Phase 4
N=344
Pre-Mix Insulin Lispro Treatment for Type 2 Diabetes Patients Who Consume a Light Breakfast
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT00664534 ↗Enrolled (actual)
344
Serious AEs
2.9%
Results posted
Dec 2011
Primary outcome: Primary: Baseline Adjusted Glycosylated Hemoglobin (HbA1c) at Endpoint — 7.55; 7.40 percent glycosylated hemoglobin
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Insulin Glargine (Drug); Insulin Lispro Premix (mid-mixture and low-mixture) (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Adjusted Glycosylated Hemoglobin (HbA1c) at Endpoint |
7.55; 7.40 | — |
| SECONDARY Percentage of Participants Using Each Possible Final Insulin Regimen |
0; 15; 0; 33; 0; 42 | — |
| SECONDARY HbA1c Over Time |
7.57; 7.62; 7.43; 7.46; 7.40; 7.33 | — |
| SECONDARY Percentage of Patients Achieving HbA1c Less Than or Equal to 6.5% and Less Than or Equal to 7% Over Time |
24.2; 30.3; 14.6; 18.7; 32.1; 37.6 | 0.2127 |
| SECONDARY 7-point Self-monitored Blood Glucose Profiles |
6.94; 7.36; 6.65; 7.20; 6.79; 6.94 | — |
| SECONDARY Mean Postprandial Blood Glucose Values |
6.25; 5.69; 9.69; 9.52; 10.54; 10.81 | 0.6615 |
| SECONDARY Mean Daily Total, Basal and Prandial Insulin Dose |
29.94; 26.94; 40.80; 38.45; 46.45; 46.20 | — |
| SECONDARY Body Weight Change From Baseline to Endpoint |
2.70; 2.61 | — |
| SECONDARY Incidence of All Self-reported Hypoglycemic Episodes |
60.1; 64.5 | 0.4935 |
| SECONDARY Rate Per 30 Days of All Self-reported Hypoglycemic Episodes |
0.67; 0.79 | — |
| SECONDARY Number of Participants With Adverse Events |
3; 7; 53; 52 | — |
Summary
This study is designed to look at how best to start and then gradually intensify (as needed) the insulin lispro premix regimen in type 2 diabetes patients who consume a light breakfast.
Eligibility Criteria
Inclusion Criteria
- Diabetes Mellitus, Type 2
- have been receiving metformin plus at least one other oral antihyperglycemic medication (OAM) (sulfonylurea or Thiazolidinedione [TZD]) without insulin, for at least 90 days prior to Visit 1
- glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than 11.0%
- regularly consume a light breakfast (less than 15% of total daily calorie intake)
- capable and willing to follow the protocol
- give written consent
Exclusion Criteria
- are taking a TZD whose country label does not allow in combination with insulin
- are taking any glucose-lowering agents (other than specified in the inclusion criteria above)
- have a body mass index greater than 40 kg/m^2
- have a history of severe hypoglycemia in past 24 weeks
- 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 study medications
- have an irregular sleep/wake cycle
Data sourced from ClinicalTrials.gov (NCT00664534). 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.