Phase 4
N=426
A Study for Type 2 Diabetic Patients
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT00548808 ↗Enrolled (actual)
426
Serious AEs
7.6%
Results posted
Sep 2010
Primary outcome: Primary: Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c) — -1.91; -1.87 percent (%) glycated hemoglobin — p=0.716
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Insulin lispro low mixture (Drug); Insulin glargine (Drug); Insulin lispro (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c) |
-1.91; -1.87 | 0.716 |
| SECONDARY Change in Hemoglobin A1c (HbA1c) Over Time |
-1.65; -1.76; -1.92; -1.90; -1.91; -1.87 | 0.279 |
| SECONDARY Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time |
10.2; 12.5; 28.2; 32.6; 19.4; 17.5 | 0.465 |
| SECONDARY 7-point Self-monitored Blood Glucose Profiles |
9.92; 10.04; 13.64; 13.70; 10.36; 10.62 | — |
| SECONDARY Change From Baseline in Postprandial Blood Glucose Over Time |
3.32; 3.55; 4.69; 4.56; 5.24; 4.89 | 0.604 |
| SECONDARY Daily Total Insulin Dose (U/Day) at 16, 32, and 48 Weeks |
36.42; 35.87; 50.38; 48.16; 54.97; 54.03 | — |
| SECONDARY Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks |
0.49; 0.49; 0.65; 0.65; 0.71; 0.71 | — |
| SECONDARY Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles |
-0.18; -0.08; -0.09; 0.03; -0.11; -0.06 | 0.162 |
| SECONDARY Safety: Number of Participants With Serious and Non-Serious Adverse Events |
19; 13; 107; 116 | — |
Summary
The purpose of the study is to compare the insulin lispro low mixture (1, 2 or 3 daily injections) with insulin glargine (alone or with 1, 2 or 3 insulin lispro daily injections) on lowering the blood sugar level
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus
- Receiving oral antihyperglycemic medications (including metformin) without insulin injection in the last 90 days
- Hemoglobin A1c (HbA1c) equal to or greater than 7.0% but less than 11.0%
- Willing to receive insulin injection while continuing to take the prestudy oral antihyperglycemic medications
- Able to perform self monitoring of blood glucose
Exclusion Criteria
- Are taking any other glucose-lowering agents other than metformin, sulfonylurea or Thiazolidinedione (Pioglitazone)
- Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks, or for a total of 30 days or more, in the last 24 weeks
- Have a body mass index greater than 35 kg/m2
- History or presence of kidney disease
- Have cardiac disease (Class III or IV)
Data sourced from ClinicalTrials.gov (NCT00548808). 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.