidyl peptidase IV inhibitor, or any combination of these
- Have a qualifying hemoglobin A1c (HbA1C) value ≥7.0% and ≤11.0% at screening
- Have a body mass index (BMI) ≥18.5 and <35.0 kilogram per square meter (kg/m²)
- Have given written informed consent to participate in the study in accordance with local regulations and the ethical review board (ERB) governing the study site
Exclusion Criteria
- Have a diagnosis of type 1 diabetes
- Have had more than 1 episode of severe hypoglycemia within the 6 months before screening
- Have any of the following cardiovascular conditions within 3 months prior to screening: acute myocardial infarction, New York Heart Association (NYHA) class III or class IV heart failure, or cerebrovascular accident (stroke)
- Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase levels ≥3.0 times the upper limit of the reference range at screening, as determined by the central laboratory
- Have an estimated creatinine clearance (CrCl), Cockcroft-Gault formula <30 milliliter per minute (mL/min), as determined by the central laboratory at screening
- Have evidence of a significant, active, uncontrolled endocrine or autoimmune abnormality, as judged by the investigator
- Have an active or untreated malignancy or have been in remission from a clinically significant malignancy for <5 years
- Have any other condition (such as, known drug or alcohol abuse or a psychiatric disorder) that may prevent the participants from following and completing the protocol
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Data sourced from ClinicalTrials.gov (NCT01773473). 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.