Phase 4
N=135
A Study of Insulin Lispro Mix in Type 2 Diabetic Asian Patients
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT00971997 ↗Enrolled (actual)
135
Serious AEs
5.2%
Results posted
Apr 2012
Primary outcome: Primary: Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 6.5% at Week 48 Endpoint — 18.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lispro Mix 50/50 (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 6.5% at Week 48 Endpoint |
18.5 | — |
| SECONDARY Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 6.5% at Week 16 and Week 32 Endpoints |
6.7; 20.0 | — |
| SECONDARY Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 7.0% at Week 16, 32 and 48 Endpoints |
22.2; 43.0; 52.6 | — |
| SECONDARY Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Level Below 6.5% and Below 7.0% by Regimen at Week 48 Endpoint |
22.2; 61.9; 11.6; 77.8; 95.2; 51.2 | — |
| SECONDARY Change From Baseline in Hemoglobin A1c (HbA1c) at Week 48 Endpoint |
-1.27 | — |
| SECONDARY Change From Baseline in Fasting Glucose at Week 48 Endpoint |
-19.9 | — |
| SECONDARY Change From Baseline in Blood Glucose Profile at Week 48 Endpoint |
-25.4; -58.6; -40.6; -44.0; -40.0; -55.9 | — |
| SECONDARY Change From Baseline in Fasting C-Peptide at Week 48 to Endpoint |
-0.339 | — |
| SECONDARY Change From Baseline in Fasting Serum Lipids at Week 48 Endpoint |
1.6; 2.44; -0.5 | — |
| SECONDARY Change From Baseline in Body Weight at Week 48 Endpoint |
1.51 | — |
| SECONDARY Total Daily Dose of Insulin at Baseline, Week 16, Week 32 and Week 48 |
4.34; 9.94; 15.92; 19.42 | — |
| SECONDARY Percentage of Participants Developing Hypoglycemia at Any Time From Baseline Through Week 48 |
65.9 | — |
| SECONDARY Number of Hypoglycemia Episodes Participants Experienced at Any Time From Baseline Through Week 48 |
535 | — |
Summary
The purpose is to evaluate the proportion of subjects achieving a Hemoglobin A1c (HbA1c) level below 6.5%, when lispro mix 50/50 is introduced in a stepwise manner from every day (QD) administration to type 2 diabetic patients who have failed to achieve adequate glycemic control on oral antidiabetic drugs (OADs).
Eligibility Criteria
Inclusion Criteria
- Patients diagnosed as having type 2 Diabetes.
- Patients who have not been on insulin treatment within 6 months.
- Patients who have been taking OADs for at least 90 days.
- Patients with an HbA1c level in the range of 7.5% to 11.0%.
- Patients with a Body-Mass Index (BMI) of 35 kg/m² or below.
Exclusion Criteria
- Patients having pre-proliferative or proliferative retinopathy (except for old retinopathy with no need for treatment).
- Patients having or suspected of having malignancy
- Patients having serious complications of the heart, liver, or kidney.
- Patients hypersensitive or allergic to insulin or insulin analog preparations or a history of it.
- Patients receiving systemic steroids.
- Are currently enrolled in a clinical trial of a non-approved drug. Or patients who participated in other clinical trials including post-marketing clinical trials within 90 days prior to informed consent being obtained.
- Patients of child-bearing potential. Breastfeeding patients. Patients with a positive result in a pregnancy test performed for women of child-bearing potential.
Data sourced from ClinicalTrials.gov (NCT00971997). 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.