Phase 3
Completed N=374
A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients
Source: ClinicalTrials.gov NCT00666718 ↗Enrolled (actual)
374
Serious AEs
6.2%
Results posted
Mar 2011
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24 — -1.28; -1.18 Percent of Glycosylated Hemoglobin
Summary
This study is designed to look at if a basal bolus regimen of insulin lispro protamine suspension (ILPS) provides the same glycemic control as a basal bolus regimen of insulin glargine (when one basal bolus regimen is injected once daily together with insulin lispro injected 2-3 times daily).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24 |
-1.28; -1.18 | — |
| SECONDARY Change From Baseline in HbA1c at Week 12 and Week 24 |
-0.99; -0.90; -1.29; -1.07 | 0.4580 |
| SECONDARY Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint |
50; 36; 24; 14 | 0.1333 |
| SECONDARY 7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint |
8.26; 8.63; 8.93; 9.19; 8.19; 7.90 | — |
| SECONDARY Glycemic Variability at Endpoint |
0.86; 0.95; 1.56; 1.64; 1.61; 1.51 | 0.5568 |
| SECONDARY Rate Of All Self-reported Hypoglycemic Episodes |
1.38; 0.84; 0.19; 0.15; 1.16; 0.71 | — |
| SECONDARY Percentage of Participants With Self-Reported Hypoglycemic Episodes |
63.6; 56.1; 19.3; 25.7; 61.0; 54.0 | 0.1701 |
| SECONDARY Number of Participants With Adverse Events (AE) |
81; 65; 9; 14 | — |
| SECONDARY Change in Body Weight From Baseline to Week 24 |
1.19; 1.03 | — |
| SECONDARY Total Daily Insulin Dose at Endpoint |
78.05; 80.23 | — |
| SECONDARY Number of Injections of Insulin at Week 24 |
8; 10; 129; 102; 4; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Diabetes Mellitus, Type 2
- Have been receiving metformin and at least one other oral antihyperglycemic medication (sulfonylurea or thiazolidinedione) with insulin for at least 3 months prior to Visit 1 (Screening)
- Hemoglobin A1C (HbA1c) greater than or equal to 7.5% and less than or equal to 11.0%
- Body Mass Index (BMI) greater than or equal to 25 and less than or equal to 45 kg/m^2
- Capable and willing to follow the protocol
- Give written consent
Exclusion Criteria
- Are taking any glucose-lowering agents (other than those listed in the inclusion criteria above)
- Have a history of severe hypoglycemia in the past 6 months
- Are pregnant or may become pregnant
- Women who are breastfeeding
- Have significant cardiac disease
- Have significant renal or liver disease
- Undergoing therapy for a malignancy
- Contraindications to the study medications
- Have an irregular sleep/wake cycle
- Have a serious disease or any condition considered by the investigator to be exclusionary
Data sourced from ClinicalTrials.gov (NCT00666718). 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.