Phase 3
N=339
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT00560417 ↗Enrolled (actual)
339
Serious AEs
4.2%
Results posted
Dec 2010
Primary outcome: Primary: Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF]) — 8.48; 8.47; -1.21; -1.43 percent of glycosylated hemoglobin
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Insulin Lispro Protamine Suspension (Drug); Insulin Glargine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF]) |
8.48; 8.47; -1.21; -1.43 | — |
| SECONDARY Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF) |
6.94; 6.70; 7.00; 6.78 | 0.003 sig |
| SECONDARY Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF) |
8.48; 8.47; -1.25; -1.49; -1.21; -1.43 | 0.003 sig |
| SECONDARY Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5% |
46.9; 50.7; 24.8; 28.7; 54.8; 69.1 | 0.561 |
| SECONDARY 7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF) |
175.41; 180.86; 195.31; 190.84; 165.18; 166.34 | 0.179 |
| SECONDARY Glycemic Variability at Baseline and Endpoint (LOCF) |
41.15; 39.02; 36.78; 30.96 | 0.131 |
| SECONDARY Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe) |
41.8; 43.1; 70.6; 74.9; 30.6; 40.1 | 0.826 |
| SECONDARY Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year) |
14.51; 15.29; 16.27; 18.05; 10.40; 13.20 | 0.628 |
| SECONDARY Actual Body Weight at Baseline and Endpoint (LOCF) |
101.57; 102.62; 101.85; 103.28 | 0.343 |
| SECONDARY Change From Baseline in Body Weight at Endpoint (LOCF) |
0.27; 0.66 | 0.417 |
| SECONDARY Total Daily Insulin Dose at Endpoint (LOCF) |
31.11; 37.93 | <0.001 sig |
Summary
This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in combination with the patient's oral diabetes medications and exenatide, for their ability to control blood sugar in patients with type 2 diabetes.
Eligibility Criteria
Inclusion Criteria
- Must have type 2 diabetes
- Must be at least 18 years of age and less than 75 years of age
- Must be taking exenatide 10 micrograms twice a day (BID) for at least 3 months
- Must be taking one of the following oral diabetes medication regimens for at least 3 months: (1) metformin (2) metformin + sulfonylurea (3) metformin + thiazolidinedione (TZD). Doses must be at or above the following: Metformin--1500 mg/day, Sulfonylurea--1/2 the maximum daily dose according to the product label, TZD--30 mg/day pioglitazone
- Must have a hemoglobin A1C greater than or equal to 7.0% and less than or equal to 10.0%
Exclusion Criteria
- Must not have used insulin on a regular basis during the past 2 years
- Must not have taken any glucose-lowering medications not included in the inclusion criteria in the past 3 months
- Must not have had more than one episode of severe hypoglycemia in the past 6 months
- Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease
- Must not be pregnant or intend to get pregnant during the course of the study
Data sourced from ClinicalTrials.gov (NCT00560417). 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.